In March 2023 CMS announced a January 1, 2025 implementation date for the addition and deletion of analytes or microbiology tests, and the updates to the grading criteria. This date aligns with PT provider approval and laboratory PT enrollment processes.
This means not much will change for most laboratories in 2024 unless you want to start increasing the number of samples you are testing ahead of the 2025 change. API already has 5-sample programs for most of the analytes that will be regulated in 2025.
Please see the attachment 2025 CLIA CHANGES for more information. More guidance will be available from API and other channels later in 2024 as the industry prepares for 2025.