Summary & Overview
CPT 0477U: Pharmacogenomic Mental Health Medication Report
CPT code 0477U denotes a Proprietary Laboratory Analyses (PLA) test — the RightMed® Mental Health Medication Report from OneOme LLC — which evaluates 14 genes plus the CYP2D6 copy number variant to report pharmacogenomic phenotypes and gene–drug interactions for psychiatric medications. This code matters nationally as pharmacogenomic testing increasingly informs medication selection, adverse effect risk reduction, and personalized psychiatric care across ambulatory and specialty settings.
Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. The publication summarizes payer coverage patterns, coding and billing considerations, and clinical context for the test’s use. Readers will find benchmarks for utilization and common payer approaches, a concise explanation of the clinical implications of the 14-gene panel and CYP2D6 copy number assessment, and summaries of typical site-of-service workflows for ordering and reporting results. The material also outlines typical modifiers encountered in claims (listed separately) and clarifies that the code is PLA-specific to OneOme’s RightMed® report. Data not available in the input is noted where applicable.
Billing Code Overview
CPT code 0477U is a Proprietary Laboratory Analyses (PLA) code that applies only to the RightMed® Mental Health Medication Report from OneOme LLC. The test analyzes 14 genes and the CYP2D6 copy number variant to characterize drug metabolism phenotypes and gene–drug interactions relevant to psychiatric medications. The report translates genetic findings into reported phenotypes and documented gene–drug interactions specific to mental health medication management.
Service type: Genetic/pharmacogenomic testing for psychiatric medication management
Typical site of service: Clinical laboratory or reference laboratory, with results used by outpatient psychiatric clinics, primary care offices, and other ambulatory care settings for medication selection and management.
Clinical & Coding Specifications
Clinical Context
A 34-year-old patient with treatment-resistant major depressive disorder is evaluated in an outpatient psychiatric clinic after inadequate response and adverse effects from multiple antidepressant trials. The psychiatrist orders the RightMed® Mental Health Medication Report (0477U) to assess pharmacogenomic factors influencing drug metabolism and gene–drug interactions. The clinical workflow: the clinician documents the indication and obtains informed consent; a buccal swab or blood sample is collected in the outpatient lab or clinic; the specimen is sent to OneOme LLC for proprietary analysis of 14 genes plus CYP2D6 copy number; results are returned as a report describing predicted metabolic phenotypes, gene–drug interactions, and medication selection/optimization information. The treating clinician reviews the report to interpret phenotypes (for example, CYP2D6 poor or ultrarapid metabolizer) and gene–drug interaction guidance in the context of the patient’s psychiatric medications, documents the findings in the medical record, and applies the information to optimize pharmacotherapy and reduce risk of adverse effects.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Default / No modifier | When no special circumstances apply to the service. |
22 | Increased procedural services | If additional work beyond typical processing is required and documented. |
26 | Professional component | When billing only the professional component of a split-service lab test (interpretation) if applicable. |
52 | Reduced services | If testing is partially performed with reduced services documented. |
53 | Discontinued procedure | If specimen collection or testing was started but discontinued for documented reasons. |
62 | Two surgeons (not typical) | Rarely used; not typically applicable but included per payer rules when two providers share responsibility for specimen acquisition or testing oversight. |
78 | Unplanned return to OR (not typical) | Not generally applicable to laboratory PLA testing; use only in exceptional documented scenarios. |
80 | Assistant surgeon (not typical) | Not typically applicable; some payers require for specific technical assistance during specimen collection. |
QK | Medical direction of 2-4 by physician | When a physician directs multiple (2–4) qualified nonphysician personnel performing portions of the service. |
QX | Service performed by a qualified nonphysician under supervision | When a qualified nonphysician performs specimen collection or processing under appropriate supervision. |
QY | Service ordered by a physician or other qualified health care professional | When ordering clinician meets payer requirements for ordering this lab. |
TC | Technical component | When billing only the technical component (laboratory processing) of the test. |
SH | Physician or other lic. health care perform simple tests | When a licensed clinician in the office performs the specimen collection as a waived/simple test setting. |
SJ | Clinic or ambulatory setting for specimen procurement | When specimen collection occurs in an ambulatory clinic setting. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 2084P0800X | Psychiatry & Neurology | Psychiatrists commonly order pharmacogenomic testing for medication management. |
| 207L00000X | Clinical Pathology | Pathology/laboratory directors oversee testing validity and reporting. |
| 208000000X | Family Medicine | Primary care and family physicians may order testing for medication optimization. |
| 207R00000X | Internal Medicine | Internists treating psychiatric comorbidities or medication management may order testing. |
| 363A00000X | Genetic Testing Laboratory | Labs specialized in genetic and pharmacogenomic testing perform the assay. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
F32.1 | Major depressive disorder, single episode, moderate | Common indication for pharmacogenomic testing to guide antidepressant selection and dosing. |
F33.1 | Major depressive disorder, recurrent, moderate | Helps inform medication choice after prior treatment failures or side effects. |
F41.1 | Generalized anxiety disorder | Pharmacogenomic data can influence anxiolytic medication selection and metabolism considerations. |
F41.0 | Panic disorder [episodic paroxysmal anxiety] | Guides selection and dosing of antidepressants and other medications used for panic disorder. |
F43.21 | Adjustment disorder with depressed mood | May inform safe medication choices when pharmacotherapy is considered. |
F32.9 | Major depressive disorder, single episode, unspecified | Used when exact severity is not specified but testing is indicated for medication management. |
F90.0 | Attention-deficit hyperactivity disorder, predominantly inattentive type | Pharmacogenomic testing can impact stimulant or adjunctive medication strategies. |
Z13.79 | Encounter for screening for other disorder | Used when testing is performed for preemptive pharmacogenomic screening prior to medication initiation. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
0477U | RightMed® Mental Health Medication Report — analysis of 14 genes and CYP2D6 copy number, proprietary PLA code | Primary code reporting the proprietary pharmacogenomic test performed by OneOme LLC. |
81025 | Urinalysis, by dipstick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity and urobilinogen; automated, non-automated with microscopy | May be performed in psychiatric evaluation workflows for baseline metabolic screening before medication changes. |
36415 | Collection of venous blood by venipuncture | Common specimen collection code when blood draw is used for genomic testing instead of buccal swab. |
99000 | Handling and/or conveyance of specimen for transfer from physician's office to a laboratory | Used when office documents specimen handling/shipping to the reference lab. |
99499 | Unlisted evaluation and management service | Occasionally used for nonstandard counseling or complex result interpretation services not captured by standard E/M codes when documented per payer rules. |