Listed below are the latest tests approved by the FDA as waived tests under CLIA. The tests are valid as soon as they are approved. 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 |
82465QW, 83718QW, 84478QW, 80061QW, 82947QW, 82950QW, 82951QW, 82952QW |
December 2, 2009 |
Infopia USA LipidPro lipid profile and glucose measuring system |
82465QW, 83718QW, 84478QW, 80061QW |
December 2, 2009 |
Infopia USA LipidPro lipid profile and glucose measuring system (LipidPro Lipid Profile test strips) |
G0430QW |
January 1, 2010 |
American Screening Corporation One Screen Drug Test Cards |
G0430QW |
January 1, 2010 |
American Screening Corporation One Screen Drug Test Cups |
G0430QW |
January 1, 2010 |
Express Diagnostics International Inc. DrugCheck Waive Drug Test Cards |
G0430QW |
January 1, 2010 |
UCP Biosciences, Inc., UCP Home Drug Screening Test Cards |
G0431QW |
January 1, 2010 |
Phamatech QuickScreen One Step Amphetamine Test |
G0431QW |
January 1, 2010 |
Phamatech QuickScreen One Step THC Screening Test |
86308QW |
January 4, 2010 |
Acceava Mono Cassette {For whole blood} |
81003QW, 82044QW, 82570QW, 84703QW |
January 4, 2010 |
Siemens, Clinitek Status+ Analyzer |
81003QW, 82044QW, 82570QW, 84703QW |
January 4, 2010 |
Siemens, Clinitek Status Connect System |
82274QW, G0328QW |
January 26, 2010 |
Care Diagnostics Clarity IFOB Test |
CR 6852 also mentioned the following:
- If a laboratory with a CLIA certificate of waiver performs a qualitative drug screening test for multiple drug classes using a non-chromatographic method, then the test code G0430QW would be the appropriate code to bill;
- The test code G0431 is a direct replacement for CPT Code 80101;
- Clinical laboratories with a CLIA certificate of waiver should utilize new test code G0431QW; and
- Effective July 1, 2010, CPT Code 80101 will no longer be covered by Medicare, and CPT Code 80101QW was deleted on April 1, 2010.
