On Thursday, July 23, US Secretary of Health and Human Services Alex Azar officially renewed his determination that the novel coronavirus disease (COVID-19) constitutes a nationwide public health emergency (PHE). As we have detailed in prior alerts, the PHE declaration is an important legal prerequisite for certain major emergency measures that the government has deployed to help address COVID-19. Section 1135 of the Social Security Act authorizes the Secretary to waive certain statutory constraints on the Medicare program. Congress has expanded that waiver authority in recent months to include additional highly consequential matters such as certain restrictions on Medicare payment for telehealth services. HHS has also used Section 1135 to suspend select portions of the federal physician self-referral law (or Stark Law), which places tight limits on financial relationships between physicians and the entities to which they refer patients for certain Medicare-covered designated health services, during the PHE. These and many other modifications to Medicare and Medicaid requirements, ranging from relatively minor technical allowances to massive changes to the manner in which healthcare providers may do business, are collected at this government website.
Section 1135 depends on both an HHS PHE determination under the Public Health Services Act (42 USC 247d), and a presidential emergency declaration under either the Stafford Act or the National Emergencies Act. Prior to Thursday night’s renewal, the PHE was set to expire on Saturday, July 25. An HHS spokesperson claimed in a tweet late last month that the Department “expect[ed] to renew” the PHE, but some providers and even governors remained concerned about the fate of various sweeping Section 1135 waivers due to Azar’s refusal to commit to an extension.
Assuming the President does not revoke his current declaration of a national emergency, the Section 1135 waivers can remain in place for another 90 days, after which the Secretary will have to once again renew the declaration under the Public Health Service Act. In other words, the next renewal opportunity will fall less than two weeks before the 2020 presidential election. Some members of Congress have proposed removing the requirement that the President exercise Stafford Act or National Emergency Act powers to trigger Section 1135. In the meantime, as the US coronavirus death toll approaches 150,000 and the virus wreaks massive social and economic disruption, providers have to hope that the President will permit the Secretary to re-up the PHE determination before the next expiration date.
DLA Piper continues to closely monitor federal and state governmental actions as this situation unfolds. For information on other ways COVID-19 is changing the healthcare industry and how your company can help serve patients, please contact your DLA Piper relationship partner or any member of our healthcare industry group. Please visit our Coronavirus Resource Center and subscribe to our mailing list to receive alerts, webinar invitations and other publications to help you navigate this challenging time.
This information does not, and is not intended to, constitute legal advice. All information, content, and materials are for general informational purposes only. No reader should act, or refrain from acting, with respect to any particular legal matter on the basis of this information without first seeking legal advice from counsel in the relevant jurisdiction.