New Waived Tests effective 7/1/2016

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.

81007QW, September 25, 2015, Jant Pharmacal Corporation Accutest Uriscreen (Bacteriuria);

• G0434QW [from November 3, 2015 to December 31, 2015] and G0477QW [on and after January 1, 2016], Nantong Egens Biotechnology Co., Ltd., EGENS Urine Test Marijuana (THC) Cassette;

• G0434QW [from November 3, 2015 to December 31, 2015] and G0477QW [on and after January 1, 2016], Nantong Egens Biotechnology Co., Ltd., EGENS Urine Test Marijuana (THC) Cup;

• G0434QW [from November 3, 2015 to December 31, 2015] and G0477QW [on and after January 1, 2016], Nantong Egens Biotechnology Co., Ltd., EGENS Urine Test Marijuana (THC) DipCard;

• G0434QW [from November 3, 2015 to December 31, 2015] and G0477QW [on and after January 1, 2016], Nantong Egens Biotechnology Co., Ltd., EGENS Urine Test MDMA Cup;

• G0434QW [from November 3, 2015 to December 31, 2015] and G0477QW [on and after January 1, 2016], Nantong Egens Biotechnology Co., Ltd., EGENS Urine Test MDMA DipCard;

• 87631QW, December 3, 2015, Cepheid Gene Xpert Xpress System (Xpert Flu+RSV Xpress);

• G0434QW [from December 17, 2015 to December 31, 2015] and G0477QW [on and after January 1, 2016], Premier BIOTECH Premier Bio-cup & Bio-Dip;

• G0477QW, January 13, 2016, Medical Distribution Group Inc., Identify Diagnostics Drug Test Cards;

• G0477QW, January 13, 2016, Medical Distribution Group Inc., Identify Diagnostics Drug Test Cups;

• G0477QW, January 21, 2016, American Screening Corporation, Inc. Discover Plus Drug Test Cards; and

• G0477QW, January 21, 2016, American Screening Corporation, Inc. Discover Plus Multi-Panel Drug Test Cups.

Source: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R3479CP.pdf