New CLIA Waived Tests for Jul. 2008
July 1, 2008The latest CLIA waived tests approved by the FDA. Effective Date: July 1, 2008
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.
FDA Approved Waived Tests under CLIA
| CPT Code | Description | Date of Service |
| 80047 QW | Basic metabolic panel (Calcium, ionized) | January 1, 2008 |
| 80048QW | Basic Metabolic Panel, (Calcium, total) | January 16, 2008 |
| 80051QW | Electrolyte Panel | October 30, 2007 |
| 80053QW | Comprehensive Metabolic Panel | January 16, 2008 |
| 82042QW | Albumin; Urine or Other source, Quantitative, Each Specimen | October 4, 2006 |
| 82150QW | Amylase | October 4, 2006 |
| 82247QW | Bilirubin; Total | October 4, 2006 |
| 82977QW | Glutamyltransferase, Gamma (GGT) | October 4, 2006 |
| 84075QW | Phosphatase, Alkaline | October 4, 2006 |
| 84157QW | Protein, Total, Except by Refractometry;Other Source (e.g., Synovial Fluid, Cerebrospinal Fluid) | October 4, 2006 |
| 84520QW | Urea Nitrogen;Quantitative | October 4, 2006 |
| 87808QW | Infectious Agent Antigen Detection by Immunoassay with Direct Optical Observation; Trichomonas Vaginalis | January 1, 2007 |
| 87999QW | Unlisted Microbiology Procedure | July 1, 2007 |
The following table includes the latest new tests approved by the Food and Drug Administration as waived tests under CLIA
| CPT Code | Description | Effective Date |
| 86318QW | Alfa Scientific Designs Instant View H. Pylori Whole Blood Rapid Test | February 1, 2005 |
| 82977QW, 84460QW | Abaxis Piccolo Blood Chemistry Analyzer (General Chemistry 6 Panel){Whole Blood} | January 22, 2007 |
| 82977QW, 84460QW | Abaxis Piccolo xpress Chemistry Analyzer (General Chemistry 6 Panel){Whole Blood} | January 22, 2007 |
| 82150QW, 82977QW, 84075QW, 84460QW | Abaxis Piccolo Blood Chemistry Analyzer (General Chemistry 13 Panel){Whole Blood} | January 22, 2007 |
| 82150QW, 82977QW, 84075QW, 84460QW | Abaxis Piccolo xpress Chemistry Analyzer (General Chemistry 13 Panel){Whole Blood} | January 22, 2007 |
| 82565QW, 82947QW, 82950QW, 82951QW, 82952QW, 84450QW, 84520QW | Abaxis Piccolo Blood Chemistry Analyzer (General Chemistry 6 Panel){Whole Blood} | March 14, 2007 |
| 82565QW, 82947QW, 82950QW, 82951QW | Abaxis Piccolo xpress Chemistry Analyzer | March 14, 2007 |
| 82952QW, 84450QW, 84520QW | (General Chemistry 6 Panel){Whole Blood} | |
| 82042QW, 82247QW, 82310QW, 82565QW, 82947QW, 82950QW, 82951QW, 82952QW, 84157QW, 84450QW, 84520QW, 84550QW | Abaxis Piccolo Blood Chemistry Analyzer (General Chemistry 13 Panel){Whole Blood} | March 14, 2007 |
| 82042QW, 82247QW, 82310QW, 82565QW, 82947QW, 82950QW, 82951QW, 82952QW, 84157QW, 84450QW, 84520QW, 84550QW | Abaxis Piccolo xpress Chemistry Analyzer (General Chemistry 13 Panel){Whole Blood} | March 14, 2007 |
| 80101QW | Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test | June 28, 2007 |
| 80101QW | Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test | June 28, 2007 |
| 82330QW, 82374QW, 82435QW, 82565QW, 82947QW, 82950QW, 82951QW, 82952QW, 84132QW, 84295QW, 84520QW | Abbott i-STAT Chem8+ Cartridge {Whole Blood} | September 21, 2007 |
| 82274QW, G0328QW | BTNX Inc. Rapid Response Fecal Occult Blood (FOB) Self Test | October 5, 2007 |
| 82274QW, G0328QW | BTNX Inc. Know Fecal Occult Blood (FOB) Self Test | October 5, 2007 |
| 80101QW | Abbott Diagnostics Signify ER Drug Screen Test | January 8, 2008 |
| 86308QW | Jant Pharmacal Accutest Value + Mononucleosis Rapid Test {Whole Blood} | October 5, 2007 |
| 86308QW | Stanbio Rely Mono Rapid Test{Whole Blood} | January 8, 2008 |
| 87880QW | Becton Dickinson BD Chek Group A Strep A Test | January 22, 2008 |
| 86318QW | Diagnostic Test Group Clarity H. pylori Rapid Test Device {Whole Blood} | January 22, 2008 |
| 80101QW | BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine) | January 30, 2008 |
| 80101QW | BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine) | January 30, 2008 |
| 87807QW | Quidel Quick Vue RSV Test | February 25, 2008 |
| 84443QW | Qualigen, Inc. FastChek TSH {Whole Blood} | February 29, 2008 |
| 83036QW | Bayer A1CNow+ {For professional use} | March 31, 2008 |