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The CPT® Code 80210 refers to a laboratory test specifically designed for the monitoring of therapeutic levels of rufinamide, which is an antiepileptic medication. Rufinamide is primarily utilized in the treatment of seizures associated with Lennox-Gastaut syndrome, a severe form of epilepsy that affects both children and adults, as well as for managing focal seizures in adolescents and adults. The purpose of therapeutic drug monitoring (TDM) is to ensure that the drug levels remain within a therapeutic range, which is crucial for maximizing efficacy while minimizing the risk of toxicity. This monitoring is particularly important for patients who may be taking other medications that could interact with rufinamide or those undergoing hemodialysis, as these factors can significantly influence drug metabolism and clearance. The elimination half-life of rufinamide ranges from 6 to 10 hours, indicating the time it takes for half of the drug to be eliminated from the body, which occurs through hepatic metabolism. Effective management of seizures is associated with mean plasma concentration trough levels of rufinamide between 5.0 and 30 mcg/mL. This range is broad due to individual variability in drug absorption and clearance, as well as the potential impact of co-administered medications. Levels exceeding 30 mcg/mL have been associated with toxicity, which can manifest through various adverse effects, including headache, dizziness, fatigue, nausea, and drowsiness. To accurately assess rufinamide levels, a blood specimen is typically collected just before the next scheduled dose or at least 12 hours after the last dose of a sustained-release formulation. The collected sample must be processed promptly; it is centrifuged to separate the serum from blood cells within two hours of collection and then stored in a plastic vial for analysis. The concentration levels of rufinamide are determined using advanced techniques such as quantitative solid phase extraction-tandem mass spectrometry or quantitative liquid chromatography-tandem mass spectrometry, ensuring precise measurement of the drug in the bloodstream.
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The laboratory test associated with CPT® Code 80210 is indicated for the following conditions:
The procedure for conducting the laboratory test associated with CPT® Code 80210 involves several critical steps to ensure accurate measurement of rufinamide levels:
Post-procedure care following the blood specimen collection for CPT® Code 80210 is generally minimal, as the primary focus is on the analysis of the serum sample. However, it is important to monitor the patient for any immediate adverse reactions to the blood draw, such as bruising or discomfort at the puncture site. Once the results of the rufinamide level are obtained, healthcare providers will review the findings to assess whether the drug concentration is within the therapeutic range. If the levels are found to be outside the recommended range, adjustments to the dosage may be necessary. Additionally, ongoing monitoring may be required for patients on rufinamide, especially those who are also taking other medications or undergoing hemodialysis, to ensure continued efficacy and safety of the treatment regimen.
| Short Descr | DRUG ASSAY RUFINAMIDE | Medium Descr | DRUG ASSAY RUFINAMIDE | Long Descr | Rufinamide | Status Code | Statutory Exclusion (from MPFS, may be paid under other methodologies) | Global Days | XXX - Global Concept Does Not Apply | PC/TC Indicator (26, TC) | 9 - Not Applicable | Multiple Procedures (51) | 9 - Concept does not apply. | Bilateral Surgery (50) | 9 - Concept does not apply. | Physician Supervisions | 09 - Concept does not apply. | Assistant Surgeon (80, 82) | 9 - Concept does not apply. | Co-Surgeons (62) | 9 - Concept does not apply. | Team Surgery (66) | 9 - Concept does not apply. | Diagnostic Imaging Family | 99 - Concept Does Not Apply | CLIA Waived (QW) | No | APC Status Indicator | Conditionally packaged laboratory tests | Type of Service (TOS) | 5 - Diagnostic Laboratory | Berenson-Eggers TOS (BETOS) | none | MUE | 1 |
| 90 | Reference (outside) laboratory: when laboratory procedures are performed by a party other than the treating or reporting physician or other qualified health care professional, the procedure may be identified by adding modifier 90 to the usual procedure number. |
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| 2021-01-01 | Added | Code added. |
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