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New Waived Tests


CLIA requires that for each test it performs, a laboratory facility must be appropriately certified. The CPT codes that the Centers for Medicare & Medicaid Services (CMS) consider 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 as waived tests under CLIA. The tests are valid as soon as they are approved. The CPT codes for the following new tests MUST have the modifier QW to be recognized as a waived test.

87880-QW BTNX Rapid Response Strep A Rapid Test Strips, Effective date: February 2, 2011

82274-QW & G0328-QW OC-Light iFOB Test, Effective date: March 24, 2011

G0434-QW CLIAwaived, Inc. Rapid Drug Test Cup {OTC}, Effective date: April 1, 2011

G0434-QW Instant Technologies, iCup DX Drug Screen Cup, Effective date: April 1, 2011

86318-QW Stanbio Rely H. plyori Rapid Test (Whole Blood) (Finger-stick only), Effective date: April 7, 2011

Reference: http://www.cms.gov/MLNMattersArticles/downloads/MM7435.pdf

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