The COVID Project
The record
- Jurisdiction
- United States
- Level
- Federal
- Authority
- 42 U.S.C. 1395i-3(d)(3), 1396r(d)(3); 42 C.F.R. 483.80 (as amended 85 Fed. Reg. 27627 (May 8, 2020) and 85 Fed. Reg. 54873 (Sept. 2, 2020))
- Issued
- 2016-10-04 Oct. 4, 2016
- Effective
- standing; (g) effective May 8, 2020; (h) effective Sept. 2, 2020 (read as 2020-05-08)
- End
- standing through the claim period (read as 2021-09-30)
- In force
- Standing since May 8, 2020 (a statutory duty; in force throughout the six quarters)
- Quarters
- 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3
2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3
- Limitation types
- Health care ordersWorkplace rulesVaccination or testingStanding duty
- Addressees
- long-term care facilities participating in Medicare or Medicaid
- Character
- regulatory duty
- Collection
- Standing duties: Federal layer DUT-FED
Operative words
(a)... The facility must establish and maintain an infection prevention and control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections.... (g) COVID-19 reporting. The facility must-- (1) Electronically report information about COVID-19 in a standardized format specified by the Secretary.... (h) COVID-19 Testing. The LTC facility must test residents and facility staff, including individuals providing services under arrangement and volunteers, for COVID-19.
Penalty
42 C.F.R. part 488, subpart F: civil money penalties, denial of payment, termination; QSO-20-29-NH sets CMPs for reporting failures; QSO-20-38-NH sets enforcement for testing failures (Exs. FED-161, -168)
What it required
Every Medicare or Medicaid nursing facility (about 15,400 employers) was under a standing 'must' duty to run an infection prevention and control program, and from May 8, 2020 to report COVID-19 data weekly to the CDC's NHSN and to notify residents and families, and from September 2, 2020 to test residents and all staff on the Secretary's parameters (set in QSO-20-38-NH, Ex. FED-168, by county positivity rate); the May 13, 2021 rule added § 483.80(d)(3) education and offering of vaccination (Ex. FED-094). Character as recorded: regulatory_duty (condition of Medicare and Medicaid participation).
Retrieval noteThe 2020 edition captures both 2020 amendments; the interim final rules themselves are Exs. FED-161 (CMS-5531-IFC/QSO-20-29) and FED-092 (CMS-3401-IFC, 85 Fed. Reg. 54820).