New CLIA Waived Tests for Aug. 2007

Laboratory claims are currently edited at the CLIA certificate level in order to ensure that CMS only pays for laboratory tests categorized as waived complexity under CLIA (for facilities with a CLIA certificate of waiver).

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

Description Effective Date CPT Code / Modifier
Wolfe Drug Testing RealityCheck Integrated Specimen Cup December 28, 2006 80101QW
Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup December 28, 2006 80101QW
Insure Quik Fecal Immunochemical Test (F.I.T.) January 26, 2007 82274QW, G0328QW
Polymer Technology Systems CardioChek PA Analyzer (PTS Panels Metabolic Chemistry Panel Test Strips) February 7, 2007 82947QW, 82950QW, 82951QW, 82952QW, 83718QW and 84478QW
Inverness Medical Clearview H. pylori Test {whole blood} February 7, 2007 86318QW
Innovacon Integrated E-Z Split Key Cup II {Professional Use} February 22, 2007 80101QW
Redwood Toxicology Laboratory Reditest 6 Cassette substance abuse screening device {Professional Use} March 14, 2007 80101QW
Roche Diagnostics CoaguChek XS March 23, 2007 85610QW

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