The Vachette Pathology team has recently worked to provide MolDX guidance/clarification on appropriately coding single gene as opposed to multiple gene test orders. Here are two distinct examples:
- Single service example: Five specific genes associated with Breast Cancer. The lab analyzes the 5 genes for common mutations using PCR. All 5 PCR procedures are started prior to the results of any one PCR procedure being known. The results are signed off simultaneously, and all 5 results are sent to a clinician. This would be considered a single procedure services – a 5 gene panel, and it must be billed as such.
- Multiple Distinct Procedural service example: A clinician requests that genes associated with early onset colorectal cancer be analyzed in a patient. The clinician orders stepwise reflex testing where a negative or positive result in one gene determines whether additional analysis on other genes will be performed or what that will be. Each gene assayed represents on procedural service, so if more than one gene is analyzed, then multiple procedural services may be billed in some patients for whom reflex testing goes beyond the first gene.