Summary & Overview
CPT 0076U: CYP2D6 3' Duplication/Multiplication Targeted Sequence Analysis
CPT code 0076U identifies a Proprietary Laboratory Analyses (PLA) assay: a Mayo Clinic Laboratory–developed targeted sequence analysis for CYP2D6 3' gene duplication/multiplication used as a follow-up when initial testing (0070U) does not determine genotype. This molecular diagnostic clarifies CYP2D6 copy number variations that influence metabolic capacity for numerous medications, making it clinically significant for personalized prescribing and adverse drug-event risk reduction nationwide. Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the code’s clinical purpose and testing context, payer coverage landscape, common billing modifiers, and operational considerations for laboratory and ordering clinicians. The publication summarizes available benchmarks and coverage trends where available, explains clinical implications of unresolved CYP2D6 genotyping, and highlights policy or coding clarifications relevant to PLA codes. Data not available in the input is noted explicitly where applicable.
Billing Code Overview
CPT code 0076U is a Proprietary Laboratory Analyses (PLA) code for the CYP2D6 3' gene duplication/multiplication targeted sequence analysis, developed by the Mayo Clinic Laboratory. The test is a follow-up molecular diagnostic assay performed when the initial 0070U test does not resolve a patient’s CYP2D6 genotype. Results can affect clinical interpretation of a patient’s ability to metabolize certain medications that are substrates of the CYP2D6 enzyme.
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Service type: Follow-up molecular diagnostic targeted sequence analysis (proprietary laboratory test)
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Typical site of service: Clinical reference laboratory setting; specimen collection typically originates in outpatient clinics or hospital outpatient departments prior to referral to the performing laboratory.
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Clinical & Coding Specifications
Clinical Context
A 42-year-old patient with a history of chronic pain and prior trial of multiple antidepressants is undergoing pharmacogenetic evaluation to optimize medication selection. Initial targeted CYP2D6 testing (0070U) returned inconclusive results for copy number variants and could not determine whether the patient carries a CYP2D6 gene duplication or multiplication that would predict ultrarapid metabolism. The ordering clinician (typically a clinical pharmacologist, pain specialist, or psychiatrist) requests the follow-up targeted sequence analysis 0076U from the Mayo Clinic Laboratory to resolve copy number status.
The clinical workflow: the clinician documents the indication (medication selection/poor response or adverse effects potentially related to CYP2D6 metabolism), completes a genetics laboratory order including relevant medications and prior test results, and obtains an appropriate specimen (usually whole blood or saliva per lab instructions). The sample is shipped to the performing laboratory. The laboratory performs the proprietary CYP2D6 duplication/multiplication targeted sequence analysis (0076U) and returns a report specifying copy number and allele configuration, which the clinician uses to adjust drug choice or dosing for medications metabolized by CYP2D6 (for example certain antidepressants, opioids, and antipsychotics). Typical site of service is a clinical laboratory or hospital outpatient laboratory where molecular diagnostic testing is performed.
Coding Specifications
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