The COVID-19 pandemic has left an indelible mark on long-term care and skilled-nursing facilities. As COVID-19 cases continue to fall, regulatory and criminal enforcement agencies are now digesting data that has emerged from the pandemic’s darkest days, which will inform where those agencies will direct their enforcement efforts. Here, I will discuss the regulatory and criminal enforcement trends that will impact the industry on the heels of the one-year anniversary of the pandemic’s outbreak.
The focus of regulatory enforcement will continue to be facilities’ source-control measures and provision of appropriate personal protective equipment.
The Department of Health and Human Services’ Office of the Inspector General will continue to scrutinize facilities’ staffing levels. In 2018, well before the COVID-19 pandemic, the OIG undertook a study of nursing home staffing levels. It discovered that at least 40% of facilities were regularly not meeting required staffing levels. In response, OIG recommended, among other things, that the Centers for Medicare & Medicaid Services enhance its efforts to ensure facility compliance with required staffing levels.
Then, the OIG’s review of early 2020 nursing home onsite surveys and contemporaneous interviews of CMS representatives about on-the-ground challenges posed by the pandemic revealed ongoing issues with infection control measures and staffing levels. The OIG has since noted a nexus between inadequate staffing levels and its impact on source-control measures; that is, inadequate staffing can make it more difficult for a facility to adequately respond to the exigencies of a disease outbreak.
As in the early days of the pandemic, OSHA continues to be concerned with facilities’ provision of appropriate PPE to employees. In the fourth quarter of 2020, most COVID-19-related workplace violations were assessed to nursing homes and skilled nursing facilities. And the largest fine assessed by OSHA during that time was to a rehabilitation and nursing center for, among other things, failing to provide and to properly fit employees with appropriate PPE.
Facilities should remain cognizant of and remedy recurring staffing issues and remain apprised of current industry PPE guidance.
Long-term care and skilled-nursing facilities should also be mindful of the risk of criminal investigation or prosecution. Failure to reasonably prevent or contain a large-scale or fatal COVID-19 outbreak may put facility leadership in the crosshairs of law enforcement.
Criminal investigations into COVID-19 outbreaks may be spurred by information about facility outbreaks brought to or obtained by law enforcement from the following sources: tips from employees or other insiders at a facility (i.e., whistleblowers); publicly filed documents (e.g., documents filed in connection with wrongful death lawsuits); site inspections and audits undertaken by federal and state authorities; COVID-19 reporting data from CMS and the Centers for Disease Control and Prevention; or from anti-fraud monitoring data flowing from the receipt of CARES Act funds.
In cases of especially egregious outbreaks, facility leadership or other decision makers may face criminal prosecution. For example, in September 2020, leaders of a Massachusetts veterans’ home were charged with causing or permitting serious bodily injury or neglect of an elder following a fatal COVID-19 outbreak at their facility.
The outbreak occurred after the combination of two dementia units into one due to short staffing, which resulted in overcrowded conditions. During this combination, leaders failed to isolate known COVID-19-positive residents. The resulting outbreak impacted 160 residents and staff members and killed 76 residents.
Though criminal prosecution for COVID-19 outbreaks is uncommon, it may become more common as the pandemic continues and public health guidance becomes increasingly consistent and more widely understood.
Leadership must be cognizant of the potential for criminal investigations or enforcement when making decisions about and documenting actions relating to staffing, infection control practices, staff screening, and visitor policies during the pandemic. Further, staff should be trained on how to respond to contacts from law enforcement.
Stay one step ahead
Even as national infection rates dwindle and vaccination rates increase, long-term and skilled nursing facilities should remain vigilant of their exposure to enforcement actions. Facilities should:
- Remain apprised of current and applicable federal, state, local and regulatory guidance;
- Develop means by which to clearly and consistently communicate changes in PPE, visitor and other source-control measures and policies to residents, their families, employees, vendors and other visitors;
- Determine the likelihood of enforcement action by regularly conducting internal evaluations — perhaps with the assistance of experienced counsel — of your facility’s risk profile, especially with regard to PPE, infection-control measures and staffing;
- Document and be prepared to defend all efforts at compliance, corrective actions and all reasonable efforts undertaken to protect residents and staff;
- Remediate or otherwise address known deficiencies;
- In the event of an enforcement action by a government agency, retain experienced counsel to guide you through the investigative process and to prepare a defense.
Lauren F. Schoeberl is an associate at Saul Ewing Arnstein & Lehr. Along with Joseph A. Valenti and Jennifer L. Beidel, she regularly assists long-term care facilities navigate their regulatory duties and rights.