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New Waived Test

The purpose of this Change Request (CR) is to inform the 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 eight (8) newly added waived complexity tests. 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: August 04, 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.