FDA Approves New Waived Tests

The Food and Drug Administration (FDA) recently approved a collection of new waived tests under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). CPT® codes 83036, 81003, 82274, G0328, and 80101 must include modifier QW CLIA waived test to be recognized as a waived test.

CPT® codes 81002, 81025, 82270, 82272, G0394, 82962, 83026, 84830, 85013, and 85651 do not require the QW modifier to be recognized as a waived test, according to the Centers for Medicare & Medicaid Services (CMS) guidelines.

New CPT® code 87905 Infectious agent enzymatic activity other than virus (eg, sialidase activity in vaginal fluid) describes the enzyme activity test for the detection of sialidase activity in vaginal fluid specimens, an enzyme produced by bacterial pathogens such as Gardnerella vaginais, Bacteroides spp., Prevotella spp., and Mobiluncus spp. The CPT® code assigned to the Gyrphus Diagnostics BVBlue test and the Genzyme Diagnoistics OSOM BVBlue test is changed to 87905-QW, effective Jan. 1.

For further details, please refer to CMS Transmittal 1652.


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