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 |
22 | Increased procedural service | Use when work or resources for coordinating testing exceed typical requirements (uncommon for PLA tests) |
26 | Professional component | Use when billing only the professional component of a split service, if applicable and the lab separates components |
52 | Reduced services | Use if testing was partially completed or limited (e.g., inadequate specimen preventing full analysis) |
53 | Discontinued procedure | Use if specimen collection or testing was begun but discontinued for clinical reasons before completion |
54 | Surgical care only | Not typically applicable; included when another provider bills the test component attributable to surgical care |
55 | Postoperative management only | Not typically applicable to this outpatient laboratory test |
56 | Preoperative management only | Not typically applicable to this outpatient genetic test |
62 | Two surgeons | Not applicable to this laboratory test but listed among available modifiers |
78 | Unplanned return to OR | Not applicable to this procedure |
80 | Assistant surgeon | Not applicable to this laboratory test |
AS | Physician assistant, nurse practitioner, or clinical nurse specialist services for assistant at surgery | Not applicable to this laboratory test |
QK | Medical direction of two, three, or four concurrent anesthesia procedures | Not applicable to this laboratory test |
QX | CRNA service: with medical direction by physician | Not applicable to this laboratory test |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
2084P0800X | Psychiatry | Ordering clinicians for psychotropic pharmacogenomic testing |
208D00000X | Clinical Pathology | Laboratory oversight and interpretation of genetic test results |
207Q00000X | Clinical Laboratory | Performing molecular diagnostic assays and specimen processing |
207L00000X | Molecular Diagnostic Laboratory | Specialty lab performing proprietary algorithmic analyses |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
F32.9 | Major depressive disorder, single episode, unspecified | Common indication when patients have inadequate response to antidepressants and clinicians seek pharmacogenomic guidance |
F33.1 | Major depressive disorder, recurrent, moderate | Recurrent depression with partial response where medication selection may be influenced by pharmacogenomic results |
F41.1 | Generalized anxiety disorder | Anxiety disorders frequently treated with psychotropic agents evaluated by the assay |
F20.9 | Schizophrenia, unspecified | Antipsychotic selection and dosing can be informed by pharmacogenomic interactions reported by the test |
F31.9 | Bipolar disorder, unspecified | Mood stabilizer and antipsychotic choices in bipolar disorder may be reviewed in light of gene-drug interaction data |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
99000 | Handling and/or conveyance of specimen for transfer from the office to a laboratory | Used when the clinic documents specimen handling and courier fees associated with sending the buccal swab to the testing laboratory |
36415 | Collection of venous blood by venipuncture | May be billed if blood is collected for ancillary tests alongside the buccal swab (not for GeneSight® buccal collection) |
99070 | Supplies and materials (e.g., durable medical equipment, drugs) | Used to bill clinic-supplied swabs or mailing kits when separately reimbursable |
G0344 | Care planning for dementia (example G-code) | Not directly related; included to illustrate that specific care-management or genetic counseling CPTs may occur in parallel but are billed separately |
96160 | Administration of patient-focused health risk assessment instrument | Used when formal pre-test counseling or patient-reported outcome measures are administered alongside testing |