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:

CPT®/HCPCS Code Effective Date Description
87880QW Oct. 4, 2010 BTNX, Inc. Strep A Rapid Test
86308QW Oct. 4, 2010 Consult Diagnostics Mononucleosis Cassette {Whole Blood}
82274QW G0328QW Oct. 4, 2010 BTNX Inc. Rapid Response Fecal Immunochemical Test (FIT)
82274QW G0328QW Oct. 4, 2010 American IVD Biotechnology Services Inc. FOB/CRC Advanced+
G0434QW Jan. 1, 2011 Amedica Biotech AmediCheck Instant Test Cup
G0434QW Jan. 1, 2011 Confirm Biosciences Drugconfirm instant multi-drug test kit, Multi-Drug of Abuse Urine Test
G0434QW Jan. 1, 2011 Insight Medical Multi-Drug of Abuse Urine Test
G0434QW Jan. 1, 2011 Jant Pharmacal Corporation Accutest Drug Test Cup
G0434QW Jan. 1, 2011 Micro Distributing II, Ltd Multi-Drug of Abuse Urine Test
G0434QW Jan. 1, 2011 Millennium Laboratories Multi-Drug of Abuse Urine Test
G0434QW Jan. 1, 2011 NexScreen LLC, NexScreen Cup
G0434QW Jan. 1, 2011 On the Spot Drug Testing Multi-Drug of Abuse Urine Test
G0434QW Jan. 1, 2011 Physicians’ Test Multi-Drug of Abuse Urine Test
G0434QW Jan. 1, 2011 Total Diagnostic Solutions Multi-Drug of Abuse Urine Test
G0434QW Jan. 1, 2011 UCP Biosciences, Inc. Drug Screening Test Cards
G0434QW Jan. 1, 2011 UCP Biosciences, Inc. Multiple Drug Screen Cups

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

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5 Responses to “New CLIA Waived List Released”

  1. GRACEMON KURIAKOSE says:

    Hi,
    Medicare is not paying 81003.I checked in online ,it says code deleted in 01/01/2011.Is that right?Can you please tell me the replacement CPT.

    Thanks

  2. Maureen says:

    Just wondering, does anyone know the maximum number of units billable for the new code G0434QW? I’m not sure if it’s 4 or 9units on a line.

  3. Rebecca Grates says:

    From our understanding, you can only bill 1 unit for the G0434QW and MCR is only allowing/paying $20.47. They stated due to the “per patient encounter” part of the descriptor, you may not bill multiple units when submitting G0434 on the claim form.
    Hope this helps.

  4. konrad strozyk says:

    does anyone know where the lines are supposed to show up on the amedicheck instant test cup?
    thanks I’d really appreciate an answer

  5. C Knox says:

    I am trying to find out if 88305, 88312, 88313 are waived test with CLIA? I have searched the CLIA for a listing of waived test and these procedure codes do NOT show up?

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