Question: Our physician office lab performs the VS-SENSE test for vaginal symptoms, which is listed as a CLIA-waived test. But we've been told that because we operate in Pennsylvania, it's a Level 1 test. Can you explain this?Pennsylvania SubscriberAnswer: Labs are subject to the rules and regulations of both federal and state governments, and you'll find different test categorization under the federal law -- Clinical Laboratory Improvement Amendments (CLIA) -- versus Pennsylvania law. Under CLIA, physician office labs generally operate with a CLIA certificate of waiver. As such, the labs can only perform CLIA-waived tests, and must report most test codes with modifier QW (CLIA waived test). You can find a complete list of CLIA waived tests at
www.cms.gov/CLIA/10_Categorization_of_Tests.asp#TopOfPage -- click on the download option "list of waived tests."The CLIA-waived list indicates that you should report 83986QW (pH, body fluid, not otherwise specified) for the VS-Sense Test (qualitative).The Pennsylvania Department of [...]