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)

The record

Jurisdiction

United States (Medicare and Medicaid long-term care facilities; hospitals and CAHs; CLIA laboratories)

Level

Federal

Authority

Social Security Act §§ 1819, 1919, 1861(e), 1871; CLIA

Issued

2020-09-02 Sept. 2, 2020

Effective

2020-09-02 ('These regulations are effective on September 2, 2020') (read as 2020-09-02)

End

for the duration of the PHE (May 11, 2023) (read as 2023-05-11)

In force

Sept. 2, 2020 to May 11, 2023

Quarters

2020 Q32020 Q42021 Q12021 Q22021 Q3

2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3

Limitation types

Health care ordersWorkplace rulesQuarantine and isolation

Addressees

• every Medicare/Medicaid nursing facility (staff and resident testing, including 'individuals providing services under arrangement and volunteers')
• hospitals and critical access hospitals (daily COVID-19 data reporting as a condition of participation)
• CLIA laboratories (test-result reporting)

Functions reached

• 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 'providing services under arrangement' (staffing agencies PL; home health HC; physicians CL)
• IP/ED hospitals (federal daily reporting)

Collection

Federal health, safety and transport layer FED-A

Operative words

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... § 483.80(h): The LTC facility must test residents and facility staff, including individuals providing services under arrangement and volunteers, for COVID-19.

Enforcement

Notes