Sat Mar 23, 2024 11:33 pm by globalturbo
Exclusive: Public Health Emergency in U.S. Set to Expire May 11 — But EUA Vaccines, Liability Shields Aren’t Going Away Anytime Soon
President Biden earlier this month signed a bill that immediately rescinded the COVID-19 national emergency declared in March 2020, by former President Trump. But a separate Public Health Emergency won’t expire until May 11 — and at least two other COVID-19-related federal emergencies are set to remain in effect past that date.
By
Michael Nevradakis, Ph.D.
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President Joe Biden earlier this month signed H.J.Res. 7, a bill that immediately rescinded the COVID-19 national emergency declared in March 2020, by former President Donald Trump.
But a separate Public Health Emergency (PHE), declared in January 2020 by Trump’s U.S. Department of Health and Human Services (HHS) secretary, won’t expire until May 11 — and there are at least three more emergency declarations in effect at the federal level, at least two of which are set to remain in effect past May 11.
These two emergency declarations — issued under the Public Readiness and Emergency Preparedness (PREP) Act and the Emergency Use Authorization (EUA) provision of the Federal Food, Drug and Cosmetic Act — affect the administration of COVID-19 vaccines and therapeutics and their accompanying liability shield.
For example, COVID-19 vaccines issued under EUA will continue to be administered even past May 11, despite the end of the PHE and the national emergency, and their legal liability shield will remain in place.
“The president’s decision to end the COVID pandemic emergency will not affect vaccines, masks or other public health emergency responses, said Ray Flores, senior counsel to Children’s Health Defense (CHD).
Flores told The Defender:
“There is a gross misconception out there that only licensed vaccines will become available, that COVID-19 vaccine cases would be heard in the U.S. Court of Federal Claims under the National Childhood Vaccine Injury Act of 1986, and that all public health measures and mandates will abruptly end.
“It doesn’t matter if a biologic is approved or simply EUA only. Whether approved or not, it is still covered by PREP, and COVID-19 countermeasure protections are definitely not going away next month.”
In addition to the five federal emergency declarations in place during the pandemic, the federal government separately implemented a number of other policies — affecting everything from non-citizens entering the U.S. by air, to Medicaid provisions, to federal student loans.
For some of these programs, a separate end date is in sight. For others, it remains unclear to what extent ending the national emergency and the PHE could affect them.
The same holds true for a number of pending lawsuits challenging vaccine mandates and other aspects of the federal COVID-19 response.
State-level COVID-19 emergencies also remain in effect in four states, while the underlying laws granting such emergency powers remain in effect at both the federal and state levels.
And the World Health Organization’s (WHO) own global COVID-19 public health emergency also remains in effect.
The Defender presents a comprehensive overview of the recently passed legislation, the five COVID-19-related federal emergencies and the state-level emergencies, and examines the potential impact of the end of two of the COVID-19 emergencies on Medicaid, ongoing federal court cases, student loans and more.
CHD’s fact sheet on COVID-19 emergency declarations outlines key aspects of and differences between the five federal emergency declarations.
Bill ending national emergency passed despite opposition
H.J.Res. 7 took more than two months to reach Biden’s desk. It initially passed the U.S. House of Representatives on Feb. 1 in a 229-197 vote, with Democrats casting all of the votes opposing the measure.
On March 29, the Senate passed the bill by a veto-proof 68-23 majority. All votes against the bill came from Democrat lawmakers, although 21 Democrats voted in favor along with 47 Republicans.
Previously, on Jan. 30, Biden informed Congress he intended to end both the PHE and the national emergency jointly on May 11. As The Associated Press (AP) reported:
“The move to end the national emergency and public health emergency declarations would formally restructure the federal coronavirus response to treat the virus as an endemic threat to public health that can be managed through agencies’ normal authorities.”
The AP reported that the Biden administration considered ending the national emergency as early as last year, “but held off amid concerns about a potential ‘winter surge’ in cases and to provide adequate time for providers, insurers and patients to prepare for its end.”
Instead, in a Jan. 30 Statement of Administration Policy, the administration said it planned to “use the next three months to transition the response to conventional methods” in order to avoid “confusion and chaos.”
On Sept. 18, 2022, speaking to CBS’ “60 Minutes,” Biden said the “pandemic is over.” And on Aug. 30, 2022, the Biden administration announced its intention to shift distribution of COVID-19 therapeutics to the private sector by January 2023 — although this transition appears to have been delayed.
Trump declared national emergency in March 2020
The National Emergencies Proclamation Act 9994, issued on March 13, 2020, and ended on April 10, 2023, was issued under sections 201, 202 and 301 of the National Emergencies Act, 50 U.S. Code sections 1601, 1621 and 1631.
Such declarations are made by the president when there is a “national emergency” — which is not otherwise defined.
Trump issued the proclamation the same day the HHS issued a classified document declaring the National Security Council would lead the COVID-19 response.
The Biden administration renewed the national emergency on March 1, 2021, and again on March 1, 2022.
The duration of a national emergency is indefinite. There are three methods for ending it: The president proclaims the emergency is over; the president does not renew it; or Congress issues a joint resolution — as was the case with COVID-19.
According to The Hill, “Under federal law, Congress has the power to ask for periodic votes to terminate a national emergency.”
The national emergency declaration bestows powers on the federal government that are activated only when a national emergency is declared — in this way, the declaration is like the “on” switch for activating certain powers.
According to the Brennan Center for Justice, there are up to 148 optional statutory powers that become available to the president upon declaration of a national emergency.
In relation to COVID-19, the national emergency was used to invoke authority under the Social Security Act to modify or waive certain requirements of Medicare, Medicaid and state children’s health insurance programs and HIPAA rules, as long as the COVID-19 PHE declaration remained in effect.
The national emergency also “allowed the Federal Emergency Management Agency (FEMA) to mobilize personnel to support state and local agencies as they worked to combat the virus [and] allowed FEMA to access billions of dollars,” The Hill reported.
According to the Brownstone Institute, the COVID-19 national emergency was the first such declaration ever issued for an infectious disease.
End of public health emergency could affect Medicaid, other federal programs
Alex Michael Azar, HHS secretary under Trump, on Jan. 31, 2020, declared a PHE under section 319 of the Public Health Service Act, 42 U.S. Code section 247d. Azar made the declaration retroactive to Jan. 27, 2020.
The HHS secretary is authorized to declare a nationwide PHE upon determining that either a disease or disorder presents a public health emergency, or that a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists.
The PHE declaration has a 90-day duration, but the secretary may renew it. The COVID-19 PHE has been continuously renewed every 90 days from its initial declaration, with the most recent renewal occurring on Jan. 11.
The latest renewal expires May 11 — and according to CNBC, HHS Secretary Xavier Becerra will not extend it.
Under the Public Health Service Act, the declaration of a PHE provides the HHS secretary with many new powers, including the ability to:
“Take such action as may be appropriate to respond to the public health emergency, including making grants, providing awards for expenses, and entering into contracts and conducting and supporting investigations into the cause, treatment, or prevention of a disease or disorder.”
The secretary may distribute funds from the Public Health and Social Services Emergency Fund to public health agencies and other entities, waive data submittal and reporting deadlines and aspects of the Paperwork Reduction Act and temporarily reassign federally funded personnel, among other powers.
According to HHS, several changes are in store with the end of the PHE, an indication of the broad range of powers that existed under this declaration.
For instance, the national emergency enabled HHS to waive or loosen requirements for enrollment in Medicaid. Under these rules, Medicaid programs were required to keep people continuously enrolled until the end of the PHE.
According to the Kaiser Family Foundation:
“At the start of the pandemic, Congress enacted the Families First Coronavirus Response Act (FFCRA), which included a requirement that Medicaid programs keep people continuously enrolled through the end of the COVID-19 public health emergency (PHE), in exchange for enhanced federal funding.
“As part of the Consolidated Appropriations Act, 2023, signed into law on December 29, 2022, Congress delinked the continuous enrollment provision from the PHE, ending continuous enrollment on March 31, 2023.”
As a result, states could resume Medicaid disenrollments on April 1. It is estimated that between 5-14 million individuals will lose Medicaid coverage as a result.
According to HHS, “a combination of emergency authority waivers, regulations, and sub-regulatory guidance” has been used during the COVID-19 PHE “to ensure and expand access to care and to give health care providers the flexibilities needed to help keep people safe,” including providing expanded capacity that “is no longer necessary.”
In addition, coverage for COVID-19 tests will change: Access to free over-the-counter COVID-19 tests for Medicare beneficiaries will end. Private insurers will no longer be required to cover COVID-19 tests without cost sharing. State Medicaid programs, however, will provide COVID-19 tests without cost sharing until Sept. 30, 2024.
According to the HHS, “dependent on supply and resources, the USG [U.S. government] may continue to distribute free COVID-19 tests from the Strategic National Stockpile through the United States Postal Service, states, and other community partners.”
HHS also will no longer have the “express authority” to require labs to report the results of COVID-19 tests. This “may affect the reporting of negative test results and impact the ability to calculate percent positivity for COVID-19 tests in some jurisdictions.”
Hospital data reporting will continue through April 30, 2024, but “may be reduced from the current daily reporting to a lesser frequency.”
Under PREP Act, liability shield for COVID vaccines to continue through December 2024
Unlike the national emergency and the PHE, COVID-19-related emergency declarations issued under PREP Act will remain in force — and this directly affects the continued availability of and liability shield for COVID-19 vaccines.
The first COVID-19-related PREP Act declaration was issued March 17, 2020, but was made retroactive to Feb. 4, 2020. Ten amendments have followed, the most recent on Jan. 7, 2022.
The HHS secretary issues PREP Act declarations upon determining that “a disease or other health condition or other threat to health constitutes a public health emergency, or that there is a credible risk that the disease, condition, or threat may in the future constitute such an emergency.”
The secretary can recommend the manufacture, testing, development, distribution, administration or use of one or more “covered countermeasures,” which include products such as COVID-19 vaccines.
Moreover, the PREP Act declaration immunizes manufacturers, distributors
and others from any liability for injuries caused by a covered countermeasure, except in
cases of “willful misconduct.” These cases must follow narrowly prescribed procedural steps.
Barring proof of “willful misconduct,” anyone injured by a countermeasure covered under the PREP Act must seek redress through the Countermeasures Injury Compensation Program.
HHS states, “A PREP Act declaration is specifically for the purpose of providing immunity from liability, and is different from, and not dependent on, other emergency declarations.”
HHS further explains:
“Over the past three years, the PREP Act declaration has provided liability protection to manufacturers, distributors, and other organizations conducting countermeasure programs and providers administering COVID-19 countermeasures.
“This coverage includes liability protection for those entities engaged in manufacturing, distribution, or administration of COVID-19 countermeasures (such as tests, treatments, and vaccines) purchased by the Federal government for administration at pharmacies and other locations.
“All COVID-19 vaccines and treatments for which distribution is currently directed by the United States Government (USG) are covered by PREP Act protections and flexibilities.”
The HHS secretary has the power to terminate the PREP Act declaration, which otherwise has no expiration date. On April 14, HHS announced that PREP Act coverage will be extended to December 2024, for the administration of COVID-19 and seasonal influenza vaccines.
Specifically:
“PREP Act immunity from liability will be extended through December 2024 to pharmacists, pharmacy interns, and pharmacy technicians to administer COVID-19 and seasonal influenza vaccines (to those individuals three and over, consistent with other requirements), and COVID-19 tests, regardless of any USG agreement or emergency declaration.
“[Extended] coverage through December 2024 for Federal agreements. This includes all activities related to the provision of COVID-19 countermeasures that are 1) provided based on a Federal agreement (including the vaccines and treatments purchased and provided by the USG), or 2) directly conducted by the USG, including by Federal employees, contractors or volunteers.”
In other words, HHS said: “The amended PREP Act declaration will not have any immediate impact on COVID-19 vaccines, treatments, and tests currently distributed by the USG — either now or when the COVID-19 PHE ends on May 11.”
Conversely, PREP Act coverage will end for products no longer distributed under a USG agreement, including COVID-19 vaccination by “non-traditional providers” such as recently retired providers and students, and “COVID-19 vaccinations across state lines by licensed providers and pharmacists and pharmacy interns.”
According to HHS:
“No change to coverage for certain prescribing and dispensing of COVID-19 oral antivirals.
“The PREP Act will continue to offer liability immunity for pharmacists, pharmacy technicians, and pharmacy interns dispensing COVID-19 treatments, in accordance with a U.S. Food and Drug Administration (FDA) authorization, such as the oral antiviral treatments Paxlovid and Lagevrio.”
According to Flores, the PREP Act provides generous guarantees for COVID-19 vaccine manufacturers, such as Pfizer:
“The U.S. government expressly guaranteed that it would not distribute Pfizer vaccines unless Pfizer was covered by PREP or better, and the emergency’s ending generally affects areas such as relief money, insurance programs and shifts the development of vaccines and treatments away from the direct management of the federal government.”
According to the [url=https://www.cdc.gov/vaccines/covid-19/provider-enrollment.html#:~:text=*At this time%2C all COVID,until administered to the recipient]Centers for Disease Control and Prevention[/url] (CDC):
“At this time, all COVID-19 vaccine in the United States has been purchased by the U.S. government (USG) for administration exclusively by providers enrolled in the CDC COVID-19 Vaccination Program and remains U.S. government property until administered to the recipient.”
However, according to STAT, HHS will let some emergency flexibilities expire, “since vaccines and treatments will soon be available through the normal health care system instead of being bought by the government directly.”
STAT previously reported that the costs of COVID-19 vaccines “are also expected to skyrocket once the government stops buying them, with Pfizer saying it will charge as much as $130 per dose.”
Emergency Use Authorization to remain for COVID vaccines
The fourth emergency declaration during the COVID-19 pandemic came under the EUA provision of the Federal Food, Drug, and Cosmetic Act, 21 U.S. Code section 360bbb-3.
The first such declaration was issued Feb. 7, 2020, while the most recent was issued March 20, 2023.
The HHS secretary issues an EUA emergency declaration upon finding that circumstances justify the introduction of a product into interstate commerce because, among other reasons:
“There is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents.”
Simply put, this declaration allows the introduction of products that received EUA from the FDA, into interstate commerce.
This has been the case for all existing COVID-19 vaccines available in the U.S., including those from Pfizer-BioNTech, Moderna, Johnson & Johnson (Janssen) and Novavax.
The EUA emergency declaration can be terminated under the earlier of “(i) a determination by the Secretary, in consultation as appropriate with the Secretary of Homeland Security or the Secretary of Defense, that the circumstances … have ceased to exist; or (ii) a change in the approval status of the product such that the circumstances … have ceased to exist.”
In the March 20 amendment to the existing COVID-19 EUA authority, the previous language stating that “there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad” was amended to add “or a significant potential for a public health emergency.”
As reported by STAT, the end of the PHE “doesn’t have any bearing on emergency use authorizations for vaccines or treatments.”
The FDA on April 18 ended authorizations of the Moderna and Pfizer monovalent COVID-19 vaccines, recommending instead the drugmakers’ bivalent vaccines. While this change affects the status of the vaccines, it has no effect on the emergency declarations issued pursuant to the EUA statute.
FEMA determines when Stafford Act federal emergencies end
The fifth and final federal emergency applicable to COVID-19 is the declaration of emergency or disaster under section 501(b) of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S. Code section 5121.
Presidents can declare a national emergency under the Stafford Act upon determining that “federal assistance is needed to supplement state and local efforts and capabilities to save lives and to protect property and public health and safety, or to lessen or avert the threat of a catastrophe in any part of the United States.”
Such declarations, which can be issued nationally or for individual states, generally authorize various forms of individual and public assistance from the federal government and agencies such as FEMA, in states, tribes and communities that receive major or emergency disaster declarations.
Trump issued an emergency determination under this act on March 13, 2020, providing public assistance for various [url=https://www.fema.gov/disaster/coronavirus/disaster-declarations#:~:text=On March 13%2C 2020%2C President,emergency declaration for COVID%2D19]emergency protective measures[/url].
Such declarations do not expire — instead, FEMA can simply determine that the “incident period” has ended.
FEMA announced that the incident periods for all COVID-19-related declarations will end on May 11.
What about state-level COVID emergencies?
At one time, governors and state agencies in all 50 states had declared COVID-19-related emergencies.
Governors relied on the national emergency and PHE to enact various pandemic-related restrictions, such as lockdowns and church closures — although in some instances, courts have ruled that governors exceeded their powers.
According to Ballotpedia, state emergency declarations authorized governors to enact lockdown and stay-at-home orders, mask mandates and other restrictions on businesses and individuals.
Presently, four states — Connecticut, Illinois, Rhode Island and Texas — have active COVID-19 emergency orders in place:
A Dec. 19, 2022, letter to Biden signed by 25 state governors called for the end of the national emergency and PHE by April.
The World Health Organization’s global COVID emergency
In parallel with the national and state-level emergency declarations in the U.S., the WHO’s own COVID-related emergency remains in effect. On Jan. 27, the WHO extended its COVID-19 public health emergency of international concern (PHEIC), acknowledging that “the COVID-19 pandemic is probably at a transition point.” The agency made the declaration on Jan. 30, 2020, and has renewed ever since.
At an April 18 press conference “on COVID-19 and other global health issues,” the WHO warned that the COVID-19 pandemic was still “volatile,” adding that “we don’t turn off the pandemic switch.”
The next meeting of the WHO’s COVID-19 emergency committee is in early May. This committee advises the WHO’s secretary-general, Tedros Adhanom Ghebreyesus, on the status of the PHEIC. Tedros has final say over whether to keep the PHEIC in place or rescind it.
The WHO and its member states continue to negotiate amendments to the International Health Regulations — under which a PHEIC can be declared — and/or the establishment of a new “pandemic treaty,” with further updates or a vote expected at the 76th WHO World Health Assembly, May 21-30.
Status of COVID-related federal court cases yet to be determined
A number of lawsuits and cases challenging various aspects of the COVID-19 response, from vaccine mandates to student loan forgiveness enacted under the aegis of the COVID-19 national emergency, remain pending before federal courts.
This has resulted in speculation that the cases may now be dismissed as moot.
Legal experts who spoke with The Defender took a more nuanced view, saying that it depends on the details of each individual case, including the right involved in the lawsuit and how the government entities in question responded to the end of the national emergency and PHE.
Lawsuits directly challenging mandates that are no longer in effect may or may not be ruled moot — for example, cases such as the U.S. Department of Justice’s appeal of a court decision rescinding the mask mandate on airplanes and public transportation.
In that appeal, the 11th Circuit on April 11, 2023, told the parties, “Given the national emergency has been terminated, the parties are DIRECTED to brief the issue of mootness.”
Attorney Brant Hadaway for the plaintiffs/appellees told the court:
“Because the Mask Order would only end upon termination of the HHS declaration of a public health emergency, see 86 Fed. Reg. at 8030, it is unclear at this point whether CDC will agree that the Mask Order has in fact been terminated. The undersigned awaits clarity on the Government’s position.”
Both parties moved to extend the deadline for fully responding.
An open question remains as to how the end of the national COVID-19 emergency may impact the Supreme Court in its pending ruling regarding two cases challenging Biden’s student loan forgiveness plan.
According to SCOTUS Blog, the Biden administration’s plan was formulated on the basis of the Higher Education Relief Opportunities for Students Act of 2001 Act, passed after the 9/11 attacks, that allows the U.S. Department of Education to “waive or modify” provisions of student loan programs in connection with a “national emergency.”
The White House argues that it retains the authority to waive student loan debt even past the end of the national emergency, because of the ongoing financial hardship borrowers face due to the pandemic. During oral arguments, certain justices — conservative and liberal — appeared to question this rationale.
Separately, a variety of educational and research institutions announced the end of their own emergency policies — many in alignment with the end of the national emergency and PHE. For instance:
In turn, the Mayo Clinic “eased” its universal face mask requirement on April 10.
Foreigners traveling to the U.S. via airplane will also no longer face vaccine-related restrictions. In an emergency amendment issued by the Transportation Security Administration on April 11, an expiration date of May 11 was set for the rule requiring foreigners (non-citizens or legal residents) to be vaccinated in order to enter the U.S.
This rule has been used to bar entry to Serbian tennis star Novak Djokovic, who has not received a COVID-19 vaccine, not allowing him to compete in the U.S. Open as a result.
Changes are afoot in federal agencies as well. According to a March 29 Washington Post report, several members of the federal administration who were closely connected to the federal government’s COVID-19 response, including White House COVID-19 Response Coordinator Ashish Jha, M.D., MPH, are expected to leave the administration.
Jha recently helped announce “Project NextGen,” a new Biden administration initiative that will provide $5 billion to accelerate the development of new coronavirus vaccines and therapeutics, indicating that even with the end of several COVID-19-related emergencies, federal funding for vaccine development initiatives will continue.
THANKS TO: https://childrenshealthdefense.org/defender/united-states-covid-eua/?utm_source=luminate&utm_medium=email&utm_campaign=defender&utm_id=20230425
President Biden earlier this month signed a bill that immediately rescinded the COVID-19 national emergency declared in March 2020, by former President Trump. But a separate Public Health Emergency won’t expire until May 11 — and at least two other COVID-19-related federal emergencies are set to remain in effect past that date.
By
Michael Nevradakis, Ph.D.
Miss a day, miss a lot. Subscribe to The Defender's Top News of the Day. It's free.
President Joe Biden earlier this month signed H.J.Res. 7, a bill that immediately rescinded the COVID-19 national emergency declared in March 2020, by former President Donald Trump.
But a separate Public Health Emergency (PHE), declared in January 2020 by Trump’s U.S. Department of Health and Human Services (HHS) secretary, won’t expire until May 11 — and there are at least three more emergency declarations in effect at the federal level, at least two of which are set to remain in effect past May 11.
These two emergency declarations — issued under the Public Readiness and Emergency Preparedness (PREP) Act and the Emergency Use Authorization (EUA) provision of the Federal Food, Drug and Cosmetic Act — affect the administration of COVID-19 vaccines and therapeutics and their accompanying liability shield.
For example, COVID-19 vaccines issued under EUA will continue to be administered even past May 11, despite the end of the PHE and the national emergency, and their legal liability shield will remain in place.
“The president’s decision to end the COVID pandemic emergency will not affect vaccines, masks or other public health emergency responses, said Ray Flores, senior counsel to Children’s Health Defense (CHD).
Flores told The Defender:
“There is a gross misconception out there that only licensed vaccines will become available, that COVID-19 vaccine cases would be heard in the U.S. Court of Federal Claims under the National Childhood Vaccine Injury Act of 1986, and that all public health measures and mandates will abruptly end.
“It doesn’t matter if a biologic is approved or simply EUA only. Whether approved or not, it is still covered by PREP, and COVID-19 countermeasure protections are definitely not going away next month.”
In addition to the five federal emergency declarations in place during the pandemic, the federal government separately implemented a number of other policies — affecting everything from non-citizens entering the U.S. by air, to Medicaid provisions, to federal student loans.
For some of these programs, a separate end date is in sight. For others, it remains unclear to what extent ending the national emergency and the PHE could affect them.
The same holds true for a number of pending lawsuits challenging vaccine mandates and other aspects of the federal COVID-19 response.
State-level COVID-19 emergencies also remain in effect in four states, while the underlying laws granting such emergency powers remain in effect at both the federal and state levels.
And the World Health Organization’s (WHO) own global COVID-19 public health emergency also remains in effect.
The Defender presents a comprehensive overview of the recently passed legislation, the five COVID-19-related federal emergencies and the state-level emergencies, and examines the potential impact of the end of two of the COVID-19 emergencies on Medicaid, ongoing federal court cases, student loans and more.
CHD’s fact sheet on COVID-19 emergency declarations outlines key aspects of and differences between the five federal emergency declarations.
Bill ending national emergency passed despite opposition
H.J.Res. 7 took more than two months to reach Biden’s desk. It initially passed the U.S. House of Representatives on Feb. 1 in a 229-197 vote, with Democrats casting all of the votes opposing the measure.
On March 29, the Senate passed the bill by a veto-proof 68-23 majority. All votes against the bill came from Democrat lawmakers, although 21 Democrats voted in favor along with 47 Republicans.
Previously, on Jan. 30, Biden informed Congress he intended to end both the PHE and the national emergency jointly on May 11. As The Associated Press (AP) reported:
“The move to end the national emergency and public health emergency declarations would formally restructure the federal coronavirus response to treat the virus as an endemic threat to public health that can be managed through agencies’ normal authorities.”
The AP reported that the Biden administration considered ending the national emergency as early as last year, “but held off amid concerns about a potential ‘winter surge’ in cases and to provide adequate time for providers, insurers and patients to prepare for its end.”
Instead, in a Jan. 30 Statement of Administration Policy, the administration said it planned to “use the next three months to transition the response to conventional methods” in order to avoid “confusion and chaos.”
On Sept. 18, 2022, speaking to CBS’ “60 Minutes,” Biden said the “pandemic is over.” And on Aug. 30, 2022, the Biden administration announced its intention to shift distribution of COVID-19 therapeutics to the private sector by January 2023 — although this transition appears to have been delayed.
Trump declared national emergency in March 2020
The National Emergencies Proclamation Act 9994, issued on March 13, 2020, and ended on April 10, 2023, was issued under sections 201, 202 and 301 of the National Emergencies Act, 50 U.S. Code sections 1601, 1621 and 1631.
Such declarations are made by the president when there is a “national emergency” — which is not otherwise defined.
Trump issued the proclamation the same day the HHS issued a classified document declaring the National Security Council would lead the COVID-19 response.
The Biden administration renewed the national emergency on March 1, 2021, and again on March 1, 2022.
The duration of a national emergency is indefinite. There are three methods for ending it: The president proclaims the emergency is over; the president does not renew it; or Congress issues a joint resolution — as was the case with COVID-19.
According to The Hill, “Under federal law, Congress has the power to ask for periodic votes to terminate a national emergency.”
The national emergency declaration bestows powers on the federal government that are activated only when a national emergency is declared — in this way, the declaration is like the “on” switch for activating certain powers.
According to the Brennan Center for Justice, there are up to 148 optional statutory powers that become available to the president upon declaration of a national emergency.
In relation to COVID-19, the national emergency was used to invoke authority under the Social Security Act to modify or waive certain requirements of Medicare, Medicaid and state children’s health insurance programs and HIPAA rules, as long as the COVID-19 PHE declaration remained in effect.
The national emergency also “allowed the Federal Emergency Management Agency (FEMA) to mobilize personnel to support state and local agencies as they worked to combat the virus [and] allowed FEMA to access billions of dollars,” The Hill reported.
According to the Brownstone Institute, the COVID-19 national emergency was the first such declaration ever issued for an infectious disease.
End of public health emergency could affect Medicaid, other federal programs
Alex Michael Azar, HHS secretary under Trump, on Jan. 31, 2020, declared a PHE under section 319 of the Public Health Service Act, 42 U.S. Code section 247d. Azar made the declaration retroactive to Jan. 27, 2020.
The HHS secretary is authorized to declare a nationwide PHE upon determining that either a disease or disorder presents a public health emergency, or that a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists.
The PHE declaration has a 90-day duration, but the secretary may renew it. The COVID-19 PHE has been continuously renewed every 90 days from its initial declaration, with the most recent renewal occurring on Jan. 11.
The latest renewal expires May 11 — and according to CNBC, HHS Secretary Xavier Becerra will not extend it.
Under the Public Health Service Act, the declaration of a PHE provides the HHS secretary with many new powers, including the ability to:
“Take such action as may be appropriate to respond to the public health emergency, including making grants, providing awards for expenses, and entering into contracts and conducting and supporting investigations into the cause, treatment, or prevention of a disease or disorder.”
The secretary may distribute funds from the Public Health and Social Services Emergency Fund to public health agencies and other entities, waive data submittal and reporting deadlines and aspects of the Paperwork Reduction Act and temporarily reassign federally funded personnel, among other powers.
According to HHS, several changes are in store with the end of the PHE, an indication of the broad range of powers that existed under this declaration.
For instance, the national emergency enabled HHS to waive or loosen requirements for enrollment in Medicaid. Under these rules, Medicaid programs were required to keep people continuously enrolled until the end of the PHE.
According to the Kaiser Family Foundation:
“At the start of the pandemic, Congress enacted the Families First Coronavirus Response Act (FFCRA), which included a requirement that Medicaid programs keep people continuously enrolled through the end of the COVID-19 public health emergency (PHE), in exchange for enhanced federal funding.
“As part of the Consolidated Appropriations Act, 2023, signed into law on December 29, 2022, Congress delinked the continuous enrollment provision from the PHE, ending continuous enrollment on March 31, 2023.”
As a result, states could resume Medicaid disenrollments on April 1. It is estimated that between 5-14 million individuals will lose Medicaid coverage as a result.
According to HHS, “a combination of emergency authority waivers, regulations, and sub-regulatory guidance” has been used during the COVID-19 PHE “to ensure and expand access to care and to give health care providers the flexibilities needed to help keep people safe,” including providing expanded capacity that “is no longer necessary.”
In addition, coverage for COVID-19 tests will change: Access to free over-the-counter COVID-19 tests for Medicare beneficiaries will end. Private insurers will no longer be required to cover COVID-19 tests without cost sharing. State Medicaid programs, however, will provide COVID-19 tests without cost sharing until Sept. 30, 2024.
According to the HHS, “dependent on supply and resources, the USG [U.S. government] may continue to distribute free COVID-19 tests from the Strategic National Stockpile through the United States Postal Service, states, and other community partners.”
HHS also will no longer have the “express authority” to require labs to report the results of COVID-19 tests. This “may affect the reporting of negative test results and impact the ability to calculate percent positivity for COVID-19 tests in some jurisdictions.”
Hospital data reporting will continue through April 30, 2024, but “may be reduced from the current daily reporting to a lesser frequency.”
Under PREP Act, liability shield for COVID vaccines to continue through December 2024
Unlike the national emergency and the PHE, COVID-19-related emergency declarations issued under PREP Act will remain in force — and this directly affects the continued availability of and liability shield for COVID-19 vaccines.
The first COVID-19-related PREP Act declaration was issued March 17, 2020, but was made retroactive to Feb. 4, 2020. Ten amendments have followed, the most recent on Jan. 7, 2022.
The HHS secretary issues PREP Act declarations upon determining that “a disease or other health condition or other threat to health constitutes a public health emergency, or that there is a credible risk that the disease, condition, or threat may in the future constitute such an emergency.”
The secretary can recommend the manufacture, testing, development, distribution, administration or use of one or more “covered countermeasures,” which include products such as COVID-19 vaccines.
Moreover, the PREP Act declaration immunizes manufacturers, distributors
and others from any liability for injuries caused by a covered countermeasure, except in
cases of “willful misconduct.” These cases must follow narrowly prescribed procedural steps.
Barring proof of “willful misconduct,” anyone injured by a countermeasure covered under the PREP Act must seek redress through the Countermeasures Injury Compensation Program.
HHS states, “A PREP Act declaration is specifically for the purpose of providing immunity from liability, and is different from, and not dependent on, other emergency declarations.”
HHS further explains:
“Over the past three years, the PREP Act declaration has provided liability protection to manufacturers, distributors, and other organizations conducting countermeasure programs and providers administering COVID-19 countermeasures.
“This coverage includes liability protection for those entities engaged in manufacturing, distribution, or administration of COVID-19 countermeasures (such as tests, treatments, and vaccines) purchased by the Federal government for administration at pharmacies and other locations.
“All COVID-19 vaccines and treatments for which distribution is currently directed by the United States Government (USG) are covered by PREP Act protections and flexibilities.”
The HHS secretary has the power to terminate the PREP Act declaration, which otherwise has no expiration date. On April 14, HHS announced that PREP Act coverage will be extended to December 2024, for the administration of COVID-19 and seasonal influenza vaccines.
Specifically:
“PREP Act immunity from liability will be extended through December 2024 to pharmacists, pharmacy interns, and pharmacy technicians to administer COVID-19 and seasonal influenza vaccines (to those individuals three and over, consistent with other requirements), and COVID-19 tests, regardless of any USG agreement or emergency declaration.
“[Extended] coverage through December 2024 for Federal agreements. This includes all activities related to the provision of COVID-19 countermeasures that are 1) provided based on a Federal agreement (including the vaccines and treatments purchased and provided by the USG), or 2) directly conducted by the USG, including by Federal employees, contractors or volunteers.”
In other words, HHS said: “The amended PREP Act declaration will not have any immediate impact on COVID-19 vaccines, treatments, and tests currently distributed by the USG — either now or when the COVID-19 PHE ends on May 11.”
Conversely, PREP Act coverage will end for products no longer distributed under a USG agreement, including COVID-19 vaccination by “non-traditional providers” such as recently retired providers and students, and “COVID-19 vaccinations across state lines by licensed providers and pharmacists and pharmacy interns.”
According to HHS:
“No change to coverage for certain prescribing and dispensing of COVID-19 oral antivirals.
“The PREP Act will continue to offer liability immunity for pharmacists, pharmacy technicians, and pharmacy interns dispensing COVID-19 treatments, in accordance with a U.S. Food and Drug Administration (FDA) authorization, such as the oral antiviral treatments Paxlovid and Lagevrio.”
According to Flores, the PREP Act provides generous guarantees for COVID-19 vaccine manufacturers, such as Pfizer:
“The U.S. government expressly guaranteed that it would not distribute Pfizer vaccines unless Pfizer was covered by PREP or better, and the emergency’s ending generally affects areas such as relief money, insurance programs and shifts the development of vaccines and treatments away from the direct management of the federal government.”
According to the [url=https://www.cdc.gov/vaccines/covid-19/provider-enrollment.html#:~:text=*At this time%2C all COVID,until administered to the recipient]Centers for Disease Control and Prevention[/url] (CDC):
“At this time, all COVID-19 vaccine in the United States has been purchased by the U.S. government (USG) for administration exclusively by providers enrolled in the CDC COVID-19 Vaccination Program and remains U.S. government property until administered to the recipient.”
However, according to STAT, HHS will let some emergency flexibilities expire, “since vaccines and treatments will soon be available through the normal health care system instead of being bought by the government directly.”
STAT previously reported that the costs of COVID-19 vaccines “are also expected to skyrocket once the government stops buying them, with Pfizer saying it will charge as much as $130 per dose.”
Emergency Use Authorization to remain for COVID vaccines
The fourth emergency declaration during the COVID-19 pandemic came under the EUA provision of the Federal Food, Drug, and Cosmetic Act, 21 U.S. Code section 360bbb-3.
The first such declaration was issued Feb. 7, 2020, while the most recent was issued March 20, 2023.
The HHS secretary issues an EUA emergency declaration upon finding that circumstances justify the introduction of a product into interstate commerce because, among other reasons:
“There is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents.”
Simply put, this declaration allows the introduction of products that received EUA from the FDA, into interstate commerce.
This has been the case for all existing COVID-19 vaccines available in the U.S., including those from Pfizer-BioNTech, Moderna, Johnson & Johnson (Janssen) and Novavax.
The EUA emergency declaration can be terminated under the earlier of “(i) a determination by the Secretary, in consultation as appropriate with the Secretary of Homeland Security or the Secretary of Defense, that the circumstances … have ceased to exist; or (ii) a change in the approval status of the product such that the circumstances … have ceased to exist.”
In the March 20 amendment to the existing COVID-19 EUA authority, the previous language stating that “there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad” was amended to add “or a significant potential for a public health emergency.”
As reported by STAT, the end of the PHE “doesn’t have any bearing on emergency use authorizations for vaccines or treatments.”
The FDA on April 18 ended authorizations of the Moderna and Pfizer monovalent COVID-19 vaccines, recommending instead the drugmakers’ bivalent vaccines. While this change affects the status of the vaccines, it has no effect on the emergency declarations issued pursuant to the EUA statute.
FEMA determines when Stafford Act federal emergencies end
The fifth and final federal emergency applicable to COVID-19 is the declaration of emergency or disaster under section 501(b) of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S. Code section 5121.
Presidents can declare a national emergency under the Stafford Act upon determining that “federal assistance is needed to supplement state and local efforts and capabilities to save lives and to protect property and public health and safety, or to lessen or avert the threat of a catastrophe in any part of the United States.”
Such declarations, which can be issued nationally or for individual states, generally authorize various forms of individual and public assistance from the federal government and agencies such as FEMA, in states, tribes and communities that receive major or emergency disaster declarations.
Trump issued an emergency determination under this act on March 13, 2020, providing public assistance for various [url=https://www.fema.gov/disaster/coronavirus/disaster-declarations#:~:text=On March 13%2C 2020%2C President,emergency declaration for COVID%2D19]emergency protective measures[/url].
Such declarations do not expire — instead, FEMA can simply determine that the “incident period” has ended.
FEMA announced that the incident periods for all COVID-19-related declarations will end on May 11.
What about state-level COVID emergencies?
At one time, governors and state agencies in all 50 states had declared COVID-19-related emergencies.
Governors relied on the national emergency and PHE to enact various pandemic-related restrictions, such as lockdowns and church closures — although in some instances, courts have ruled that governors exceeded their powers.
According to Ballotpedia, state emergency declarations authorized governors to enact lockdown and stay-at-home orders, mask mandates and other restrictions on businesses and individuals.
Presently, four states — Connecticut, Illinois, Rhode Island and Texas — have active COVID-19 emergency orders in place:
- Connecticut Gov. Ned Lamont (D) extended his state’s COVID-19 emergency on Dec. 20, 2022, through June 28 or the end of the federal COVID-19 emergency.
- Illinois Gov. J.B. Pritzker (D) extended his state’s COVID-19 emergency on March 3, through May 11, coinciding with the end of the federal PHE.
- Rhode Island Gov. Daniel McKee (D) extended his state’s COVID-19 emergency on April 10, through May 5.
- Texas Gov. Greg Abbott (R) extended his state’s COVID-19 emergency on March 16. This declaration will remain in place “until the Legislature can enact laws this session to prohibit local governments from imposing restrictions like mask mandates and vaccine mandates,” noting that “local governments are divested of any lawful authority to subject Texans to mask mandates, vaccine mandates, or business-closure mandates.”
A Dec. 19, 2022, letter to Biden signed by 25 state governors called for the end of the national emergency and PHE by April.
The World Health Organization’s global COVID emergency
In parallel with the national and state-level emergency declarations in the U.S., the WHO’s own COVID-related emergency remains in effect. On Jan. 27, the WHO extended its COVID-19 public health emergency of international concern (PHEIC), acknowledging that “the COVID-19 pandemic is probably at a transition point.” The agency made the declaration on Jan. 30, 2020, and has renewed ever since.
At an April 18 press conference “on COVID-19 and other global health issues,” the WHO warned that the COVID-19 pandemic was still “volatile,” adding that “we don’t turn off the pandemic switch.”
The next meeting of the WHO’s COVID-19 emergency committee is in early May. This committee advises the WHO’s secretary-general, Tedros Adhanom Ghebreyesus, on the status of the PHEIC. Tedros has final say over whether to keep the PHEIC in place or rescind it.
The WHO and its member states continue to negotiate amendments to the International Health Regulations — under which a PHEIC can be declared — and/or the establishment of a new “pandemic treaty,” with further updates or a vote expected at the 76th WHO World Health Assembly, May 21-30.
Status of COVID-related federal court cases yet to be determined
A number of lawsuits and cases challenging various aspects of the COVID-19 response, from vaccine mandates to student loan forgiveness enacted under the aegis of the COVID-19 national emergency, remain pending before federal courts.
This has resulted in speculation that the cases may now be dismissed as moot.
Legal experts who spoke with The Defender took a more nuanced view, saying that it depends on the details of each individual case, including the right involved in the lawsuit and how the government entities in question responded to the end of the national emergency and PHE.
Lawsuits directly challenging mandates that are no longer in effect may or may not be ruled moot — for example, cases such as the U.S. Department of Justice’s appeal of a court decision rescinding the mask mandate on airplanes and public transportation.
In that appeal, the 11th Circuit on April 11, 2023, told the parties, “Given the national emergency has been terminated, the parties are DIRECTED to brief the issue of mootness.”
Attorney Brant Hadaway for the plaintiffs/appellees told the court:
“Because the Mask Order would only end upon termination of the HHS declaration of a public health emergency, see 86 Fed. Reg. at 8030, it is unclear at this point whether CDC will agree that the Mask Order has in fact been terminated. The undersigned awaits clarity on the Government’s position.”
Both parties moved to extend the deadline for fully responding.
An open question remains as to how the end of the national COVID-19 emergency may impact the Supreme Court in its pending ruling regarding two cases challenging Biden’s student loan forgiveness plan.
According to SCOTUS Blog, the Biden administration’s plan was formulated on the basis of the Higher Education Relief Opportunities for Students Act of 2001 Act, passed after the 9/11 attacks, that allows the U.S. Department of Education to “waive or modify” provisions of student loan programs in connection with a “national emergency.”
The White House argues that it retains the authority to waive student loan debt even past the end of the national emergency, because of the ongoing financial hardship borrowers face due to the pandemic. During oral arguments, certain justices — conservative and liberal — appeared to question this rationale.
Separately, a variety of educational and research institutions announced the end of their own emergency policies — many in alignment with the end of the national emergency and PHE. For instance:
- American University, Columbia University, Duke University, Georgetown University and New York University will end their vaccine mandates on May 11.
- The City University of New York will end its vaccine mandate effective May 23.
- Dartmouth College ended its vaccine mandate effective immediately on April 11.
- Fordham University will end its vaccine mandate effective May 15.
- Portland State University has lifted its vaccine mandate.
- Stanford University ended its vaccine requirement April 10.
- The State University of New York will end its vaccine mandate beginning with its summer session.
- Washington State University will end its vaccine mandate for students beginning with the summer 2023 session. It previously lifted its mandate for faculty and staff in October 2022, when the state’s COVID-19 emergency was lifted.
In turn, the Mayo Clinic “eased” its universal face mask requirement on April 10.
Foreigners traveling to the U.S. via airplane will also no longer face vaccine-related restrictions. In an emergency amendment issued by the Transportation Security Administration on April 11, an expiration date of May 11 was set for the rule requiring foreigners (non-citizens or legal residents) to be vaccinated in order to enter the U.S.
This rule has been used to bar entry to Serbian tennis star Novak Djokovic, who has not received a COVID-19 vaccine, not allowing him to compete in the U.S. Open as a result.
Changes are afoot in federal agencies as well. According to a March 29 Washington Post report, several members of the federal administration who were closely connected to the federal government’s COVID-19 response, including White House COVID-19 Response Coordinator Ashish Jha, M.D., MPH, are expected to leave the administration.
Jha recently helped announce “Project NextGen,” a new Biden administration initiative that will provide $5 billion to accelerate the development of new coronavirus vaccines and therapeutics, indicating that even with the end of several COVID-19-related emergencies, federal funding for vaccine development initiatives will continue.
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