{"id":"SEC-04-004","kind":"order","level":"federal","jurisdiction":"United States","state":"","metro":"","industry":"04","agency":"","eco":"","issuer":"Centers for Medicare \u0026 Medicaid Services, Department of Health and Human Services","authority":"Social Security Act 1819(d)(3), 1919(d)(3), 1102, 1871; interim final rule with comment period","instrument":"CMS-3401-IFC, 85 Fed. Reg. 54820","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 (adding 42 C.F.R. 483.80(h))","dateIssued":"2020-09-02","effective":"2020-09-02","end":"Testing requirement in force through the PHE (expired May 11, 2023)","startDate":"2020-09-02","endDate":"2023-05-11","quarters":["2020Q3","2020Q4","2021Q1","2021Q2","2021Q3"],"types":["HC","EMP","QUAR"],"addressees":["all Medicare- and Medicaid-certified long-term care facilities"],"clause":"483.80(h)(1): the facility must test residents and facility staff, including individuals providing services under arrangement and volunteers, for COVID-19.... (h)(2)... in a manner that is consistent with current standards of practice... [and] parameters set forth by the Secretary... (h)(3)... procedures for addressing residents and staff... who refuse testing or are unable to be tested... (h)(4)... staff with symptoms or a positive test must be prohibited from entering the facility until return-to-work criteria are met.","enforcement":"F886; civil money penalties under 42 C.F.R. 488.430 for failure to test","functions":["IC mandatory resident and staff testing","RS admissions and cohorting by test status","HR staff excluded pending results","IN contracted personnel entering the facility tested","WF staff removed on symptoms or positive test"],"notes":"Condition of participation; implemented by QSO-20-38-NH (Ex. SEC-04-005) and its revisions (Ex. SEC-04-073).","sourceUrl":"https://www.govinfo.gov/content/pkg/FR-2020-09-02/pdf/2020-19150.pdf","snapshot":"","fileExists":true,"fileBytes":582506,"grade":"primary","character":"","description":"","collection":"SEC-04","url":"/library/SEC-04-004","exhibitUrl":"/exhibit/SEC-04-004","citation":"Centers for Medicare \u0026 Medicaid Services, Department of Health and Human Services, CMS-3401-IFC, 85 Fed. Reg. 54820 (Sept. 2, 2020) (Ex. SEC-04-004)","stateName":"","related":["SEC-04-005","SEC-04-073","SEC-04-022","SEC-04-GM-004"]}