New Waived Tests effective 10/1/2017

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.

The CPT code, effective date and description for the latest tests approved by the FDA as waived tests under CLIA are the following:

• 87880QW, December 8, 2016, Quidel Sofia Strep A+ FIA (from throat swab only);

• 80305QW, April 28, 2017, Alere Toxicology Services Alere iCup Rx Multi-Drug Urine Test Cup;

• 82044QW, and 82570QW, May 10, 2017, Acon Laboratories, Inc. Mission U120 Urine Chemistry Test System (Mission Urinalysis Reagent Strips …

• 80305QW, May 16, 2017, Assure Tech. Co., Ltd. AssureTech Amphetamine Dip;

• 80305QW, May 16, 2017, Assure Tech. Co., Ltd. AssureTech Oxazepam Panel Dip;

• 80305QW, May 16, 2017, Assure Tech. Co., Ltd. AssureTech Cocaine Panel Dip;

• 80305QW, May 16, 2017, Assure Tech. Co., Ltd. AssureTech Marijuana Panel Dip;

• 80305QW, May 16, 2017, Assure Tech. Co., Ltd. AssureTech Methamphetamine Panel Dip;

• 80305QW, May 16, 2017, Assure Tech. Co., Ltd. AssureTech Morphine Panel Dip;

• 80305QW, May 16, 2017, Assure Tech. Co., Ltd. AssureTech Oxycodone Panel Dip;

• 80305QW, May 16, 2017, Assure Tech. Co., Ltd. AssureTech Barbiturates Panel Dip;

• 80305QW, May 16, 2017, Assure Tech. Co., Ltd. AssureTech Buprenorphine Panel Dip;

• 80305QW, May 16, 2017, Assure Tech. Co., Ltd. AssureTech Methylenedioxymethamphetamine Panel Dip;

• 80305QW, May 16, 2017, Assure Tech. Co., Ltd. AssureTech Phencyclidine Panel Dip;

• 80305QW, May 16, 2017, Assure Tech. Co., Ltd. AssureTech Methadone Panel Dip;

• 87804QW, May 30, 2017, Quidel Sofia 2 {Sofia Influenza A+B FIA}; and

• 82274QW, G0328QW, June 5, 2017, Jant Pharmacal Coporation Accutest ValuPak Immunochemical Fecal Occult Blood Test.

Source: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R3812CP.pdf