New Waived Tests
The purpose of this Change Request (CR) is to inform contractors of new Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived tests approved by the Food and Drug Administration. Since these tests are marketed immediately after approval, the CMS must notify its contractors of the new tests so that the contractors can accurately process claims. There are 80 newly added waived complexity tests. This Recurring Update Notification applies to Chapter 16, section 70.8 of the Internet Only Manual (IOM).
Final
Issued by: Centers for Medicare & Medicaid Services (CMS)
Issue Date: November 24, 2023
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