On July 23, 2020, U.S. Department of Health and Human Services (HHS) Secretary Alex Azar renewed the declaration that a national public health emergency (PHE) exists due to the COVID-19 pandemic. This declaration is effective as of July 25, 2020, and extends the PHE for an additional 90 days until October 23, 2020, or unless earlier terminated by the Secretary. This renewal extends the wide array of waivers and flexibilities that have been issued by HHS in response to COVID-19. AGG has been closely monitoring the outbreak of COVID-19 and providing legal updates on the myriad issues that are impacting providers, including various waivers and flexibilities.
The declaration of the PHE, as well as President Trump’s declaration of a national emergency, confers authority on the Secretary under §1135 of the Social Security Act (Act) to waive a variety of statutory and regulatory requirements, including certain conditions of participation for various healthcare providers, sanctions under §1877(g) of the Act relating to limitations on physician self-referral, and sanctions and penalties for noncompliance with certain HIPAA requirements, among others. In addition, the Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020 and the Coronavirus Aid, Relief, and Economic Security (CARES) Act both conferred additional authority on the Secretary to waive requirements related to telehealth under §1834(m) of the Act.
The Secretary and the Centers for Medicare and Medicaid Services (CMS) have taken broad waiver action under this authority in response to COVID-19, and also issued two interim final rules that extended additional flexibilities. The HHS Office for Civil Rights similarly announced enforcement discretion for a variety of HIPAA requirements.
Providers have relied heavily on these flexibilities, which largely are tied to the declaration of the PHE. Once the declaration of the PHE expires or is terminated, so will be the dependent waivers and flexibilities, unless additional Congressional or administrative action is taken in the interim. Thus, the extension will likely come as welcome news to providers. Nonetheless, the declaration will not extend indefinitely, so providers should keep one eye to the future and be aware of how changes implemented to respond to COVID-19 will have to be reverted once the flexibilities terminate. For more information, see the Healthcare section of AGG’s COVID-19 Resource Center or contact a member of AGG’s Healthcare Law Team.