In January 2020, Alex M. Azar, II, then secretary of the US Department of Health and Human Services (HHS), signed a nationwide declaration of a Public Health Emergency (PHE) that would largely shape the response of public and private sector healthcare stakeholders to the spread of COVID-19 in the United States and the business and operational challenges that came as a result of the pandemic. Between January 2020 and January 2021, the PHE was renewed four times. In addition to renewing the PHE in January 2021, Acting HHS Secretary Norris Cochran stated in a letter to the state governors that HHS would provide states with a 60-day notice prior to the termination of the PHE. The letter also stated that the PHE would likely extend through the end of 2022, which has proved to be true, with the current extension for the PHE effective through January 11, 2023.
The PHE declaration worked to connect, streamline, and increase accessibility to various aspects of healthcare services that had been disrupted or interfered with because of the COVID-19 pandemic (the Pandemic). Specifically, through Section 1135 of the Social Security Act, the PHE allowed the HHS secretary to waive or modify certain requirements for benefits provided under Medicare, Medicaid, Children’s Health Insurance Program, and Health Insurance Portability and Accountability Act privacy rule requirements. Instances of the secretary exercising this discretion by relaxing certain requirements are referred to as § 1135 Waivers. However, much of this flexibility was intended to be temporary. Thus, the waivers will generally expire with the termination of the PHE, with some limited exceptions.
During the past two years, many healthcare providers and stakeholders across the industry have integrated the PHE and the accompanying waivers into their business practices. The end of the PHE signals the end of many of these waivers, so healthcare providers and industry stakeholders will need to be aware of how to navigate the return to post-Pandemic operations without the waiver flexibility. Such a transition will require significant changes, including (1) reinstituted policies limiting the use of telehealth, (2) a reinstatement of reporting requirements for hospitals and long-term care centers, and (3) a revert to pre-Pandemic definitions and practices concerning which types of medical professionals can provide care to Medicare patients. The expiration of these and other major waivers is outlined below, and the entire list of waivers set to expire can be found here.
While the array of waivers is too vast to exhaustively examine here, suffice it to say that they affect essentially every type of healthcare provider, from hospice providers to telehealth service providers and everything in between. The § 1135 Waivers have allowed for sweeping changes and flexibilities necessary to allow our healthcare system to respond nimbly to, and operate appropriately through, the Pandemic. Policies that made this possible included expanding the range of practitioners who could bill Medicare for telehealth services, lessening various reporting requirements, and modifying equipment sanitation and disposal protocols to manage scarce resources. Some waivers have already been terminated, but of those that are still in effect, the only types that will continue beyond the end of the PHE are those pertaining to flexibility for Medicare telehealth services, which are set to end 151 days after the conclusion of the PHE. Relatedly, when the PHE ends, CMS will continue deferring to state law regarding licensure requirements for practitioners providing telehealth services.
In contrast to these narrow exceptions, which will last beyond the PHE, hospitals, psychiatric hospitals, and critical access hospitals will need to swiftly cease PHE-era practices of screening patients at offsite locations and the liberal use of verbal orders. Such providers will need to revert to more thorough reporting requirements and ensure that Medicare patients are under the care of a physician, policies that were deviated from only out of necessity in managing the COVID-19 surge in hospital patients.
With the 60-day notice prior to the end of the PHE, businesses will have some time to begin adjusting practices and policies to the return of old requirements in some cases, while also continuing to adjust to new regulations put in place as a result of the Pandemic. Proactive preparation is key for all types of healthcare providers. Additionally, even with the 60-day notice period, stakeholders who have utilized or been affected by the PHE flexibilities need to start preparing now for changes to come. The White House and others in Washington, DC have reported that the end of the PHE is near.
* The authors would like to thank Tristan Smith, a Law Clerk in Venable’s Tysons, VA office, and Noah Holman, an Associate in Venable’s Baltimore, MD office for their assistance in writing this article.
 42 USCA § 1320b-5 (West); https://aspr.hhs.gov/legal/PHE/Pages/Letter-to-Governors-on-the-COVID-19-Response.aspx
 See, egCenter for Medicare & Medicaid Services (CMS), Additional Emergency and Disaster-Related Policies and Procedures That May Be Implemented Only with a § 1135 Waiver (Mar. 15, 2019); CMS, COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers (Oct 13, 2022) [hereinafter Blanket Waivers].
 Blanket Waivers.
 See Blanket Waivers.
 Blanket Waivers.
 Blanket Waivers.