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 | Professional component | Use if billing separately for interpretation when the facility bills technical component |
52 | Reduced services | Use when the test is partially performed and results are limited |
53 | Discontinued procedure | Use if specimen was collected but testing discontinued for documented reasons |
62 | Two surgeons | Rarely applicable; use if two independent labs/providers share professional responsibilities and payer permits |
78 | Unplanned return to OR | Not typically applicable; included when an associated surgical complication requires subsequent testing |
80 | Assistant surgeon | Not typically applicable; include only if an assistant provider bills for a component of professional interpretation per payer policy |
82 | Assistant surgeon (when qualified resident unavailable) | See 80; seldom used for lab testing |
AS | Physician assistant or advanced practitioner | Use when an advanced practice clinician performs specimen collection or orders and bills under their NPI where permitted |
TC | Technical component | Use when billing only the laboratory processing and not the professional interpretation |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 208D00000X | Medical Geneticist | Clinical oversight of pharmacogenomics interpretation and consultation |
| 207Q00000X | Clinical Pharmacology | Medication management and interpretation of pharmacogenomic results |
| 207L00000X | Psychiatry & Neurology | Frequent ordering clinicians for psychotropic pharmacogenomic guidance |
| 207P00000X | Pain Medicine | Use for guidance on opioid prescribing related to CYP2D6 status |
| 363LF0000X | Clinical Laboratory | Performing laboratory specialty for genotyping and test processing |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
Z13.6 | Encounter for screening for cardiovascular disorders | Used when screening medication response risk that affects cardiovascular drugs (e.g., clopidogrel) |
Z13.79 | Encounter for other screening for genetic and chromosomal anomalies | Applied for general pharmacogenomic screening encounters |
F32.9 | Major depressive disorder, single episode, unspecified | Common indication when selecting or adjusting antidepressant therapy based on metabolizer status |
G89.29 | Other chronic pain | Used when optimizing analgesic regimens influenced by CYP2D6 and other gene variants |
I10 | Essential (primary) hypertension | Relevant when pharmacogenomic results may guide antihypertensive drug choice or dosing |
Z79.899 | Other long term (current) drug therapy | Indicates chronic medication use where pharmacogenomic testing informs ongoing therapy |
T40.2X5A | Poisoning by other opioids, accidental (initial encounter) | Used in contexts of opioid management and risk assessment where CYP2D6 status may be relevant |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
36415 | Collection of venous blood by venipuncture | Often performed immediately before sending sample for the pharmacogenomic test |
99000 | Handling and/or conveyance of specimen for transfer from phlebotomy site to laboratory | Used when facility bills for special specimen transport services per payer policy |
0054U | Pharmacogenomic panel (example PLA) | Other pharmacogenomic PLA codes may be ordered in parallel when different vendor tests are used (laboratory-dependent) |
80307 | Drug metabolizing enzyme genotype, common variants | Single-gene pharmacogenomic tests sometimes ordered when confirmatory or limited testing is requested alongside a broad panel |
81025 | Urine drug screen, presumptive, different classes | Medication monitoring tests frequently performed in patients whose therapy will be adjusted based on pharmacogenomic results |