Summary & Overview
CPT 0395U: Plasma Microbial DNA and Protein Algorithm for Indeterminate Lung Nodule
CPT code 0395U identifies a Proprietary Laboratory Analyses (PLA) assay—OncobiotaLUNG from Micronoma™—that analyzes plasma microbial DNA and two proteins with an algorithm to stratify risk of malignancy for indeterminate lung nodules. Nationally, PLA codes matter because they represent single-source, manufacturer- or lab-specific diagnostics that can affect coverage decisions, utilization management, and payment policy for precision diagnostics.
Key payers included in this analysis are Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the test’s clinical context, the typical service and site of service, and the core considerations payers use when addressing proprietary molecular diagnostics. The publication outlines benchmarking areas relevant to PLA codes—coverage policy patterns, prior authorization and medical necessity considerations, and coding/reporting clarity—while summarizing how this code fits into existing diagnostic pathways for indeterminate pulmonary nodules.
The content is intended for a national audience and provides practical context for billing staff, laboratory directors, and policy analysts evaluating how CPT code 0395U is positioned within payer policy and diagnostic workflows. Data not available in the input is noted where applicable.
Billing Code Overview
CPT code 0395U is a Proprietary Laboratory Analyses (PLA) code specific to a single commercial test: OncobiotaLUNG from Micronoma™. The assay uses a plasma specimen from a patient with an indeterminate lung nodule to extract and evaluate microbial DNA and two proteins listed in the code, applying an algorithmic analysis to classify the patient as high or low risk for malignancy.
Service type: Laboratory molecular/biomarker diagnostic test (proprietary PLA)
Typical site of service: Clinical laboratory or reference laboratory; specimen collected in an outpatient or ambulatory setting and sent to the performing lab.
Clinical & Coding Specifications
Clinical Context
A 64-year-old current or former smoker undergoes routine chest imaging that identifies an indeterminate solitary pulmonary nodule (SPN) measuring 8–30 mm. The managing pulmonologist or thoracic surgeon evaluates risk factors (age, smoking history, nodule size and morphology) and orders a blood-based proprietary molecular test, OncobiotaLUNG (0395U), performed on a plasma specimen. The test extracts microbial DNA and measures two specified plasma proteins; an algorithm integrates these analytes to generate a categorical risk prediction (high versus low) for lung malignancy.
Workflow:
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The clinician obtains informed consent and collects a peripheral blood draw into the appropriate tube per laboratory instructions.
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The specimen is handled and shipped to Micronoma™ (the proprietary laboratory) under required temperature and chain-of-custody conditions.
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The laboratory performs DNA extraction, targeted microbial sequencing or PCR, and protein assays, runs the proprietary algorithm, and returns a result to the ordering clinician indicating high or low risk for malignancy.
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The clinician integrates the test result with imaging, clinical risk models, and multidisciplinary discussion to determine next steps such as surveillance imaging, PET/CT, percutaneous biopsy, bronchoscopy, or surgical evaluation.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Default/No modifier | Rarely appended; use when no other modifier applies |
22 | Increased procedural services | Use when the testing required substantially greater resources or complexity beyond typical processing and reporting |
26 | Professional component | Use when reporting only the professional interpretation component separate from technical lab processing (rare for PLAs) |
52 | Reduced services | Use if testing was partially performed or limited relative to standard protocol |
53 | Discontinued procedure | Use if the assay could not be completed due to specimen or processing failure and testing was aborted |
62 | Two surgeons | Use when two qualified providers share responsibility for care decisions related to the test and procedure (uncommon) |
78 | Unplanned return to OR | Not typically used; only if related surgical procedures were required emergently after test results |
80 | Assistant at surgery | Not typically applicable; include only if surgical assistant billing is relevant to subsequent procedures |
AS | Physician assistant, nurse practitioner, or clinical nurse specialist services | Use when an advanced practitioner orders or manages the test under their taxonomy and payor rules |
QK | Medical direction of two, three, or four technicians | Apply when a physician directs multiple lab personnel in specialized processing (rare for commercial lab tests) |
QX | Ordering/servicing lab split (CLIA) | Use when there is a split billing arrangement between ordering and performing laboratories |
QY | Ordering/servicing lab split (physician billing) | Use when the physician bills for specimen handling and a separate lab bills for testing (rare) |
TC | Technical component | Use when reporting only the technical laboratory processing component separate from professional interpretation |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
207RP0000X | Pulmonary Disease | Ordering and interpreting clinicians for lung nodule evaluation |
2084P0800X | Thoracic Surgery | Surgical consults for nodule management and decision-making |
363L00000X | Clinical Laboratory | Laboratories and laboratory directors performing specialized molecular assays |
208000000X | Internal Medicine | Primary care physicians managing initial discovery and referral |
207K00000X | Emergency Medicine | Occasional ordering in acute presentation of pulmonary complaints |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
R91.1 | Solitary pulmonary nodule | Primary indication for ordering OncobiotaLUNG to assess malignancy risk |
R91.8 | Other nonspecific abnormal finding of lung field | Used when imaging shows indeterminate pulmonary findings prompting molecular risk assessment |
R91.9 | Abnormality of lung unspecified | General code when specifics of the nodule are not fully characterized at time of testing |
Z03.0 | Encounter for medical observation for suspected malignant neoplasm of respiratory organs | Used when evaluating a suspicious lung nodule with tests including 0395U |
Z12.2 | Encounter for screening for malignant neoplasm of respiratory organs | Applied when screening processes identify a nodule and further risk stratification is performed |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
0395U | OncobiotaLUNG (Micronoma™) — plasma assay extracting microbial DNA and two proteins to algorithmically predict malignancy risk for indeterminate lung nodule | Primary proprietary laboratory analysis used to stratify malignancy risk in patients with indeterminate pulmonary nodules |
0001M | Proprietary laboratory analysis — example other PLA code (placeholder format) | Not applicable to this PLA; Data not available in the input |
71260 | Computed tomography, thorax; with contrast material | Often performed before or after 0395U to characterize nodule morphology and guide management |
78432 | Positron emission tomography (PET), tumor imaging, entire body | Performed when imaging and molecular risk assessment suggest higher malignancy probability |
32405 | Thoracoscopy, diagnostic, with or without biopsy | Performed if tissue diagnosis is required after risk stratification |
32480 | Biopsy, lung or pleura, percutaneous needle | Commonly performed when test results plus imaging indicate need for histologic diagnosis |