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Data Reporting, Patient Access and Malpractice Liability: Nursing Homes and Long-Term Care Facilities Command Federal and State Attention during the COVID-19 Public Health Emergency

On April 23, 2020, the Kaiser Family Foundation (“KFF”) issued a report authored by Priya Chidambaram entitled, “State Reporting of Cases and Deaths Due to COVID-19 in Long-Term Care Facilities.” In the KFF report, Ms. Chidambaram cited to previous KFF studies showing that COVID-19 has had a disproportionate impact on people who reside or work in long-term care facilities – such populations including 1.3 million nursing home residents, 800,000 assisted living facility residents, 75,000 intermediate care facility residents, and 3 million people who work in skilled nursing or residential care facilities.

According to the KFF report cited above, as of April 23, 2020, in the 23 states that publicly report mortality data, there have been over 10,000 reported deaths due to COVID-19 in nursing homes and other long-term care facilities (including residents and staff), representing 27% of deaths due to COVID-19. According to KFF data drawn from 29 reporting states, there have been over 50,000 reported cases in nursing homes and long term care facilities (including residents and staff) representing 11% of all coronavirus cases in the 29 reporting states. KFF analysis shows that deaths in long-term care facilities account for over 50% of all COVID-19 deaths in the states of Delaware, Massachusetts, Oregon, Pennsylvania, Colorado, and Utah, combined. The KFF report concludes that the total number of COVID-19 cases and deaths from all reporting states accounts for just over half (53%) of all cases, and 81% of all deaths.

In light of the foregoing, nursing homes and other long-term care providers are commanding significant attention at both the federal and state levels.  At the federal level, the Centers for Medicare and Medicaid Services (“CMS”) has recently issued pronouncements about best practices for the care and treatment of long-term care patients in nursing homes and other long-term care facilities, as well as the issuance of new COVID-19 data reporting guidance and requirements for such facilities.  At the state level, there has been a significant focus on how to safely secure COVID-19 patient access to nursing home care while limiting the spread of infection from one resident/staff member to another and limiting nursing home liability from the risks associated with the care of a particularly vulnerable population that may include both COVID-19 positive and negative residents.

FEDERAL ACTION: NURSING HOME TRANSPARENCY THROUGH NEW COVID-19 DATA REPORTING REQUIREMENTS

In an April 17, 2020 Sheppard Mullin Healthcare Law Blog post, “CMS Addresses Nursing Home and Long-Term Care Providers Amidst COVID-19 Pandemic: Best Practices and What’s to Come,” we reported on an April 9, 2020 conference call hosted by CMS during which CMS discussed best practices and forthcoming guidance for nursing homes to be applied during the current public health emergency (“PHE”).

On April 19, 2020, as an apparent follow-up/supplement to the April 9th conference call, CMS released an announcement (the “Announcement”) to State Survey Agency Directors regarding, “Upcoming Requirements for Notification of Confirmed COVID-19 (or COVID- 19 Persons under Investigation) Among Residents and Staff in Nursing Homes.” The Announcement, which does not mention the best practices guidance discussed in the conference call, focuses on nursing home transparency and reporting as to the presence of COVID-19 cases among nursing home residents and staff.

  1. Current Infectious Disease Reporting Requirements

Currently and prior to the current PHE, Medicare and/or Medicaid-participating long-term care facilities are and have been required to establish and maintain, “an infection prevention and control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections.” 42 C.F.R. § 483.80 (“Infectious Disease Control Regulations”).

According to the Infectious Disease Control Regulations and as described in the Announcement, a compliant infection prevention and control program must include, “a system of surveillance designed to identify possible communicable diseases or infections before they can spread to persons in the facility.” 42 C.F.R. § 483.80(a)(2)(i). In addition, guidance (“CDC Guidance”) issued by the Centers for Disease Control and Prevention (“CDC”) prior to the Announcement specifies that nursing homes must notify State or Local health departments about residents or staff with suspected or confirmed COVID-19, residents with severe respiratory infection resulting in hospitalization or death, or ≥ 3 residents or staff with new-onset respiratory symptoms within 72 hours of each other.

As reported in the Announcement and as described below, CMS has determined that the current PHE and the need to “ensure appropriate tracking, response, and mitigation of COVID-19 in nursing homes” requires CMS to take action to reinforce the Infectious Disease Control Regulations and the current requirement that nursing homes report communicable diseases, healthcare-associated infections, and potential outbreaks to State or Local health departments.

  1. Direct Reporting to the CDC and Nursing Home Residents

As described in the Announcement, CMS is now taking action to require nursing homes to report COVID-19 data to both the CDC and to nursing home residents and resident representatives (families, guardians, etc.).

CDC Reporting Requirements. While the current reporting requirements set forth in the Infectious Disease Control Regulations and the CDC Guidance only mandate reporting to State or Local health departments, CMS is now taking action to require that nursing homes directly report COVID-19 data to the CDC through the CDC’s National Health Safety Network. Such data will include the same data that nursing homes are currently mandated to report to State and Local Health Departments: – (i) confirmed COVID-19 infections within 12 hours of occurrence, (ii) three or more residents or staff with new-onset of respiratory symptoms occurring within 72 hours of each other, and (iii) weekly updates regarding (i) and (ii).  According to CMS, such additional reporting is required to “support surveillance of COVID-19 locally and nationally, monitor trends in infection rates, and inform public health policies and actions.”

Resident Reporting Requirements. CMS is also taking action to require nursing homes to notify residents and resident representatives of the same COVID-19 data that nursing homes are currently required to report to their State or Local health departments and will be required to report to the CDC on an ongoing basis.

All notifications described above – including notifications required as part of the Public Health Approach and the Patient-Centric Approach – will have to include information on mitigation strategies, including if normal operations in the nursing home will be altered. As reported in the Announcement, failure to provide these notifications could result in enforcement action.

STATE ACTIONS: NURSING HOME ADMISSION REQUIREMENTS FOR COVID-19 PATIENTS; NURSING HOME LIABILITY PROTECTIONS

As CMS and the federal government seek to gain a better understanding of the prevalence and spread of coronavirus infection in the country’s nursing homes, states are struggling to find facilities for patients who are being discharged from hospitals after receiving treatment for COVID-19.  Although such patients are stable enough to no longer require acute care treatment, many of these patients require post-discharge monitoring and/or treatment that cannot be provided on an at-home basis.  More and more, states are looking to nursing homes to meet the needs of such post-discharge patients.

At the same time that states are looking to nursing homes to help transition patients out of scarce acute care hospital beds, nursing homes are often reluctant to admit such patients. Given the statistics described at the outset of this article, there is an understandable fear within the nursing home community that the presence of post-hospital discharge COVID-19 patients in a nursing home setting could easily lead to the spread of coronavirus infection to other residents and nursing home staff members. This fear is best seen in the current efforts by nursing homes and nursing home trade associations to obtain from the states temporary state immunity from potential civil suits that could arise from the spread of coronavirus infection among nursing home residents and staff.

  1. Nursing Home COVID-19 Patient Admission Obligations

As described below, some states have mandated that nursing homes accept coronavirus patients as their strategy to relieve stress on hospitals that need to move post-acute COVID-19 patients out of, and move acute COVID-19 patients into, scarce hospital beds. Other states have designated COVID-19 exclusive facilities as their way to alleviate the stress on hospital resources while limiting the risk of coronavirus transmission within their state’s nursing homes.

As an example of state action requiring nursing homes to admit COVID-19 patients, on March 25, 2020, the New York Department of Health issued an advisory entitled, “Advisory: Hospital Discharges and Admissions to Nursing Homes,” (the “NYDOH Advisory”) to nursing home administrators and hospital discharge planners. According to the NYDOH Advisory, “[n]o resident shall be denied re-admission or admission to [a nursing home] solely based on a confirmed or suspected diagnosis of COVID-19.” In addition, the NYDOH Advisory stated that nursing homes are “prohibited from requiring a hospitalized resident who is determined medically stable to be tested for COVID-19 prior to admission or readmission.” As a clarification regarding the NYDOH Advisory requirement, Governor Andrew Cuomo said during an April 23, 2020 News Briefing that nursing homes need to allow the readmission of “COVID-positive residents” but only if they, “have the ability to provide the adequate level of care under Department of Health and CDC guidelines.” It was made clear during the News Briefing that this caveat also applies to the admission of new COVID-positive nursing home residents.

In contrast to the mandatory admission strategy adopted by New York State, the Connecticut Department of Public Health (“CDPH”) issued a letter dated March 30, 2020 (the “CDPH Letter”) announcing that the State will designate specific nursing homes for residents who have tested positive for COVID-19 and those who have not. As explained in the CDPH Letter, CDPH’s segregation of COVID-19 patients from non-COVID-19 patients represent the State’s attempt to, “concentrate the care and service needed to provide the highest level of care for each group of residents.”  In order to finance the operation of the COVID-19 facilities, the State is providing financial assistance to cover start-up costs for the newly designated COVID-19 facilities, plus a $600/day payment rate to such facilities for the care and treatment of their residents.

  1. Nursing Home Liability Protections

Because the death tolls in nursing homes continue to rise and nursing homes are being required to admit and manage COVID-19 patients, many have started to push for protection from civil liability.  As capacity is stretched thin, rules and recommendations regarding the treatment of COVID-19 residents are ever-changing, and access to personal protective equipment and test kits is limited, nursing homes and their professional associations are worried that nursing homes may be held civilly liable for outcomes that they were not given the resources to prevent.

Given the fear of civil liability among nursing homes and, as described above, the urgent need to place post-discharge COVID-19 patients, many states have started to adopt civil liability protections for nursing homes.  Such states include Michigan, New Jersey, and New York, which have been particularly impacted by COVID-19.

Michigan instituted the protections via executive order on March 29, 2020. Governor Gretchen Whitmer issued Executive Order 2020-30, which provides that “any licensed health care professional or designated health care facility that provides medical services in support of this state’s response to the COVID-19 pandemic is not liable for an injury sustained by a person by reason of those services, regardless of how or under what circumstances or by what cause those injuries are sustained, unless it is established that such injury or death was caused by the gross negligence[.]”

In New Jersey and New York, the protections were instituted via legislation. On April 14, 2020, New Jersey passed S2333, which provides that a health care facility may not be “liable for civil damages for injury or death alleged to have been sustained as a result of an act or omission by one or more of its agents, officers, employees, servants, representatives or volunteers, if, and to the extent that, such agent, officer, employee, servant, representative or volunteer” is in the course of “providing medical services in support of the State’s response to the outbreak of coronavirus” during the PHE. The immunity provided by S2333 includes “any act or omission undertaken in good faith by a health care professional or health care facility or a health care system to support efforts to treat COVID-19 patients and to prevent the spread of COVID-19” during the PHE, including telemedicine or telehealth and diagnosing or treating patients outside the normal scope of the health care professional’s license or practice. However, the it does not include acts or omissions constituting a crime, actual fraud, actual malice, gross negligence, recklessness, or willful misconduct.

New York’s protections were passed as part of the Emergency Disaster Treatment Protection Act, provides “any health care facility or health care professional shall have immunity from any liability, civil or criminal, for any harm or damages alleged to have been sustained as a result of an act or omission in the course of arranging for or providing health care services” if done in good faith, “pursuant to a COVID-19 emergency rule or otherwise in accordance with applicable law,” and the treatment is “impacted by the health care facility’s or health care professional’s decisions or activities in response to or as a result of the COVID-19 outbreak and in support of the state’s directives.” As with the Michigan and New Jersey laws, the immunity does not extend to harm or damages caused by an act or omission constituting willful or intentional criminal misconduct, gross negligence, reckless misconduct, or intentional infliction of harm, provided that “acts, omissions or decisions resulting from a resource or staffing shortage” are not encompassed by the carveout.

The extension of liability protections to nursing homes and other healthcare facilities and healthcare professionals is not without its detractors.  For example, some advocates are worried that these protections may end up shielding bad actors and negligent providers from the accountability they deserve in the face of this crisis.  While the state protections don’t offer immunity in cases of gross negligence or willful misconduct, the protections could make it more difficult to bring suit in these instances.  Not only does this mean affected parties could be negatively impacted on the backend of the PHE, but patient rights’ groups are also concerned these protections could mean risking lives amidst it.

This article is not an unequivocal statement of the law, but instead represents our best interpretation of where things currently stand.  This article does not address the potential impacts of the numerous other local, state and federal orders that have been issued in response to the COVID-19 pandemic, but which are not referenced in this article.

Copyright © 2020, Sheppard Mullin Richter & Hampton LLP.National Law Review, Volume X, Number 118

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About this Author

Kenneth Yood Healthcare Attorney SheppardMullin
Partner

Ken is a partner in the Corporate practice group in the firm's Los Angeles office. Chambers USAranks him highly for Healthcare, where he was commended for his "broad-based ability in the regulatory area." Clients appreciate that "his explanations are clear, and he understands the business side of things," notes Chambers 2016.

Areas of Practice

Ken represents a wide range of healthcare providers and healthcare companies, including specialty and general acute hospitals (including local district, nonprofit and...

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Theresa E. Thompson, Sheppard Mullin Law Firm, Washington DC, Corporate Law Attorney
Associate

Theresa E. Thompson is an associate in the Corporate and Securities Practice Group in the firm's Washington, D.C. office.

Areas of Practice

Ms. Thompson's practice focuses on such areas as health care fraud and abuse, particularly in matters relating to the civil False Claims Act, physician self-referral (Stark law), and anti-kickback issues, as well as telehealth and telemedicine. She has experience in government investigations, litigation, and regulatory compliance, including in response to government anti-fraud and abuse enforcement efforts and regulatory inquiries.

A contributing author for the American Health Lawyers Association's Health Care Reform Educational Task Force, Ms. Thompson received her J.D., with a Health Law Certificate, from the University of Maryland Francis King Carey School of Law, where she also served as the Manuscripts Editor of the Journal of Health Care Law and Policy, President of the Student Health Law Organization, and Treasurer of the Women’s Bar Association. She is a recipient of two CALI Excellence for the Future Awards—one for the study of Health Law Fraud and Abuse and the other for Written and Oral Advocacy—and was part of a team that won first place in the Fifth Annual Health Law Regulatory and Compliance Competition.

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