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New Waived Tests

The purpose of this change request is to 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 eight (8) newly added waived complexity tests. The initial release of this recurring update notification applies to chapter 16, section 70.8 of the Internet Only Manual (IOM).

Download the Guidance Document

Issued by: Centers for Medicare & Medicaid Services (CMS)

Issue Date: November 23, 2022

DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.