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HHS/CMS RIN: 0938-AU33 Publication ID: Fall 2020 
Title: ●Clinical Laboratory Improvement Amendments and Patient Protection and Affordable Care Act; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (CMS-3401)(Completion of a Section 610 Review) 
Abstract:

This interim final rule with comment period (IFC) strengthens CMS’ ability to enforce compliance with Medicare and Medicaid Requirements for Participation, improves Long-Term Care (LTC) Facilities for Infection Control including reporting on information related to COVID-19 by specifying penalty amounts, revises regulations for tracking the incidence and impact of COVID-19 in hospitals and CAHs to assist public health officials in detecting outbreaks and saving lives, and requires all CLIA laboratories to report SARS-CoV-2 test results in such form and manner, and at such timing and frequency, as the Secretary during the Secretary’s Public Health Emergency (PHE) declaration with respect to COVID19. 

 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: Yes  Unfunded Mandates: No 
EO 14192 Designation: Other 
RFA Section 610 Review: Completion of a Section 610 Review 
CFR Citation: 42 CFR 410    42 CFR 413    42 CFR 414    42 CFR 422    ...     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 42 U.S.C. 1302    42 U.S.C. 1395hh    42 U.S.C. 1395rr   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Interim Final Rule  09/02/2020  85 FR 54820   
Interim Final Rule Effective  09/02/2020 
Interim Final Rule Comment Period End  11/02/2020 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Federal, State 
Small Entities Affected: Businesses, Organizations  Federalism: Yes 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
CDR Scott J. Cooper
Health Insurance Specialist, Clinical Standards Group
Department of Health and Human Services
Centers for Medicare & Medicaid Services
7500 Security Boulevard, Mail Stop S3-02-01,
Baltimore, MD 21244
Phone:410 786-9465
Email: scott.cooper@cms.hhs.gov