New Waived Tests effective April 1, 2015

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

• G0434QW, September 18, 2014, CLIA waived Inc. Rapid Drug Test Cup {Cassette Dip Card format};

• 86308QW, September 23, 2014, AimStep Mono {Whole Blood};

• G0434QW, September 26, 2014, Polymed Therapeutics FaStep Marijuana Panel Dip;

• G0434QW, September 26, 2014, Polymed Therapeutics FaStep Marijuana Quick Cup;

• G0434QW, September 26, 2014, Polymed Therapeutics FaStep Marijuana Strip;

• G0434QW, September 26, 2014, Polymed Therapeutics FaStep Marijuana Turn-Key Split Cup;

• G0434QW, September 26, 2014, Polymed Therapeutics FaStep Methamphetamine Panel Dip;

• G0434QW, September 26, 2014, Polymed Therapeutics FaStep Methamphetamine Quick Cup;

• G0434QW, September 26, 2014, Polymed Therapeutics FaStep Methamphetamine Strip;

• G0434QW, September 26, 2014, Polymed Therapeutics FaStep Methamphetamine Turn-Key Split Cup;

• G0434QW, October 9, 2014, Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Dip Card Tests;

• G0434QW, October 9, 2014, Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Cassette Tests;

• G0434QW, October 9, 2014, Chemtron Biotech, Inc. Chemtrue Multi-Panel Drug Screen Dip Card Tests;

• G0434QW, October 9, 2014, Chemtron Biotech, Inc. Chemtrue Multi-Panel Drug Screen Dip Card with OPI 2000 Test;

• G0434QW, October 17, 2014, Healgen Oxazepam Test Strip;

• G0434 QW, October 17, 2014, Healgen Oxazepam Test Dip Card;

• G0434QW, October 17, 2014, Healgen Oxazepam Test Cup;

• G0434QW, October 17, 2014, Healgen Oxazepam Test Cassette;

• G0434QW, October 17, 2014, Healgen Morphine Test Strip;

• G0434QW, October 17, 2014, Healgen Morphine Test Dip Card;

• G0434QW, October 17, 2014, Healgen Morphine Test Cup;

• G0434QW, October 17, 2014, Healgen Morphine Test Cassette;

• G0433QW, October 29, 2014, Chembio Diagnostic Systems, Inc. DPP HIV 1/2 Assay {Oral Fluid}; and

• 87389QW [from December 5, 2014 to December 31, 2014], Oregenics, Alere Determine HIV-1/2 Ag/Ab Combo {fingerstick Whole Blood}; and

• 87806QW [on and after January 1, 2015] , Oregenics, Alere Determine HIV-1/2 Ag/Ab Combo {fingerstick Whole Blood};

• G0434QW, December 10, 2014, Transmetron Invitro Pro Drug Test Cups;

• G0434QW, December 10, 2014, Coastline Medical Management Coastline Explorer Cup {Cassette Dip Card Format};

• 86780QW, December 15, 2014, Diagnostics Direct LLC Syphilis Health Check {FingerStick Whole Blood};

• G0434QW, December 19, 2014, On-Site Testing Specialists, Inc. On-Site Testing Specialist Single/Multi-Panel Drug Screen Dip Card Tests;

• G0434QW, December 19, 2014, On-Site Testing Specialists, Inc. On-Site Testing Specialist Single/Multi-Panel Drug Screen Dip Card with OPI 2000 Tests; and

• 87502QW, January 5, 2015, Alere i Influenza A & B Test {Direct Nasal swab only}.

From December 5, 2014, to December 31, 2014, the CPT code 87389QW has been assigned for the detection of antigen to HIV-1, and antibodies to HIV-1 and HIV-2 performed using the Oregenics, Alere Determine HIV-1/2 Ag/Ab Combo {fingerstick Whole Blood}. On and after January 1, 2015, the CPT code assigned to Oregenics, Alere Determine HIV-1/2 Ag/Ab Combo {fingerstick Whole Blood} will be 87806QW.

The new CPT code 86780QW has been assigned for the immunochromatographic assay for the detection of Treponema pallidum (syphilis) antibodies in whole blood performed using the Diagnostics Direct LLC Syphilis Health Check {FingerStick Whole Blood}.

The new CPT code 87502QW has been assigned for the differential and qualitative detection of influenza A and influenza B viral nucleic acids using isothermal nucleic acid amplification technology performed using the Alere i Influenza A & B Test {Direct Nasal swab only}.