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MM12581 - New Waived Tests

This revised Article comprises Subregulatory Guidance for the latest tests approved by the FDA as waived tests under CLIA, laboratory claim edits and facility certification requirement. MLN Matters (MM) Articles are based on information contained within Change Requests (CRs). In this case, this article is based on content within CR12581 that is posted on the CMS website at https://www.cms.gov/files/document/r11363CP.pdf .

Download the Guidance Document

Final

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

Issue Date: January 18, 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.