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 […]
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.
**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.
| 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.
Subscribe to view Essential
Start a Free Trial for immediate access to this article