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New Waived Tests

This Change Request (CR) will 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 Centers for Medicare & Medicaid Services (CMS) must notify its contractors of the new tests so that the contractors can accurately process claims.

Download the Guidance Document

Final

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

Issue Date: January 14, 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.