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. |
22 | 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.
52 | Reduced services | Use when testing is partially performed or a limited analysis is completed relative to full assay specifications.
53 | Discontinued procedure | Use when the test specimen collection or processing was started but discontinued for documented clinical reasons.
59 | Distinct procedural service | Use when billing an additional, unrelated technical service for the same patient on the same day (use cautiously with PLA codes).
76 | Repeat procedure by same provider | Use when the same test is repeated on the same date of service by the same provider due to specimen failure or other repeat-indicated reason.
77 | Repeat procedure by another provider | Use when another provider repeats the same test on the same date.
91 | Repeat clinical diagnostic laboratory test | Use when the laboratory repeats the same molecular assay on the same day to confirm results.
LT | Left side | Not typically applicable to plasma-based assays; included for completeness when laterality fields are required by payer systems.
RT | Right side | Not typically applicable to plasma-based assays; included for completeness when laterality fields are required by payer systems.
| Taxonomy Code | Specialty | Notes |
|---|---|---|
207RG0300X | Medical Oncology | Ordering provider specialty commonly requesting comprehensive ctDNA/ctRNA testing for systemic therapy selection. |
2083P0205X | Hematology/Oncology | Combined specialty common for cancer genomic testing and interpretation.
207L00000X | Pathology | Anatomic and clinical pathologists involved in molecular reporting and test result interpretation.
363A00000X | Phlebotomist/Laboratory Technician | Personnel performing specimen collection in outpatient lab or infusion center.
208000000X | Internal Medicine | Internists or hospitalists ordering testing for patients with solid tumors in some settings.
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
C34.90 | Malignant neoplasm of unspecified part of unspecified bronchus or lung | Common primary diagnosis in patients undergoing ctDNA testing to identify actionable mutations for targeted therapy. |
C78.01 | Secondary malignant neoplasm of right lung | Metastatic disease sites prompting systemic molecular profiling via plasma assay when tissue biopsy is unavailable or to assess heterogeneity.
C79.51 | Secondary malignant neoplasm of bone | Frequent metastatic site in solid tumors; molecular profiling may guide systemic treatment decisions.
C50.912 | Malignant neoplasm of unspecified site of right female breast | Breast cancer patients may receive plasma NGS testing for actionable alterations or to monitor resistance mutations.
C18.9 | Malignant neoplasm of colon, unspecified | Colorectal cancer patients may have plasma-based testing for RAS/BRAF and MSI/TMB status when tissue is limited.
C61 | Malignant neoplasm of prostate | Advanced prostate cancer may utilize ctDNA assays to identify actionable genomic alterations or mechanisms of resistance.
Z85.118 | Personal history of malignant neoplasm of other female genital organs | Documented history codes used in surveillance contexts where liquid biopsy is ordered to evaluate recurrence or progression.
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
80048 | Basic metabolic panel | Ancillary laboratory testing often performed at baseline or during systemic therapy alongside genomic testing for comprehensive patient assessment. |
84153 | Prostate specific antigen (PSA) | Tumor marker testing that may be ordered concurrently for certain malignancies as part of staging or surveillance; not specific to ctDNA assay.
86336 | Immunoassay for infectious agents (qualitative/semiquantitative) | Representative of other lab tests that can be ordered same visit; included as common outpatient laboratory service code class.
36415 | Collection of venous blood by venipuncture | Code used for the blood draw performed in the outpatient clinic or laboratory prior to sending the plasma specimen to Caris Life Sciences.
99000 | Handling and/or conveyance of specimen for transfer from the physician's office to a laboratory | Use when specimen handling/shipping costs are billed separately in certain outpatient settings.