Changes to CLIA Waived Tests Effective July 1

The U.S. Food and Drug Administration (FDA) has announced new waived tests under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. The tests become effect July 1 and will be implemented July 5.

The new tests include the following:


Codes Effective Date Description
82274QW/G0328QW Jan. 1, 2011 Polymedco Poly Stat OC-light FOB Test
87804QW Jan. 10, 2011 BTNX, Inc. Rapid Response Influenza A Test Cassette
87804QW Jan. 10, 2011 BTNX, Inc. Rapid Response Influenza B

The FDA informed the Centers for Medicare & Medicaid Services (CMS), which administers the CLIA regulations, that the Teco Diagnostics Uritek TC-101 Urine Analyzer was no longer categorized as a waived test under CLIA. It is now a moderate complexity test. CPT® code 81003QW Urinalysis, by dip stick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrate, pH, protein, specific gravity, urobilinogen, any number of these constituents; automated, without microscopy has been removed from the CLIA Waived Test list. Report HCPCS Level II code G0433 Infectious agent antibody detection by enzyme-linked immunosorbent assay (ELISA) technique, HIV-1 and/or HIV-2, screening for the OraSure Technologies OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test; and the code now assigned to the Clearview Complete HIV 1/2 test should be G0433QW in the Waived Test list, rather than 86703QW Antibody; HIV-1 and HIV-2, single assay.

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