Summary & Overview

CPT 0317U: LungLB® FISH Blood Assay for Indeterminate Lung Nodules

CPT code 0317U designates LungLB®, a proprietary FISH-based blood test from LungLife AI® that evaluates patients with indeterminate pulmonary nodules identified on imaging. As a PLA code, 0317U applies to this single, manufacturer-specific laboratory assay and is used to stratify nodules as benign or malignant by detecting rare target cells with four FISH probes. This clinical application can influence decisions between invasive biopsy and continued noninvasive monitoring, making it relevant for pulmonology, oncology, and diagnostic laboratory services.

Key payers considered in the analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a national overview of the code’s clinical context, typical site of service, and the role of the assay in care pathways for indeterminate lung nodules. The publication also covers payer coverage landscape and benchmark considerations where available, policy and coding guidance updates affecting proprietary laboratory analyses, and implications for lab service lines and hospital outpatient departments. Data not available in the input are noted explicitly where applicable.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0317UCPTProprietary Laboratory AnalysesLungLBFISHmolecular diagnosticslung nodulelaboratory testdiagnostic oncology

Billing Code Overview

CPT code 0317U is a Proprietary Laboratory Analyses (PLA) code assigned specifically to LungLB® from LungLife AI®. The test evaluates a peripheral blood specimen from a patient with an indeterminate lung nodule identified by imaging. Using four fluorescence in situ hybridization (FISH) probes to detect rare target cells associated with lung cancer, the assay stratifies nodules as likely benign or likely cancerous to aid clinician decision-making for biopsy versus noninvasive monitoring.

Service type: Laboratory molecular diagnostic test (proprietary FISH-based blood assay)
Typical site of service: Clinical laboratory or reference laboratory; specimen collection commonly occurs in an outpatient clinic, phlebotomy center, or hospital outpatient setting.

Data not available in the input for associated taxonomies, ICD-10 diagnoses, and related codes.

Clinical & Coding Specifications

Clinical Context

A 66-year-old current or former smoker undergoes chest CT for respiratory symptoms or lung cancer screening and is found to have a 6–20 mm indeterminate pulmonary nodule. The referring pulmonologist or thoracic surgeon orders 0317U (LungLB® from LungLife AI®) on a peripheral blood specimen to aid risk stratification of malignancy when imaging alone is inconclusive and when the clinician is weighing invasive biopsy versus radiologic surveillance. Blood is drawn in the outpatient clinic or ambulatory phlebotomy lab, couriered to the performing laboratory, and processed using the four-probe FISH assay to detect rare circulating tumor-related cells. Laboratory result reporting includes a binary or risk-stratified interpretation (benign vs. cancerous or low/intermediate/high risk) that informs the multidisciplinary discussion and shared decision-making about next steps: percutaneous biopsy, surgical consultation, or interval CT surveillance. Typical sites of service include outpatient clinic, hospital outpatient department, or independent clinical laboratory/phlebotomy center.

Coding Specifications

Modifier	Description	When to Use
`00`	Modifier not otherwise specified (not a standard CMS modifier)	Use only if payer requires a proprietary two-character code; confirm payer guidance before use.
`22`	Increased procedural services	When additional work beyond the standard laboratory analysis is documented and meets payer criteria for increased services.
`26`	Professional component	When billing only the professional component (interpretation) separate from technical processing if payer allows split billing.
`52`	Reduced services	When the laboratory test is partially performed or a limited analysis is provided.
`53`	Discontinued procedure	When testing is started but discontinued for documented clinical reasons before completion.
`62`	Two surgeons or clinicians	Rare for this lab service; only used if two qualified providers share responsibility for interpretation and payer permits.
`78`	Unplanned return to the operating/procedure room	Not typically applicable; include only when applicable per payer rules for related procedural events.
`80`	Assistant at surgery	Not applicable to laboratory testing; include only if contractual billing scenarios require it.
`82`	Assistant at surgery when regular assistant not available	As above, rarely applicable for lab services.
`AS`	Physician assistant, nurse practitioner, or clinical nurse specialist services in facility setting	Use when a certified advanced practice provider performs specimen collection or documents a portion of the clinical interpretation and payer allows modifier reporting.
`QK`	Medical direction of two, three, or four technicians/technologists	If the physician or qualified provider medically directs multiple lab technologists in performing test components and payer recognizes the modifier.
`QX`	Qualified nonphysician practitioner service	Use when a qualified nonphysician practitioner performs services that meet payer rules for reporting.
`QY`	Clinic or physician group billing under a physician or other billing rules	Use per payer policy when applicable.
`TC`	Technical component	When billing only the technical component (laboratory processing) separate from professional interpretation.

Taxonomy Code	Specialty	Notes
2084P0800X	Pulmonary Disease	Pulmonologists order the test for nodule evaluation and risk stratification.
207L00000X	Thoracic Surgery	Thoracic surgeons use results to decide on biopsy or resection versus surveillance.
208D00000X	Clinical Pathology	Laboratory directors and clinical pathologists oversee testing methods and interpretation.
207K00000X	Diagnostic Radiology	Radiologists correlate imaging findings with test results in multidisciplinary decision-making.
363A00000X	Phlebotomy/Clinical Laboratory Technician	Specimen collection and processing personnel responsible for technical execution.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`R91.8`	Other nonspecific abnormal finding of lung field	Common reason to order `0317U` when imaging shows an indeterminate nodule requiring further risk stratification.
`R91.1`	Solitary pulmonary nodule	Directly relevant; `0317U` is intended for evaluation of indeterminate pulmonary nodules.
`R91.0`	Solitary pulmonary nodule, unspecified	Used when documentation indicates a solitary nodule without definitive characterization.
`C34.90`	Malignant neoplasm of unspecified part of unspecified bronchus or lung	Relevant if there is high suspicion or confirmation of lung cancer; test aids in triage toward definitive diagnosis.
`Z03.89`	Encounter for observation for other suspected diseases and conditions ruled out	Used when monitoring or evaluating a suspected malignancy where noninvasive testing like `0317U` is part of the workup.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0317U`	LungLB® (LungLife AI®) test using four-probe FISH on blood to stratify indeterminate lung nodules	Primary proprietary laboratory analysis; report when this specific test is performed.
`36415`	Collection of venous blood by venipuncture	Commonly performed immediately prior to `0317U` to obtain the specimen for the assay.
`88342`	Immunohistochemistry or special stains (per specimen); quantitative or semiquantitative interpretation may be used for ancillary tissue testing	May be billed for complementary tissue-based molecular or cytogenetic testing if a tissue biopsy is performed after positive stratification.
`88377`	Morphometric analysis; computer-assisted image analysis	May be used in the laboratory workflow if image analysis tools contribute to interpretation of FISH signals and payer allows billing.
`81275`	EGFR (epidermal growth factor receptor) gene analysis (this is an example of a molecular oncology test)	Performed on tissue or blood in subsequent oncologic workup if `0317U` suggests malignancy and molecular profiling is indicated.