Summary & Overview
CPT 0345U: GeneSight Psychotropic 15-Gene Pharmacogenomic Test
CPT code 0345U designates the proprietary GeneSight® Psychotropic test, a 15-gene pharmacogenomic assay performed on a buccal swab to identify potential gene–drug interactions for psychotropic medications. As a PLA code tied to a specific manufacturer and test, 0345U clarifies billing for a single laboratory-developed service that supports personalized medication selection in mental health care. Nationally, such pharmacogenomic testing is increasingly relevant as clinicians and payers consider precision medicine approaches to improve medication response and reduce adverse effects.
Key payers in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. The content outlines which payers are addressed and highlights coverage dynamics for proprietary genetic tests at a national level.
Readers will learn the clinical purpose of the test, typical sites of service, and the implications of using a PLA code tied to a specific manufacturer. The publication summarizes benchmark considerations, common billing elements, and policy context affecting reimbursement and adoption, and it provides clinical context for how the assay informs psychotropic medication decision-making. Data not available in the input is identified where applicable.
Billing Code Overview
CPT code 0345U is a Proprietary Laboratory Analyses (PLA) code that applies only to a single, specific proprietary test. Report 0345U only for GeneSight® Psychotropic as offered by Assurex Health Inc. and Myriad Genetics Inc. The test analyzes 15 genes from a buccal (cheek) swab specimen and uses an algorithmic analysis to report a list of psychotropic medications with indications of possible interactions based on the patient’s genetic profile.
Service Type: Genetic pharmacogenomic testing for psychotropic medication guidance
Typical Site of Service: Outpatient laboratory or specialized diagnostic laboratory; specimen collection often performed in ambulatory clinic settings or via at-home buccal swab kits sent to the performing laboratory.
Clinical & Coding Specifications
Clinical Context
A 34-year-old adult patient with a history of major depressive disorder and partial response to two prior antidepressant trials presents to an outpatient psychiatry clinic. The treating psychiatrist orders pharmacogenomic testing to guide selection of psychotropic medications. A buccal (cheek) swab is collected in clinic and sent to the laboratory for the GeneSight® Psychotropic assay (0345U). The lab analyzes 15 genes and applies a proprietary algorithm to classify commonly used antidepressants, antipsychotics, mood stabilizers, and anxiolytics for potential gene-drug interactions. The laboratory returns a report indicating medication categories (e.g., use as directed, moderate gene-drug interaction, major gene-drug interaction) to inform the clinician’s medication review during a follow-up visit. Typical workflow includes ordering the test, obtaining patient consent, collecting the buccal swab at an outpatient clinic or specialty psychiatry office, specimen transport to the manufacturer’s laboratory, laboratory processing and algorithmic analysis, and receipt of the final report in the electronic health record for clinician review and documentation.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Unspecified | Rarely used; reserved when no specific modifier applies and a claim requires a placeholder |