Summary & Overview
CPT 0070U: CYP2D6 Common Variants and Copy Number Test
CPT code 0070U designates a proprietary genetic test — the CYP2D6 Common Variants and Copy Number assay developed by the Mayo Clinic Laboratory — used to detect variants and copy number changes in the CYP2D6 gene that influence drug metabolism. As a PLA code, 0070U applies to this single manufacturer/laboratory-specific assay. Nationally, pharmacogenomic testing for CYP2D6 has implications for medication safety and efficacy across oncology, pain management, and psychiatry because CYP2D6 metabolizes widely used drugs such as tamoxifen, codeine, and tramadol.
Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. The publication outlines payer coverage considerations and benchmarking where available, and summarizes the clinical context for ordering this pharmacogenomic assay.
Readers will learn the clinical purpose and testing scope of CPT code 0070U, typical sites of service and service type, and which major national payers are relevant to coverage discussions. The report also identifies where input data was unavailable and highlights areas for follow-up, including payer-specific coverage policies and coding relationships. Data not available in the input includes detailed payer policy language, associated taxonomies, ICD-10 diagnosis codes, and related CPT/HCPCS crosswalks.
Billing Code Overview
CPT code 0070U is a Proprietary Laboratory Analyses (PLA) code for the CYP2D6 Common Variants and Copy Number test, developed by the Mayo Clinic Laboratory. The test identifies common genetic variants and copy number changes in the CYP2D6 gene that can affect metabolism rates for many medications, including tamoxifen, codeine, and tramadol.
Service Type: Genetic/Pharmacogenomic testing
Typical Site of Service: Clinical laboratory setting (specimens collected in outpatient clinics or inpatient settings and sent to the performing laboratory for analysis).
Clinical & Coding Specifications
Clinical Context
A 48-year-old woman with estrogen receptor–positive breast cancer is being considered for adjuvant tamoxifen therapy. Her oncology team orders the CYP2D6 Common Variants and Copy Number test to determine her CYP2D6 metabolizer status because variants and gene copy number alter conversion of tamoxifen to its active metabolites. A peripheral blood or buccal sample is collected in the outpatient oncology clinic or specialty laboratory. The sample is sent to the Mayo Clinic Laboratory for the proprietary assay reported under 0070U. Results are returned to the ordering clinician and integrated into the medication management plan: ultrarapid, normal, intermediate, or poor metabolizer status may inform selection or dosing of tamoxifen, alternative endocrine therapy, or avoidance of CYP2D6‑metabolized analgesics such as codeine or tramadol. Typical site of service: outpatient oncology clinic, genetic testing laboratory, or hospital outpatient laboratory. Service type: proprietary molecular diagnostic laboratory test (Proprietary Laboratory Analysis, PLA).
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Instance not applicable (placeholder) | Rarely used; include only if payer-specific billing system requires a default instance code. |
26 | Professional component | When reporting only the professional interpretation component if separated from the technical component. |
TC | Technical component | When reporting only the technical component (laboratory processing) separate from professional interpretation. |
59 | Distinct procedural service (note: not in provided list) | Data not available in the input. |
82 | Assistant surgeon (when a qualified resident surgeon is unavailable) | Generally not applicable to lab-only tests; not routinely used for 0070U but included in input list. |
AD | Anesthesia-related modifier (surgical team) | Not typically used for lab testing; include only if billing system lists it. |
CO | Staged or related to prior surgery (contracted out) | Uncommon for this PLA; used per payer rules if specimen collection is related to prior surgery billing. |
QX | Services furnished under a qualified nonphysician practitioner’s supervision | Use when a qualified nonphysician practitioner orders/collects specimen per payer policy. |
QK | Medical direction of two or more qualified individuals by a physician | Use only if billing requires documentation of supervisory structure for specimen collection. |
QY | Attending under physician supervision (nonphysician provider) | When a nonphysician performs the service under physician attendance per payer rules. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
208000000X | Medical Oncology | Oncologists commonly order CYP2D6 testing for tamoxifen therapy planning. |
207RI0200X | Clinical Molecular Genetics | Laboratory specialists who interpret and report molecular genotype and copy number results. |
207RG0100X | Clinical Pathology | Pathologists and laboratory directors overseeing testing quality and reporting. |
163W00000X | Oncology (Radiation Oncology not primary) | Oncology team members involved in multidisciplinary therapy decisions may order testing. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
Z15.01 | Genetic susceptibility to malignant neoplasm of breast | Relevant when assessing hereditary or pharmacogenomic factors that may influence breast cancer therapy decisions, including tamoxifen metabolism. |
C50.912 | Malignant neoplasm of unspecified site of left female breast | Breast cancer diagnosis for which tamoxifen may be prescribed and CYP2D6 testing considered. |
C50.911 | Malignant neoplasm of unspecified site of right female breast | As above; indicates laterality when documenting reason for pharmacogenomic testing. |
Z79.810 | Long term (current) use of aromatase inhibitors | Relevant alternative endocrine therapy considerations when tamoxifen metabolism is impaired. |
Z79.899 | Other long term (current) drug therapy | General code for long-term medication use when drug-gene interactions are evaluated. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
81225 | CYP2C19 gene analysis; common variants | Pharmacogenomic panel companion test for drugs metabolized by CYP2C19; may be ordered along with CYP2D6 for broader pharmacogenomic profiling. |
0001U | Pharmacogenomic multigene assay (example proprietary PLA) | Other PLA or multigene assays may be ordered in parallel for comprehensive drug-gene interaction assessment. |
88360 | Immunohistochemistry; multiple specific proteins (per slide) | Tissue-based ancillary testing in oncology patients; may be part of broader biomarker workup alongside germline/somatic genotyping. |
36415 | Collection of venous blood by venipuncture | Common specimen collection procedure for blood-based pharmacogenomic testing. |
99000 | Handling and/or conveyance of specimen for transfer to another laboratory | Used when specimen shipping or special handling for a proprietary lab assay is billed per payer policy. |