New Waived Tests for May 2011

This change request announces two newly added CLIA waived tests approved by the FDA.

• On February 8, 2011, the FDA informed CMS that the Teco Diagnostics Uritek TC-101 Urine Analyzer was no longer categorized as a waived test under CLIA. This test has been removed from the list.
• On February 9, 2011, CMS determined that the code to assign to the OraSure Technologies OraQuick ADVANCEÆ Rapid HIV-1/2 Antibody Test is G0433 effective January 1, 2011. In addition, the code assigned to the Clearview Complete HIV 1/2 test should be G0433. Therefore, the code assigned both tests was changed from 86703QW to G0433QW in the list.

Listed below are the latest tests approved by the FDA as waived tests under CLIA. The CPT codes for the following new tests must have the modifier QW to be recognized as a waived test.

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

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