0938-AT55 202204 Unified Agenda of Federal Regulatory and Deregulatory Actions 0938 Centers for Medicare & Medicaid Services CMS 0900 Department of Health and Human Services HHS Proficiency Testing Regulations Related to Analytes and Acceptable Performance (CMS-3355)

This final rule responds to comments received on the proposal to update proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to address current analytes (that is, substances or constituents for which the laboratory conducts testing) and newer technologies. This rule may also make additional technical changes to PT referral regulations to more closely align them with the CLIA statute.

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 42 CFR 493 42 U.S.C. 263a Statutory Final 02/04/2023 Under MMA sec. 902, 3-year deadline extended for 1 additional year. MMA section 902 requires Medicare final rules publish within 3 years of a proposed or interim final rule. A notice may publish in the Federal Register before the 3-year deadline extending the timeline by 1-year. We do not intend to delay publishing the final regulation if we are able to publish it sooner. No NPRM 02/04/2019 84 FR 1536 NPRM Comment Period End 04/05/2019 NPRM Comment Period Extended 04/08/2019 84 FR 13857 NPRM Comment Period Extended End 06/04/2019 Final Rule Timeline Extension Notice 01/19/2022 87 FR 2736 Final Action 02/00/2023 No No None No No No Jessica Wright Health Insurance Specialist 0938 Centers for Medicare & Medicaid Services CMS 410 786-3838 jessica.wright@cms.hhs.gov Center for Clinical Standards and Quality, MS: C2-21-16, 7500 Security Boulevard, Baltimore MD 21244