CMS Updates CLIA Waived Tests Effective January 1, 2024

The Centers for Medicare and Medicaid Services (CMS) recently issued revised guidance  to its Medicare Administrative Contractors (MACs) to inform them 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 CMS must notify its contractors of the new tests so that the contractors can accurately process claims. There are 104 newly added waived complexity tests. This Recurring Update Notification applies to Chapter 16, section 70.8 of the Internet Only Manual (IOM).  

While these tests are bundled into the SNF Part A payment rates, many SNF providers bill for certain CLIA waived tests under Medicare Part B for long stay residents. Billing staff of such providers are encouraged to review the NEW Waived Tests MLN Matters Article to learn more about:  

• Clinical Laboratory Improvement Amendments (CLIA) requirements   
• New CLIA-waived tests approved by the FDA as of December 5, 2023  
• Use of modifier QW for CLIA-waived tests

Source: AHCA/NCAL