Summary & Overview
CPT 0406U: CyPath® Lung Sputum Flow Cytometry Assay
CPT code 0406U designates CyPath® Lung, a proprietary laboratory assay that uses flow cytometry on self‑collected sputum to measure five cellular markers and an algorithmic analysis to estimate lung cancer likelihood. As a PLA code, 0406U applies solely to the single manufacturer/lab test from Precision Pathology Services and bioAffinity Technologies Inc., ensuring specificity in billing and payer review. Nationally, PLA codes like 0406U matter because they represent novel, single‑source diagnostics whose coverage, coding clarity, and reimbursement can affect access to emerging tests.
Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the code’s clinical purpose and service setting, payer coverage considerations, and typical billing context for laboratory diagnostic services. The publication also summarizes benchmarking and policy implications for proprietary diagnostics, highlights common modifier usage where relevant, and situates 0406U within laboratory service lines and coding practice.
This summary is written for a national audience and focuses on code definition, clinical context, payer landscape, and what to expect when billing or reviewing claims for a proprietary lung cancer diagnostic assay.
Billing Code Overview
CPT code 0406U is a Proprietary Laboratory Analyses (PLA) code reported only for the CyPath® Lung test developed by Precision Pathology Services and bioAffinity Technologies Inc. The assay uses flow cytometry to evaluate a self‑collected sputum specimen for levels of five cellular markers associated with lung cancer and applies an algorithmic analysis to report the likelihood that a patient has lung cancer.
Service Type: Laboratory diagnostic assay using flow cytometry with algorithmic interpretation
Typical Site of Service: Clinical laboratory or independent diagnostic testing facility (specimen self‑collected by the patient; analysis performed in a certified lab)
Clinical & Coding Specifications
Clinical Context
A 62-year-old current or former smoker with a 30–pack-year history presents to a primary care clinic with a 2–3 month history of chronic cough and intermittent hemoptysis. Chest radiograph shows a suspicious focal opacity, and the clinician orders noninvasive adjunct testing to stratify lung cancer risk prior to advanced imaging or invasive biopsy. The laboratory test reported with 0406U (CyPath® Lung) is performed on a self-collected sputum specimen. The patient receives a collection kit with instructions, provides a specimen at home or in clinic, and the sample is shipped to the performing laboratory (Precision Pathology Services / bioAffinity Technologies). The laboratory performs flow cytometry to quantify five cell-marker signals and runs an algorithmic analysis to generate a report indicating the probability of lung cancer. Results are returned to the ordering clinician, who integrates the report with imaging and clinical findings to determine need for CT, PET-CT, bronchoscopy, or tissue biopsy.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier — default reporting | Use for standard billing when no special circumstances apply |
26 |