The U.S. Department of Health and Human Services (HHS) must renew the COVID-19 Federal Public Health Emergency (PHE) Determination every 90 days to maintain certain healthcare flexibilities and waivers. On October 13, 2022, HHS Secretary Xavier Becerra renewed the PHE that was originally effective January 31, 2020. The current extension is set to expire on January 11, 2023. In a letter to governors, then-acting HHS Secretary Norris Cochran promised that HHS would provide states with 60 days’ notice prior to the PHE termination. Since it is less than 60 days until January 11 and no termination notice has been provided, the PHE will likely extend through April 11, 2023.
Even if it is extended beyond April 11, 2023, it is likely the PHE will expire sometime in 2023. Additionally, many states have already announced that their Emergency Orders have expired or are set to end in 2023. A list of state Emergency Orders can be found on the National Academy for State Health Policy’s website.
Over the past two years, health systems and hospitals have changed their practices and processes regarding reliance on waivers of section 1877(g) (the “Blanket Waivers”) of the Act as authorized under section 1135 of the Social Security Act, as well as state emergency waivers. During this same period, the healthcare industry turnover rate has been at an all-time high. It is very possible that health system and hospital leaders who were instrumental in initiating the changes allowed under the Blanket Waivers are no longer employed by the health system or hospital. Unless there was a coordinated handoff between the prior leader and these replacements, including a download of waivers being relied upon, new leaders may be unaware of which services are being provided pursuant to waivers. If leaders are uninformed regarding which waivers are being relied upon, when those waivers expire, the health system or hospital is at risk of being out of compliance with state and federal regulations or of violating state and federal laws. If your health system has made changes based on state and federal waivers, which have become the “new normal”, it will be important for you to allow ample time to ensure compliance after the expiration of the PHE.
If your health system has made changes based on state and federal waivers, which have become the “new normal”, it will be important for you to allow ample time to ensure compliance after the expiration of the PHE.
1. Create a Global List of Waivers Being Relied Upon
The first step you will need to take to ensure compliance is to assign an individual the task of creating a global list of the current services and functions that rely on the Blanket Waivers. It is likely this assignment will fall to a compliance officer or potentially in-house counsel. If assigned to a compliance officer, it would be best to have the compliance officer working under the direction of an attorney to maintain attorney-client privilege. A determination of which services are being provided pursuant to Blanket Waivers or state waivers may require legal analysis, and you should take steps if possible to make sure that the analysis is privileged.
Creating a global list will require a survey of operational compliance, and legal personnel to determine potential areas that may be affected. Consider starting with a list of the areas covered by Blanket Waivers as well as any applicable state waivers. Ask operational compliance, and legal personnel about changes that have been implemented in areas governed by the waived regulations. Some examples of the waived regulatory requirements cover EMTLA, Verbal Orders, CMS Reporting Requirements, Credentialing, Licensing, Staffing, Telemedicine, Length of Stay, Conditions of Participation, HIPAA, Stark and Anti-kickback laws.
Give yourself enough time to speak with leaders who have the requisite knowledge. Due to turnover, this inquiry may require speaking with leaders on multiple levels of management to fully understand what practices have changed due to the waivers. It will require speaking with individuals who were in leadership positions prior to spring 2020.
Look for areas that have changed due to COVID-19, recognizing that it may not always be obvious. For example, many health systems are now providing virtual continuing medical education (“CME”) for medical staff members. This is similar to education that was being provided at hospitals, but, because of COVID, was moved to a virtual format. However, there were several existing exceptions to the Stark Law, which would cover medical staff members receiving education through grand rounds and other CME. These exceptions, however, require that the training take place at the hospital. Health systems have not worried about potential legal violations regarding virtual education because of the Blanket Waivers. Once they expire, it will be imperative for legal to review whether or not virtual education is a Stark violation. An awareness that this legal analysis must be conducted is, perhaps, what is most important.
2. Create a Timeline for Regulatory Compliance
After creating a global list of areas utilizing waivers, create a timeline for regulatory compliance. Some Blanket Waivers end 151 days after the conclusion of the PHE while others end at the PHE expiration. Review the Blanket Waiver being utilized, and the time frame required for compliance in order to determine what change will be necessary to comply with the currently waived regulations.
3. Implement Changes and Conduct Privileged Compliance Review
Once you identify the affected areas, the changes needed for compliance, and the time frame required, empower a team to make the necessary changes within the time frame required to implement such changes. Is a 60-day notice of the ending of the PHE sufficient for implementing the change, or in cases where the Blanket Waiver does not expire until 151 days after the PHE ends, how much time is necessary to make the needed changes? This team should consist of individuals in compliance, operations, and legal who will be able to update policies and procedures as well as processes. The team must identify individuals in the service areas that will be affected, provide clear communication of the upcoming changes necessary for legal compliance, and establish the time frame within which those changes must be made.
Sometimes large, complex health systems believe they have communicated and implemented changes, only to discover there was a disconnect whereby the changes were not adopted at certain system locations or along specific service lines. After the changes have been implemented, there should be a privileged compliance review of the changes to ensure all changes were effectively implemented and that there is no risk of non-compliance.
Healthcare operations have dramatically changed over the past two years. Many of these changes were facilitated by the Blanket Waiver and state waivers. Do not underestimate the time that will be necessary to put a PHE expiration compliance plan in place. If you need assistance developing a PHE expiration compliance plan, Jackson Walker’s Healthcare team will be happy to help.
The opinions expressed are those of the author and do not necessarily reflect the views of the firm, its clients, or any of its or their respective affiliates. This article is for informational purposes only and does not constitute legal advice. For questions related to these cases, please contact Jeff Frost or a member of the Healthcare practice.
Jeffrey H. Frost draws on more than 20 years of experience as in-house counsel to advise clients on healthcare regulatory matters, hospital operations, and medical staff issues. As the former Deputy General Counsel at an integrated health network in Northern California, Jeff’s experience includes advising medical staffs, medical groups, and hospitals on a full range of credentialing, privileging, peer review, and quality assurance topics, as well as assisting hospital administration with governmental investigations, fraud and abuse claims, agency complaints, and medical staff hearings.
Companies and professionals engaged in the healthcare industry face a tangled web of state and federal laws and regulations. Our Healthcare practice group offers all facets of legal advice to healthcare industry clients, including compliance plan implementation, self-disclosure decisions, defense, entity structure and formation, day-to-day operations, licensing, and reimbursement. Healthcare regulations, and the internal processes needed to deal with them effectively, are constantly changing. Our team represents hospitals and healthcare systems in all aspects of healthcare regulations, including federal regulations such as the Anti-Kickback Statute, Stark Law, False Claims Act, Civil Monetary Penalties Law, as well as state licensing, state anti-kickback, anti-referral, healthcare fraud laws, and laws regarding medical practice structure.