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CMS Manual System
CMS Manual System Department of Health & Human Services (DHHS) Pub 100-04 Medicare Claims Processing Centers for Medicare & Medicaid Services (CMS) Transmittal 10897 Date: August 6, 2021 Change Request 12381 SUBJECT: New Waived Tests I. SUMMARY OF CHANGES: This change will inform contractors of new 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 of the IOM.
• 80305QW, October 9, 2020, American Screening LLC Reveal Panel Dip Card Tests MOR300; • 80305QW, May 3, 2021, Lendas UAB EXPLORO Highly Sensitive THC Test; and • 80305QW, May 5, 2021, Clinical Reference Laboratory CRLStat Multi-Drug Urine Test Cup.
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