{"abstract":"This interim final rule with comment period (IFC) revises regulations to strengthen CMS' ability to enforce compliance with Medicare and Medicaid long-term care (LTC) facility requirements for reporting information related to coronavirus disease 2019 (COVID-19), establishes a new requirement for LTC facilities for COVID-19 testing of facility residents and staff, establishes new requirements in the hospital and critical access hospital (CAH) Conditions of Participation (CoPs) for tracking the incidence and impact of COVID-19 to assist public health officials in detecting outbreaks and saving lives, and establishes requirements for all CLIA laboratories to report COVID-19 test results to the Secretary of Health and Human Services (Secretary) in such form and manner, and at such timing and frequency, as the Secretary may prescribe during the Public Health Emergency (PHE).","action":"Interim final rule with comment period.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2020/09/02/2020-19150.html","cfr_references":[{"chapter":null,"citation_url":null,"part":410,"title":42},{"chapter":null,"citation_url":null,"part":413,"title":42},{"chapter":null,"citation_url":null,"part":414,"title":42},{"chapter":null,"citation_url":null,"part":422,"title":42},{"chapter":null,"citation_url":null,"part":423,"title":42},{"chapter":null,"citation_url":null,"part":482,"title":42},{"chapter":null,"citation_url":null,"part":483,"title":42},{"chapter":null,"citation_url":null,"part":485,"title":42},{"chapter":null,"citation_url":null,"part":488,"title":42},{"chapter":null,"citation_url":null,"part":493,"title":42}],"citation":"85 FR 54820","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Effective date: These regulations are effective on September 2, 2020.","disposition_notes":null,"docket_ids":["CMS-3401-IFC"],"dockets":[],"document_number":"2020-19150","effective_on":"2020-09-02","end_page":54874,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/09/02/2020-19150.xml","html_url":"https://www.federalregister.gov/documents/2020/09/02/2020-19150/medicare-and-medicaid-programs-clinical-laboratory-improvement-amendments-clia-and-patient","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-19150?publication_date=2020-09-02","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-09-02/2020-19150/mods.xml","not_received_for_publication":null,"page_length":55,"page_views":{"count":30505,"last_updated":"2026-04-17 22:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-09-02/pdf/2020-19150.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-19150.pdf?1598559315","publication_date":"2020-09-02","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/09/02/2020-19150.txt","regulation_id_number_info":{"0938-AU33":null},"regulation_id_numbers":["0938-AU33"],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":171,"agency_id":"CMS","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=CMS-2020-0097","supporting_documents_count":0,"docket_id":"CMS-2020-0097","document_id":"CMS-2020-0097-0001","regulation_id_number":"0938-AU33","title":"Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency  CMS-3401-IFC","checked_regulationsdotgov_at":"2020-11-09T04:30:08Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":54820,"subtype":null,"title":"Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency","toc_doc":"Additional Policy and Regulatory Revisions in Response to the COVID19 Public Health Emergency","toc_subject":"Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments, and Patient Protection and Affordable Care Act:\n","topics":["Administrative practice and procedure","Biologics","Diseases","Drugs","Emergency medical services","Grant programs-health","Health facilities","Health maintenance organizations (HMO)","Health professions","Health records","Hospitals","Laboratories","Medicaid","Medicare","Nursing homes","Nutrition","Penalties","Privacy","Puerto Rico","Reporting and recordkeeping requirements","Rural areas","Safety","X-rays"],"type":"Rule","volume":85}