Pathology/Lab Coding Alert

Question: Our lab will begin performing a new test manufactured by OraSure Technologies called OraQuick Rapid HIV-1 Antibody Test. How should we code this test?

Answer: The U.S. Food and Drug Administration recently approved this HIV test as a waived test under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). You should report the test using 86701 (Antibody; HIV-1).

If you operate as a CLIA-waived status lab, you must report the code with modifier -QW (CLIA-waived test) to indicate that your lab is allowed to perform the test. CMS has issued a National Coverage Determination (NCD) for multi-step HIV-1 immunoassays, so claims for 86701-QW are subject to the NCD coverage restrictions.