New Waived Tests effective 10/1/2015

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, January 28, 2015, Healgen Amphetamine Test Cassette;

• G0434QW, January 28, 2015, Healgen Amphetamine Test Cup;

• G0434QW, January 28, 2015, Healgen Amphetamine Test Dip Card;

• G0434QW, January 28, 2015, Healgen Amphetamine Test Strip;

• G0434QW, January 28, 2015, Healgen Oxycodone Test Cassette;

• G0434QW, January 28, 2015, Healgen Oxycodone Test Cup;

• G0434QW, January 28, 2015, Healgen Oxycodone Test Dip Card;

• G0434QW, January 28, 2015, Healgen Oxycodone Test Strip;

• G0434QW, March 4, 2015, Healgen Scientific LLC Healgen MDMA (Ecstasy) Test Cassette;

• G0434QW, March 4, 2015, Healgen Scientific LLC Healgen MDMA (Ecstasy)Test Cup;

• G0434QW March 4, 2015, Healgen Scientific LLC Healgen MDMA (Ecstasy) Test Dip Card;

• G0434QW, March 4, 2015, Healgen Scientific LLC Healgen MDMA (Ecstasy) Test Strip;

• G0434QW, March 4, 2015, Healgen Scientific LLC Healgen Phencyclidine Test Cassette;

• G0434QW, March 4, 2015, Healgen Scientific LLC Healgen Phencyclidine Test Cup;

• G0434QW March 4, 2015, Healgen Scientific LLC Healgen Phencyclidine Test Dip Card;

• G0434QW, March 4, 2015, Healgen Scientific LLC Healgen Phencyclidine Test Strip;

• G0434QW, March 31, 2015, Medical Distribution Group Inc., Identify Home Drug Testing Device Test Cards;

• G0434QW, March 31, 2015, Medical Distribution Group Inc., Identify Home Drug Testing Device Test Cups;

• G0434QW, April 20, 2015, Chemtron Biotech, Inc. Chemtrue Drug Screen Cup Tests;

• G0434QW, April 20, 2015, Chemtron Biotech, Inc. Chemtrue Drug Screen Cup Tests with OPI 2000;

• G0434QW, April 29, 2015, Quest Products, Inc. DrugHAWK MDMA and OPI Drug Test Cup (Urine){Cup format};

• G0434QW, April 30, 2015, Quest Products, Inc. DrugHAWK Drug Test Cup;

• G0434QW, May 6, 2015, Quest Products, Inc. DrugHAWK Buprenorphine Drug Test Cup;

• 87651QW, May 15, 2015, Roche Molecular, cobas Liat System;

• 87880QW, May 26, 2015, Medline Strep A Test Strip {Throat Swabs};

• 80061QW, 82465QW, 83718QW, 84478QW, May 28, 2015, Poylmer Technology Systems, Inc., CardioChek Plus Test Systems (PTS Panels Lipid Panel test strips);

• 80061QW, 82465QW, 83718QW, 84478QW, May 28, 2015, Poylmer Technology Systems, Inc., CardioChek Home Test Systems (CardioChek Home Lipid Panel test strips);

• 82947QW, May 28, 2015, Poylmer Technology Systems, Inc., CardioChek Plus Test Systems (PTS Panels eGLU test strips);

• 82947QW, May 28, 2015, Poylmer Technology Systems, Inc., CardioChek Plus Test Systems (PTS Panels Glucose test strips;

• 82947QW, May 28, 2015, Poylmer Technology Systems, Inc., CardioChek Home Test Systems (CardioChek Home eGLU test strips);

• 82947QW, May 28, 2015, Poylmer Technology Systems, Inc., CardioChek Home Test Systems (CardioChek Home Glucose test strips);

• G0434QW, June 3, 2015, Native Diagnostics International; DrugSmart Drug Screen Cup Tests with OPI 2000;

• G0434QW, June 3, 2015, Onsite Testing Specialists, Inc. On-site Testing Specialists Drug Screen Cup Tests;

• G0434QW, June 3, 2015, Onsite Testing Specialists, Inc. On-site Testing Specialists Drug Screen Cup Tests with OPI 2000;

• G0434QW, June 4, 2015, Transmetron, Inc. Invitro Pro Drug Test Cards; and

• 87651QW, July 15, 2015. Alere i Instrument.

 

Source: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R3327CP.pdf