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Ex. FED-163 Order Primary source read

CMS-3414-IFC, 86 Fed. Reg. 26306 (May 13, 2021) (42 C.F.R. 483.80(d)(3)) and QSO-21-19-NH

QSO-21-19-NH

CMS, Quality, Safety & Oversight Group · United States (Medicare and Medicaid LTC facilities) (Federal)

The COVID Project

The record

Jurisdiction
United States (Medicare and Medicaid LTC facilities)
Level
Federal
Authority
42 C.F.R. § 483.80(d)(3), (g)(1)(viii)-(ix) (CMS-3414-IFC, FED-094)
Issued
2021-05-11 May 11, 2021
Effective
2021-05-21 (with the IFC) (read as 2021-05-21)
End
through the PHE (later revised) (read as 2021-09-30)
In force
May 21, 2021 to Sept. 30, 2021
Quarters
2021 Q22021 Q3
Limitation types
Health care ordersWorkplace rulesVaccination or testing
Addressees
  • all Medicare/Medicaid certified LTC facilities; State Survey Agencies
Functions reached
  • RS/IC
  • HR/WF (education and offering to all staff including contract staff)
  • OF reporting
Collection
Federal health, safety and transport layer FED-A

Operative words

On May 11, 2021, CMS published an interim final rule with comment period (IFC). This rule establishes Long-Term Care (LTC) Facility Vaccine Immunization Requirements for Residents and Staff. This includes new requirements for educating residents or resident representatives and staff regarding the benefits and potential side effects associated with the COVID-19 vaccine, and offering the vaccine. Furthermore, LTC facilities must report COVID-19 vaccine and therapeutics treatment information to the Centers for Disease Control and Prevention's (CDC) National Healthcare Safety Network (NHSN).... Noncompliance related to the new requirements for educating and offering COVID-19 vaccination to residents and staff will be cited at F-tag 887, and noncompliance related to COVID-19 vaccination reporting will be cited at F-tag 884.

Enforcement

F-tags F887 and F884; civil money penalties

Notes

Implements FED-094; in force on every day of 2021Q3.