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Official Description

Leflunomide

© Copyright 2026 American Medical Association. All rights reserved.

Common Language Description

The CPT® Code 80193 refers to a laboratory test specifically designed to monitor therapeutic levels of leflunomide, which is classified as a disease-modifying antirheumatic drug (DMARD). This medication is primarily utilized in the treatment of moderate to severe rheumatoid arthritis in adult patients. Leflunomide functions by suppressing the immune system, thereby reducing joint damage and alleviating inflammation that leads to pain and swelling. It is important to note that leflunomide has been associated with significant risks, including the potential for birth defects in children of individuals—both men and women—who are undergoing treatment with this drug. Additionally, there is a risk of liver damage, necessitating regular monitoring through blood tests. These tests are typically conducted every 6 to 8 weeks to assess liver function and ensure that therapeutic levels of the drug are maintained. It is noteworthy that a substantial proportion of patients, up to 50%, may discontinue leflunomide treatment within the first year due to adverse drug reactions. The monitoring process involves assessing the levels of leflunomide or its active metabolite, A77 1726, in the patient's plasma, utilizing high-performance liquid chromatography. This testing is crucial for evaluating the relationship between drug levels and disease activity in the joints, ensuring that patients receive optimal therapeutic benefits while minimizing potential risks.

© Copyright 2026 Coding Ahead. All rights reserved.

1. Indications

The laboratory test associated with CPT® Code 80193 is indicated for the following conditions:

  • Monitoring Therapeutic Levels This test is performed to monitor the therapeutic levels of leflunomide in patients undergoing treatment for moderate to severe rheumatoid arthritis.
  • Assessing Liver Function Regular blood tests are conducted to evaluate liver function, as leflunomide is known to potentially cause liver damage.
  • Evaluating Disease Activity The test helps in assessing the relationship between leflunomide plasma levels and disease activity in the joints, which is critical for effective management of rheumatoid arthritis.

2. Procedure

The procedure for conducting the laboratory test under CPT® Code 80193 involves several key steps to ensure accurate monitoring of leflunomide levels:

  • Step 1: Sample Collection A blood sample is collected from the patient, typically through venipuncture. This sample is essential for determining the concentration of leflunomide or its active metabolite in the plasma.
  • Step 2: Laboratory Analysis The collected blood sample is then sent to a laboratory where high-performance liquid chromatography (HPLC) is utilized. This analytical technique allows for the precise measurement of leflunomide levels in the plasma.
  • Step 3: Data Interpretation Once the analysis is complete, the laboratory results are interpreted to assess whether the therapeutic levels of leflunomide are within the desired range. This information is crucial for determining the effectiveness of the treatment and making any necessary adjustments.
  • Step 4: Reporting Results The results of the test are compiled and reported to the healthcare provider, who will use this information to monitor the patient's response to treatment and to check for any potential adverse effects, particularly concerning liver function.

3. Post-Procedure

After the laboratory test associated with CPT® Code 80193 is completed, patients may be advised to continue regular follow-up appointments every 6 to 8 weeks for ongoing monitoring. This is essential to ensure that liver function remains stable and that therapeutic levels of leflunomide are maintained. Healthcare providers will review the test results and may adjust the treatment plan based on the findings, particularly if there are indications of adverse drug reactions or if the therapeutic levels are not optimal. Patients should be informed about the importance of adhering to the testing schedule and reporting any unusual symptoms or side effects experienced during treatment.

Short Descr DRUG ASSAY LEFLUNOMIDE
Medium Descr DRUG ASSAY LEFLUNOMIDE
Long Descr Leflunomide
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.
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.
Date
Action
Notes
2021-01-01 Added Code added.
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