Despite the mounting pressures on healthcare entities related to the COVID-19 (coronavirus) pandemic and recent announcements of regulatory waivers and flexibility in particular areas, regulators are still showing interest in the enforcement of federal requirements for life safety and emergency and infectious disease control preparedness for long-term care facilities.

OIG Medicaid Nursing Home Life Safety and Emergency Preparedness Reviews

On March 23, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) updated its Work Plan in response to the COVID-19 pandemic. Please see this post for more information about all of the OIG Work Plan updates. One of the areas that the OIG Office of Audit Services will focus on is Medicaid Nursing Home Life Safety and Emergency Preparedness Reviews.

OIG’s rationale for focusing on this is, in part, because the patient population in long-term care (LTC) facilities is especially vulnerable to COVID-19 and other disease outbreaks. The focus of the audit is LTC facilities’ compliance with federal requirements for life safety and emergency preparedness, as well as 2019 Centers for Medicare & Medicaid Services (CMS) expanded guidance on emerging infectious disease control.

The expected issue date for the report is in the fiscal year 2020 and the Report Number is W-00-20-31525.

The OIG has recently issued reports with recommendations that New York, California, Texas, Florida, and Missouri should take to improve nursing homes’ compliance with the federal requirements for life safety and emergency preparedness.

Federal Emergency Preparedness Requirements and Guidance

CMS released the Final Rule for Emergency Preparedness on September 16, 2016, and nursing homes were required to comply by November 15, 2017. In 2019, CMS issued updated guidance to State Survey Agency Directors on emergency preparedness requirements for Medicare and Medicaid participating providers.  The updates included adding “emerging infectious diseases” to the definition of an “all-hazards approach.” The interpretive guidance can be found in Appendix Z- Emergency Preparedness for All Provider and Certified Supplier Types Interpretive Guidance in CMS’s State Operation Manual.  Additional guidance to state surveyors on infection control can be found in Appendix PP – Guidance to Surveyors for Long Term Care Facilities.

Long-Term Care Facility Inspections Related to COVID-19

On March 23, CMS announced the preliminary results of an inspection of the Life Care Center nursing home in Kirkland, Washington. This facility is believed to be the epicenter of the COVID-19 outbreak in Washington state and is reported to have assumed that it was managing an outbreak of seasonal influenza. The Washington Post was able to obtain a copy of CMS’s enforcement letter to Life Care Center of Kirkland and reports that the facility faces a fine of more than $611,000. The fine may increase or decrease based on the facility’s efforts to comply with all requirements. The facility has a right to appeal the fine. The cited deficiencies include the failure to report the outbreak of respiratory illness to local authorities within the time required by law, inadequate care of residents during the outbreak, and failure to provide 24-hour emergency doctor services.

In a press release, CMS announced that on March 18, CMS notified the facility that it would be terminated from participation in federal health programs within 23 days if immediate dangers to residents were not remedied and that the facility is required to provide a plan to remove these immediate dangers. For all other deficiencies, the facility must correct them and return to compliance by September 16 or it will be excluded from federal healthcare programs.

On March 13, CMS issued Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes and on March 23, the agency announced a new targeted plan for healthcare facility inspections in light of COVID-19. Under the targeted plan, only complaint inspections, targeted infection control inspections, and self-assessments will be conducted over the next few weeks.

On April 2, CMS, in consultation with the Centers for Disease Control and Prevention (CDC), issued additional guidance to LTC facilities and state and local governments related to COVID-19.

CMS and CDC are recommending the following immediate actions:

  1. Nursing homes should immediately ensure that they are complying with all CMS and CDC guidance related to infection control.
  2. As LTC facilities are a critical part of the healthcare system, and because of the ease of spread in LTC facilities and the severity of illness that occurs in residents with COVID-19, CMS urges state and local leaders to consider the needs of LTC facilities with respect to supplies of personal protective equipment (PPE) and COVID-19 tests.
  3. LTC facilities should immediately implement symptom screening for all.
  4. LTC facilities should ensure all staff is using appropriate PPE when they are interacting with patients and residents, to the extent PPE is available and per CDC guidance on conservation of PPE.
  5. To avoid transmission within LTC facilities, facilities should use separate staffing teams for COVID-19-positive residents to the best of their ability, and work with state and local leaders to designate separate facilities or units within a facility to separate COVID-19 negative residents from COVID-19 positive residents and individuals with unknown COVID-19 status.

Key Takeaways for Long-Term Care Facilities

LTC facilities will face heightened scrutiny over their compliance with regulatory requirements during and after the COVID-19 pandemic, particularly related to life safety and emergency and infectious disease control preparedness, due to the at-risk patients they serve and the risk of community transmission.

LTC providers need to take appropriate steps to follow related guidance for the health and safety of the vulnerable patient populations that they serve and their communities.  This includes ensuring the facility is compliant with life safety and emergency and infectious disease control preparedness requirements and ensuring all compliance processes and procedures are up-to-date and operational.  Although waivers and flexibility in particular areas have been announced, regulators are still initiating enforcement actions.  As the recent public health emergency demonstrates, LTC facilities should be focusing on compliance to protect their patients and communities.

If you have any questions related to LTC facility life safety and emergency and infectious disease control preparedness, please contact the authors of this post.

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Photo of Lindsey Fetzer Lindsey Fetzer

Lindsey Fetzer, a member in the Washington, D.C. office, represents clients in connection with government and internal investigations and litigations involving alleged violations of the False Claims Act (FCA), Anti-Kickback Statute (AKS), Foreign Corrupt Practice Act (FCPA), and other criminal and civil regulations.

Lindsey Fetzer, a member in the Washington, D.C. office, represents clients in connection with government and internal investigations and litigations involving alleged violations of the False Claims Act (FCA), Anti-Kickback Statute (AKS), Foreign Corrupt Practice Act (FCPA), and other criminal and civil regulations. Lindsey has represented clients in foreign and domestic matters involving the U.S. Department of Justice (DOJ), U.S. Securities and Exchange Commission (SEC), and other primary enforcement agencies.

Photo of Sheaniva Murray Sheaniva Murray

Sheaniva Murray represents clients in response to government actions, investigations, and litigation related to claims brought under various federal and state regulations. In addition, Sheaniva regularly counsels healthcare companies on fraud and abuse matters related to alleged violations under the False Claims Act…

Sheaniva Murray represents clients in response to government actions, investigations, and litigation related to claims brought under various federal and state regulations. In addition, Sheaniva regularly counsels healthcare companies on fraud and abuse matters related to alleged violations under the False Claims Act (FCA), Anti-Kickback Statute (AKS), the Stark Law and Medicare and Medicaid reimbursement rules.

Photo of Julia Tamulis Julia Tamulis

Julia Tamulis focuses her practice on counseling a diverse range of clients on complex healthcare regulatory issues affecting operations and compliance matters. Julia provides healthcare regulatory guidance to health plans on Medicare Advantage and risk adjustment matters. She also advises pediatric hospital systems…

Julia Tamulis focuses her practice on counseling a diverse range of clients on complex healthcare regulatory issues affecting operations and compliance matters. Julia provides healthcare regulatory guidance to health plans on Medicare Advantage and risk adjustment matters. She also advises pediatric hospital systems on compliance issues, including daily operations matters and internal compliance audits and reviews.