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The CPT® Code 80197 refers to a laboratory test specifically designed to measure the levels of tacrolimus in the blood. Tacrolimus, commonly known by its brand name Prograf, is an immunosuppressant medication that plays a critical role in preventing organ rejection in transplant patients. It works by inhibiting the activity of certain white blood cells, which are essential for the immune response against transplanted organs such as the kidney, liver, heart, and lung. The administration of tacrolimus is typically done intravenously, either as a standalone treatment or in conjunction with other immunosuppressive agents to enhance its effectiveness. Due to its narrow therapeutic range, careful monitoring of tacrolimus levels is essential to ensure that patients receive the appropriate dosage. Initially, blood levels may be assessed daily when starting therapy, then tapering to 1-2 times per week, and eventually to once every 1-2 months for routine monitoring. The blood specimen for this test is collected as a trough level, which means it is taken just before the next scheduled dose and at least 12 hours after the last dose. The testing process involves obtaining a blood sample through a separately reportable venipuncture, followed by analysis using liquid chromatography-tandem mass spectrometry. It is important to note that tacrolimus can also be tested using chromatographic or immunoassay techniques, which may yield slightly different results; therefore, the specific technique used should be documented when comparing current results with previous levels.
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The tacrolimus blood test (CPT® Code 80197) is indicated for the following conditions:
The procedure for measuring tacrolimus levels involves several key steps:
After the blood sample has been collected and sent for analysis, there are no specific post-procedure care requirements for the patient. However, it is important for healthcare providers to monitor the patient’s response to tacrolimus therapy and adjust dosages as necessary based on the test results. Patients should be informed about the importance of regular monitoring and adherence to their medication schedule to maintain therapeutic levels and prevent organ rejection.
| Short Descr | ASSAY OF TACROLIMUS | Medium Descr | DRUG SCREEN QUANTITATIVE TACROLIMUS | Long Descr | Tacrolimus | 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) | T1H - Lab tests - other (non-Medicare fee schedule) | MUE | 2 | CCS Clinical Classification | 235 - Other Laboratory |
| 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 | Q1 | Routine clinical service provided in a clinical research study that is in an approved clinical research study | 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. | 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. | 77 | Repeat procedure by another physician or other qualified health care professional: it may be necessary to indicate that a basic procedure or service was repeated by another physician or other qualified health care professional subsequent to the original procedure or service. this circumstance may be reported by adding modifier 77 to the repeated procedure or service. note: this modifier should not be appended to an e/m service. | 76 | Repeat procedure or service by same physician or other qualified health care professional: it may be necessary to indicate that a procedure or service was repeated by the same physician or other qualified health care professional subsequent to the original procedure or service. this circumstance may be reported by adding modifier 76 to the repeated procedure or service. note: this modifier should not be appended to an e/m service. | AY | Item or service furnished to an esrd patient that is not for the treatment of esrd | CR | Catastrophe/disaster related | 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 | GW | Service not related to the hospice patient's terminal condition | 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 | XE | Separate encounter, a service that is distinct because it occurred during a separate encounter |
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| 2013-01-01 | Changed | Medium description changed per AMA 2013 corrections document dated January 25, 2013. |
| 1997-01-01 | Added | First appearance in code book in 1997. |
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