Laboratory Question for the Week of May 20, 2019

Laboratory Compliance Question of the Week

Question:

How many new waived tests will be effective in July 2019?

Answer:

On July 1, 2019, 12 new Clinical Laboratory Improvement Amendments (CLIA) of 1988 waived tests approved by the Food and Drug Administration (FDA) will be implemented. As always, the tests have various effective dates. The Centers for Medicare & Medicaid Services (CMS) presented these test additions in Transmittal 4277 (issued April 12, 2019).


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