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New CLIA Waived Tests


Clinical Laboratory Improvement Amendments of 1998 (CLIA) requires that a laboratory be appropriately certified for each test it performs. The CPT codes that CMS considers to be laboratory tests under CLIA (and thus requiring certification) change each year.

Listed below are the latest tests approved by the Food and Drug Administration (FDA) as waived tests under CLIA. The CPT codes for the following new tests must have the modifier QW to be recognized as a waived test. However, CPT codes 81002, 81025, 82270, 82272, 82962, 83026, 84830, 85013 and 85651 do not require a QW modifier to be recognized as a waived test.

G0434QW Diagnostic Test Group Clarity Multiple Drug Screen Cups (Effective from  April 22, 2011)

87804QW BD Veritor System for Rapid Detection of Flu A+B (For use with nasal and nasopharyngeal swabs) (includes a reader) (Effective from  December 9, 2011)

G0434QW Alere Toxicology Services Alere iCassette DX Drug Screen (Effective from  December 14, 2011)

82055QW Jant Pharmacal Corporation Accustrip Saliva Alcohol Test Strip (Effective from  January 6, 2012)

82055QW Alfa Scientific Designs Inc. Oral-View Saliva Alcohol Test Strip (Effective from  January 6, 2012)

83861QW TearLab Corporation TearLab Osmolarity System (Effective from  January 23, 2012)

G0434QW Alere iCassette Drug Screen (Effective from  January 26, 2012)

87804QW Alere Influenza A & B Test (for use with nasal swabs only) (Effective from  January 27, 2012)

87808QW Sekisui Diagnostics, LLC OSOM Trichomonas Rapid Test (Effective from  February 3, 2012)

87880QW Sekisui Diagnostics, LLC, OSOM Ultra Strep A Test (Effective from  February 3, 2012)

87880QW Sekisui Diagnostics, LLC, OSOM Strep A Test (direct from throat swab) (Effective from  March 1, 2012)

The new waived CPT code 83861QW has been assigned for the osmolarity test performed using the TearLab Corporation TearLab Osmolarity System.

Reference(s): http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM7795.pdf

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