Pathology/Lab Coding Alert

Coding of HER-2/neu Testing Depends on Method, Reason for Test

HER-2/neu testing for breast cancer patients may involve procedures from surgical pathology to clinical lab tests to cytogenetic studies. Although the purpose is the same the analysis of breast cancer for changes in the HER-2/neu gene or its protein product the source, method and indications for the tests vary widely.
 
With recent code changes and no clear consensus regarding which test methods are most predictive, coding and reimbursement for these procedures can be tricky. "Local Medicare carriers and third-party payers have a wide range of coverage criteria for these tests," says Richard Zarbo, MD, DMD, chairman of pathology at Henry Ford Hospital and Medical Group in Detroit. In addition to knowing these local rules, coders must be familiar with the procedure methods to accurately report the services.
HER-2/neu Testing Methods and Indications
Elevated levels of the HER-2/neu gene or its protein product generally indicate a poor prognosis for breast cancer patients. With the breast cancer tissue as the specimen, some tests identify amplification of the gene, while others identify overexpression of the protein product of the gene. Yet another test identifies elevated levels of the protein in the serum, rather than in the tumor tissue.
 
The tests may be used for risk assessment, treatment indication, and monitoring. Specifically, assessment of HER-2 status plays a major clinical role in determining a patient's suitability for Herceptin (trastuzumab) treatment. Herceptin is a monoclonal antibody targeted at the HER-2/neu protein.
 
Although selection for Herceptin therapy was originally determined through tissue immunohistochemical (IHC) testing, some studies indicate selection based on the results of fluorescence in situ hybridization (FISH) gene detection assay. "However, there is not a clear consensus regarding how the tests should be performed and the results reported and interpreted for diagnostic and therapeutic purposes," Zarbo says. A description of the procedures, codes and clinical applications for the various forms of HER-2/neu assessment follows.
HER-2/neu Protein Overexpression Testing
"The immunohistochemical HER-2/neu test is a special stain of the breast tumor tissue that indicates overexpression of a specific protein associated with aggressive tumor growth," says Peggy Slagle, CPC, billing compliance coordinator, University of Nebraska Medical Center in Omaha. "The test is typically carried out with an estrogen receptor assay (ERA) and progesterone receptor assay (PRA) on the breast tumor tissue." Each of the three stains is reportable as a separate unit of 88342 (Immunocytochemistry [including tissue immunoperoxidase], each antibody) and is reported in addition to the surgical pathology code for evaluation of the breast tumor (e.g., 88307, Level V Surgical pathology, gross and microscopic examination, breast, mastectomy partial/simple).
 
Assessment of HER-2/neu protein [...]
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