Summary & Overview
CPT 0461U: RightMed Oncology Medication Report, 24-Gene SNP Panel
CPT code 0461U designates a Proprietary Laboratory Analyses (PLA) test specific to OneOme® LLC’s RightMed® Oncology Medication Report. The assay performs single–nucleotide polymorphism (SNP) genotyping across 24 genes using whole blood or buccal swab specimens and reports phenotypes and predicted gene–drug interactions relevant to oncology medication selection. Nationally, pharmacogenomic panels like this are increasingly used to tailor cancer therapy and anticipate drug response or toxicity, influencing prescribing and care pathways.
Key payers included in the national context are Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise explanation of what the code represents, the clinical and laboratory service model, and what types of service benchmarks and policy considerations typically apply to PLA genomic testing. The publication outlines how this test fits into the clinical workflow, typical sites of collection and processing, and the implications for coverage determinations and billing practices. Data not provided in the input—such as specific payer coverage policies, reimbursement benchmarks, associated taxonomies, ICD-10 mappings, and related codes—are noted as unavailable in source material.
Billing Code Overview
CPT code 0461U is a Proprietary Laboratory Analyses (PLA) code reported only for the RightMed® Oncology Medication Report from OneOme® LLC. The test uses a whole blood or buccal (cheek) swab specimen and performs single–nucleotide polymorphism (SNP) genotyping of 24 genes. Results report phenotypes and likely gene–drug interactions to help inform provider decision-making about cancer therapy selection and medication management.
Service type: Clinical genomic pharmacogenomic testing (SNP genotyping, targeted panel)
Typical site of service: Clinical laboratory or outpatient clinic where specimen collection occurs (blood draw or buccal swab collection)
Clinical & Coding Specifications
Clinical Context
A 58-year-old patient with a recently diagnosed solid tumor (e.g., colorectal or breast cancer) is scheduled to start systemic anticancer therapy. The oncology care team orders the RightMed® Oncology Medication Report (0461U) to inform selection and dosing of chemotherapeutic agents and targeted therapies. A buccal cheek swab or whole blood specimen is collected during an outpatient oncology clinic visit or at an external specimen collection site. The sample is sent to OneOme® LLC for proprietary SNP genotyping across 24 pharmacogenes. The laboratory returns a report that translates genotypes to phenotypes and identifies likely gene–drug interactions relevant to oncology medications. The oncologist and clinical pharmacist review the report in the electronic health record, document results in the chart, and use the information to discuss therapy options, dose adjustments, or monitoring strategies with the patient. Typical sites of service include outpatient oncology clinics, hospital outpatient departments, and contracted phlebotomy or specimen collection centers. The service type is specialized pharmacogenomic laboratory testing (Proprietary Laboratory Analyses).
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Default/No modifier | Use when no special circumstances apply to the billed PLA service. |
22 | Increased procedural services | Use when additional work or interpretation beyond the typical report is required and properly documented (rare for PLA but applicable if substantial consulting time is billed separately and documented). |
52 | Reduced services | Use when the test is partially performed or limited (for example, specimen inadequate requiring partial analysis) and documentation supports reduced service. |
53 | Discontinued procedure | Use when specimen collection or testing was started but discontinued for documented clinical reasons prior to completion. |
59 | Distinct procedural service | Use when reporting an unrelated, separate service on the same date (may be applicable if another lab test or procedure is performed distinct from the PLA report). |
76 | Repeat procedure by same physician | Use if the same PLA test is legitimately repeated by the same laboratory/ordering provider for clinical reasons. |
77 | Repeat procedure by another physician | Use when a different provider orders a repeat of the PLA test and documentation supports medical necessity. |
90 | Reference (outside) laboratory | Use when the performing laboratory is a reference lab different from the ordering or billing provider. |
91 | Repeat clinical diagnostic laboratory test | Use when repeat genotyping is performed on the same day to confirm results (documentation required). |
RT | Right side | Not typically applicable to this test; included only if laterality coding is specifically required (unlikely for genotyping). |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 2085R0200X | Medical Oncology | Medical oncologists commonly order and interpret oncology pharmacogenomic reports. |
| 207RC0000X | Clinical Pharmacology | Clinical pharmacologists or pharmacogenomics specialists provide interpretation and medication management recommendations. |
| 207L00000X | Clinical Laboratory / Pathology | Laboratory directors and molecular pathology specialists oversee test performance and result validation. |
| 363LP0800X | Genetic Laboratory | Molecular geneticists and laboratory geneticists are responsible for assay validation and reporting. |
| 207K00000X | Hematology/Oncology | Hematologist–oncologists involved in systemic cancer therapy decisions may use the report. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
C18.9 | Malignant neoplasm of colon, unspecified | Common solid tumor indication where pharmacogenomic testing can inform chemotherapy selection and dosing. |
C50.919 | Malignant neoplasm of unspecified site of right female breast, unspecified | Breast cancer patients often undergo pharmacogenomic assessment to guide endocrine and cytotoxic therapy. |
C34.90 | Malignant neoplasm of unspecified part of bronchus or lung, unspecified | Lung cancer management may incorporate pharmacogenomic results for targeted agents and supportive care medications. |
C61 | Malignant neoplasm of prostate | Prostate cancer systemic therapy planning can include pharmacogenomic considerations for drug selection and toxicity risk. |
Z85.3 | Personal history of malignant neoplasm of breast | Survivorship or recurrent disease contexts where updated pharmacogenomic profiling may influence therapy decisions. |
Z15.09 | Genetic susceptibility to other malignant neoplasm | Relevant when patients have recognized genetic risks; pharmacogenomic testing complements broader genomic risk assessment. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
81000 | Urinalysis, by dip stick or tablet reagent for bilirubin, glucose, ketones, etc.; without microscopy | Performed as part of baseline labs prior to initiating systemic therapy; not directly related to genotyping but commonly ordered at the same visit. |
36415 | Collection of venous blood by venipuncture | Common specimen collection procedure when 0461U is performed using whole blood. |
88120 | Cytopathology, evaluation of fine needle aspirate, immediate cytohistologic study to determine adequacy of specimen | May be performed in parallel when tumor sampling is required; separate workflow from PLA genotyping. |
G0452 | Pharmacogenomic testing (drug metabolism enzyme polymorphism) — note: example of non-PLA pharmacogenomic code | Represents alternate or complementary pharmacogenomic testing when billed outside PLA framework; helps identify related payer coverage pathways. |
80307 | Drug testing, qualitative; multiple drug classes (e.g., for therapeutic drug monitoring) | May be ordered during oncology management for medication monitoring; complements pharmacogenomic information in therapy decisions. |