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The CPT® Code 80145 refers to a laboratory test specifically designed to monitor therapeutic drug levels of adalimumab. Adalimumab is a fully human monoclonal antibody that targets and binds to tumor necrosis factor alpha (TNFa), a protein involved in the inflammatory response of the immune system. Elevated levels of TNFa are commonly associated with various inflammatory diseases, including uveitis, rheumatoid arthritis, ankylosing spondylitis, inflammatory bowel diseases, and plaque psoriasis. Monitoring the levels of adalimumab is crucial, as therapeutic activity may be compromised in a significant percentage of patients. Approximately 10-30% of patients may experience inadequate dosing during the initial induction phase of treatment, leading to what is termed primary non-response. Additionally, around 50% of patients who initially respond to treatment may later show a lack of long-term clinical improvement, known as secondary non-response. These non-responses are often linked to low serum trough concentrations of adalimumab, which can be influenced by various factors such as high serum albumin levels, body weight, gender, smoking habits, disease severity, and the development of antibodies against TNFa. The rapid point-of-care test for adalimumab levels allows healthcare providers to assess serum drug trough concentrations immediately before the next scheduled dose, enabling timely dose adjustments without delaying the drug infusion schedule. The testing process involves obtaining a blood sample, which is then processed by diluting the serum with a buffering agent, mixing it, and loading it into a test cartridge. This cartridge is inserted into a preprogrammed reading device provided by the manufacturer and incubated for a duration of 15 minutes, after which the results are displayed on a digital screen.
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The laboratory test for adalimumab levels is indicated for monitoring therapeutic drug levels in patients undergoing treatment with adalimumab. The specific indications include:
The procedure for testing adalimumab levels involves several key steps to ensure accurate measurement of the drug concentration in the serum. The process begins with the collection of a blood sample from the patient, which is a separate procedure that must be reported accordingly. Once the blood sample is obtained, the serum is separated and diluted with a buffering agent to prepare it for testing. This dilution is crucial as it helps to stabilize the serum for accurate measurement. After mixing the diluted serum, it is loaded into a test cartridge specifically designed for the adalimumab assay. The cartridge is then inserted into a preprogrammed reading device supplied by the manufacturer. This device is programmed to perform the necessary calculations and analyses. The cartridge undergoes an incubation period of 15 minutes, during which the test reactions occur. After the incubation, the results are displayed on a digital screen, providing the clinician with immediate access to the quantitative levels of adalimumab in the patient's serum.
Post-procedure care following the adalimumab level test primarily involves the interpretation of the test results by the clinician. Based on the quantitative levels obtained, the clinician can make informed decisions regarding the patient's treatment plan, including potential dose adjustments of adalimumab. It is essential to monitor the patient's response to any changes in dosage closely. Additionally, the clinician may consider other factors that could influence drug levels, such as the patient's body weight, serum albumin levels, and any development of antibodies to TNFa. Regular monitoring may be recommended to ensure that therapeutic levels are maintained and to optimize treatment outcomes.
| Short Descr | DRUG ASSAY ADALIMUMAB | Medium Descr | DRUG ASSAY ADALIMUMAB | Long Descr | Adalimumab | 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. | 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. | GW | Service not related to the hospice patient's terminal condition |
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| 2020-01-01 | Added | Code added. |
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