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Ex. SEC-04-004 Order Primary source read

CMS-3401-IFC, 85 Fed. Reg. 54820

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))

Centers for Medicare & Medicaid Services, Department of Health and Human Services · United States (Federal)

The COVID Project

The record

Jurisdiction
United States
Level
Federal
Authority
Social Security Act 1819(d)(3), 1919(d)(3), 1102, 1871; interim final rule with comment period
Issued
2020-09-02 Sept. 2, 2020
Effective
2020-09-02
End
Testing requirement in force through the PHE (expired May 11, 2023) (read as 2023-05-11)
In force
Sept. 2, 2020 to May 11, 2023
Quarters
2020 Q32020 Q42021 Q12021 Q22021 Q3
Limitation types
Health care ordersWorkplace rulesQuarantine and isolation
Addressees
  • all Medicare- and Medicaid-certified long-term care facilities
Functions reached
  • 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
Collection
Home Care, Nursing and Senior Living SEC-04

Operative words

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

Notes

Condition of participation; implemented by QSO-20-38-NH (Ex. SEC-04-005) and its revisions (Ex. SEC-04-073).

Retrieval note

Codified text as of Oct. 1, 2021 at Ex. SEC-04-022.