New Waived Tests effective 4/1/2016

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.

• 83036QW, August 10, 2015, PTS Diagnostics A1C + Professional Use;

• 82274QW, G0328QW, September 14, 2015, Tanner Scientific iFOB One Step Rapid Test;

• 87502QW, September 18, 2015, Roche Molecular, cobas Liat System (cobas Liat Influenza A/B Assay;

• G0434QW [from October 27, 2015 to December 31, 2015] and G0477QW [on and after January 1, 2016], Clarity Diagnostics LLC, Clarity Multi-Drug Urine Test Cup;

• G0434QW [from October 27, 2015 to December 31, 2015] and G0477QW [on and after January 1, 2016], Clarity Diagnostics LLC, Clarity Multi-Drug Urine Test DipCard;

• G0434QW [from November 10, 2015 to December 31, 2015] and G0477QW [on and after January 1, 2016], W.H.P.M., Inc. First Sign® Drug of Abuse Butalbital Cup Test;

• G0434QW [from November 10, 2015 to December 31, 2015] and G0477QW [on and after January 1, 2016], W.H.P.M., Inc. First Sign® Drug of Abuse Butalbital Dip Card Test;

• G0434QW [from November 10, 2015 to December 31, 2015] and G0477QW [on and after January 1, 2016], W.H.P.M., Inc. First Sign® Drug of Abuse Morphine Dip Card Test;

• G0434QW [from November 13, 2015 to December 31, 2015] and G0477QW [on and after January 1, 2016], UCP Biosciences, Inc. U-Cup Drug Test Cards;

• G0434QW [from November 13, 2015 to December 31, 2015] and G0477QW [on and after January 1, 2016], UCP Biosciences, Inc. U-Card Drug Test Cups; and

• G0434QW [from December 14, 2015 to December 31, 2015] and G0477QW [on and after January 1, 2016], Tanner Scientific, Platinum Line® Multi-Panel Drug Test Cup.

The new HCPCS code G0477 [Drug tests(s), presumptive, any number of drug classes; any number of devices or procedures, (eg immunoassay) capable of being read by direct optical observation only (eg, dipsticks, cups, cards, cartridges), includes sample validation when performed, per date of service] was effective 1/1/2016. HCPCS code G0477QW describes the waived testing previously assigned code G0434QW.

Source: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R3440CP.pdf