Renewal of Public Health Emergency Provides for Continued Waiver Relief - McDermott Will & Emery

Renewal of Public Health Emergency Provides for Continued Waiver Relief

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In an announcement welcomed by many healthcare providers, on July 23, 2020, the US Department of Health and Human Services announced that the COVID-19 public health emergency would be extended 90 days, through October 23, 2020. While this enables providers to continue operating under the waivers and other relief extended as a result of the pandemic, they should use this window of opportunity to prepare for a return to pre-public health emergency operations.

In Depth

Providers around the country that have relied upon the waivers and flexibilities afforded under Section 1135 of the Social Security Act (Act) and other rulemaking welcomed the July 23, 2020, announcement by the US Department of Health and Human Services (HHS) that the public health emergency (PHE) in relation to the COVID-19 pandemic would be extended for 90 days, through October 23, 2020 (unless earlier terminated by the Secretary of HHS). This PHE extension functioned to keep in place the waivers under Section 1135 of the Act, including those involving the use of alternate care sites, reduced regulatory reporting burdens, and compliance with certain facility conditions or requirements for participation.

As noted in our prior client alert, both the HHS declaration and the presidential declaration must be in effect to maintain much of the waiver relief that many types of healthcare providers and facilities have utilized in responding to the unique and unprecedented needs brought about by the pandemic. While the presidential declaration remained in force, the HHS declaration was due to expire on July 25, 2020. Prior to the extension, providers expressed concern that the PHE declaration may not be renewed, which would have triggered a cascade of effects as the waiver relief simultaneously expired.

In light of increasing case counts and hospitalization surges in numerous states, it remains uncertain how long providers will need the benefit of waivers to provide services; however, it makes it less likely that the Secretary will end the PHE before the October 23, 2020, date. Regardless, the extension of the PHE provides an opportunity for providers to lay the groundwork for a return to pre-PHE operations, smoothing the transition that will come with the end of the PHE in the future.

Key Takeaways

The extension of the PHE into October was welcome news for providers that have become accustomed to operating under the Section 1135 waivers and other regulatory flexibilities. Without new legislation and modification of existing regulations, many of the waivers and flexibilities will expire along with the PHE in October, and no regulatory pathway currently exists for a “phased” or stepwise approach to pre-PHE operations.

Accordingly, during this extension period, it would be prudent for providers to:

  1. Identify and catalog (if not previously documented) the waivers and flexibilities under which they have and are operating as a result of the COVID-19 pandemic.
  2. Prepare a plan for return to pre-PHE operations, to assess challenges and advance work that might be needed to effect the necessary changes.
  3. Develop a mechanism for clear communication to stakeholder groups (i.e., clinicians, administrators and other staff) of the timeline and the reasons and need for returning to standard practices and procedures.
  4. Reach out to hospital or other trade or professional organizations to assess opportunities for advocacy on more permanent regulatory changes, particularly where functioning in a waiver environment may have identified specific areas in which flexibilities improved patient outcomes and experience.