CLIA Waived Tests Released for First Quarter 2011

The Centers for Medicare & Medicaid Services (CMS) updated, Nov. 5, its list of waived tests approved by the Food and Drug Administration (FDA) under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), and instructed Medicare administrative contractors (MACs) to do the same. To ensure accurate claims payment, clinical diagnostic labs should follow suit.

CLIA regulations require a facility to be appropriately certified for each test performed.

Listed below are the latest tests approved by the FDA under the CLIA. Effective Jan. 1, 2011, the CPT® codes for the following tests must have the modifier QW CIA Waived test to be recognized as such.

CPT® Code Effective Date Description
G0430QW Jan. 1, 2010 American Screening Corporation OneScreen Drug Test Cups
84443QW March 2, 2010 Aventir Biotech LLC, Forsure TSH Test {Whole Blood}
84443QW March 4, 2010 BTNX, Inc. Rapid Response Thyroid Stimulating Hormone (TSH) Test Cassette
G0430QW April 21, 2010 CLIAwaived, Inc. Rapid Drug Test Cup {OTC}
G0430QW April 21, 2010 Millennium Laboratories Clinical Supply, Inc. Multi-Drug Pain Med Screen Cup
G0430QW May 10, 2010 US Diagnostics ProScreen Drugs of Abuse Cup {OTC}
G0430QW July 1, 2010 Ameditech, Inc. ImmuTest Drug Screen Cup
G0430QW July 4, 2010 Quik Test USA, Inc. Multi-Drug of Abuse Urine Test
G0430QW July 4, 2010 Screen Tox Multi-Drug of Abuse Urine Test
82274QW, G0328QW July 8, 2010 Consult Diagnostics Immunochemical Fecal Occult Blood Test (iFOBT)
G0430QW July 19, 2010 Alfa Scientific Designs, Inc. Instant-View Drug of Abuse Urine Cassette Test
G0430QW July 19, 2010 Alfa Scientific Designs, Inc. Instant-View Drug of Abuse Urine Cup Test
G0430QW Aug. 18, 2010 American Screening Corporation Reveal Multi-Drug Testing Cups
87880QW Aug. 18, 2010 PSS Consult Diagnostics Strep A Dipstick

CMS Transmittal 2084, Change Request (CR) 7184, issued Nov. 5, includes an attachment that lists all the current tests granted waived status under the CLIA.


Note that CPT® codes: 81002, 81025, 82270, 82272, 82962, 83026, 84830, 85013, and 85651 do not require modifier QW to be recognized as a waived test.

2 Responses to “CLIA Waived Tests Released for First Quarter 2011”

  1. shontal edmondson says:

    I need to sign up for the aapc exam but i don’t know how please help

  2. lucy lop says:

    Go to the aapc website.

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