Summary & Overview
CPT 0360U: Nodify CDT® Plasma Autoantibody Risk Score
CPT code 0360U designates a proprietary laboratory test — Nodify CDT® from Biodesix Inc. — that measures seven autoantibodies in plasma and produces an algorithm-derived risk score for the likelihood of lung cancer in patients with incidental lung nodules. As a PLA code, 0360U is assigned to a single manufacturer’s assay and signals specialized, proprietary diagnostics rather than broadly used analyte panels. Nationally, such PLA codes matter because they influence coverage determinations, prior authorization practices, and laboratory billing workflows for precision diagnostics.
Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find an overview of clinical context for use with incidental pulmonary nodules, typical sites of service, and the implications of a PLA designation. The publication also summarizes payer coverage patterns and benchmarking where available, highlights policy updates affecting proprietary laboratory analyses, and explains billing and coding considerations relevant to laboratories and clinician billing staff. The content serves clinicians, laboratory administrators, and payers seeking clarity on clinical intent, service type, and payer coverage landscape for this specific proprietary diagnostic assay.
Billing Code Overview
CPT code 0360U is a Proprietary Laboratory Analyses (PLA) code that applies only to a single laboratory test: Nodify CDT® from Biodesix Inc. The test evaluates a plasma specimen from a patient with an incidental lung nodule to detect seven autoantibodies and applies an algorithmic analysis to report a risk score for the likelihood of lung cancer.
Service type: Laboratory — proprietary plasma-based autoantibody panel with algorithmic risk scoring
Typical site of service: Clinical laboratory or reference lab processing a patient plasma specimen; specimen collection commonly occurs in an outpatient phlebotomy or ambulatory clinic setting.
Clinical & Coding Specifications
Clinical Context
A 64-year-old current or former smoker undergoes a chest CT for screening or evaluation of respiratory symptoms and is found to have an incidental pulmonary nodule (solitary pulmonary nodule). The ordering pulmonologist, thoracic surgeon, or primary care clinician requests the Nodify CDT® test (0360U) to assist risk stratification for malignancy. A single peripheral blood (plasma) specimen is collected in the outpatient clinic or a designated phlebotomy laboratory and sent to the performing laboratory (Biodesix Inc.) under chain-of-custody and specimen-handling protocols specified by the test manufacturer. The laboratory performs autoantibody assay for the seven specified proteins and applies the proprietary algorithm to generate a risk score for the likelihood of lung cancer. Results are reported to the ordering clinician and incorporated into the shared clinical decision-making process for surveillance imaging, PET/CT, percutaneous biopsy, bronchoscopic biopsy, or surgical referral. Typical site of service is outpatient clinic, ambulatory radiology center, or outpatient phlebotomy/laboratory service.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier; standard reporting | Use when no special circumstances apply and the test is billed per usual payor rules. |