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Official Description

Lacosamide

© Copyright 2026 American Medical Association. All rights reserved.

Common Language Description

The CPT® Code 80235 refers to a laboratory test specifically designed to monitor therapeutic drug levels of lacosamide. Lacosamide is an anti-epileptic medication primarily utilized in the treatment of partial-onset seizures in patients aged 4 years and older, as well as for managing peripheral neuropathy. The mechanism of action for lacosamide involves the selective enhancement of slow inactivation of sodium channels located in brain synapses. Additionally, it interacts with a neuroplasticity-relevant target known as collapsin-response mediator protein-2 (CRMP-2), which plays a role in neuronal signaling and plasticity. When administered, peak levels of lacosamide are typically reached approximately one hour following intravenous infusion and around four hours after oral administration. The drug has a half-life of about 13 hours, which necessitates a dosing regimen of twice daily to effectively prevent breakthrough seizures in patients. Lacosamide is metabolized in the liver and subsequently excreted through urine, making monitoring of its levels crucial for ensuring therapeutic efficacy and safety. To assess the drug levels, a blood sample is collected, which is reported as a separate procedure. The serum is then analyzed for peak levels within 1 to 4 hours post-dose administration and for trough levels 12 hours after the last dose, utilizing a sophisticated testing method known as liquid chromatography/tandem mass spectrometry (LC/MS-MS). This detailed monitoring is essential for optimizing treatment and minimizing potential side effects associated with lacosamide therapy.

© Copyright 2026 Coding Ahead. All rights reserved.

1. Indications

The laboratory test associated with CPT® Code 80235 is indicated for the following conditions:

  • Monitoring Therapeutic Drug Levels This test is performed to ensure that the levels of lacosamide in the patient's system are within the therapeutic range, which is crucial for effective seizure management.
  • Partial-Onset Seizures Lacosamide is specifically used to treat partial-onset seizures in patients aged 4 years and older, making this test essential for those individuals to monitor the drug's effectiveness.
  • Peripheral Neuropathy The test is also indicated for patients with peripheral neuropathy who are being treated with lacosamide, ensuring that the drug is providing the intended therapeutic benefits.

2. Procedure

The procedure for testing lacosamide levels involves several critical steps to ensure accurate measurement and monitoring of the drug in the patient's system.

  • Step 1: Blood Sample Collection A blood sample is obtained from the patient, which is a necessary first step in the testing process. This sample must be collected at specific times to accurately reflect the drug levels in relation to the dosing schedule.
  • Step 2: Timing of Sample Analysis The serum is tested for peak levels of lacosamide within 1 to 4 hours after the administration of the dose. This timing is crucial as it allows for the assessment of the maximum concentration of the drug in the bloodstream.
  • Step 3: Trough Level Testing Additionally, trough levels are measured 12 hours after the last dose of lacosamide. This step is important to determine the lowest concentration of the drug before the next dose is administered, ensuring that the levels remain within the therapeutic range.
  • Step 4: Laboratory Analysis The analysis of the serum is conducted using liquid chromatography/tandem mass spectrometry (LC/MS-MS), a highly sensitive and specific method that allows for precise quantification of lacosamide levels in the blood.

3. Post-Procedure

After the procedure, the results of the lacosamide level testing will be reviewed to determine if the drug levels are within the therapeutic range. If the levels are found to be too low, adjustments to the dosing regimen may be necessary to prevent breakthrough seizures. Conversely, if levels are too high, it may indicate a risk of toxicity, necessitating a reevaluation of the treatment plan. Continuous monitoring and follow-up testing may be required to ensure optimal therapeutic outcomes and patient safety.

Short Descr DRUG ASSAY LACOSAMIDE
Medium Descr DRUG ASSAY LACOSAMIDE
Long Descr Lacosamide
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.
26 Professional component: certain procedures are a combination of a physician or other qualified health care professional component and a technical component. when the physician or other qualified health care professional component is reported separately, the service may be identified by adding modifier 26 to the usual procedure number.
GW Service not related to the hospice patient's terminal condition
59 Distinct procedural service: under certain circumstances, it may be necessary to indicate that a procedure or service was distinct or independent from other non-e/m services performed on the same day. modifier 59 is used to identify procedures/services, other than e/m services, that are not normally reported together, but are appropriate under the circumstances. documentation must support a different session, different procedure or surgery, different site or organ system, separate incision/excision, separate lesion, or separate injury (or area of injury in extensive injuries) not ordinarily encountered or performed on the same day by the same individual. however, when another already established modifier is appropriate it should be used rather than modifier 59. only if no more descriptive modifier is available, and the use of modifier 59 best explains the circumstances, should modifier 59 be used. note: modifier 59 should not be appended to an e/m service. to report a separate and distinct e/m service with a non-e/m service performed on the same date, see modifier 25.
91 Repeat clinical diagnostic laboratory test: in the course of treatment of the patient, it may be necessary to repeat the same laboratory test on the same day to obtain subsequent (multiple) test results. under these circumstances, the laboratory test performed can be identified by its usual procedure number and the addition of modifier 91. note: this modifier may not be used when tests are rerun to confirm initial results; due to testing problems with specimens or equipment; or for any other reason when a normal, one-time, reportable result is all that is required. this modifier may not be used when other code(s) describe a series of test results (eg, glucose tolerance tests, evocative/suppression testing). this modifier may only be used for laboratory test(s) performed more than once on the same day on the same patient.
GA Waiver of liability statement issued as required by payer policy, individual case
GV Attending physician not employed or paid under arrangement by the patient's hospice provider
GY Item or service statutorily excluded, does not meet the definition of any medicare benefit or, for non-medicare insurers, is not a contract benefit
GZ Item or service expected to be denied as not reasonable and necessary
Date
Action
Notes
2020-01-01 Added Code added.
Code
Description
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