Effective Date: July 1, 2008

Implementation Date: July 6, 2008

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations require a facility to be appropriately certified for each test performed. To ensure that Medicare 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.

This article provides the latest tests approved by the Food and Drug Administration as waived tests under CLIA. These new tests must have the modifier QW to be recognized as a waived test. However, procedures 81002, 81025, 82270, 82272, G0394, 82962, 83026, 84830, 85013, and 85651 do not require a QW modifier to be recognized as a waived test.

For a one-stop resource Web page focused on the informational needs and interests of Medicare Fee-for-Service (FFS) clinical laboratory providers and suppliers, go to the Clinical Laboratory Center at http://www.cms.hhs.gov/center/clinical.asp .

Here is the link to the MLN Matters article MM6060 .