North Carolina has been under a state of emergency due to the COVID-19 pandemic for nearly two and a half years. On July 11, a press release from the Governor’s Office said that North Carolina’s state of emergency due to COVID-19 will be lifted on August 15. However, the state will remain under other declarations of emergency that apply nationwide.

This post begins with a timeline of the different federal and state emergency declarations (sometimes called determinations) that were made due to COVID-19 and that are presently applicable to North Carolina. It then discusses the effect of the end of the declarations/determinations on public health activities in North Carolina, with a particular focus on the statewide state of emergency that is expected to end in August, and the national public health emergency that was recently extended to mid-October.

Timeline of emergency declarations prompted by COVID-19

At the time of this writing, there are multiple emergency declarations or determinations prompted by COVID-19 that affect North Carolina. This timeline identifies who made which declaration or determination, under what legal authority, and when the declaration or determination is expected to end.

January 31, 2020: Then-U.S. Secretary of Health and Human Services (HHS) Alex Azar determined that a nationwide public health emergency existed as a result of confirmed cases of COVID-19 in the United States. The Secretary is empowered to make this determination under Section 319 of the federal Public Health Service Act. A Section 319 public health emergency (PHE) terminates after 90 days, unless it is renewed. The Section 319 PHE has been renewed every 90 days since it was initially declared, most recently by Secretary Xavier Becerra on July 15, 2022. It will expire on October 13, 2022, unless it is terminated earlier or extended again. The Biden Administration has stated that it will give 60 days’ notice of the termination of the Section 319 PHE.

February 4, 2020: U.S. HHS Secretary Azar issued a separate determination of a public health emergency under a different authority, Section 564 of the federal Food, Drug, and Cosmetics Act. This determination was necessary to permit emergency use authorization (EUA) for products needed to address the emerging pandemic, and it was accompanied by the Secretary’s declaration that the PHE justified EUAs for diagnostic tests for COVID-19. On March 27, 2020, Secretary Azar issued a subsequent determination, retroactive to March 24, that EUAs were justified for drugs and other biologicals. This paved the way for vaccinations and treatments for COVID-19 to be made available to the public quickly. A Section 564 PHE determination terminates either when the products developed pursuant to it are no longer under EUAs, or when the HHS Secretary, in consultation with the Secretary of Homeland Security or Secretary of Defense, determines that the circumstances supporting the PHE determination no longer exist.

March 10, 2020: North Carolina Governor Roy Cooper declared a statewide state of emergency due to COVID-19 (Executive Order 116), under the authority of the North Carolina Emergency Management Act. According to the Governor’s July 11 press release, North Carolina’s state of emergency will end on August 15, 2022.

March 13, 2020: President Donald Trump declared a national emergency due to the COVID-19 pandemic and made the declaration retroactive to March 1 (Proclamation 9994). This declaration was made pursuant to the National Emergencies Act, which provides that emergency declarations may last for up to a year and may be extended at the end of a year. President Joe Biden extended the declaration of national emergency on February 24, 2021, and then again on February 18, 2022. It will expire on March 1, 2023, unless terminated earlier or extended again.

March 17, 2020: U.S. HHS Secretary Azar issued yet another declaration, this time under the Public Readiness and Emergency Preparedness (PREP) Act, to provide immunity from liability for entities involved in the development, manufacture, testing, distribution, administration or use of medical countermeasures for COVID-19 (collectively, “covered countermeasures”). This type of declaration requires the Secretary to specify a time period during which such immunity from liability for the covered countermeasures is in effect, but then to provide an additional time period to allow those who received immunity under the declaration to arrange for disposition of the covered countermeasures (e.g., by accepting returns of products or other actions). Secretary Azar’s declaration specified that immunity from liability will be in effect until October 1, 2024, and specified that the additional time period for arranging for disposition will be 12 months.

What happens when the declarations end?

There are two important things to keep in mind when contemplating the end of the emergency declarations or determinations related to COVID-19.

First, the different declarations address the same emergency and are meant to work together to support the emergency response, but they are nevertheless independent of each other, will end at different times, and the effects of the end of each will be different.

Second, public health officials at the state[1] and federal[2] level have legal authorities during communicable disease outbreaks that are independent of public health emergency declarations at the state or federal level and that will continue when the emergency declarations end.

North Carolina’s State of Emergency

Early in the pandemic, a number of COVID-19 mitigation strategies were implemented via executive orders issued by the Governor or administrative orders issued by the N.C. Secretary of Health and Human Services. (The COVID-19 orders have been compiled here.)

The earliest orders, issued in March 2020, closed schools, dine-in restaurants, and other businesses; prohibited mass gatherings; and directed individuals to stay at home to the extent possible. By May 2020, North Carolina was beginning a phased re-opening and additional orders began lifting restrictions in a manner that then-N.C. Secretary of Health and Human Services Mandy Cohen described as a “dimmer switch” approach.

As part of the re-opening strategy, the first statewide requirement for masks appeared in Executive Order 141, which was issued on May 20, 2020 and required face coverings in certain businesses that had previously been closed. Subsequently, an order requiring face covering use by most members of the general public was issued on June 24, 2020.

By February 2021, COVID-19 vaccines were being made available to the public in a staged rollout and hopes were high that the vaccines would contain the pandemic. In addition, the costs of some of the restrictions—including the economic, social, and educational costs—were becoming clear and the need to take those into account in determining the emergency response was apparent. Executive Order 215, issued on May 14, 2021, lifted the statewide mask requirement and most of the other requirements that were focused on mitigating the pandemic. Restrictions that remained applicable in certain settings, such as schools, continued to be negotiated and adapted as the NC General Assembly enacted legislation related to COVID-19 and public health officials worked with governmental and community partners to provide a pandemic response while attempting to minimize other harms.

Today, no statewide emergency order remains that requires the general public to comply with COVID-19 mitigation requirements. Private entities or local governments may still have requirements in place, and public health officials are still obliged to respond to communicable disease outbreaks of all types. But at present there is no statewide mask requirement, no statewide closure of businesses, no mass gathering restrictions, no stay-at-home order—all of those were lifted some time ago. When it comes to those matters, the end of the state of emergency due to COVID-19 will not make a difference.

Throughout the state of emergency, numerous executive orders addressed other aspects of emergency response: certain regulatory requirements were eased, some administrative deadlines were extended, and procedures were adopted to facilitate different aspects of the pandemic response. I will not attempt to address all of them here, but I do want to note one aspect of those orders that will continue after the state of emergency ends and that is of particular importance to public health.

Since the autumn of 2021, some of the executive orders issued under the Governor’s emergency powers authorized the State Health Director to issue standing orders that made it possible for COVID-19 testing, treatment, and vaccination to be made available statewide. This summer, the North Carolina General Assembly included substantially similar authorities for the State Health Director in the 2022 budget bill (S.L. 2022-74, sec. 9G.7.(a)). Therefore, these authorities will continue after the state of emergency ends. Governor Cooper’s July 11 press release that announced the plan to lift the state of emergency in August referred to this when it noted that “[t]he budget includes the changes in the law requested by the NC Department of Health and Human Services to ensure flexibility that is currently made possible by the Governor’s COVID-19 State of Emergency.”

National Public Health Emergency Declarations

As the timeline showed, there are multiple national declarations and determinations that address different aspects of the public health emergency response. The eventual end of the different declarations/determinations will affect public and private health insurance coverage, the availability of COVID-19 tests and treatments under EUAs, pandemic response funding, telehealth, immunity from liability for emergency actions, and more. I am not going to attempt to address all of these issues, but will briefly address the PHE affecting EUAs, and then will discuss the effects of the end of the Section 319 PHE on local health departments’ HIPAA compliance. (For a more comprehensive treatment of the implications of ending the emergency declarations, see this compilation from the Kaiser Family Foundation).

The Section 564 Public Health Emergency (Food, Drug, & Cosmetics Act)

The Section 564 PHE determination does not have a set ending date. Instead, it terminates either when the products developed pursuant to it are no longer under EUAs, or when the HHS Secretary (in consultation with other federal officials) determines that the circumstances supporting the PHE determination no longer exist.

I have no inside information from the FDA, but based on the usual criteria for termination, I believe it is highly unlikely that the PHE determination under Section 564 of the Federal Food, Drug, and Cosmetics Act will end any time soon. There are many COVID-19 tests, treatments, and vaccines that are still under EUAs, and new products are still in development that will need EUAs to be deployed quickly.

The Section 319 Public Health Emergency (Public Health Service Act)

The question of when to end the Section 319 PHE is politically charged but also highly consequential to health care and public health practice. A principal effect of the PHE has been to give the federal government the flexibility to waive or modify regulatory requirements, including some that affect HIPAA compliance.

Throughout the pandemic, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) has taken actions to address HIPAA compliance as it relates to COVID-19. These actions, which are compiled here, have included:

• Guidance documents explaining how the usual HIPAA rules apply to particular questions raised by COVID-19;
• Waivers of some HIPAA requirements and penalties for certain hospitals during the nationwide public health emergency for hospitals; and
• Notifications of enforcement discretion (NEDs)—statements that OCR will not enforce some of the requirements of the HIPAA Privacy or Security Rules during the Section 319 public health emergency.

The NEDs have been of particular importance to North Carolina health departments, and they are all tied to the Section 319 PHE—when it ends, they also will cease to be effective. An NED is not a permanent change in HIPAA obligations. Rather, by promising that certain rules won’t be enforced during the PHE, the NED has provided HIPAA-covered entities temporary relief from complying with some of HIPAA’s rules. This has allowed health departments and community health care providers to do some of the things that they needed to do to respond effectively to the pandemic, such as providing care via telehealth, or operating mass vaccination clinics.

There are four NEDs that will expire when the Section 319 PHE ends. Of these, the most significant is one intended to facilitate the use of telehealth. The telehealth NED has been in effect since March 17, 2020, and has allowed HIPAA-covered health care providers to use technologies such as FaceTime, Zoom, Skype, or similar products to provide telehealth services, even if the technology normally would not be allowed because it doesn’t satisfy the requirements of HIPAA’s Security Rule, and even if the health care provider does not have a HIPAA business associate agreement with the technology provider. Because the telehealth NED will expire when the Section 319 PHE expires, for some time now providers have been anticipating that the rules will eventually be enforced again and they will need to bring their use of telehealth into compliance. This is a big deal, because patients as well as providers have become accustomed to being able to use different methods for telehealth, and it’s highly popular for some populations and some kinds of services. In January 2022, the American Medical Association wrote U.S. DHHS to formally request a “glide path” to HIPAA compliance for telehealth after the PHE ends.

Some action has been taken in the months since. The most significant is an extension to the telehealth flexibilities for Medicare beneficiaries that Congress adopted as part of its omnibus spending package in March 2022. This legislation provides that the extension will last for 5 months past the end of the Section 319 PHE (for now, that appears to mean until mid-March 2023—potentially later if the PHE is extended again). In June, OCR issued guidance regarding audio-only telehealth for all HIPAA-covered providers, but the guidance is largely limited to explaining how the use of traditional landline telephones complies with the HIPAA Security Rule, which is nothing new. The guidance does not authorize audio-only telehealth using VoIP or similar technologies, or smartphones, unless all the requirements of the HIPAA Security Rule are met. It is possible, perhaps likely, that future actions will support the continuation of telehealth, but that remains to be seen.

Two other NEDs that have affected local health department operations during the pandemic pertain to community-based testing sites and using online or web-based scheduling apps to make covid vaccination appointments (I wrote about the latter here). I’m not sure to what extent people are still relying on the flexibility that those NEDs offered, but they too will expire at the end of the Section 319 PHE, as will a fourth NED that pertains to some disclosures made by business associates for public health or health care oversight purposes.

Conclusion

North Carolina’s state of emergency due to the COVID-19 pandemic is expected to end soon, but multiple national emergency declarations or determinations will remain in place for at least a few more months. The most significant of these for North Carolina’s local health departments is likely the public health emergency declared under Section 319 of the Public Health Service Act. Among other things, certain HIPAA flexibilities that have been provided during the Section 319 PHE will end. The Section 319 PHE was recently extended to mid-October. The Biden Administration has promised that it will provide 60 days’ advance notice of the end of the Section 319 PHE, so we should know by mid-August whether it will end in October or be extended again. A major issue for health departments (and other HIPAA-covered health care providers) will be to what extent they will be able to continue to provide telehealth, relying on regulatory flexibility that has been exercised during the pandemic. In the meantime, health departments should plan for the eventual end of the PHE and the HIPAA enforcement discretion that has been associated with it.

[1] Public health officials in North Carolina have the legal authority and duty to respond to communicable disease outbreaks in G.S. Chapter 130A and implementing regulations. This authority is independent of a declared state of emergency at the state or federal level. (For more information, see my 2017 book, North Carolina Communicable Disease Law.) Separately, G.S. Chapter 166A authorizes the Governor and local governments to take certain actions to address emergencies of all types, and those authorities have been used to require actions intended to prevent the spread of disease during the pandemic. However, there does not need to be a declared state of emergency for public health officials to respond to communicable disease outbreaks affecting the whole state or portions of it.

[2] At the federal level, Section 361 of the Public Health Service Act and its implementing regulations authorize the CDC to take measures to prevent the interstate spread of communicable disease. The scope of the CDC’s authority has been limited during the pandemic—see Alabama Ass’n of Realtors v. Dep’t of Health and Human Services, 594 U.S. ___ (2021) (holding that CDC does not have the authority to impose a nationwide eviction moratorium during a pandemic); Health Freedom Defense Fund, Inc. v. Biden, 2022 WL 1134138 (M.D. Fla.). 594 U.S. ___ (Apr. 18, 2021), (vacating CDC’s order requiring the use of face masks on public transportation), appeal filed (11^th Cir., Apr. 21, 2021)—but my core point stands: the exercise of such authority as the CDC has does not require a declared state of emergency.