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.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0395UCPTProprietary Laboratory AnalysesOncobiotaLUNGmolecular diagnosticslung noduleplasma assaybiomarker algorithmprecision medicine

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:

The clinician obtains informed consent and collects a peripheral blood draw into the appropriate tube per laboratory instructions.
The specimen is handled and shipped to Micronoma™ (the proprietary laboratory) under required temperature and chain-of-custody conditions.
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.
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

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

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

`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

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