CMS releases requirements and enforcement process for reporting of COVID-19 data for hospitals and CAHs
The Centers for Medicare & Medicaid Services (CMS) stated it has released new regulatory requirements for all hospitals and critical access hospitals (CAHs) at 42 C.F.R. §§482.42(e) and 485.640(d), respectively, to report information in accordance with a frequency and in a standardized format as specified by the Secretary during the PHE for COVID-19.
Failure to report the specified data needed to support broader surveillance of COVID-19 may lead to the imposition of the remedy to terminate a provider’s participation from the Medicare and Medicaid programs.
The reporting requirements apply to all Medicare and Medicaid hospitals and critical access hospitals (CAHs) throughout the duration of the public health emergency (PHE). Hospitals are expected to report all required data sets completely.
Daily Reporting: As detailed in the interpretive guidance chart, hospitals (except psychiatric and rehabilitation hospitals, which will submit weekly) will be required to report 25 data sets daily. Those sets include hospital information, various bed occupancy and capacity information, ventilator utilization and capacity, various elements around COVID-19 hospitalizations, admissions and emergency department information and critical staffing shortage data. While data around remdesivir utilization and staffing shortages are required, those reporting requirements will become optional on November 4.
Weekly Reporting: The following data sets require data submission once per week on Wednesday. These data include personal protective equipment (PPE), testing and ventilator on-hand supply, information around the ability to acquire necessary supplies, information on re-use or extended use of certain PPE, the ability of the facility to maintain a three-day supply of necessary items and critical medical or pharmaceutical supply shortages.
Optional Daily Influenza Reporting Requirements That Will Become Mandatory. Starting October 19, hospitals (except psychiatric and rehabilitation hospitals, which will report weekly) will have the option to report several data elements focused on influenza. Those elements include confirmed cases of influenza, admissions, ICU utilization, confirmed cases of patients with both influenza and COVID-19, and previous day’s deaths. CMS indicates that more information will be provided in the near future about these requirements, but hospitals should expect the reporting of these data sets to become mandatory.
The reporting requirements described in this guidance are applicable to all Medicare and Medicaid hospitals and CAHs, as infection prevention and control is, and continues to be, a primary goal during the PHE for COVID-19.
The requirement to collect these data and transmit them will also encourage greater awareness and promotion of best practices in infection prevention and control within these facilities. A streamlined approach to reporting data will greatly assist the White House Coronavirus Task Force (COVID-19 Task Force) in tracking the movement of the virus and identifying potential strains in the healthcare delivery system.
The completeness, accuracy, and timeliness of the data will inform the COVID-19 Task Force decisions to address capacity and resource needs to ensure a fully coordinated effort across the nation. As noted in the IFC, if a hospital or CAH fails to consistently report test results throughout the duration of the PHE for COVID-19, CMS will determine the provider to be non-compliant with the hospital or the CAH CoPs set forth at §§ 482.42(e) and 485.640(d), respectively, and will be subject to termination pursuant to 42 CFR 489.53(a)(3). Data Reporting Elements and Reporting Mechanisms On July 29, 2020, HHS published updated guidance for hospital COVID-19 reporting: https://www.hhs.gov/sites/default/files/covid-19-faqs-hospitals-hospital-laboratory-acute-carefacility-data-reporting.pdf.
The guidance states that hospitals should report specified information at least once daily through one of the prescribed methods described below. Facilities to Report The following hospitals should report the data elements specified in the table below on a daily basis, except Psychiatric and Rehabilitation hospitals will report weekly:
• Short term
• Long term
• Critical access hospital
• Children’s
• Distinct part psychiatric hospital
• Medicaid only short term
• Medicaid only children’s,
• Medicaid only long-term hospitals Reporting Timing Reporting should be completed within one business day of the reporting period. If a hospital does not have the ability to report on weekends or holidays, the data can be submitted on the next business day.
In the guidance, CMS outlines the enforcement process for a hospital’s failure to report. The timeline spans 14 weeks and includes:
· Beginning October 7, an initial notification from CMS informing a hospital that it is not in compliance with the reporting requirements
· If reporting requirements remain unmet, the hospital will receive another notice informing the facility of non-compliance and indicating that additional enforcement actions may be necessary.
· If a hospital remains non-compliant after six weeks, the hospital will receive the first in a series of weekly enforcement letters.
· Failure to come into compliance after receiving the first weekly enforcement letter will result in a second enforcement letter.
· Failure to come into compliance after receiving the second weekly enforcement letter will result in a third and final enforcement letter.
· Failure to meet the reporting requirements after receiving the third enforcement letter will result in a notice of termination, which provides the hospital a final 30 days to come into compliance with the requirements. Failure to do so can result in termination of the Medicare provider agreement.
This process will be ongoing throughout the duration of the PHE. Please note that steps 1-2 of the above process are only applicable from October 2 through November 13. Should a hospital fail to demonstrate compliance and face termination from participation in the Medicare program, appeal and reasonable assurance options remain intact.
For those hospitals having difficulty meeting the reporting requirements, CMS indicates that those entities will have the opportunity to work with HHS to develop a plan to successfully meet the requirements. Hospitals or CAHs may contact the HHS Protect Service Desk at [email protected] to make those arrangements.
The complete guidance is at: https://www.cms.gov/files/document/interim-final-rule-ifc-cms-3401-ifc-requirements-and-enforcement-process-reporting-covid-19-data.pdf.
