0938-AT55 201910 The Regulatory Plan and the 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-F)

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.

]]> Economically Significant Previously Published in The Unified Agenda Long-Term Actions Yes No Regulatory 42 CFR 493 42 U.S.C. 263a Statutory Final 02/04/2022 MMA sec. 902 requires Medicare final rules publish within 3 years of a proposed or interim final rule. Per the CMS notice published December 30, 2004 (69 FR 78442), except for certain Medicare payment regulations and certain other statutorily-mandated regulations, we schedule all Medicare final regulations for publication within the 3-year standardized time limit in the current Unified Agenda. We do not intend to delay publishing a Medicare final regulation for 3 years if we are able to publish it sooner. No NPRM 02/04/2019 84 FR 1536-1567 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 Action 02/00/2022 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