Summary & Overview
CPT 80366: Pregabalin Presence or Quantitation in Patient Specimen
CPT code 80366 represents a laboratory assay that measures or detects pregabalin in a patient specimen. Pregabalin is prescribed for neuropathic pain and certain seizure disorders, and monitoring its presence or concentration can inform clinical management, adherence checks, and safety assessments. Nationally, drug-specific toxicology and therapeutic drug monitoring codes like 80366 support medication safety programs and enable payers and providers to track use of controlled or high-risk medications.
Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a clinical and billing context for the test, typical sites of service, and the scope of common modifiers used with laboratory services. The publication outlines typical payer coverage patterns and benchmarks where available, highlights coding considerations for laboratory reporting, and summarizes clinical scenarios in which pregabalin testing may be ordered.
This summary is intended for billing managers, laboratory directors, compliance officers, and clinicians seeking a concise reference on the purpose and use of CPT code 80366, its place within therapeutic drug monitoring and toxicology services, and the payer landscape relevant to national practice.
Billing Code Overview
CPT code 80366 describes a laboratory test in which a lab analyst measures the amount of, or detects the presence of, pregabalin in a patient specimen. This service is a therapeutic drug monitoring/toxicology assay for a prescription medication used to treat neuropathic pain and certain seizure disorders.
Service Type: Therapeutic drug monitoring / toxicology testing
Typical Site of Service: Clinical laboratory or hospital laboratory
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Clinical & Coding Specifications
Clinical Context
A 54-year-old patient with a history of diabetic peripheral neuropathy and chronic postherpetic neuralgia presents for medication management and therapeutic monitoring. The clinician prescribes pregabalin and orders a laboratory assay to detect and/or quantify pregabalin in the patient’s plasma to assess adherence, confirm ingestion prior to medication changes, evaluate potential overdose, or support a medicolegal or workplace evaluation. A phlebotomy technician collects a blood specimen in the outpatient laboratory; the sample is labeled and sent to the hospital clinical chemistry/toxicology laboratory. A laboratory analyst performs the targeted assay for pregabalin using validated methods (for example, liquid chromatography–tandem mass spectrometry or immunoassay where available), documents the result in the electronic medical record, and the ordering provider reviews the result to inform clinical decisions such as dose adjustment, discontinuation, or further toxicology testing.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier — standard billing | Use when no special circumstances apply and full services were provided. |
26 | Professional component |