CPT® Code 81535

Official Description

Oncology (gynecologic), live tumor cell culture and chemotherapeutic response by DAPI stain and morphology, predictive algorithm reported as a drug response score; first single drug or drug combination

Common Language Description

The CPT® Code 81535 pertains to a specialized laboratory test utilized in the field of oncology, specifically focusing on gynecologic tumors. This procedure involves the culture of live tumor cells obtained from a gynecologic tumor, which are then subjected to a series of tests to evaluate their response to various chemotherapeutic agents. The primary objective of this test is to determine how effectively these drugs can target and kill the tumor cells, thereby aiding in the selection of the most appropriate chemotherapy regimen for the patient. The test employs DAPI (4’, 6-diamidino-2-phenylindole) stain, a fluorescent dye that binds to DNA, allowing for the differentiation between live and dead cells. This is crucial as it provides insight into the viability of the tumor cells after exposure to the chemotherapeutic agents. The results are quantified and reported as a drug response score, which is derived from a predictive algorithm that assesses the cells' morphological characteristics and their reaction to the drugs tested. This code specifically covers the first single drug or drug combination tested, while additional drugs or combinations can be reported using CPT® Code 81536. Overall, this procedure is instrumental in personalizing cancer treatment, ensuring that patients receive the most effective therapies based on the unique characteristics of their tumors.

1. Indications

The procedure associated with CPT® Code 81535 is indicated for the evaluation of live gynecologic tumor cells to assess their response to chemotherapeutic agents. This test is particularly useful in the following scenarios:

Assessment of Chemotherapy Efficacy The test is performed to determine how well specific chemotherapeutic drugs can target and kill the tumor cells, which is critical for selecting the most effective treatment regimen.
Personalized Treatment Planning The results from this assay help oncologists tailor chemotherapy plans based on the unique morphological characteristics and drug response of the individual tumor, enhancing the likelihood of treatment success.
Evaluation of Drug Resistance The procedure can identify potential resistance to certain chemotherapeutic agents, allowing for adjustments in treatment strategies to avoid ineffective therapies.

2. Procedure

The procedure for CPT® Code 81535 involves several detailed steps to ensure accurate assessment of the tumor cells' response to chemotherapy. The following outlines the key procedural steps:

Isolation of Live Tumor Cells Initially, live tumor cells are isolated from a gynecologic tumor specimen. This is a critical step as the viability of the cells is essential for the subsequent testing. The cells are carefully extracted and prepared for culture in an appropriate in vitro medium.
Incubation with Chemotherapeutic Agents Once the tumor cells are established in culture, they are incubated with a selected chemotherapeutic agent or a combination of agents. This incubation period is predetermined and is crucial for allowing the drugs to interact with the tumor cells effectively.
Staining with DAPI After the incubation period, the cells are stained with DAPI, a fluorescent dye that binds to A-T-rich regions of DNA. This staining process is vital as it allows for the differentiation between live and dead cells, with DAPI staining dead cells more intensely than live ones.
Assessment and Reporting Following staining, the cells are assessed under a fluorescence microscope to evaluate their viability. The results are then analyzed using a predictive algorithm, which generates a drug response score that reflects the effectiveness of the tested chemotherapeutic agents on the tumor cells.

3. Post-Procedure

Post-procedure care for patients undergoing the testing associated with CPT® Code 81535 typically involves monitoring for any immediate reactions to the tumor sampling process. Since this is a laboratory test, there are no specific recovery protocols required for the patient following the procedure itself. However, it is essential for healthcare providers to discuss the results of the drug response score with the patient, as this information will guide future treatment decisions. Additionally, any necessary follow-up appointments should be scheduled to review the findings and adjust the treatment plan accordingly based on the test results.

Short Descr	ONCOLOGY GYNECOLOGIC
Medium Descr	ONCOLOGY GYNE LIVE TUM CELL CLTR&CHEMO RESP 1ST
Long Descr	Oncology (gynecologic), live tumor cell culture and chemotherapeutic response by DAPI stain and morphology, predictive algorithm reported as a drug response score; first single drug or drug combination
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	Service Paid under Fee Schedule or Payment System other than OPPS
Type of Service (TOS)	5 - Diagnostic Laboratory
Berenson-Eggers TOS (BETOS)	T1H - Lab tests - other (non-Medicare fee schedule)
MUE	1

This is a primary code that can be used with these additional add-on codes.

81536

Female Edit Addon Code MPFS Status: Statutory exclusion (from MPFS, may be paid under other methodologies) APC A Oncology (gynecologic), live tumor cell culture and chemotherapeutic response by DAPI stain and morphology, predictive algorithm reported as a drug response score; each additional single drug or drug combination (List separately in addition to code for primary procedure)