{"id":"FED-092","kind":"order","level":"federal","jurisdiction":"United States (Medicare and Medicaid long-term care facilities; hospitals and CAHs; CLIA laboratories)","state":"","metro":"","industry":"","agency":"","eco":"","issuer":"Centers for Medicare \u0026 Medicaid Services, HHS","authority":"Social Security Act §§ 1819, 1919, 1861(e), 1871; CLIA","instrument":"CMS-3401-IFC, 85 Fed. Reg. 54820 (Sept. 2, 2020) (42 C.F.R. 483.80(h) testing; 482.42(e) hospital reporting) and QSO-20-38-NH (Aug. 26, 2020; revised through Sept. 23, 2022)","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, 85 Fed. Reg. 54820 (Sept. 2, 2020)","dateIssued":"2020-09-02","effective":"2020-09-02 (\u0027These regulations are effective on September 2, 2020\u0027)","end":"for the duration of the PHE (May 11, 2023)","startDate":"2020-09-02","endDate":"2023-05-11","quarters":["2020Q3","2020Q4","2021Q1","2021Q2","2021Q3"],"types":["HC","EMP","QUAR"],"addressees":["every Medicare/Medicaid nursing facility (staff and resident testing, including \u0027individuals providing services under arrangement and volunteers\u0027)","hospitals and critical access hospitals (daily COVID-19 data reporting as a condition of participation)","CLIA laboratories (test-result reporting)"],"clause":"This interim final rule with comment period (IFC) revises regulations to strengthen CMS\u0027 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... § 483.80(h): The LTC facility must test residents and facility staff, including individuals providing services under arrangement and volunteers, for COVID-19.","enforcement":"F-tag F886 citations and civil money penalties for LTC facilities; hospital CoP enforcement (42 C.F.R. § 482.42(e)); CLIA sanctions","functions":["RS residential care and IC infection control (nursing homes: mandatory routine staff testing keyed to county positivity, FED-168)","HR/WF of nursing homes and of every contractor, therapist, hospice worker, agency nurse and vendor \u0027providing services under arrangement\u0027 (staffing agencies PL; home health HC; physicians CL)","IP/ED hospitals (federal daily reporting)"],"notes":"In force on every day of 2021Q3; the testing frequency (monthly, weekly, twice weekly by county positivity) is in QSO-20-38-NH (FED-168).","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":"FED-A","url":"/library/FED-092","exhibitUrl":"/exhibit/FED-092","citation":"Centers for Medicare \u0026 Medicaid Services, HHS, CMS-3401-IFC, 85 Fed. Reg. 54820 (Sept. 2, 2020) (42 C.F.R. 483.80(h) testing; 482.42(e) hospital reporting) and QSO-20-38-NH (Aug. 26, 2020; revised through Sept. 23, 2022) (Ex. FED-092)","stateName":"","related":["FED-168","DUT-FED-023","DUT-FED-024"]}