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 the incidence of novel Coronavirus (COVID-19) incidences in long term care facilities (LTCFs), including skilled nursing facilities and nursing facilities. On May 8, 2020, the Centers for Medicare & Medicaid Services (CMS) published an interim final rule with comment period (85 Fed. Reg. 27550) containing certain revisions to 42 C.F.R. § 483.80. These revisions obligate LTCFs to report information related to COVID-19 cases among facility residents and staff. In the interest of public health urgency, CMS is waiving the opportunity for the public to comment on these new reporting requirements, and they became effective immediately upon publication.
Under the Social Security Act and existing regulations, 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 C.F.R. § 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 of that rapid reporting has in surveillance, CMS added several new reporting obligations to enhance LTCFs’ efforts to monitor and prevent communicable diseases:
New provision 42 C.F.R. § 483.80(g)(1): LTCFs are 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 C.F.R. § 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 electronic reporting format. This information will be shared with CMS and will be made publicly available in a file accessible at https://data.cms.gov. pursuant to any Freedom of Information Act requests. This new requirement does not eliminate LTCFs’ existing obligation to comply with state and local COVID-19 requirements.
New provision 42 C.F.R. § 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. LTCFs must submit their first set of data by 11:59 pm on May 17, 2020. Compliance requires at least one data submission every seven days. The new reporting regulations supplement LTCFs’ existing responsibility to report possible incidents of communicable disease and infections to other parties as specified in the LTCF’s infection prevention and control program, including compliance with state and local reporting requirements for COVID-19.
Revised COVID-19-Focused Survey for Nursing Homes; Penalties; FAQs
Related to the new LTCF reporting obligations, on May 6, 2020, CMS released a Quality, Safety & Oversight Group memorandum, QSO-20-29-Nursing Homes, (QSO Memo) that updates the “COVID-19 Focused Survey for Nursing Homes” utilized by federal and state survey agencies. Although LTCF survey activities continue to be limited to immediate jeopardy situations that involve urgent patient safety threats and infection control issues, surveyors are instructed to begin evaluating LTCFs’ reporting compliance immediately. To that end, CMS added two new deficiency tags that will be used to cite non-compliance. A deficiency citation at F884 will be cited offsite by federal inspectors if a facility fails to meet its obligation to report data to CDC via NHSN in a timely manner. A deficiency citation at F885 will arise if onsite inspections by state or federal surveyors find noncompliance with a facility’s obligations to report confirmed or suspected COVID-19 infections to residents, their representatives and families.
CMS has made clear that it views these obligations as high-priority compliance items and will impose civil monetary penalties (CMPs) upon facilities that fail to report data to NHSN. Although non-compliant facilities will receive a deficiency citation at F884, CMS is putting in place an effective three-week grace period before facilities will be subject to a CMP for their failure to report. The specific timeline for reporting set forth in the QSO Memo, and the unusual mechanism for calculating the potential CMPs that will apply to facilities that fail to report, are set forth below:
May 8 – May 24, 2020: Initial two-week grace period for LTCFs to register with NHSN and to begin reporting.
Week Three (Ending May 31, 2020): Facilities that fail to submit reports by 11:59 pm on May 31 will receive a warning letter notifying the facilities of their reporting obligation.
Week Four (Ending June 7, 2020): Facilities that are non-compliant with the reporting obligations will have imposed upon them a CMP of $1,000, representing a one-day failure to report that week’s required information.
Subsequent Weeks: Facilities that are non-compliant with the reporting obligations will incur the baseline CMP of $1,000. If this non-compliance represents a second (or more) instance of failing to report, CMS will also impose an additional one-day CMP of $500 for each cumulative week’s failure to report timely. For example, if a facility fails to report during Week Four and Week Five, reports successfully during Week Six, and fails again to report during Week Seven, the CMP imposed in Week Seven will be $2,000 (representing the $1,000 baseline CMP and an additional $500 for each of the two weeks where the facility failed to report). The cumulative penalties would be as follows:
Week Four: $1,000 CMP
Week Five: $1,500 CMP (total penalties of $2,500)
Week Six: no penalty (total penalties of $2,500)
Week Seven: $2,000 CMP (total penalties of $4,500)
Facilities’ reporting obligations will continue until CMS notifies stakeholders that reporting is no longer required. CMS has not communciated how this notification will be disseminated.
The QSO Memo also included several answers to frequently asked questions. Some of the most pertinent guidance is as follows:
State and local health departments may submit data on an LTCF’s behalf after the LTCF has enrolled with NHSN. Data can also be batched for submission on behalf of multiple facilities.
The presence of COVID-19 and reporting of same will not necessarily result in a citation for infection control violations. Surveyors will continue to survey only for immediate jeopardy situations, and citations for infection control and prevention non-compliance will arise if observed in such surveys.
Facilities have the ability to report cases retroactively and are encouraged to do so, but CMS will not require retrospective reporting of cases that arose prior to May 8, 2020.
For the purposes of reporting clusters of three or more staff experiencing new respiratory symptoms within 72 hours of each other, “staff” includes employees, consultants, contractors, volunteers and caregivers who provide care and services to residents in the facility, including nurse aides who have not yet completed a Nurse Aide Training and Competency Evaluation program but who are providing services to residents.
LTCFs are now required to report COVID-19-related information to the CDC, residents, and residents’ representatives and family members. Failure to do so will result in citations and could result in CMPs. 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) enroll in the CDC NHSN COVID-19 reporting module, (iv) familiarize themselves with instructions for report submissions and reporting logistics, and (v) work closely with counsel to develop resident and family reporting pathways in compliance with the new regulations and survey guidance.