Summary & Overview

CPT 0610U: LifeScale Gram Negative Antibiotic Susceptibility Test

CPT code 0610U designates a proprietary laboratory assay—the LifeScale Gram Negative Kit (LSGN) paired with the LifeScale AST system from Affinity Biosensors LLC—that delivers rapid antimicrobial susceptibility results from a positive blood culture using microfluidic sensor technology. The test reports organism susceptibility categories and a minimum inhibitory concentration (MIC) with interpretive comments, supporting timely antimicrobial selection for gram-negative bacteremia. Nationally, PLA codes like 0610U matter because they identify manufacturer-specific diagnostics that can affect laboratory procurement, payer coverage decisions, and hospital workflow for sepsis care.

Key payers discussed in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the clinical purpose and laboratory setting for this assay, a summary of payer coverage considerations and benchmarks where available, and context on how the PLA designation shapes coding and billing practices. The publication also outlines potential policy and reimbursement implications tied to single-source diagnostic technologies and highlights points of interest for laboratory administrators, hospital billing teams, and policy analysts evaluating adoption and coverage of novel antimicrobial susceptibility tests.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0610UCPTProprietary Laboratory AnalysesAntimicrobial Susceptibility TestingMicrofluidic DiagnosticsBlood CultureClinical MicrobiologyLaboratory Billing

Billing Code Overview

CPT code 0610U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the LifeScale Gram Negative Kit (LSGN) used with the LifeScale AST system from Affinity Biosensors LLC. The test measures bacterial growth from a positive blood culture in the presence of different antibiotics using microfluidic sensor technology, reporting organism susceptibility categories and the minimum inhibitory concentration (MIC) value along with interpretive comments.

Service type: Microfluidic-based antimicrobial susceptibility testing from positive blood culture (proprietary laboratory diagnostic assay)
Typical site of service: Clinical laboratories and hospital laboratory settings where positive blood cultures are processed

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

Clinical & Coding Specifications

Clinical Context

A 62-year-old hospitalized patient with a central line develops fever and hypotension. Blood cultures drawn from the central line and peripheral vein flag positive for gram-negative rods on preliminary Gram stain. The microbiology laboratory receives the positive blood culture bottle and performs rapid organism identification and susceptibility testing using the LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (0610U). The workflow: the positive blood culture is loaded onto the LifeScale microfluidic AST platform, which measures bacterial growth in the presence of multiple antibiotics and reports categorical susceptibility (susceptible, intermediate, resistant), minimum inhibitory concentration (MIC) values, and interpretive comments. Results are transmitted to the ordering clinician and antimicrobial stewardship team to inform targeted therapy adjustments, source control decisions, and infection control measures. Typical sites of service include hospital inpatient laboratories and hospital outpatient reference laboratories that process positive blood cultures.

Coding Specifications

Modifier	Description	When to Use
`26`	Professional component	Use when reporting only the professional interpretation component, if applicable and separately billable (rare for PLA tests).
`TC`	Technical component	Use when reporting only the technical component performed by the laboratory.
`90`	Reference (outside) lab	Use when the service is performed by an outside laboratory and billed by the performing lab.
`59`	Distinct procedural service	Use when distinct services are performed on the same day that are unrelated to the PLA test.
`GY`	Item or service statutorily excluded	Use when payer requires denial indication for services not covered.
`QW`	CLIA waived test	Not typically applicable; include only if CLIA status changes billing rules.
`52`	Reduced services	Use when the full test is not performed and a reduced service is reported.
`RT`	Right side	Not clinically applicable to blood-culture AST but used if laterality is required by payer (uncommon).
`LT`	Left side	See `RT` note above.
`XE`	Separate encounter	Use when the procedure is distinct by encounter per modifier rules.

Taxonomy Code	Specialty	Notes
`363LF0200X`	Clinical Laboratory	Labs performing microbiology and AST.
`2080P0202X`	Infectious Disease	Physicians who order and interpret results for inpatient management.
`207L00000X`	Pathology	Pathologists overseeing clinical microbiology services.
`207K00000X`	Clinical Pathology	Laboratory medicine specialists responsible for testing protocols.
`170100000X`	Hospitalist	Hospital-based physicians who act on AST results.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`A41.9`	Sepsis, unspecified organism	Common indication for blood cultures and rapid AST to guide therapy.
`R65.21`	Severe sepsis with septic shock	Rapid susceptibility results are critical for management in septic shock.
`B96.2`	Escherichia coli as the cause of diseases classified elsewhere	Specific organism codes are added when ID is confirmed and guides AST interpretation.
`B96.5`	Klebsiella pneumoniae as the cause of diseases classified elsewhere	Relevant for gram-negative bloodstream infections assessed by the LSGN test.
`A41.51`	Sepsis due to Pseudomonas aeruginosa	Pseudomonas is a gram-negative pathogen frequently requiring targeted AST.
`T80.2XXA`	Infection following infusion, initial encounter	Device- or infusion-related bloodstream infections prompt blood culture and AST.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`87070`	Culture, bacterial, any source, other than blood, with isolation and presumptive identification of isolates	Performed when additional cultures or isolate workup is required; not for the primary positive blood culture but for follow-up specimens.
`87077`	Culture, bacterial, blood, aerobic, with isolation and presumptive identification of isolates	Often performed alongside rapid AST; represents standard culture and ID workflow for blood specimens.
`87880`	Infectious agent antigen detection by immunoassay with direct optical observation; multiple-step technique	May be used for rapid organism identification adjunctively prior to AST (depends on lab methods).
`87490`	Infectious agent detection by nucleic acid (DNA or RNA); organism not otherwise specified, amplified probe technique	Molecular identification tests used before or alongside AST for species-level ID.
`87186`	Antimicrobial susceptibility; microdilution technique, per antimicrobial agent	Traditional reference susceptibility methods performed in parallel or confirmatory to rapid AST results.

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Summary & Overview

CPT 0610U: LifeScale Gram Negative Antibiotic Susceptibility Test

Billing Code Overview

Service type: Microfluidic-based antimicrobial susceptibility testing from positive blood culture (proprietary laboratory diagnostic assay)
Typical site of service: Clinical laboratories and hospital laboratory settings where positive blood cultures are processed

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

Clinical & Coding Specifications

Clinical Context

Coding Specifications

Modifier	Description	When to Use
`26`	Professional component	Use when reporting only the professional interpretation component, if applicable and separately billable (rare for PLA tests).
`TC`	Technical component	Use when reporting only the technical component performed by the laboratory.
`90`	Reference (outside) lab	Use when the service is performed by an outside laboratory and billed by the performing lab.
`59`	Distinct procedural service	Use when distinct services are performed on the same day that are unrelated to the PLA test.
`GY`	Item or service statutorily excluded	Use when payer requires denial indication for services not covered.
`QW`	CLIA waived test	Not typically applicable; include only if CLIA status changes billing rules.
`52`	Reduced services	Use when the full test is not performed and a reduced service is reported.
`RT`	Right side	Not clinically applicable to blood-culture AST but used if laterality is required by payer (uncommon).
`LT`	Left side	See `RT` note above.
`XE`	Separate encounter	Use when the procedure is distinct by encounter per modifier rules.

Taxonomy Code	Specialty	Notes
`363LF0200X`	Clinical Laboratory	Labs performing microbiology and AST.
`2080P0202X`	Infectious Disease	Physicians who order and interpret results for inpatient management.
`207L00000X`	Pathology	Pathologists overseeing clinical microbiology services.
`207K00000X`	Clinical Pathology	Laboratory medicine specialists responsible for testing protocols.
`170100000X`	Hospitalist	Hospital-based physicians who act on AST results.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`A41.9`	Sepsis, unspecified organism	Common indication for blood cultures and rapid AST to guide therapy.
`R65.21`	Severe sepsis with septic shock	Rapid susceptibility results are critical for management in septic shock.
`B96.2`	Escherichia coli as the cause of diseases classified elsewhere	Specific organism codes are added when ID is confirmed and guides AST interpretation.
`B96.5`	Klebsiella pneumoniae as the cause of diseases classified elsewhere	Relevant for gram-negative bloodstream infections assessed by the LSGN test.
`A41.51`	Sepsis due to Pseudomonas aeruginosa	Pseudomonas is a gram-negative pathogen frequently requiring targeted AST.
`T80.2XXA`	Infection following infusion, initial encounter	Device- or infusion-related bloodstream infections prompt blood culture and AST.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`87070`	Culture, bacterial, any source, other than blood, with isolation and presumptive identification of isolates	Performed when additional cultures or isolate workup is required; not for the primary positive blood culture but for follow-up specimens.
`87077`	Culture, bacterial, blood, aerobic, with isolation and presumptive identification of isolates	Often performed alongside rapid AST; represents standard culture and ID workflow for blood specimens.
`87880`	Infectious agent antigen detection by immunoassay with direct optical observation; multiple-step technique	May be used for rapid organism identification adjunctively prior to AST (depends on lab methods).
`87490`	Infectious agent detection by nucleic acid (DNA or RNA); organism not otherwise specified, amplified probe technique	Molecular identification tests used before or alongside AST for species-level ID.
`87186`	Antimicrobial susceptibility; microdilution technique, per antimicrobial agent	Traditional reference susceptibility methods performed in parallel or confirmatory to rapid AST results.