As previously reported, President Trump’s Opening Up America plans introduce measures to slowly ease business and social restrictions and require enhanced testing and reporting of Coronavirus (COVID-19) incidences in long term care facilities (LTCFs), which include skilled nursing facilities and nursing facilities. On April 30, 2020, the US Centers for Medicare & Medicaid Services (CMS) pre-published an interim final rule containing its planned revisions to 42 CFR § 483.80, obligating LTCFs to report information related to COVID-19 cases among facility residents and staff. These reporting requirements are immediately effective when the interim final rule is published in the Federal Register, and the public will not have the opportunity to comment. We do not anticipate material changes in the published version.
Under the Social Security Act, LTCFs are required to develop and maintain an infection control plan that protects the health and safety of residents, staff, visitors and the general public (42 CFR § 483.80). The infection control plan must balance the obligation to provide a safe, sanitary and comfortable environment for residents while also taking efforts to prevent, identify, report, investigate, and control infections and communicable diseases. This includes a requirement for LTCFs to prepare written surveillance standards to identify communicable diseases before they can be transmitted to other residents, staff, volunteers, visitors or members of the community.
Recognizing the role that rapid reporting has in surveillance, CMS is adding several new reporting obligations to enhance LTCFs’ efforts to monitor and prevent communicable diseases:
New provision 42 CFR § 483.80(g)(1): LTCFs will be required to electronically report certain information related to COVID-19 that will be used to monitor trends in infection rates and to allow public health authorities to establish policies, including:
Suspected and confirmed COVID-19 infections among residents and staff, including residents previously treated for COVID-19.
Total deaths (including total COVID-19-related deaths) among residents and staff.
Personal protective equipment and hand hygiene supplies in the facility.
Ventilator capacity and supplies in the facility.
Resident beds and resident census.
Access to COVID-19 testing while the resident is in the facility.
Other information that the Secretary of Health and Human Services deems necessary.
New provision 42 CFR § 483.80(g)(2): No less than weekly, LTCFs must report the above-listed information to the Centers for Disease Control (CDC) National Healthcare Safety Network (NHSN) following a standard reporting format. This information will be shared with CMS and will be made publicly available pursuant to any Freedom of Information Act requests. This new requirement does not obviate LTCFs’ existing obligation to comply with state and local COVID-19 requirements.
New provision 42 CFR § 483.80(g)(3): LTCFs must inform residents, their representatives and families of residents of any confirmed or suspected COVID-19 cases in the facility among residents and staff. These notifications may be issued through mail, listserv or website postings, recorded telephone messages, or other convenient mass communication efforts, but they must occur by 5:00 p.m. on the next calendar day following the occurrence of either of the below:
A singled confirmed infection of COVID-19 in a resident, staff or volunteer
Three or more residents or staff with new respiratory symptoms that emerge within 72 hours of each other.
Facilities also must provide cumulative updates to residents, their representatives and families by 5:00 p.m. on the next calendar day following any subsequent occurrences of the above reportable events. CMS emphasizes the importance of empowering residents to be informed participants in their care while reassuring residents that the facility is taking meaningful steps to mitigate risk of COVID-19 to the extent practicable. Reports should not include any personally identifiable information, and any messaging should address the LTCF’s efforts to prevent or mitigate transmission, including any impact such efforts have on the LTCF’s daily operations, visitation policies or group activities.
The CDC NHSN COVID-19 reporting module for LTCFs is now populated with instructions for LTCFs to submit reports. The reporting module focuses on four pathways: (i) resident impact and facility capacity, (ii) staff and personnel impact, (iii) supplies and personal protective equipment, and (iv) ventilator capacity and supplies. CDC encourages LTCFs to monitor the NHSN website for further instructions, including a schedule for upcoming training sessions.
In anticipation of the interim final rule’s publication in the Federal Register, LTCF administrators and management should (i) identify the staff responsible for coordinating required reports and overseeing resident and family reporting obligations, (ii) develop or reinforce existing policies and processes for data gathering and reporting of the information identified in the new regulatory provisions, (iii) familiarize themselves with the CDC NHSN COVID-19 reporting module instructions for report submissions, and (iv) work closely with counsel to develop resident and family reporting pathways in compliance with the rule.