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HHS/CMS | RIN: 0938-AT55 | Publication ID: Fall 2020 |
Title: Proficiency Testing Regulations Related to Analytes and Acceptable Performance (CMS-3355) | |
Abstract:
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. |
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Agency: Department of Health and Human Services(HHS) | Priority: Economically Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Long-Term Actions |
Major: Yes | Unfunded Mandates: No |
EO 13771 Designation: Regulatory | |
CFR Citation: 42 CFR 493 | |
Legal Authority: 42 U.S.C. 263a |
Legal Deadline:
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Overall Description of Deadline: 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. |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Small Entities Affected: No | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Jessica Wright Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Center for Clinical Standards and Quality, MS: C2-21-16, 7500 Security Boulevard, Baltimore, MD 21244 Phone:410 786-3838 Email: jessica.wright@cms.hhs.gov |