What to expect now that we’re expecting: What the end of the public health emergency means for healthcare providers

On January 30, 2023, President Biden announced that both the COVID-19 national emergency and the public health emergency (PHE) will end May 11, 2023. This announcement has left many healthcare providers considering how the end of these emergencies will affect their operations. Indeed, many federal programs and waivers developed in response to the PHE will have been in effect for over three years when these emergency declarations expire. Providers should evaluate their current operations to determine if they are still relying on these programs and how they may return to “normal” operations after these programs expire.

This article is the first in a series of articles that will describe several major programs the Federal government developed in response to the PHE and explain how these programs may be affected by the end of the PHE. Many of these programs will terminate alongside the end of these emergency declarations; however, some will remain in effect past the end of the PHE.

 

1. Section 1135 Waivers

Under the Section 1135 of the Social Security Act, the Secretary of Health and Human Services (HHS) is empowered to waive certain provisions of the Medicare and Medicaid programs when the President announces a public health emergency or disaster declaration. The goal of 1135 waivers is to ease burdensome Medicare and Medicaid requirements for providers undergoing an unprecedented disaster so that they may focus on patient care. Historically, HHS issued these waivers for natural disasters like hurricanes and only applied these waivers to a limited geographic area. Such waivers are only temporary during periods of the declared public health emergency. The COVID-19 PHE and the resulting 1135 waivers were unique in that they applied nationwide and that the PHE was extended multiple times. Every 90-day extension of the PHE also extended the 1135 waivers. Under the Social Security Act, 1135 waivers are limited to the following categories:

• Medicare Conditions of Participation or certification requirements
• Provisions under The Emergency Medical Treatment and Active Labor Act (EMTALA)
• Sanctions and fines imposed under The Health Information Portability and Accountability Act (HIPAA)
• Federal (but not state) physician licensure requirements
• Violations of the physician self-referral law, also known as the “Stark Law”

 

COVID-19 1135 Waivers

Specific to the COVID-19 PHE, HHS offered two general categories of waivers: “blanket” waivers and application waivers. Blanket waivers were specific program waivers that healthcare providers participating in the Medicare and Medicaid programs did not have to apply for; providers automatically qualified and could use such waivers under the directives published by HHS. Application waivers were also published by HHS, but they required providers to apply for the waiver to be approved, usually by the provider’s fiscal intermediary. CMS published several dozen 1135 waivers – too numerous to address individually. Both blanket and application waivers implemented since the March 13, 2020, disaster declaration are published here and divided according to provider or facility type. Providers were also permitted to make direct requests to HHS to request their own specific waivers. If your organization applied for and received any non-published waivers, you should consult your documentation and communications regarding the termination of these waivers.

All of the published waivers by HHS are set to expire on May 11, 2023, or a certain period of time after the PHE expires. Several waivers have already expired – these are noted in the link above with a strikethrough and comment from CMS. Providers should review these published waivers and plan to end any current practice that relies on them by May 11, 2023, or their applicable expiration period. 1135 waivers touch on many facets of facility provider operations – from revenue cycle, discharge planning, and quality, to compliance and accreditation standards. It will take the same multi-disciplinary teams to evaluate and implement a plan to address these changes as these waivers expire.

 

2. PREP Act

The Public Readiness and Emergency Preparedness (PREP) Act of 2006 allows HHS to declare a PREP Act declaration in response to a public health or other disaster. When the PREP Act is invoked through such declaration, HHS grants certain immunities to providers from liability from lawsuits that pertain to losses “caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions.” Specific to COVID-19, HHS’ declaration issued on March 17, 2020, and the ten succeeding amendments issued thereafter generally provided immunity protections to healthcare providers, distributors and manufacturers who provided certain countermeasures to combat the COVID-19 pandemic.  

Key liability protections under the COVID-19 PREP Act declarations include the following:

• Product liability protections for manufacturers of any drug, biological product, or device approved, cleared for emergency use or licensed by the FDA that is used to diagnose, mitigate, prevent, treat, cure or limit the harm of COVID-19. This extends to vaccine manufacturing, drugs and devices authorized for COVID-19 emergency use and personal protective equipment;
   
• Medical negligence claims against healthcare providers for prescribing, administering, delivering, distributing, or dispensing COVID-19 countermeasures. This includes vaccine administration and COVID-19 treatments cleared for emergency use by the FDA.