Summary & Overview

CPT 0075U: CYP2D6 5’ Gene Duplication/Multiplication Targeted Sequence Analysis

CPT code 0075U designates a Proprietary Laboratory Analyses (PLA) test for targeted sequencing to detect CYP2D6 5’ gene duplication or multiplication, developed by the Mayo Clinic Laboratory. It is intended as a reflex or follow-up assay when the primary PLA test 0070U fails to resolve a patient’s CYP2D6 genotype. This genotype can influence the metabolism of multiple commonly prescribed drugs, making accurate determination clinically important for personalized medication management.

Key national payers included in coverage considerations are Aetna, Blue Cross Blue Shield, Cigna, UnitedHealthcare and Medicare. Readers will find a concise description of the clinical role of the test, how it functions as a follow-up molecular assay in reference laboratory settings, and what aspects typically affect payer coverage decisions for PLA molecular diagnostics. The publication outlines benchmarks and policy-relevant topics such as PLA coding implications, clinical utility in pharmacogenomics, and common payer considerations for single-manufacturer diagnostics. Data not provided in the input — including specific payer coverage policies, associated taxonomies, ICD-10 mappings, and related codes — are noted as unavailable. The report is geared to billing managers, laboratory directors, and policy analysts seeking a national-level briefing on CPT code 0075U and its clinical context.

AetnaBlue Cross Blue ShieldCignaUnitedHealthcareMedicare0075UCPTProprietary Laboratory AnalysesCYP2D6pharmacogenomicsmolecular-diagnosticslaboratory-testfollow-up-test

Billing Code Overview

CPT code 0075U is a Proprietary Laboratory Analyses (PLA) code for the CYP2D6 5’ gene duplication/multiplication targeted sequence analysis developed by the Mayo Clinic Laboratory. This test is a follow-up molecular diagnostic assay used when the initial 0070U test does not determine a patient’s CYP2D6 genotype. The result can impact drug metabolism and pharmacogenomic decision-making for medications processed by the CYP2D6 pathway.

Service type: Targeted molecular diagnostic laboratory test (gene duplication/multiplication analysis)
Typical site of service: Clinical molecular laboratory / reference laboratory testing performed on patient specimens

Clinical & Coding Specifications

Clinical Context

A patient undergoing pharmacogenomic assessment for medication selection and dosing presents for targeted follow-up testing after an initial CYP2D6 assay returned ambiguous results. Typical scenario: a 45-year-old patient with chronic pain and major depressive disorder is being evaluated because prior treatment failures and adverse drug reactions suggest atypical CYP2D6 metabolism. The initial CYP2D6 targeted sequence analysis (0070U) yielded inconclusive genotype calls related to copy number variation. The clinician orders the CYP2D6 5' gene duplication/multiplication targeted sequence analysis (0075U) performed by a specialized laboratory (Mayo Clinic Laboratory) to resolve gene duplication/multiplication and finalize the patient’s CYP2D6 diplotype.

Clinical workflow:

Referral/order: The prescribing clinician (pain specialist, psychiatrist, primary care physician, or clinical pharmacogeneticist) places an order for 0075U when 0070U is inconclusive for copy number variants.
Sample collection: A peripheral blood sample or validated DNA specimen is collected at an outpatient phlebotomy center or hospital laboratory and sent to the specialized laboratory.
Laboratory processing: The Mayo Clinic Laboratory performs the proprietary targeted sequence analysis to detect 5' gene duplications/multiplications and reports definitive copy number and allele structure.
Result reporting: The laboratory issues a report indicating resolved CYP2D6 genotype (eg, ultrarapid, normal, intermediate, or poor metabolizer classification) with interpretation relevant to medications metabolized by CYP2D6.

Coding Specifications

Modifier	Description	When to Use
`26`	Professional component	Use when billing separate professional interpretation/reporting component if facility or reference lab bills technical and ordering provider bills professional portion.
`TC`	Technical component	Use when billing only the technical component (laboratory processing) by the performing lab.
`90`	Data not provided in input	Data not available in the input.
`62`	Two surgeons	Use only if two independent physicians share responsibility for a complex sample acquisition procedure (rare for this lab test).
`78`	Return to OR for related procedure	Not typically applicable; included for completeness when specimen collection involves a procedure requiring re-operation.
`52`	Reduced services	Use when the laboratory performs a limited or partial test compared with full proprietary assay (rare and by payer policy).
`53`	Discontinued procedure	Use if collection or testing was started but discontinued for reasons beyond control.
`22`	Increased procedural services	Use when additional work or complexity justifies reporting increased service for interpretation beyond typical reporting.
`59`	Data not provided in input	Data not available in the input.
`QK`	Medical direction of two or more CRNAs/Anesthetists	Not applicable to laboratory testing but listed among common modifiers.

Taxonomy Code	Specialty	Notes
`207L00000X`	Clinical Pathology	Pathologists who oversee molecular diagnostic testing and interpretation.
`207RP1001X`	Medical Genetics	Medical geneticists involved in pharmacogenomic interpretation and consultative services.
`207V00000X`	Clinical Molecular Genetics	Laboratory directors or molecular geneticists performing complex genomic assays.
`208D00000X`	Psychiatry	Psychiatrists ordering CYP2D6 testing for psychotropic medication management.
`208M00000X`	Pain Medicine	Pain medicine specialists ordering pharmacogenomic testing for analgesic selection.

ICD-10 Code	Description	Clinical Relevance
`Z13.79`	Encounter for screening for other disorder	Used when a pharmacogenomic test is ordered as part of medication therapy management or screening prior to therapy.
`F32.9`	Major depressive disorder, single episode, unspecified	Depression often treated with CYP2D6-metabolized antidepressants; genotype guides therapy.
`G89.29`	Other chronic pain	Chronic pain patients considered for opioid therapy benefit from CYP2D6 metabolizer status for opioid selection/dosing.
`T40.2X5A`	Poisoning by other opioids, accidental (initial encounter)	Relevant in assessment after adverse opioid event where genotype may explain susceptibility.
`Z79.899`	Other long term (current) drug therapy	Patients on chronic medications metabolized by CYP2D6 may have testing to optimize long-term therapy.

CPT Code	Description	Relationship to This Procedure
`0070U`	CYP2D6 targeted sequence analysis (initial assay)	Initial CYP2D6 genotype assay; `0075U` is a follow-up when `0070U` cannot determine genotype due to copy number ambiguity.
`81225`	CYP2D6 gene analysis; full gene sequencing (when performed via standard CPT)	Alternative or supplementary genetic testing in some workflows when specialized PLA testing is not used.
`81479`	Unlisted molecular pathology procedure	Used when a specific proprietary PLA code is not available; not typical when `0075U` exists.
`8050F`	Laboratory test results documented (quality measure CPT® II)	Quality reporting or clinical documentation codes that may accompany pharmacogenomic testing results in the medical record.

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