Summary & Overview
HCPCS G9359: TB Screening and Clearance Prior to Biologic Therapy
HCPCS Level II code G9359 documents the completion of a tuberculosis (TB) screening process—either a documented negative screen or a managed positive screen with additional evidence demonstrating TB is not active—before initiating a biologic immune response modifier. Nationally, this code signals adherence to infection-screening protocols intended to reduce the risk of reactivating latent or undiagnosed active TB when prescribing immunosuppressive biologics.
Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare and Medicare. Readers will find a concise explanation of the clinical context for code use, typical sites of service, and which payers commonly recognize the code. The publication outlines billing and documentation expectations, common modifiers associated with outpatient pre-treatment services, and where payers may require supporting evidence in the chart.
The piece also summarizes benchmarks and policy updates relevant to pre-biologic infectious disease screening, clarifies clinical documentation elements that support code assignment, and points readers to areas where policy variation commonly occurs across commercial and public payers. Data not available in the input is noted where applicable.
Billing Code Overview
HCPCS Level II code G9359 documents a negative or managed positive tuberculosis (TB) screen with further evidence that TB is not active prior to treatment with a biologic immune response modifier. This code is used to record that appropriate TB screening and follow-up evaluation have been completed and that active TB disease has been excluded before initiating biologic immunosuppressive therapy.
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Service type: Pre-treatment infectious disease screening and clearance for initiation of a biologic immune response modifier
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Typical site of service: Outpatient clinic or specialty physician office where biologic therapies are evaluated and prescribed
Clinical & Coding Specifications
Clinical Context
A 45-year-old patient with moderate to severe rheumatoid arthritis is being evaluated prior to initiation of a biologic immune response modifier (e.g., a TNF inhibitor). The clinician documents a history, reviews risk factors for tuberculosis (past exposure, prior TB infection, country of origin, immunosuppression), and obtains a TB screening test (interferon-gamma release assay or tuberculin skin test) and a chest radiograph. Results show either a documented negative TB screen or evidence of a prior positive TB test with subsequent evaluation (negative chest x-ray, no clinical signs of active disease, and treatment for latent TB completed or considered not active). The practice documents the negative or managed positive TB screen and records additional evidence excluding active tuberculosis prior to biologic therapy. Typical workflow: pre-biologic visit with history and risk assessment, ordering and review of TB test(s), chest x-ray if indicated, specialist or infectious disease consultation if positive, documentation of treatment or monitoring plan, and final clearance for biologic initiation. Typical site of service: outpatient clinic, specialty rheumatology or dermatology office, infusion center evaluation, or pre-treatment screening visit.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
22 | Unusual procedural services | When documentation supports substantially greater work than usual for pre-treatment screening visit review and extensive documentation of TB evaluation. |