Summary & Overview

CPT 0347U: RightMed PGx16 Pharmacogenomic NGS Test

CPT code 0347U denotes the proprietary RightMed® PGx16 Test from OneOme® LLC, a next-generation sequencing (NGS) pharmacogenomic panel that evaluates 16 genes from whole blood or buccal swab specimens to identify variants affecting drug metabolism. As a PLA code, 0347U is unique to a single manufacturer’s test and is used nationally to support individualized medication selection and dosing decisions.

Key payers included in the national discussion are Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare and Medicare. Readers will find a concise overview of clinical context, typical sites of service, and payer landscape considerations for PLA-coded pharmacogenomic testing. The publication summarizes benchmark adoption indicators, coverage patterns among major payers, and recent policy developments influencing use of proprietary pharmacogenomic panels. It also provides clinical context on how single-manufacturer NGS panels integrate into medication management workflows and what billing administrators need to know about reporting 0347U for RightMed® PGx16 Test claims.

Data not available in the input for associated taxonomies, specific ICD-10 diagnoses, and related or line-item service code mappings.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0347UCPTpharmacogenomicsproprietary laboratory analysisNGSRightMed PGx16laboratory testingprecision medicine

Billing Code Overview

CPT code 0347U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the RightMed® PGx16 Test from OneOme® LLC. The test uses next-generation sequencing (NGS) of a whole blood or buccal (cheek) swab specimen to analyze 16 genes for variants relevant to drug metabolism and processing. This test is used to inform pharmacogenomic profiling to identify genetic variants that may affect drug response.

Service Type: Laboratory — pharmacogenomic testing using NGS of blood or buccal swab

Typical Site of Service: Clinical laboratory or reference laboratory; specimen collection performed at outpatient clinics or collection centers

Clinical & Coding Specifications

Clinical Context

A 55-year-old patient with multiple chronic conditions (depression, hypertension, and chronic pain) is experiencing inadequate response and adverse effects after recent changes to psychotropic and cardiovascular medications. The treating clinician orders the RightMed® PGx16 Test (0347U) to evaluate pharmacogenomic variants across 16 genes that affect drug metabolism, transport, and response. A whole blood or buccal swab specimen is collected in an outpatient clinic or ambulatory lab visit. The specimen is sent to OneOme® LLC for next-generation sequencing (NGS) analysis. Results are reported back to the ordering provider and incorporated into medication selection and dosing discussions during follow-up office visits or medication management consultations. Typical sites of service include physician offices, outpatient clinics, ambulatory surgical centers with lab services, and independent clinical laboratories that coordinate specimen collection.

Coding Specifications

Modifier	Description	When to Use
`00`	HIPAA Placeholder (no longer used clinically)	Rarely used; not applicable for claims — present in list but not typically submitted.
`26`	Professional component	Use when billing only the professional interpretation component, if split billing applies and the lab bills separately for technical and professional services.
`TC`	Technical component	Use when billing only the technical component (laboratory processing, sequencing) and the lab provides the technical work.
`QK`	CLIA waived testing performed in a physician office	Not typically applicable; do not use for NGS-based PLA testing.
`QX`	CLIA non-waived testing performed by the physician or qualified personnel in the physician office	Use only if the performing site meets CLIA requirements and is billing under the physician’s NPI for non-waived molecular testing.
`QY`	CLIA waived testing performed by an independent lab under a provider’s order	Not applicable to NGS PLA testing; included for completeness when CLIA categorization matters.
`52`	Reduced services	Use if the laboratory provided substantially reduced testing relative to the full RightMed PGx16 analysis (rare and must be documented).
`53`	Discontinued procedure	Use if testing was started but discontinued before completion for patient- or specimen-related reasons.
`90`	Not listed in the provided modifier list (excluded)	Data not available in the input.
`22`	Unusual procedural services	Use when additional work beyond the typical lab process is required and documented (rare for standardized PLA tests).
`59`	Distinct procedural service (not provided)	Data not available in the input.

Taxonomy Code	Specialty	Notes
`207Q00000X`	Clinical Laboratory (Laboratory Director)	Laboratories performing or directing NGS-based pharmacogenomic testing.
`363L00000X`	Pathology Laboratory	Molecular pathology and clinical laboratory specialists overseeing genomic assays.
`207K00000X`	Clinical Genetic Molecular Biologist	Professionals responsible for molecular assay validation and interpretation.
`207RG0300X`	Medical Genetics & Genomics	Medical geneticists or pharmacogenomics specialists involved in complex interpretation.
`208D00000X`	Clinical Pharmacology	Clinicians interpreting pharmacogenomic results for medication management.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`F32.9`	Major depressive disorder, single episode, unspecified	Pharmacogenomic testing can guide antidepressant selection and dosing to improve response and reduce adverse effects.
`F33.1`	Major depressive disorder, recurrent, moderate	Used when recurrent depression prompts pharmacogenomic guidance for therapy optimization.
`M54.5`	Low back pain	Chronic pain patients receiving opioids or adjuvant medications may benefit from PGx testing to predict metabolism and risk of adverse effects.
`I10`	Essential (primary) hypertension	Patients on antihypertensive therapy may have drug response influenced by pharmacogenomic variants.
`Z79.899`	Other long term (current) drug therapy	Indicates chronic medication use where PGx results can inform long-term drug selection and dosing.
`G47.00`	Insomnia, unspecified	Sleep disorders treated with medications that have variable metabolism may be informed by PGx testing.
`N18.9`	Chronic kidney disease, unspecified	Renal impairment affects drug selection/dosing; combined with PGx data can guide safer prescribing.
`R51`	Headache	Patients with chronic headaches on multiple agents may have medication failures or adverse events that PGx testing can help clarify.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`81025`	Urine pregnancy test, by visual color comparison methods	Performed prior to certain medications where pregnancy status affects drug selection; may be part of pre-therapy screening in reproductive-age patients.
`36415`	Collection of venous blood by venipuncture	Common specimen collection procedure when `0347U` is performed on a whole blood specimen.
`G0476`	Specimen handling and transport for anatomic pathology	Administrative/transport-related services may be billed by some labs for specimen processing logistics (use depends on payer policies).
`99000`	Handling and/or conveyance of a specimen for transfer from the physician to a laboratory	Ancillary service in specimen transfer; used when applicable to billing practices.
`96127`	Brief emotional/behavioral assessment (e.g., depression screening)	Often performed in medication management contexts where pharmacogenomic testing is ordered for psychiatric medication optimization.

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Summary & Overview

CPT 0347U: RightMed PGx16 Pharmacogenomic NGS Test

Data not available in the input for associated taxonomies, specific ICD-10 diagnoses, and related or line-item service code mappings.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0347UCPTpharmacogenomicsproprietary laboratory analysisNGSRightMed PGx16laboratory testingprecision medicine

Billing Code Overview

Service Type: Laboratory — pharmacogenomic testing using NGS of blood or buccal swab

Typical Site of Service: Clinical laboratory or reference laboratory; specimen collection performed at outpatient clinics or collection centers

Clinical & Coding Specifications

Clinical Context

Coding Specifications

Modifier	Description	When to Use
`00`	HIPAA Placeholder (no longer used clinically)	Rarely used; not applicable for claims — present in list but not typically submitted.
`26`	Professional component	Use when billing only the professional interpretation component, if split billing applies and the lab bills separately for technical and professional services.
`TC`	Technical component	Use when billing only the technical component (laboratory processing, sequencing) and the lab provides the technical work.
`QK`	CLIA waived testing performed in a physician office	Not typically applicable; do not use for NGS-based PLA testing.
`QX`	CLIA non-waived testing performed by the physician or qualified personnel in the physician office	Use only if the performing site meets CLIA requirements and is billing under the physician’s NPI for non-waived molecular testing.
`QY`	CLIA waived testing performed by an independent lab under a provider’s order	Not applicable to NGS PLA testing; included for completeness when CLIA categorization matters.
`52`	Reduced services	Use if the laboratory provided substantially reduced testing relative to the full RightMed PGx16 analysis (rare and must be documented).
`53`	Discontinued procedure	Use if testing was started but discontinued before completion for patient- or specimen-related reasons.
`90`	Not listed in the provided modifier list (excluded)	Data not available in the input.
`22`	Unusual procedural services	Use when additional work beyond the typical lab process is required and documented (rare for standardized PLA tests).
`59`	Distinct procedural service (not provided)	Data not available in the input.

Taxonomy Code	Specialty	Notes
`207Q00000X`	Clinical Laboratory (Laboratory Director)	Laboratories performing or directing NGS-based pharmacogenomic testing.
`363L00000X`	Pathology Laboratory	Molecular pathology and clinical laboratory specialists overseeing genomic assays.
`207K00000X`	Clinical Genetic Molecular Biologist	Professionals responsible for molecular assay validation and interpretation.
`207RG0300X`	Medical Genetics & Genomics	Medical geneticists or pharmacogenomics specialists involved in complex interpretation.
`208D00000X`	Clinical Pharmacology	Clinicians interpreting pharmacogenomic results for medication management.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`F32.9`	Major depressive disorder, single episode, unspecified	Pharmacogenomic testing can guide antidepressant selection and dosing to improve response and reduce adverse effects.
`F33.1`	Major depressive disorder, recurrent, moderate	Used when recurrent depression prompts pharmacogenomic guidance for therapy optimization.
`M54.5`	Low back pain	Chronic pain patients receiving opioids or adjuvant medications may benefit from PGx testing to predict metabolism and risk of adverse effects.
`I10`	Essential (primary) hypertension	Patients on antihypertensive therapy may have drug response influenced by pharmacogenomic variants.
`Z79.899`	Other long term (current) drug therapy	Indicates chronic medication use where PGx results can inform long-term drug selection and dosing.
`G47.00`	Insomnia, unspecified	Sleep disorders treated with medications that have variable metabolism may be informed by PGx testing.
`N18.9`	Chronic kidney disease, unspecified	Renal impairment affects drug selection/dosing; combined with PGx data can guide safer prescribing.
`R51`	Headache	Patients with chronic headaches on multiple agents may have medication failures or adverse events that PGx testing can help clarify.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`81025`	Urine pregnancy test, by visual color comparison methods	Performed prior to certain medications where pregnancy status affects drug selection; may be part of pre-therapy screening in reproductive-age patients.
`36415`	Collection of venous blood by venipuncture	Common specimen collection procedure when `0347U` is performed on a whole blood specimen.
`G0476`	Specimen handling and transport for anatomic pathology	Administrative/transport-related services may be billed by some labs for specimen processing logistics (use depends on payer policies).
`99000`	Handling and/or conveyance of a specimen for transfer from the physician to a laboratory	Ancillary service in specimen transfer; used when applicable to billing practices.
`96127`	Brief emotional/behavioral assessment (e.g., depression screening)	Often performed in medication management contexts where pharmacogenomic testing is ordered for psychiatric medication optimization.