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
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