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2025 CPT code 88365

In situ hybridization (e.g., FISH), per specimen; initial single probe stain procedure.

Refer to the current CPT coding guidelines for detailed information on the appropriate application and billing of this code.Pay attention to the guidelines on separate billing for technical and professional components and the use of modifiers.

Modifiers TC (technical component) and 26 (professional component) are applicable.Modifier TC is used when only the technical component is billed, and modifier 26 is used when only the professional component is billed.

The medical necessity for 88365 is established by the physician's clinical judgment, based on the patient's presentation, symptoms, and other diagnostic findings.The test is typically ordered when there is a suspected malignancy or the presence of specific genetic alterations is essential for guiding treatment.

The clinical responsibility is shared between the laboratory analyst who performs the technical aspects of the ISH staining procedure and the pathologist who interprets the results and generates the report. The ordering physician is responsible for ensuring the medical necessity of the test and integrating the results into the patient's overall care.

IMPORTANT:For additional single probe stains on the same specimen, use +88364. For multiplex probe stains, use 88366. For quantitative or semi-quantitative ISH, use codes 88367-88377. For cytology specimens in bladder cancer, use 88120-88121. For ISH tests for non-cancerous conditions or interpretation by non-pathologists, use 88271-88275.

In simple words: This lab test uses a special stain to find a specific gene in a tissue sample, like from a tumor. A lab technician does the staining, and a doctor looks at it under a microscope to help diagnose cancer.

This CPT code encompasses the qualitative in situ hybridization (ISH), such as fluorescence in situ hybridization (FISH), procedure performed on a single patient specimen.It involves the application of an initial single probe stain by a laboratory analyst, followed by qualitative interpretation and reporting by a pathologist. The procedure aims to detect and localize a specific gene or DNA sequence within the tissue sample to aid in diagnosis, particularly for certain cancers.The code represents the global service, including both the technical component (TC) performed by the lab analyst and the professional component (26) by the pathologist.Separate billing for technical or professional components requires the use of modifiers TC and 26, respectively.This code is not used for quantitative or semi-quantitative ISH, multiplex stains, cytology specimens for bladder cancer, or ISH tests for conditions other than cancer (e.g., heritable diseases). In those cases, alternative CPT codes should be used.

Example 1: A patient presents with a suspicious breast mass. A biopsy is performed, and the tissue is sent for 88365 to detect HER2 gene amplification, which can guide treatment decisions., A patient with cervical cancer undergoes a biopsy. 88365 is used to detect the presence of human papillomavirus (HPV) DNA, which is associated with cervical cancer development., A patient has a suspicious skin lesion. A biopsy is taken, and 88365 is used to detect specific genetic markers that can help determine the type and prognosis of the lesion.

* Patient demographics and relevant clinical history.* Detailed description of the specimen(s) and the reason for the test.* Complete information about the type and specificity of the ISH probe(s) used.* Microscopic images and findings of the ISH stain, including the location and intensity of positive signals.* Pathologist's interpretation and diagnosis, clearly documented.* Report correlating the findings with other clinical information.

** Code 0848T may be used in conjunction with 88365 when digitization of glass microscope slides is performed.Always consult the latest CPT and payer guidelines for the most up-to-date billing and coding information.

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