CPT 0285U RadTox™ cfDNA Reimbursement

CPT code 0285U designates the RadTox™ cfDNA proprietary laboratory assay from DiaCarta Inc., a plasma-based cell-free DNA test that reports quantitative results in ng/mL to aid monitoring of cancer progression and response to therapy. As a PLA code, 0285U is unique to a single manufacturer's test, which matters for coverage, coding clarity, and laboratory billing nationally because payers and providers must identify the exact proprietary assay when submitting claims.

Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. The publication summarizes payer handling and benchmarks where available, highlights how PLA designation affects coding and documentation, and outlines the clinical context for using a cfDNA plasma assay in oncology monitoring.

Readers will learn the clinical purpose of the test, the service setting and specimen type, typical billing considerations tied to PLA codes, and where to find relevant policy and coverage determinations for major national payers. Data not available in the input will be flagged as such rather than inferred. The focus is national policy and billing practice implications for laboratories, oncology providers, and revenue cycle teams working with proprietary molecular diagnostics.

Billing Code Overview

CPT code 0285U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the RadTox™ cfDNA test from DiaCarta Inc. The test analyzes a plasma specimen for specific cell-free DNA sequences and reports results in ng/mL to support monitoring of disease progression and treatment response in patients undergoing cancer therapy.

Service type: Proprietary laboratory molecular diagnostic test (cfDNA analysis)

Typical site of service: Clinical laboratory or off-site reference lab processing using a blood-derived plasma specimen

Data not available in the input.

Clinical Context

A 62-year-old patient with metastatic non-small cell lung cancer (NSCLC) is undergoing systemic therapy. The oncology team orders the RadTox™ cfDNA test (0285U) to quantify tumor-derived cell-free DNA in plasma, reported in ng/mL, to monitor treatment response and detect molecular progression. A peripheral blood draw is obtained in the outpatient oncology infusion center or clinic; the specimen is sent to DiaCarta Inc. for proprietary laboratory analysis. Results are reviewed by the treating oncologist during follow-up to inform discussions about imaging intervals, potential therapy change, or enrollment in clinical trials. Typical workflow elements include informed consent for blood-based molecular monitoring, phlebotomy by trained staff, specimen handling and shipment per lab instructions, electronic receipt of results in the medical record, and documentation of interpretation and clinical plan by the ordering provider.

Coding Specifications

Modifier	Description	When to Use
`00`	No modifier	Use when no specific modifier applies to the claim for this laboratory test.
`26`	Professional component

Taxonomy Code	Specialty	Notes
`207RC0000X`	Medical Oncology	Oncologists commonly order and interpret cfDNA monitoring tests for cancer management.
`207RH0000X`	Hematology/Oncology	Specialists managing solid-tumor or hematologic malignancies who use molecular monitoring.
`363L00000X`	Clinical Laboratory Director	Laboratory physicians or directors responsible for oversight of specialized molecular assays.
`208000000X`	Internal Medicine	Hospitalists or general internists managing cancer care in some settings and ordering monitoring tests.
`207VP0002X`	Oncology Nursing	Advanced practice providers in oncology who frequently order and coordinate testing workflows.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`C34.90`	Malignant neoplasm of unspecified part of bronchus or lung, unspecified	Common indication for plasma cfDNA monitoring in patients with advanced lung cancer receiving systemic therapy.
`C78.7`	Secondary malignant neoplasm of liver and intrahepatic bile duct	Represents metastatic disease sites where cfDNA monitoring may help detect progression.
`C79.9`	Secondary malignant neoplasm of unspecified site	Used when metastasis location is unspecified; cfDNA monitoring aids in systemic disease assessment.
`C80.1`	Malignant (primary) neoplasm, unspecified	Applied when primary site is not confirmed; cfDNA can provide molecular information to guide management.
`Z85.118`	Personal history of other malignant neoplasm of bronchus and lung	Used in surveillance contexts where cfDNA monitoring assesses for recurrence or minimal residual disease.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`36415`	Collection of venous blood by venipuncture	Performed immediately prior to `0285U` to obtain the plasma specimen for cfDNA analysis.
`G0477`	Specimen handling for transferred clinical laboratory pathology, per calendar month, technical only	May be used by reference labs or facilities for specimen handling and transfer services associated with specialized testing.
`81025`	Urinalysis; non-automated, without microscopy	Ancillary lab test sometimes ordered concurrently for baseline monitoring; not directly related to cfDNA but common in oncology panels.
`88342`	Immunohistochemistry or special stains; interpretation and report	Performed on tissue specimens when correlated molecular tissue testing complements plasma cfDNA results.
`0001U`	Molecular pathology (example PLA)	Other Proprietary Laboratory Analyses codes may be performed alongside or as alternative molecular tests depending on clinical question; these represent similar PLA workflows and billing considerations.

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Summary & Overview

CPT 0285U: RadTox™ cfDNA Plasma Test for Oncology Monitoring