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Ex. SEC-01-004 Order Primary source read

CMS-3401-IFC, 85 Fed. Reg. 54820 (Sept. 2, 2020): 42 C.F.R. 482.42(e) and 485.640(d) (hospital and CAH COVID-19 reporting as a condition of participation); 483.80(h) (LTC testing); 493.41 (laboratory SARS-CoV-2 test reporting)

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

Centers for Medicare & Medicaid Services, HHS · United States (Federal)

The COVID Project

The record

Jurisdiction
United States
Level
Federal
Authority
Social Security Act 1861(e)(9), 1866, 1902; CARES Act 18115
Issued
2020-08-25 Aug. 25, 2020
Effective
2020-09-02
End
482.42(e) in effect during the PHE for COVID-19 (ended 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 rules
Addressees
  • Medicare-participating hospitals and critical access hospitals
  • CLIA laboratories
  • long-term care facilities
Functions reached
  • IP bed and census reporting daily
  • OC hospital laboratory test reporting
  • SC PPE and ventilator supply reporting
  • OF data reporting
  • WF staffing shortage reporting
  • ED
Collection
Hospitals and Health Systems SEC-01

Operative words

482.42(e) COVID-19 Reporting. During the [PHE] the hospital must report information in accordance with a frequency, and in a standardized format, as specified by the Secretary during the PHE for COVID-19... (d) This section is in effect during and [until the] end of the PHE.

Enforcement

Condition of participation; noncompliance subject to termination from Medicare (enforcement letters from Oct. 7, 2020 under CMS's Oct. 6, 2020 memorandum); 493.41 laboratory civil money penalties

Notes

Made HHS's July 2020 hospital reporting (TeleTracking/HHS Protect) a federal condition of every hospital's Medicare participation; the daily report fields include beds, ICU occupancy, ventilators, PPE days-on-hand and staffing shortages.

Retrieval note

Bundled FH-27 covers the 483.80(h) portion.