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.
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.
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Service type: Proprietary laboratory infectious disease testing using droplet digital PCR (ddPCR)
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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 |