0938-AU33 202010 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 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)

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. 

]]> Economically Significant First Time Published in The Unified Agenda Completed Actions Yes No Other Completion of a Section 610 Review 42 CFR 410 42 CFR 413 42 CFR 414 42 CFR 422 ... 42 U.S.C. 1302 42 U.S.C. 1395hh 42 U.S.C. 1395rr No 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 Yes Businesses Organizations Federal State Yes Yes No Scott Cooper J. CDR Health Insurance Specialist, Clinical Standards Group 0938 Centers for Medicare & Medicaid Services CMS 410 786-9465 scott.cooper@cms.hhs.gov 7500 Security Boulevard, Mail Stop S3-02-01, Baltimore MD 21244