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MLN Matters Article (New) MM13162: New Waived Tests

This new Article comprises Subregulatory Guidance for clinical Laboratory Improvement Amendments (CLIA) requirements, new CLIA-waived tests approved by the FDA and use of modifier QW for CLIA-waived tests. MLN Matters (MM) Articles are based on information contained within Change Requests (CRs). In this case, this article is based on content within CR13162 that is posted on the CMS website at https://www.cms.gov/files/document/r11943CP.pdf.

Download the Guidance Document

Final

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

Issue Date: April 06, 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.