CMS Releases New CLIA-Waived Tests, Billing Codes

CMS notified contractors of new CLIA-waived tests effective January 1, 2015. There are 25 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. CMS's Transmittal indicates that contractors don't have to go back to "retract payment or retroactively pay claims" but must adjust claims accordingly when brought to their attention. 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
87807QW	Mar. 18, 2014	BD Veritor System for Rapid Detection of RSV (For use with nasopharyngeal specimens) (Includes reader)
G0434QW	May 12, 2014	Native Diagnostics International, DrugSmart Dip Single/Multi-Panel Drug Screen Dip Card Test
87807QW	May 30, 2014	Sofia RSV
G0434QW	June 9, 2014	Healgen THC One Step Marijuana Test Strip
G0434QW	June 9, 2014	Healgen THC One Step Marijuana Test Cassette
G0434QW	June 9, 2014	Healgen THC One Step Marijuana Test Cup
G0434QW	June 9, 2014	Healgen THC One Step Marijuana Test Dip Card
G0434QW	June 9, 2014	Healgen mAMP One Step Methamphetamine Test Strip
G0434QW	June 9, 2014	Healgen mAMP One Step Methamphetamine Test Cassette
G0434QW	June 9, 2014	Healgen mAMP One Step Methamphetamine Test Cup
G0434QW	June 9, 2014	Healgen mAMP One Step Methamphetamine Test Dip Card
87880QW	June 11, 2014	Poly stat Strep A Strip Test {Specimen type (Throat Swab)}
87880QW	June 25, 2014	StrepAim {Specimen type (Throat Swab)}
G0434QW	June 27, 2014	Wal-Mart Stores, Inc. ReliOn Home Drug Urine Cup Test
86308QW	July 7, 2014	Jant Pharmacal Corp. Accutest Rapid Mono Test {Whole Blood}
87880QW	July 9, 2014	Cardinal Health Strep A Dipstick - Rapid Test (Throat Swab Specimen)
G0434QW	July 18, 2014	Healgen COC One Step Cocaine Test Strip
G0434QW	July 18, 2014	Healgen COC One Step Cocaine Test Cassette
G0434QW	July 18, 2014	Healgen COC One Step Cocaine Test Cup
G0434QW	July 18, 2014	Healgen COC One Step Cocaine Test Dip Card
G0434QW	July 18, 2014	Healgen MOP One Step Morphine Test Strip
G0434QW	July 18, 2014	Healgen MOP One Step Morphine Test Cassette
G0434QW	July 18, 2014	Healgen MOP One Step Morphine Test Cup
G0434QW	July 18, 2014	Healgen MOP One Step Morphine Test Dip Card
81003QW	Aug. 8, 2014	Medline 120 Urine Analyzer

Source: CPT Codes are Copyright American Medical Association The CMS Transmittal announcing the latest FDA approved waived tests is Transmittal 3149, Change Request 8951, Pub. 100-04, dated Dec. 12, 2014. The Transmittal and a complete list of CLIA waived devices is available on the CMS website at http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R3149CP.pdf.