New Waived Tests effective 10/1/2016

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. CLIA requires that for each test it performs, a laboratory facility must be appropriately certified. To ensure that Medicare & Medicaid only pay for laboratory tests categorized as waived complexity under CLIA in facilities with a CLIA certificate of waiver, laboratory claims are currently edited at the CLIA certificate level.

• G0434QW [from August 21, 2015 to December 31, 2015] and G0477QW [on and after January 1, 2016], Healgen Scientific LLC, Healgen Multi-Drug Urine Test Dip Card;

• G0477QW, March 8, 2016, Tanner Scientific Multi-Panel Drug Test Cup;

• G0477QW, March 18, 2016, Hangzhou Clongene Biotech Co., Ltd. Clungene Marijuana Easy Cup;

• G0477QW, March 18, 2016, Hangzhou Clongene Biotech Co., Ltd. Clungene Marijuana Split Key Cup;

• G0477QW, March 18, 2016, Hangzhou Clongene Biotech Co., Ltd. Clungene Marijuana Test Cassette;

• G0477QW, March 18, 2016, Hangzhou Clongene Biotech Co., Ltd. Clungene Marijuana Test Dip Card;

• G0477QW, March 18, 2016, Hangzhou Clongene Biotech Co., Ltd. Clungene Metamphetamine Easy Cup;

• G0477QW, March 18, 2016, Hangzhou Clongene Biotech Co., Ltd. Clungene Metamphetamine Split Key Cup;

• G0477QW, March 18, 2016, Hangzhou Clongene Biotech Co., Ltd. Clungene Metamphetamine Test Cassette;

• G0477QW, March 18, 2016, Hangzhou Clongene Biotech Co., Ltd. Clungene Metamphetamine Test Dip Card;

• G0477QW, March 18, 2016, Hangzhou Clongene Biotech Co., Ltd. Clungene Morphine Easy Cup;

• G0477QW, March 18, 2016, Hangzhou Clongene Biotech Co., Ltd. Clungene Morphine Split Key Cup;

• G0477QW, March 18, 2016, Hangzhou Clongene Biotech Co., Ltd. Clungene Morphine Test Cassette;

• G0477QW, March 18, 2016, Hangzhou Clongene Biotech Co., Ltd. Clungene Morphine Test Dip Card;

• 87338QW, March 22, 2016, Meridian Bioscience Immunocard STAT! HpSA (Stool);

• G0477QW, March 31, 2016, Assure Tech Co., Ltd. AssureTech Amphetamine Dip Card;

• G0477QW, March 31, 2016, Assure Tech Co., Ltd. AssureTech Amphetamine Quick Cup;

• G0477QW, March 31, 2016, Assure Tech Co., Ltd. AssureTech Amphetamine Strip;

• G0477QW, March 31, 2016, Assure Tech Co., Ltd. AssureTech Amphetamine Turn-Key Split Cup;

• G0477QW, March 31, 2016, Assure Tech Co., Ltd. AssureTech Cocaine Dip Card;

• G0477QW, March 31, 2016, Assure Tech Co., Ltd. AssureTech Cocaine Quick Cup;

• G0477QW, March 31, 2016, Assure Tech Co., Ltd. AssureTech Cocaine Strip;

• G0477QW, March 31, 2016, Assure Tech Co., Ltd. AssureTech Cocaine Turn-Key Split Cup;

• G0477QW, March 31, 2016, Assure Tech Co., Ltd. AssureTech Morphine Dip Card;

• G0477QW, March 31, 2016, Assure Tech Co., Ltd. AssureTech Morphine Quick Cup;

• G0477QW, March 31, 2016, Assure Tech Co., Ltd. AssureTech Morphine Strip;

• G0477QW, March 31, 2016, Assure Tech Co., Ltd. AssureTech Morphine Turn-Key Split Cup;

• G0477QW, April 21, 2016, Chemtron Biotech, Inc. Chemtrue Multi-Panel Drug Screen Cup Tests; and

• G0477QW, April 21, 2016, Chemtron Biotech, Inc. Chemtrue Multi-Panel Drug Screen Cup with OPI 2000 Tests.

Source: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R3563CP.pdf