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New Waived Tests

The purpose of this Change Request (CR) is to inform contractors of new Clinical Laboratory Improvement Amendments (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 6 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

Final

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

Issue Date: April 05, 2023

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.