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January 25, 2018

Four Tests Added to List of CLIA Waived Tests

In early January, the Centers for Medicare and Medicaid Services (CMS) announced new waived tests... Learn More

New and Revised Vaccine Codes Added to 2018 CPT Code Book

The American Medical Association (AMA) added and revised several vaccine CPT codes for its 201... Learn More

OIG Recommends Measures for Curbing Opioid Misuse and Fraud

Office of Inspector General testimony before the House Committee on Ways and Means in January ... Learn More

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Medical Coding News Archives

List of CLIA Waived Tests Is Expanded

January 12, 2010:

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations require that a provider be appropriately certified for each test performed. There are some tests, however, that are classified by the Food and Drug Administration (FDA) as being waived under CLIA. This means that any provider who has a certificate of waiver may perform these tests. 

Listed below are the latest tests approved by the FDA as waived tests under CLIA.

CPT Code Effective Date Description


October 11, 2007

Siemens Medical Diagnostics DCA Vantage Analyzer


May 28, 2008

Henry Schein OneStepPlus Urine Analyzer


July 1, 2008

Germaine Laboratories Compliance Gold iFOB (immunological fecal occult blood) Test


July 1, 2008

Beckman Coulter Hemoccult ICT (K080812)


July 22, 2008

BTNX Inc. Rapid Response Immunological Fecal Occult Blood Test (IFOBT)


July 31, 2008

Aventir Biotech LLC Home Check Multiple Drug Cup Test


August 18, 2008

American Bio Medica Rapid TOX


September 18, 2008

Common Sense Ltd. VA-SENSE Kit

CLIA waived tests must be identified on the claim, and modifier QW must be appended to the CPT code. However, codes 81002, 81025, 82270, 82272, G0394, 82962, 83026, 84830, 85013, and 85651 do not require modifier QW to be recognized as waived tests.

For 2009, the American Medical Association created new CPT code 87905 for infectious agent enzymatic activity other than virus (e.g., sialidase activity in vaginal fluid) testing. Effective January 1, 2009, code 97905QW should be reported to indicate the Gryphus Diagnostics BVBlue test and the Genzyme Diagnostics OSOM BVBlue Test.

Deborah C. Hall
Clinical/Technical Editor


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