Pathology/Lab Coding Alert

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 Subscriber

Answer: 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 Health, Division of Laboratory Improvement issues your Pennsylvania State Laboratory Permit. Similar to the federal CLIA certificate, the type of state permit is indicative of the testing complexity performed and the type of facility. Pennsylvania licenses most physician offices or clinics that perform patient testing as Levels 1, 2, or 3. The state also categorizes specific diagnostic tests into certain levels. Generally, the higher the level the more complex the test is to perform.

You can find information about Pennsylvania licensure and the list of lab tests for some certification levels at www.portal.state.pa.us/portal/server.pt/document/693774/understanding_regulations_physician_labs_pdf. You'll see that Pennsylvania lists pH of vaginal fluids and other body fluids by qualitative color comparison as a Level 1 test.