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The CPT® Code 80280 refers to a laboratory test specifically designed to monitor therapeutic drug levels of vedolizumab (VDZ). Vedolizumab is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody that plays a crucial role in the treatment of inflammatory bowel diseases, including Crohn's disease and ulcerative colitis. The mechanism of action for VDZ involves its binding to the a4b7 integrin glycoprotein found on the surface of T and B lymphocytes. This binding action effectively prevents these immune cells from migrating through the vascular endothelium into the intestinal mucosa, thereby exerting an anti-inflammatory effect. Monitoring the levels of VDZ is essential, as therapeutic activity may be compromised in a significant portion of patients. Specifically, 10-30% of patients may experience inadequate dosing during the induction phase of treatment, leading to what is termed primary non-response. Additionally, about 50% of patients who initially respond to therapy may later exhibit a lack of sustained clinical improvement, known as secondary non-response. Both primary and secondary non-responses have been associated with low serum trough concentrations of VDZ. Factors contributing to low drug levels can include low serum albumin levels, elevated body weight, and the development of antibodies against VDZ. To perform this test, a blood sample is collected, which is a separate procedure from the testing itself. The serum obtained from the blood sample is then analyzed for quantitative levels of VDZ and the presence of anti-VDZ antibodies using an enzyme-linked immunosorbent assay (ELISA), providing critical information for the management of patients undergoing treatment with this medication.
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The laboratory test associated with CPT® Code 80280 is indicated for monitoring therapeutic drug levels of vedolizumab (VDZ) in patients undergoing treatment for inflammatory bowel diseases. The specific indications for this test include:
The procedure for testing vedolizumab levels involves several key steps, which are outlined as follows:
Post-procedure care following the blood sample collection is generally minimal, as the primary focus is on the analysis of the serum. However, it is important for healthcare providers to communicate the results of the test to the patient and discuss any necessary adjustments to the treatment plan based on the findings. If low levels of vedolizumab or the presence of anti-VDZ antibodies are detected, further evaluation and potential modifications to the dosing regimen may be warranted to optimize therapeutic outcomes. Additionally, patients should be monitored for any signs of adverse reactions or changes in their condition following adjustments to their treatment.
| Short Descr | DRUG ASSAY VEDOLIZUMAB | Medium Descr | DRUG ASSAY VEDOLIZUMAB | Long Descr | Vedolizumab | 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. | Q4 | Service for ordering/referring physician qualifies as a service exemption |
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| 2020-01-01 | Added | Code added. |
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