CMS Releases New CLIA-Waived Tests, Billing Codes

CMS notified contractors of new CLIA-waived tests effective July 1, 2015. There are 7 newly waived complexity tests, the latest approved by the FDA. 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.

That same transmittal notes that CPT Code 82055 was replaced by G6040QW. Therefore code G6040QW has been assigned to the following tests:

• Alere Toxicology Services, iScreen Saliva Alcohol Test Strip
• Alfa Scientific Designs Inc. Oral-View Saliva Alcohol Test Strip
• American Screening Corporation, Reveal Saliva Alcohol Test Strip
• Acon Laboratories Inc. Mission Saliva Alcohol Test Strip
• Chematics Inc. Alco-Screen Saliva Alcohol Test
• Chematics Inc. Alco-Screen 02 Saliva Alcohol Test
• CLIAwaived Inc. Rapid Saliva Alcohol Test
• Express Diagnostics International, Incorporated Saliva Alcohol Test
• Germaine Laboratories AimStrip Alcohol Saliva
• Jant Pharmacal Corporation Accustrip Saliva Alcohol Test Strip
• OraSure Technologies Q.E.D. A-150 Saliva Alcohol Test
• OraSure Technologies Q.E.D. A-350 Saliva Alcohol Test
• STC Diagnostics Q.E.D. A150 Saliva Alcohol Test
• STC Diagnostics Q.E.D. A350 Saliva Alcohol Test
• Teco Diagnostics Saliva Alcohol Test.

The CMS Transmittal announcing the latest FDA approved waived tests is Transmittal 3267, Change Request 9164, Pub. 100-04, dated May 22, 2015. The Transmittal and a complete list of CLIA waived devices is available on the CMS website in the Regulations & Guidance Tab, under Transmittals. Note that Contractors won’t look for claims affected but are required adjust claims that are brought to their attention.