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CLIA Waived Tests

The Centers for Medicare and Medicaid Services (CMS) has recently issued updated guidance to its Medicare Administrative Contractors (MACs) regarding newly approved Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived tests by the Food and Drug Administration. These tests are made available for marketing immediately after approval, necessitating CMS to notify its contractors promptly to ensure accurate claims processing. A total of 104 newly approved waived complexity tests have been added.  This Recurring Update Notification pertains to Chapter 16, section 70.8 of the Internet Only Manual (IOM).
 
It's important to note that while these tests are integrated into the SNF Part A payment rates, many SNF providers submit bills for specific CLIA waived tests under Medicare Part B for long-term residents. We encourage billing staff at such providers to review the NEW Waived Tests MLN Matters Article for further information.
 
 
Staff Contact: mcarland@mehca.org