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The CPT® Code 80195 refers to a laboratory test specifically designed to measure the levels of sirolimus in the blood. Sirolimus, also known by its brand name Rapamune, is classified as an immunosuppressant medication. It plays a crucial role in preventing the body’s immune system from rejecting transplanted organs, such as kidneys, livers, and hearts. The administration of sirolimus can occur 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 sirolimus levels is essential to ensure that the drug remains within a safe and effective concentration in the bloodstream. 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 ongoing management. For routine monitoring, blood specimens are collected as trough levels, which means the sample is taken immediately before the next scheduled dose and at least 12 hours after the previous dose. The blood sample is obtained through a venipuncture, which is a separately reportable procedure. The testing of sirolimus levels is performed using advanced techniques such as liquid chromatography-tandem mass spectrometry, although it may also be analyzed using chromatographic or immunoassay methods, which can yield slightly different results.
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The sirolimus blood test (CPT® Code 80195) is indicated for the following conditions:
The procedure for measuring sirolimus levels involves several key steps:
After the blood sample has been collected, there are no specific post-procedure care requirements for the patient. However, it is important for the healthcare provider to communicate the results of the sirolimus level test to the patient and adjust the medication dosage as necessary based on the findings. Regular monitoring may be required, especially during the initial phases of therapy or when there are changes in the patient's health status. Patients should be advised to report any side effects or concerns related to their sirolimus therapy to their healthcare provider promptly.
| Short Descr | ASSAY OF SIROLIMUS | Medium Descr | DRUG SCREEN QUANTITATIVE SIROLIMUS | Long Descr | Sirolimus | 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. | Q1 | Routine clinical service provided in a clinical research study that is in an approved clinical research study | 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. | 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. | Q4 | Service for ordering/referring physician qualifies as a service exemption | 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. | 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. | 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 | GW | Service not related to the hospice patient's terminal condition |
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| 2013-01-01 | Changed | Medium description changed per AMA 2013 corrections document dated January 25, 2013. |
| 2006-01-01 | Added | First appearance in code book in 2006. |
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