Summary & Overview
CPT 0485U: Caris Assure™ Plasma NGS for Solid Tumor Profiling
CPT code 0485U designates Caris Assure™, a proprietary plasma-based next-generation sequencing (NGS) assay that analyzes cell-free DNA and RNA to detect somatic alterations and biomarkers in solid tumors, including mutations, insertions/deletions, copy number changes, gene fusions, microsatellite instability, and tumor mutational burden. As a PLA code, 0485U is specific to a single manufacturer's test and is used for reporting that unique laboratory service nationally.
Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise national overview of the code's clinical purpose and billing context, payer coverage considerations, and where the test fits within precision oncology workflows. The publication outlines benchmark and coverage topics relevant to PLA codes, summarizes typical sites of service and specimen handling, and highlights clinical implications for tumor profiling and biomarker-driven care.
This summary is written for a national audience and focuses on what CPT code 0485U represents, why it matters for molecular diagnostics and oncology care, and the practical billing and policy contexts stakeholders should consider. Data not available in the input are noted where applicable.
Billing Code Overview
CPT code 0485U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the Caris Assure™ test from Caris MPI Inc. (doing business as Caris Life Sciences®). The test uses next-generation sequencing of cell-free DNA and RNA from blood to identify genetic mutations, insertions/deletions, copy number alterations, gene fusions, microsatellite instability, and tumor mutational burden associated with solid tumors.
Service Type: Clinical laboratory molecular diagnostic (next-generation sequencing of circulating tumor-derived nucleic acids)
Typical Site of Service: Clinical laboratory testing performed on blood samples; specimen collection commonly occurs in outpatient clinics, physician offices, or phlebotomy centers, with analysis conducted in the performing laboratory.
Clinical & Coding Specifications
Clinical Context
A 64-year-old patient with metastatic non-small cell lung cancer (NSCLC) who has progressed after first-line systemic therapy is evaluated for targeted therapy options. The oncologist orders the Caris Assure™ plasma-based next-generation sequencing assay to analyze circulating tumor DNA/RNA (ctDNA/ctRNA) for actionable somatic alterations, gene fusions, copy number changes, microsatellite instability (MSI), and tumor mutational burden (TMB). A peripheral blood draw is performed in the outpatient oncology clinic or an outpatient laboratory; the specimen is sent to the Caris Life Sciences laboratory for analysis using the proprietary assay reported under 0485U. Results inform selection of targeted agents, enrollment in clinical trials, or prognosis discussions. Typical workflow: patient encounter and documentation of clinical indication; informed consent for testing; blood specimen collection (phlebotomy) in outpatient infusion center or laboratory; specimen shipping to vendor; receipt and processing by Caris; report generation and review by the ordering oncologist; integration of results into the treatment plan and prior authorization/billing processes.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Default or no modifier specified | Use when no distinct modifier applies; code-level identifier for PLA codes when payer systems require a modifier field. |
| Increased procedural services | Use when additional, documentable work or complexity in specimen handling or interpretation beyond the usual for the assay is present and supported in the record.