Summary & Overview
CPT 0348U: RightMed Comprehensive 25-Gene Pharmacogenomic NGS Test
CPT code 0348U designates a Proprietary Laboratory Analyses (PLA) pharmacogenomic test — the RightMed® Comprehensive Test Exclude F2 and F5 from OneOme® LLC — that uses next‑generation sequencing (NGS) of whole blood or buccal swab specimens to evaluate 25 genes affecting drug metabolism. Nationally, this code matters as payers and laboratories navigate coverage and billing for manufacturer‑specific genomic assays that inform medication selection and dosing. Key payers evaluated include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare.
Readers will find an overview of what 0348U represents clinically, how it is reported, and the typical service and site of service for the assay. The publication summarizes payer coverage patterns and benchmarks, common modifier and billing considerations, and the clinical context for pharmacogenomic testing. It also highlights policy updates affecting PLA codes and practical documentation elements needed for claim submission. This material is intended for national audiences including laboratory billing staff, practice managers, and policy analysts seeking concise guidance on coding, payer engagement, and the role of a 25‑gene NGS pharmacogenomic panel in medication management.
Billing Code Overview
CPT code 0348U is a Proprietary Laboratory Analyses (PLA) code for the RightMed® Comprehensive Test Exclude F2 and F5 offered by 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 drug metabolism and function. The code is specific to a single manufacturer's test and applies when that exact proprietary assay is performed.
Service Type: Genetic testing — pharmacogenomic panel using NGS
Typical Site of Service: Clinical laboratory or other accredited diagnostic testing facility, with specimen collection occurring in outpatient clinics, physician offices, or patient collection sites.
Clinical & Coding Specifications
Clinical Context
A typical patient is an adult or pediatric outpatient being considered for pharmacogenomic-guided medication management after a history of poor response, adverse drug reaction, or planned initiation of medications metabolized by cytochrome P450 enzymes. The clinician (primary care physician, psychiatrist, cardiologist, pain specialist, or clinical pharmacist) orders the RightMed® Comprehensive test to evaluate genetic variants across 25 pharmacogenes that influence drug metabolism and response. A whole blood or buccal swab specimen is collected in clinic or at a collection site and shipped to OneOme® LLC for next-generation sequencing analysis. Results are returned in a report that maps gene variants to drug dosing recommendations and interaction alerts; the provider reviews results with the patient to inform prescribing decisions, deprescribing, or referral to a specialist or pharmacogenomics consultation service. Typical sites of service include ambulatory clinics, outpatient phlebotomy centers, physician offices, and specialty clinics where medication selection or dosing is a clinical priority.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Unspecified | Rarely used; reserved when no other modifier applies and payer requires code. |
22 | Increased Procedural Services | Use if substantially greater than usual services were required to collect specimen or coordinate complex testing logistics. |
23 | Unusual Anesthesia | Not typically applicable; included for completeness if anesthesia was unexpectedly required for specimen collection. |
26 | Professional Component | Use when billing only the professional component of the test interpretation separate from the technical lab component. |
52 | Reduced Services | Use when an abbreviated or partial test was performed vs full panel for clinical reasons. |
54 | Surgical Care Only | Not commonly applicable; for continuity when another provider performs the testing service. |
55 | Postoperative Management Only | Not commonly applicable for this laboratory procedure. |
56 | Preoperative Management Only | Not commonly applicable for this laboratory procedure. |
62 | Two Surgeons | Not applicable to laboratory testing; included when multiple clinicians share responsibility for a surgical procedure. |
78 | Unplanned Return to OR | Not applicable to this lab test. |
80 | Assistant Surgeon | Not applicable to this lab test. |
82 | Assistant Surgeon (When Qualified Assistant Not Available) | Not applicable to this lab test. |
AS | Physician Assistant, Nurse Practitioner, or Clinical Nurse Specialist services | Use when an advanced practice clinician performs specimen collection or counseling and billing rules allow. |
TC | Technical Component | Use when billing only the technical component (laboratory processing and sequencing) separate from professional interpretation. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 207Q00000X | Family Medicine | Primary care clinicians who order pharmacogenomic testing for medication management. |
| 2084P0800X | Clinical Pharmacology | Clinicians specializing in drug therapy management and pharmacogenomics interpretation. |
| 208D00000X | Psychiatry & Neurology | Psychiatrists who use results to guide psychotropic medication selection and dosing. |
| 207R00000X | Internal Medicine | Internists managing chronic conditions requiring tailored medication regimens. |
| 310400000X | Clinical Laboratory | Laboratory directors and pathologists overseeing test processing and result sign-out. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
Z13.79 | Encounter for other specified screening for genetic and chromosomal anomalies | Used for ordering panel testing to screen for pharmacogenomic variants that affect drug response. |
Z13.6 | Encounter for screening for cardiovascular disorders | Relevant when testing is ordered to guide cardiovascular medication selection/dosing. |
F33.1 | Major depressive disorder, recurrent, moderate | Psychotropic medication management may be informed by pharmacogenomic results. |
I10 | Essential (primary) hypertension | Guides selection or dosing of antihypertensives influenced by metabolic variants. |
G47.33 | Obstructive sleep apnea (adult) (pediatric) | May be relevant when medications affecting sleep or respiratory drive are being considered and pharmacogenomics could inform therapy. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
0348U | RightMed® Comprehensive Test Exclude F2 and F5 — NGS of 25 genes from whole blood or buccal swab | Primary PLA code describing the proprietary pharmacogenomic panel performed by OneOme® LLC. |
80047 | Basic metabolic panel | Performed pre-test or concurrently to assess baseline metabolic status when initiating certain medications. |
83001 | Hemoglobin; glycosylated (A1c) | Commonly ordered in chronic disease management where pharmacogenomic data may inform diabetes medication choices. |
G0478 | Pharmacogenomics testing (Medicare specific billing guidance varies; PLA codes typically billed with appropriate PLA code) | Medicare and payor-specific reporting codes may be used in parallel for administrative purposes; relates to coverage and claim adjudication. |
99401 | Preventive medicine counseling (short) | Used when brief genetic counseling or medication counseling is provided in the clinic visit concurrent with test ordering. |