Summary & Overview

CPT 0301U: Bartonella ddPCR Assay (Galaxy Diagnostics)

CPT code 0301U designates a Proprietary Laboratory Analyses (PLA) assay for the Bartonella ddPCR test developed by Galaxy Diagnostics Inc. It identifies the presence of Bartonella henselae and Bartonella quintana using droplet digital PCR on specimens such as blood. As a PLA code, 0301U is unique to a single manufacturer's assay and defines billing and tracking for that specific laboratory service nationwide. National stakeholders monitor PLA codes like 0301U because they directly affect laboratory reporting, claims processing, and access to advanced molecular diagnostics for infectious disease.

Key payers referenced in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the clinical context for Bartonella testing, the service setting and type, payer coverage considerations, and standard modifiers commonly used with laboratory CPT reporting. The publication also summarizes common billing practices, reimbursement benchmarking areas where data are available, and policy or coding updates that affect proprietary laboratory assays. The content is structured for quick reference by coding professionals, laboratory managers, and health policy analysts seeking to understand how CPT code 0301U maps to clinical testing and payer interactions at a national level.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0301UCPTProprietary Laboratory AnalysesddPCRBartonellainfectious disease testinglaboratory billingmolecular diagnosticsclinical lab

Billing Code Overview

CPT code 0301U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to a single laboratory test: the Bartonella ddPCR assay from Galaxy Diagnostics Inc. The test uses a proprietary droplet digital PCR (ddPCR) nucleic acid detection method on specimens such as whole blood to determine the presence of infectious agents Bartonella henselae and Bartonella quintana, organisms associated with conditions such as cat scratch disease and trench fever.

Service type: Proprietary laboratory infectious disease testing using droplet digital PCR (ddPCR)
Typical site of service: Clinical laboratory or hospital laboratory; specimen collection typically occurs in an outpatient clinic or phlebotomy setting

Clinical & Coding Specifications

Clinical Context

A middle-aged outpatient presents to an infectious disease clinic with persistent fever, lymphadenopathy, and a history of cat exposure. Prior empiric antibiotics produced incomplete response and the clinician suspects Bartonella infection (for example, cat-scratch disease or trench fever). The clinician orders a specialized molecular diagnostic test: 0301U (Bartonella ddPCR by Galaxy Diagnostics). A peripheral blood specimen is collected in the clinic or hospital phlebotomy service and sent to the reference laboratory. The laboratory performs a droplet digital PCR (ddPCR) assay targeting Bartonella henselae and Bartonella quintana nucleic acids. Results are reported to the ordering provider with quantitative/qualitative detection of Bartonella species to guide diagnosis and targeted therapy. Typical sites of service include outpatient clinics, urgent care centers, hospital inpatient wards when testing for unclear febrile illness, and independent/referent clinical laboratories that perform PLA tests.

Coding Specifications

Modifier	Description	When to Use
`00`	No modifier	Standard reporting when no modifier applies

Taxonomy Code	Specialty	Notes
`207R00000X`	Infectious Disease	Ordering and result interpretation for suspected Bartonella infections
`207K00000X`	Internal Medicine	Primary care or inpatient physicians who order testing for unexplained fevers and lymphadenopathy
`207L00000X`	Emergency Medicine	Clinicians ordering testing in acute care settings for febrile patients with possible exposure
`363A00000X`	Clinical Laboratory	Laboratories performing the technical ddPCR assay and reporting results
`261QM0800X`	Phlebotomy	Personnel responsible for specimen collection and processing logistics

ICD-10 Code	Description	Clinical Relevance
`A49.2`	Other staphylococcal infection	Included as an alternate cause of febrile illness to consider in differential when testing for Bartonella
`A49.9`	Bacterial infection, unspecified	Used when a bacterial etiology is suspected but not yet identified; prompts targeted testing such as `0301U`
`A18.84`	Pulmonary mycobacterial infection, other specified mycobacterial infection	Represents other intracellular organisms considered in prolonged febrile illnesses and lymphadenopathy workups
`A82.9`	Rabies, unspecified	Example of another zoonotic consideration in exposure histories; included to illustrate zoonotic differential diagnoses
`B00.9`	Herpesviral infection, unspecified	Viral causes of lymphadenopathy and fever considered in differential diagnosis

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`36415`	Collection of venous blood by venipuncture	Commonly performed to obtain the peripheral blood specimen for `0301U` testing
`99000`	Handling and/or conveyance of specimen for transfer from the physician's office to a laboratory	May be used when specimen transport services are billed separately in some settings
`87811`	Infectious agent detection by nucleic acid (DNA or RNA); amplified probe technique, multiple organisms, qualitative or quantitative, each organism	Alternative general molecular-method code families sometimes used when PLA specific code is not applicable; not applicable to reporting `0301U` but related conceptually in test category
`87471`	Infectious agent detection by nucleic acid (DNA or RNA), direct probe technique, qualitative or semi-quantitative, each organism	Represents other molecular diagnostic techniques that could be ordered for infectious agents in parallel workflows
`81002`	Urinalysis, non-automated, without microscopy	Example of a concurrent laboratory test that might be ordered in evaluation of febrile illness; performed separately from `0301U`

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