MM13455 - New Waived Tests CLIA regulations require a facility to be appropriately certified for each test they do CMS edits laboratory claims at the CLIA certificate level to make sure that Medicare and Medicaid only pay for laboratory tests in a facility with a valid, current CLIA certificate Listed below are the latest tests approved by the FDA as waived tests under
CLIA Waived Tests - seed. nih. gov CLIA categorization is determined after FDA has cleared or approved a marketing submission, or upon request for devices already legally marketed FDA categorizes clinical laboratory tests based on their complexity—from the least to the most complex: waived, moderate complexity, and high complexity tests
CLIA - Clinical Laboratory Improvement Amendments - Currently Waived . . . The following is a list of analytes that are used in laboratory test systems that have been "waived" Under the current process, waiver may be granted to: 1) any test listed in the regulation, 2) any test system for which the manufacturer or producer applies for waiver if that test meets the statutory criteria and the manufacturer provides scientifically valid data verifying that the waiver
CLIA Waived Test List 2025: Key Examples Explained The CLIA waived test list for 2025 reflects essential updates and additions that enhance diagnostic capabilities across various healthcare settings These tests maintain simplicity while providing accurate results, enabling timely medical decisions