Yes, the unimaginable has happened. Pandemic is a word we never thought would become a part of our everyday vocabulary. COVID-19 has hit us all hard. Most lawyers are focusing on how to keep their practice afloat and themselves and their loved ones healthy.

No part of society has been hit harder than the elderly who are confined to long term care facilities. Some of this is predictable. They are among the most vulnerable members of our society, and they are living in close quarters.

Some COVID infections and deaths are not preventable, but there is much that can be done  by long term health care facilities to prevent and/or limit the spread of COVID-19 infections inside their facilities.

The Root of the Problem

The nursing home industry would like to position itself as the victim of circumstance. However, long prior to COVID-19, the industry as a whole struggled with quality of care issues. To address these issues and determine where facilities fall short, the Centers for Medicare & Medicaid Services (CMS) created a five-star quality rating system, in which facilities are evaluated on a number of different factors. These star ratings are accessible to the public and can be found on https://www.medicare.gov/nursinghomecompare/search.html?.

In 2015, the Kaiser Family Foundation determined that more than one-third of nursing homes that were certified by CMS had relatively low overall star ratings of 1 or 2 stars, which accounts for 39% of all nursing home residents. This only goes to show that they were not prepared to deal with a pandemic. Those with poor track records of patient safety and lack of appropriate systems to ensure compliance with the standard of care have had dramatic spikes of cases. Richard Mollot, "Nursing Homes Were a Disaster Waiting to Happen," New York Times, April 28, 2020.

We all know at this point that the populations living in long-term care facilities are the very ones that are most at risk and most vulnerable to contracting the virus, warranting more protection. However, longstanding and widespread issues from years past are a big reason why facilities are in this state of destruction today—unprepared and  caught flat-footed.

Infection control is not new. There has long been guidance and regulations concerning infection control in nursing homes. However, compliance even before COVID-19 was spotty. The Centers for Disease Control and Precention (CDC) reported that "one million to three million serious infections occur every year in nursing homes and other long-term-care facilities, and as many as 380,000 people die of those infections every year." https://www.cdc.gov/longtermcare/index.html.

Nursing Home Reform Act

Congress enacted amendments to the Social Security Act in 1987 to create the Nursing Home Reform Act; this act has the basic objective of ensuring that residents of nursing homes receive the kind of necessary care and services that will result in their achieving or maintaining their "highest practicable physical, mental, and psychosocial well-being." 42 C.F.R. §483.10. CMS mandates that nursing homes follow regulations found under 42 C.F.R. Part 483, Subpart B, in order to receive payment under, and thus participate in, the Medicare or Medicaid programs.

Surveys, Complaint Investigations, and Non-compliance Citations

As part of the Department of Health and Human Services, CMS is the main federal agency that regulates nursing homes. In order to properly enforce the regulations that ensure the health and safety of residents and detect non-compliance, CMS utilizes surveys to issue citations and relies on state agencies to assist in responding to health and safety complaints raised by residents, their families, and nursing home staff. OIG, "Trends in Nursing Home Complaints (2016-2018)." https://oig.hhs.gov/oei/maps/2019-nursing-home/index.asp.

In addition to regulating participants of the Medicare or Medicaid programs, CMS provides clarifying guidelines as well as protocols for surveying. State agency survey teams conduct onsite observations for certification purposes, as well as a quality of care assurance measures. Through these observations, surveyors are able to adequately assess potential violations of CMS regulations which result in deficiency citations. Seven years of deficiency citations were studied in research conducted in 2011 which examined the scope and severity of these citations as well as the internal, organizational and external factors associated with these citations. Ultimately, this study highlighted the problem of resident safety in nursing homes. N.G. Castle et. al., "Nursing Home Deficiency Citations for Safety," J Aging Soc. Policy. 2011 Jan; 23(1): 34–57.

Resident Safety in Nursing Homes

Another safeguard in place for resident safety is the compliance process, which is carried out by state agencies. Because of the reliance CMS has on state agencies, it is imperative that these agencies are fulfilling their responsibilities in an effective and timely manner. The two complaint levels deemed most serious involve complaints that "allege serious injury or harm to a nursing home resident and require a rapid response to address the complaint and ensure residents' safety." OIG's recent national review of states' onsite investigations and response times throughout the years highlights the growing number of nursing home complaints received year after year. Although most states conducted onsite investigations in a timely manner, OIG discovered that there continues to be a few states that do not—as of 2018, 670 "Immediate Jeopardy" and 6,540 "High Priority" complaints were not investigated within a timely manner. OIG, "A Few States Fell Short in Timely Investigation of the Most Serious Nursing Home Complaints: 2011-2015." https://oig.hhs.gov/oei/reports/oei-01-16-00330.asp.

Without the proper conduction of on-site investigations, the needs of residents are left to the wayside, and resident safety remains a precarious issue in the United States. A May 2016 study found that a higher uptake of intervention is needed in order to enhance resident safety, however, the study pointed out financial and evidentiary barriers. Staffing costs would inevitably need to increase and, even with sufficient funding, there exist issues in limited evidence that accurately reflects the quality levels in nursing homes. The study also notes that evidence of intervention effectiveness would likely be needed in order for the sufficient amount of funding and support to be obtained. Dialogue around resident safety in nursing homes has been fairly minimal until now; with the rapid spread of COVID-19 throughout nursing homes in the nation, concerns revolving around infection control procedures in place to protect nursing home residents has suddenly emerged as the common conversation of today. Simmons, S. et. al., "Resident Safety Practices in Nursing Home Settings," May 2016. www.effectivehealthcare.ahrq.gov/reports/final.cfm.

Infection Control

Throughout this pandemic CMS has issued several policies that outline additional guidelines for nursing homes to follow during this national emergency. Prior to this, CMS had regulations requiring facilities to have both an Infection Prevention and Control Program (IPCP) and an emergency plan in place. 42 C.F.R. §483.80, 483.73. Though these regulations have been in place for some time, they only cover the basics of what facilities need to have; very few infection control-related policies have actually been issued by CMS until now, the last known policy discussing infection control updates was from 2014 and the one before that being in 2010. Aside from these two memos, four years apart, CMS began a three-year "Infection Control Pilot" project in 2016 in hopes of improving assessment of infection control and prevention among facilities through no-citation, educational surveys. These efforts, in conjunction with existing CDC guidelines on infection control, seem standard but taking a clearer look at CMS' response to the virus through continual updates and the poignant fact that nursing homes have been some of the hardest hit facilities during this time, it all begs the question of what went wrong?

By mid-March, CMS was issuing further infection control guidance on how nursing homes should proceed effectively and safely during this national emergency. After an inspection of the Life Care Center nursing home in Kirkland, WA, where the virus initially broke out, CMS began a more focused inspection process of facilities and created a self-assessment tool, urging facilities to not "wait to be inspected," but to be proactive about self-assessing in order to properly combat the virus. With more focused inspections and additional guidance throughout the last two months, nursing homes have been called to action to fight against the virus and protect their residents, the population that is most at-risk for contracting COVID-19. In hopes of making it abundantly clear to facilities that patients should be at the forefront of protection, CMS waived various requirements as a flexibility exception during this time.

Some of the more prominent pieces of recent CMS guidance that we should focus on include visitation restrictions, giving some deference to facilities in making visitation determinations in "end of life" situations, as well as stricter sanitation and PPE requirements, although CMS has conceded that facilities should not be cited for not having certain supplies which makes this area of resident safety a fuzzy one. Despite the guidance, you have all seen the rampant spread of the virus throughout nursing homes in the nation. It seems like a different nursing home is under fire every day for the number of cases and deaths they house—does this show us that regardless of updated CMS guidance, the systems in place at these nursing homes were never going to be ready for an emergency situation such as this one? Possibly so.

Causes of Action

Whether your client is an endangered and infected employee or a family member of a loved one, as the virus pushes on, we need to begin thinking about the options our clients have when considering holding a nursing home accountable for serious injury or death.

Due to "tort reform," suing long-term care facilities has always been difficult. A common industry practice is creating shell corporations to hide assets. In addition, many nursing homes vastly under-insure themselves. With the hit of COVID-19, a gross negligence standard will likely be added to the array of hurdles that victims will face. However, it is litigation which needs to be undertaken, regardless of the very high burden of proof, because civil litigants may be the ones we need to enforce better and safer practices.

Resident safety is integral in nursing home regulations and has always been, even before the virus. With additional CMS guidance on sanitation, safety, and protection of residents, we can review the protocols and procedures facilities had in place for securing the safety of staff and residents. This could be a poignant area of liability for nursing homes. Just because CMS has given some flexibility with these requirements does not mean the standard of care these residents are receiving should falter. Existing infection control and emergency preparedness plans were supposed to be in place for a reason. Nursing homes will be hard pressed in finding a defense for not having properly prepared staff or residents for an emergency.

CMS' most recent issuance of notification requirements for facilities will be an interesting piece to watch. As more notification and reporting is required, watching whether nursing homes accurately follow this guidance will be a necessary part of determining whether they are carrying out their duties.

Immunity

We are beginning to see some states grant legal immunity to health care providers on the frontlines. The emergency orders vary from state to state. Some grant immunity to all health care providers who treat COVID patients, while some may be broad enough to grant immunity to all health care providers during the COVID crisis.

With the establishment of the CARES Act on March 27, this administration included $200 million for CMS to assist nursing homes with infection control and to support states' efforts to prevent the spread of the coronavirus. Additionally, the act included Good Samaritan language that provides additional federal liability protections for volunteer health care professionals during the COVID-19 emergency response. Although the act provides protections for volunteers, it is an example of the conversations that are being held about the onslaught of potential liability for health care providers and long-term care facilities.

In sum, I do expect that long-term care facilities that fail to adhere to CMS guidelines for COVID-19 infection control may face legal liability for outbreaks at their facility. Only the most egregious cases will likely meet the gross negligence standard adopted in many states.

My hope is that the COVID crisis will shine a light on the problems we have in the nursing home industry as a whole. My concern is that the nursing home industry will try and make itself out to be the victim if and when lawsuits begin, and they will use this to push for even more legal protections. In my view, that would be completely unecessary and would further endanger residents.

Kay Van Wey is a medical malpractice attorney based in Dallas, Texas, who is most recently known for her work on behalf of the "Dr. Death" victims.