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 | Professional component | Use if billing entity reports only the professional interpretation component separate from technical services |
TC | Technical component | Use when billing only the technical component (laboratory processing and analysis) |
59 | Distinct procedural service (Note: not in provided list) | Data not available in the input. |
52 | Reduced services | Use if testing is partially performed or limited relative to the full assay (rare for PLA assays) |
53 | Discontinued procedure | Use if specimen collection or testing was started but discontinued for clinical reasons |
78 | Return to the operating/procedure room for a related procedure by the same physician (less applicable) | Use only if a related invasive diagnostic procedure was required immediately and reporting rules permit |
80 | Assistant surgeon (less applicable) | Use only if an assistant surgeon is billable for an associated procedure; not typically used for this lab test |
82 | Assistant surgeon when qualified resident not available | Same limited applicability as 80; rarely used for laboratory testing |
QX | CLIA-certified independent laboratory performing specific portion of test under arrangement (Modifier QX indicates CLIA-waived or certified independent lab?) | Use when a qualified laboratory performs the test components under an arrangement requiring reporting with a Q modifier (use only if applicable and supported by payer guidance) |
QY | Laboratory test performed while patient in ambulatory surgical center or other facility under specific billing arrangements | Use when payer requires QY for tests performed under certain contractual arrangements |
AS | Physician assistant, nurse practitioner, or clinical nurse specialist rendering service in physician's absence | Use when such a clinician orders/performs specimen collection under supervisory rules that affect billing attribution |
SH | Diagnostic service with part performed by an unlisted assistant (rare for labs) | Use only if billing rules for a payer require SH for technician assistance; uncommon for PLA assays |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 207Q00000X | Pathology | Clinical laboratory/pathology oversight and interpretation of flow cytometry-based assays |
| 207L00000X | Clinical Laboratory | Laboratory medicine specialists responsible for assay development and reporting |
| 207K00000X | Anatomic Pathology | Pathologists who may review results in context of cytology and tissue diagnosis |
| 363LP0800X | Pulmonology | Ordering clinicians who evaluate patients for suspected lung cancer and integrate results into management |
| 208000000X | Internal Medicine | Primary care providers who order the test for initial evaluation and risk stratification |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
R05 | Cough | Common presenting symptom prompting sputum-based lung cancer risk testing |
R04.2 | Hemoptysis | Symptom that raises concern for pulmonary malignancy and may prompt noninvasive risk stratification |
R91.8 | Other nonspecific abnormal finding of lung field | Radiographic abnormality for which adjunct testing like CyPath® Lung may help risk stratify |
C34.90 | Malignant neoplasm of unspecified part of unspecified bronchus or lung | Used when lung cancer is suspected or eventually confirmed; the assay informs pre-biopsy probability |
Z12.2 | Encounter for screening for malignant neoplasm of respiratory organs | May be used when testing is part of an evaluation in higher-risk screening contexts |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
36415 | Collection of venous blood by venipuncture | Often performed if parallel blood-based testing or ancillary labs are ordered at the same visit |
99000 | Handling and/or conveyance of specimen for transfer from provider to laboratory (non-covered by all payers) | May be used when specimen transport or special handling is billed separately by some facilities |
88342 | Immunohistochemistry, each antibody (if applicable for confirmatory testing) | May be performed subsequently on tissue biopsy if the assay indicates high likelihood of malignancy and tissue is obtained |
32505 | Bronchoscopy with endobronchial biopsy | Invasive diagnostic procedure often performed after positive or high-risk results to obtain tissue for histologic diagnosis |
71260 | CT, thorax, without contrast, with contrast, or high-resolution chest CT (grouped) (use exact code for CT chest) | Cross-sectional imaging commonly performed to localize suspicious lesion after risk stratification by noninvasive testing |