Subject: New Waived Tests
Summary: This change will inform contractors of new CLIA waived tests approved by the Food and Drug Administration. Since these tests are marketed immediately after approval, CMS must notify its contractors of the new tests so that the contractors can accurately process claims. There are 12 newly added waived complexity tests. The initial release of this Recurring Update Notification applies to Chapter 16, section 70.8 of the IOM.
Release Date: April 12, 2019
Effective Date: July 1, 2019
Implementation Date: July 1, 2019