Summary & Overview
CPT 0516U: MyGenVar Pharmacogenomics Test, 40-Gene Panel with CYP2D6 CNV
CPT code 0516U designates the MyGenVar Pharmacogenomics Test, a Proprietary Laboratory Analyses (PLA) code for a single-vendor genetic assay that genotypes 40 genes and assesses CYP2D6 copy number variants from whole blood to report metabolizer status. PLA codes identify unique commercial tests and matter nationally because they affect how novel diagnostics are billed, tracked, and incorporated into clinical care across payers and settings.
Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise explanation of the clinical purpose of the test, its laboratory service setting, and the implications of PLA coding for billing and administrative workflows. The publication covers benchmarking considerations for proprietary genetic tests, payer coverage patterns, coding nuances for lab-only proprietary assays, and clinical context on pharmacogenomic metabolizer reporting.
This analysis is intended for national audiences including payers, laboratory billing teams, and clinical program managers. It provides an overview of what the code represents, which payers are relevant in cross-payer comparisons, and the topics addressed in the full publication: reimbursement benchmarks, payer policy trends, and the clinical utility of multi-gene pharmacogenomic panels. Data not available in the input is noted where applicable in detailed sections.
Billing Code Overview
CPT code 0516U is a Proprietary Laboratory Analyses (PLA) code that applies specifically to the MyGenVar Pharmacogenomics Test produced by Geisinger Medical Laboratories. The test performs pharmacogenomic genotyping across 40 genes and evaluates CYP2D6 copy number variants using whole blood to report a patient’s metabolizer status.
Service type: Pharmacogenomic genotyping / laboratory diagnostic test
Typical site of service: Clinical laboratory or hospital laboratory
Clinical & Coding Specifications
Clinical Context
A 52-year-old patient with multiple chronic conditions (depression on selective serotonin reuptake inhibitor, hypertension, and chronic pain treated with opioids) is referred for pharmacogenomic testing to guide medication selection and dosing. The clinician orders the MyGenVar Pharmacogenomics Test (Geisinger Medical Laboratories) to analyze 40 pharmacogenes and CYP2D6 copy number variants using a whole blood specimen. The specimen is collected in an outpatient phlebotomy setting or during an ambulatory clinic visit. The sample is sent to the performing laboratory where genotyping and CYP2D6 copy-number analysis are completed, and a report is returned describing metabolizer status for actionable genes and recommended genotype-guided drug adjustments. Typical clinical workflow: clinician documents medication history and rationale, obtains informed consent when required, collects whole blood sample, ships sample to Geisinger Medical Laboratories, receives structured lab report, and integrates results into the electronic health record for medication optimization discussions with the patient.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier | Use when no special reporting of component or circumstance is required |
26 |