New CLIA Waived List Released

The Centers for Medicare & Medicaid Services (CMS) released Feb. 11 the latest laboratory tests approved by the Food and Drug Administration (FDA) as waived tests under Clinical Laboratory Improvement Amendments of 1988 (CLIA). The recurring update notification includes one code change and one code descriptor change which affects several tests.

Code Change

Effective Jan. 1, HCPCS Level II code G0430 Drug screen, qualitative; multiple drug classes other than chromatographic method, each procedure has been deleted and replaced by G0434 Drug screen, other than chromatographic; any number of drug classes, by clia waived test or moderate complexity test, per patient encounter.
Contractors will not search their files to either retract or retroactively adjust claims. Providers may, however, request an adjustment.

Descriptor Change

Also for 2011, the description for HCPCS Level II code G0431 has changed from “Drug screen, qualitative; single drug class method (e.g., immunoassay, enzyme assay), each drug class” to “Drug screen, qualitative; multiple drug classes by high complexity test method (e.g., immunoassay, enzyme assay), per patient encounter.” As a result, the code for the following tests has changed from G0431QW –CLIA waived test to G0434QW:

• Phamatech QuickScreen One Step Amphetamine Test
• Accu-Stat Drugs of Abuse Home Test for Marijuana (THC)
• ADC CLIA Waived Marijuana (THC) Test
• First Check Diagnostics LLC, First Check Home Drug Test Marijuana
• Phamatech QuickScreen One Step THC Screening Test
• Phamatech At Home Drug Test (Model 9078)
• Phamatech At Home Drug Test (Model 9078T)
• Worldwide Medical Corporation, First Check Home Drug Test (THC)
• Phamatech At Home Drug Test (Model 9073)
• Phamatech At Home Drug Test (Model 9073T)
• Phamatech QuickScreen One Step Cocaine Screening Test
• Phamatech At Home Drug Test (Model 9068)
• Phamatech QuickScreen One Step Methamphetamine Test
• DyanGen NicCheck II Test Strips
• Mossman Associates, Inc. NicCheck I Test Strips
• Phamatech At Home Drug Test (Model 9083)
• Phamatech QuickScreen One Step Opiate Screening Test
• Phamatech At Home Drug Test (Model 9133)

Medicare contractors will deny G0431QW for claims with dates of service on or after April 1.

New Waived Tests

Listed below are the new FDA-approved waived tests covered by Medicare:

Source: CMS Transmittal 2155, Change Request (CR) 7266

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