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Official Description

Everolimus

© Copyright 2026 American Medical Association. All rights reserved.

Common Language Description

The CPT® Code 80169 refers to a laboratory test specifically designed to measure the levels of everolimus in the blood. Everolimus is an immunosuppressive medication that plays a critical role in preventing organ rejection in patients who have undergone kidney or liver transplants. It is marketed under various brand names, including Zortress and Certican. Additionally, everolimus is utilized in the treatment of certain types of cancers, such as advanced renal cell carcinoma (aRCC), subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC), progressive or metastatic pancreatic neuroendocrine tumors (PNET), and advanced hormone-receptor positive HER2-negative breast cancer in post-menopausal women, particularly when surgical options are not viable. To ensure therapeutic effectiveness and minimize potential toxicity, it is essential to monitor everolimus levels through pre-dose (trough) blood draws. The blood sample for this test is collected via venipuncture, which is a separately reportable procedure. The analysis of the blood is conducted using quantitative liquid chromatography-tandem mass spectrometry, a sophisticated technique that allows for precise measurement of drug concentrations in the bloodstream.

© Copyright 2026 Coding Ahead. All rights reserved.

1. Indications

The procedure associated with CPT® Code 80169 is indicated for the following conditions:

  • Organ Rejection Prevention - Everolimus is used to prevent organ rejection in patients who have received kidney or liver transplants.
  • Advanced Renal Cell Carcinoma (aRCC) - This test is indicated for patients diagnosed with advanced renal cell carcinoma, where everolimus is part of the treatment regimen.
  • Subependymal Giant Cell Astrocytoma (SEGA) - The test is relevant for patients with SEGA associated with tuberous sclerosis complex (TSC) who are not candidates for curative surgical resection.
  • Progressive or Metastatic Pancreatic Neuroendocrine Tumors (PNET) - Everolimus is indicated for patients with pancreatic neuroendocrine tumors that are not surgically removable.
  • Advanced Hormone-Receptor Positive HER2-Negative Breast Cancer - This test is also indicated for post-menopausal women with advanced hormone-receptor positive HER2-negative breast cancer.

2. Procedure

The procedure for measuring everolimus levels involves several key steps, which are outlined as follows:

  • Step 1: Patient Preparation - Prior to the blood draw, the patient should be informed about the procedure and any necessary preparations, such as fasting or timing of the draw in relation to their medication schedule.
  • Step 2: Venipuncture - A qualified healthcare professional performs a venipuncture to obtain a blood sample. This involves inserting a needle into a vein, typically in the arm, to collect the required volume of blood for testing.
  • Step 3: Sample Handling - The collected blood sample must be properly labeled and handled to ensure its integrity. It should be transported to the laboratory under appropriate conditions to prevent degradation of the sample.
  • Step 4: Laboratory Analysis - In the laboratory, the blood sample is analyzed using quantitative liquid chromatography-tandem mass spectrometry. This advanced technique allows for accurate quantification of everolimus levels in the blood.
  • Step 5: Result Interpretation - Once the analysis is complete, the results are interpreted by a qualified professional, and the findings are reported to the prescribing physician for further clinical decision-making.

3. Post-Procedure

After the blood draw, patients may experience minor discomfort or bruising at the venipuncture site, which typically resolves quickly. There are no specific post-procedure care instructions related to the blood test itself; however, patients should be advised to monitor the site for any signs of excessive bleeding or infection. The results of the everolimus level test will guide the physician in adjusting the medication dosage if necessary, ensuring optimal therapeutic outcomes while minimizing potential side effects. Regular monitoring of everolimus levels is crucial for patients on this medication to maintain effective treatment and prevent complications.

Short Descr DRUG ASSAY EVEROLIMUS
Medium Descr DRUG ASSAY EVEROLIMUS
Long Descr Everolimus
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 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.
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
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.
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
Q4 Service for ordering/referring physician qualifies as a service exemption
Date
Action
Notes
2014-01-01 Added Added
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Description
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