CMS Releases New CLIA-Waived Tests, Billing Codes

CMS notified contractors of new CLIA-waived tests effective April 1, 2015. There are 30 newly waived complexity tests, the latest approved by the FDA—which are again dominated by drug testing related items. The tests, listed in the table below, all require the QW modifier be attached to the CPT code for recognition as a waived test.

The following table provides a listing of the new CLIA-waived tests with their CPT Code, effective date and description.

CPT CODE EFFECTIVE DATE DESCRIPTION
G0434QW Sept. 18, 2014 CLIAwaived Inc. Rapid Drug Test Cup (Cassette Dip Card format)
86308QW Sept. 23, 2014 AimStep Mono (Whole Blood)
G0434QW Sept. 26, 2014 Polymed Therapeutics FaStep Marijuana Panel Dip
G0434QW Sept. 26, 2014 Polymed Therapeutics FaStep Marijuana Quick Cup
G0434QW Sept. 26, 2014 Polymed Therapeutics FaStep Marijuana Strip
G0434QW Sept. 26, 2014 Polymed Therapeutics FaStep Marijuana Turn-Key Split Cup
G0434QW Sept. 26, 2014 Polymed Therapeutics FaStep Methamphetamine Panel Dip
G0434QW Sept. 26, 2014 Polymed Therapeutics FaStep Methamphetamine Quick Cup
G0434QW Sept. 26, 2014 Polymed Therapeutics FaStep Methamphetamine Strip
G0434QW Sept. 26, 2014 Polymed Therapeutics FaStep Methamphetamine Turn-Key Split Cup
G0434QW Oct. 9, 2014 Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Dip Card Tests
G0434QW Oct. 9, 2014 Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Cassette Tests
G0434QW Oct. 9, 2014 Chemtron Biotech, Inc. Chemtrue Multi-Panel Drug Screen Dip Card Tests
G0434QW Oct. 9, 2014 Chemtron Biotech, Inc. Chemtrue Multi-Panel Drug Screen Dip Card with OPI 2000 Test
G0434QW Oct. 17, 2014 Healgen Oxazepam Test Strip
G0434QW Oct. 17, 2014 Healgen Oxazepam Test Dip Card
G0434QW Oct. 17, 2014 Healgen Oxazepam Test Cup
G0434QW Oct. 17, 2014 Healgen Oxazepam Test Cassette
G0434QW Oct. 17, 2014 Healgen Morphine Test Strip
G0434QW Oct. 17, 2014 Healgen Morphine Test Dip Card
G0434QW Oct. 17, 2014 Healgen Morphine Test Cup
G0434QW Oct. 17, 2014 Healgen Morphine Test Cassette
G0433QW Oct. 29, 2014 Chembio Diagnostic Systems, Inc. DPP HIV ½ Assay (Oral Fluid)
87389QW** Dec. 5, 2014 Oregenics, Alere Determine HIV-1/2 Ag/Ab Combo (fingerstick Whole Blood)
G0434QW Dec. 10, 2014 Transmetron Invitro Pro Drug Test Cups
G0434QW Dec. 10, 2014 Coastline Medical Management Coastline Explorer Cup (Cassette Dip Card Format)
86780QW Dec. 15, 2014 Diagnostics Direct LLC Syphilis Health Check (FingerStick Whole Blood)
G0434QW Dec. 19, 2014 On-Site Testing Specialists, Inc. On-Site Testing Specialist Single/Multi-Panel Drug Screen Dip Card Tests
G0434QW Dec. 19, 2014 On-Site Testing Specialists, Inc. On-Site Testing Specialist Single/Multi-Panel Drug Screen Dip Card with OPI 2000 Tests
87502QW Jan. 5, 2015 Alere i Influenza A & B Test (Direct Nasal swab only)

**Note that CPT code 87389QW is applicable from Dec. 5, 2014 to Dec. 31, 2014 for detecting “antigen to HIV-1, and antibodies to HIV-1 and HIV-2 per- formed using the Oregenics, Alere Determine HIV-1/2 Ag/Ab Combo (fingerstick Whole Blood).” Effective Jan. 1, 2015 the appropriate CPT code is 87806QW.

The CMS Transmittal announcing the latest FDA approved waived tests is Transmittal 3207, Change Request 9072, Pub. 100-04, dated Feb. 27, 2015. The Transmittal and a complete list of CLIA waived devices is available on the CMS website here.

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