Summary & Overview
CPT 0434U: RightMed® Gene Test, 25-Gene Pharmacogenomic NGS Panel
CPT code 0434U identifies the RightMed® Gene Test Excludes F2 and F5 from OneOme® LLC, a proprietary pharmacogenomic panel performed by next-generation sequencing (NGS) on whole blood or buccal swab specimens to assess 25 genes related to drug response and adverse drug reactions. As a PLA code, 0434U applies to a single manufacturer’s test and carries implications for payer coverage, coding specificity, and laboratory reporting.
Key national payers examined include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of what this code represents, the clinical context for pharmacogenomic testing, and the operational details relevant to billing and claims (service type and typical site of service). The publication also summarizes payer coverage patterns, common modifier usage, and where policy updates or clinical guidelines could affect utilization and reimbursement.
This resource is designed to inform coding staff, laboratory billing teams, and policy analysts about the clinical purpose of 0434U, the settings in which the service is delivered, and the types of documentation and claims considerations that typically accompany proprietary pharmacogenomic testing. Data not available in the input is noted where applicable.
Billing Code Overview
CPT code 0434U is a Proprietary Laboratory Analyses (PLA) code for the RightMed® Gene Test Excludes F2 and F5 from OneOme® LLC. The test uses next-generation sequencing (NGS) of a whole blood or buccal (cheek) swab specimen to analyze 25 genes for variants relevant to adverse drug reactions and drug response.
Service Type: Genetic testing — pharmacogenomic panel using NGS
Typical Site of Service: Clinical laboratory or independent diagnostic testing facility (specimen collected via whole blood draw or buccal swab, analysis performed in a laboratory)
Clinical & Coding Specifications
Clinical Context
A 52-year-old outpatient is referred by their primary care physician for pharmacogenomic testing after experiencing repeated adverse reactions and subtherapeutic responses to multiple psychiatric and cardiovascular medications. The clinician orders the RightMed® Gene Test (reportable using 0434U) to evaluate 25 pharmacogenes from a peripheral whole blood or buccal swab specimen using next-generation sequencing. The clinical workflow: the ordering provider documents the indication and obtains informed consent, the patient provides a blood draw or buccal swab at an outpatient laboratory or clinic, the specimen is shipped to the performing laboratory, sequencing and variant interpretation are completed, and a report is returned to the ordering provider. The provider uses the report to inform medication selection and dosing decisions, coordinate care with pharmacy or specialty services, and document results in the electronic health record. Typical sites of service include outpatient clinics, physician offices, hospital outpatient laboratories, and commercial reference laboratories performing proprietary testing.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier | Use when no modifier applies to the service. |
22 | Increased procedural services | Use when additional work or complexity beyond the typical test processing requires documentation (rare for PLA but applicable if extra services billed). |
26 | Professional component | Use when billing only the professional interpretation/reporting portion separate from the technical component. |
52 | Reduced services | Use when the full test is not performed and a reduced service is furnished. |
53 | Discontinued procedure | Use if specimen collection or testing was started but terminated for patient- or system-related reasons. |
62 | Two surgeons | Use when two qualified providers share responsibility for complex sample processing or interpretation (uncommon for lab tests). |
80 | Assistant surgeon | Use if an assistant is billed for a component that qualifies under billing rules (rare for this test). |
82 | Assistant surgeon (when qualified resident not available) | Use if an assistant other than a resident is necessary (rarely applicable). |
QK | Medical direction of two, three, or four assistants | Use when medical direction of multiple assistants is billed for an applicable portion of the service. |
QX | CRNA service: CRNA not supervised by physician | Use when a certified registered nurse anesthetist provides a billable service related to the encounter (infrequent for lab testing). |
QY | Medical direction of one CRNA by an anesthesiologist | Use when physician directs CRNA care during an encounter that includes the collection procedure under specific coverage rules. |
TC | Technical component | Use when billing only the technical component (laboratory processing and sequencing) separate from professional interpretation. |
SH | Catastrophe/disaster-related (hospital) | Use when service is provided in a declared catastrophe or disaster and specific billing rules apply. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 208D00000X | Medical Genetics | Clinical geneticists or genetic counselors ordering and interpreting pharmacogenomic reports. |
| 207Q00000X | Psychiatry & Neurology | Psychiatrists who use pharmacogenomic data for psychotropic medication selection. |
| 207L00000X | Cardiology | Cardiologists who use pharmacogenomic results for anticoagulant and cardiovascular drug management. |
| 207R00000X | Internal Medicine | Primary care physicians ordering and incorporating test results into longitudinal care. |
| 3336C0002X | Clinical Laboratory | Clinical laboratory directors and pathologists overseeing test performance and reporting. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
Z13.79 | Encounter for other screening for genetic and chromosomal anomalies | Used for encounters when pharmacogenomic screening is performed to inform medication therapy. |
F32.9 | Major depressive disorder, single episode, unspecified | Relevant when pharmacogenomic testing is used to guide selection of antidepressant therapy. |
F41.1 | Generalized anxiety disorder | Relevant when selecting anxiolytic or antidepressant medications impacted by pharmacogenes. |
I48.91 | Unspecified atrial fibrillation | Relevant for patients needing anticoagulant or rate-control therapy where pharmacogenomics may influence drug choice or dose. |
Z79.899 | Other long term (current) drug therapy | Indicates ongoing medication use where pharmacogenomic results may alter chronic therapy. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
0434U | RightMed® Gene Test Excludes F2 and F5 — NGS of 25 genes from whole blood or buccal swab for pharmacogenomic variants | This is the primary PLA code used to report the proprietary pharmacogenomic assay performed by OneOme® LLC. |
80048 | Basic metabolic panel | Often ordered concurrently to assess baseline metabolic status before medication changes informed by pharmacogenomic results. |
81002 | Urinalysis, non-automated, without microscopy | May be ordered as part of routine pre-treatment baseline evaluation in outpatient settings. |
36415 | Collection of venous blood by venipuncture | CPT code for the standard whole blood specimen collection used when blood is the chosen specimen type. |
99000 | Handling and/or conveyance of specimen for transfer from a physician's office to a laboratory | Used to report specimen transport logistics when applicable. |
G0480 | Sequencing, genomic, or other molecular pathology procedure (when applicable under local coverage) | Represents molecular sequencing services that may be performed in conjunction with or as part of laboratory workflows, although 0434U is the PLA code that uniquely defines this proprietary test. |