September 18, 2008
New waived tests
Effective Date: October 1, 2008
Implementation Date: October 6, 2008
Summary
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations require a facility to be appropriately certified for each test performed. To ensure that the Centers for Medicare & Medicaid Services (CMS) only pays for laboratory tests categorized as waived complexity under CLIA in facilities with a CLIA certificate of waiver, laboratory claims are currently edited at the CLIA certificate level.
New waived tests are approved by the Food and Drug Administration (FDA) on a flow basis, and the tests are valid as soon as they are approved. The new waived tests announced by the change request (CR) related to this article (CR 6179) and their effective dates are included.
Additional information is available on the CMS Web site. Here is the link to the MLN Matters article MM6179 
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.Source: CMS MLN Matters Article MM6179
