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OpenTheBooks Investigation: Can America’s Declared Public Health Emergency Ever End? 6_Public_Health_Emergency3

January 28, 2022 11:52 AM

OpenTheBooks_Investigation

6_Public_Health_Emergency3

By Adam Andrzejewski

Two weeks ago, on January 14th, U.S. Health and Human Services Secretary Xavier Becerra declared the ninth straight “Public Health Emergency” because of the Covid-19 pandemic. It was expected.

While HHS declared the emergency, the agency also admitted to an average of 1,900 daily deaths – it was only slightly more than the 1,500 daily deaths that resulted from the common flu virus of 2017-2018.

Then, this week, Great Britain, Switzerland, Netherlands, and Denmark ditched most Covid mandates including testing, masking, and social distancing. These countries were declaring, not an emergency, but an end to their pandemic emergency response measures.

During this period, however, the Biden Administration moved aggressively in the opposite direction – enforcing a mandatory vaccine mandate of military members, federal employees, federal contractors, and America’s health care workers.

The Supreme Court slapped down the Biden’s vax mandate on private employers with 100 or more employees.

Biden’s Promise of Emergency 

Two days into the Biden Administration, on January 22, 2021, HHS told all 50 Governors to expect the “entirety of 2021” to be a public health emergency under federal law.

That pronouncement seemingly backtracked on a campaign-trail promise to “beat this virus” should Biden be elected.

Big Picture:

By law, a public health emergency (PHE) designation from the HHS Secretary allows certain emergency-based federal powers and authorities for 90 days, though the powers may be renewed or terminated early. (See 42 USC §247d). 

The Trump Administration’s HHS Secretary Alex Azar’s first COVID-related determination was made on January 31, 2020 and retroactively started on January 27, 2020. The 90-day PHE was extended four times in the Trump Administration. 

Azar, prior to becoming HHS Secretary, was an executive with Eli Lilly, a pharmaceutical company, and a board member with BIO, a pharmaceutical trade association.

Rather than wait for a 90-day evaluation like the Trump Administration, Biden’s HHS signaled to the governors that the entire year would be a federal public health emergency. If HHS opted to scrap the public health emergency designation, the governors would get a 60-day notice. 

The HHS spokesperson who responded to my comment request confirmed this

“The Covid-19 public health emergency is still in effect, and consistent with our commitment since the beginning of this Administration, HHS will provide states with 60 days’ notice prior to any possible termination or expiration in the future.”

The Details:

Governors got the HHS letter directly, and state and local health care groups were informed of the letter by their Washington-savvy associations and law firms. However, the letter was not noticed more broadly and went practically unreported in the media.

The Biden HHS, in the this-health-emergency-will-last-a-year letter, said:

“To assure you of our commitment to the ongoing response, we have determined that the PHE [Public Health Emergency] will likely remain in place for the entirety of 2021, and when a decision is made to terminate the declaration or let it expire, HHS will provide states with 60 days’ notice prior to termination.

“Predictability and stability are important given the foundation and flexibilities offered to states that are tied to the designation of the PHE.” 

They weren’t wrong on that last point. 

Much of the health care, treatment, and funds used for and because of the Covid-19 outbreak are tied to the federal public health emergency designation.

The Covid-19 tests, treatments, and vaccines are emergency use

Many of the treatments, policies, and programs created to fight Covid-19 are closely tied to the emergency use designation.

Every package of at-home tests from Abbott Laboratories, for example, says on the box that they are allowed “For use under Emergency Use Authorization only.” If the emergency designation were to end tomorrow, it appears Abbott’s ability to make new and sell existing tests would expire.

Likewise, every vial of Moderna and Johnson & Johnson/Janssen vaccine say, “For use under Emergency Use Authorization.”  That’s because Moderna and J&J/Janssen vaccines and boosters are approved for FDA use under emergency use authority. 

Pfizer’s brand-name vaccine Comirnaty, however, obtained FDA approval for those 16 and older in August, though the booster for that age group is authorized under an EUA and Pfizer’s vaccine for children 5-15 is also authorized under EUA. 

Responding to a comment request, a Pfizer spokesperson confirmed the details.

Monoclonal antibodies such as Regeneron, used by President Trump when he got sick with Covid-19 in 2020, are also under EUA, along with the recently approved Pfizer and Merck Covid treatment pills. Even convalescent plasma from recovered Covid-19 patients, used to treat others with the virus, is used under the FDA’s emergency use authority.

All treatments are legal under the law because of the declared state of Public Health Emergency (PHE). 

Emergency use authority is granted to HHS under section 564 of the Federal Food, Drug, and Cosmetic Act, as amended, which says that when the government is in a PHE, the U.S. Food and Drug Administration (FDA) can make declarations and emergency use authorizations for diagnostics, treatments, and vaccines. (See 21 USC §360bbb–3).

“… the Secretary may authorize the introduction into interstate commerce, during the effective period of a [PHE] declaration […] of a drug, device, or biological product intended for use in an actual or potential emergency (referred to in this section as an “emergency use”).”

Approximately $4.5 billion in federal Medicaid expenditures per 90-day extension?

On March 19, 2021, former democratic congressman and California Attorney General Xavier Becerra was sworn into office as President Biden’s HHS Secretary. 

The following month, Secretary Becerra renewed the Trump Administration’s last 90-day PHE declaration on April 15, 2021 (effective April 21). He did it again on July 19, 2021 (effective July 20), and then on October 15, 2021 (effective October 21). He thus fulfilled the Biden Administration’s first-week letter, designating a state of emergency through the entire 2021 year. 

Then, on January 14th, Secretary Becerra renewed the expiring 90-day emergency order, effective January 16, 2022 for another 90 days.

According to the Congressional Budget Office (CBO) one federal Medicaid funding provision tied to the renewal of the emergency declaration — a 6.2% FMAP increase— carried at least a $50 billion price tag over 33 months (January 1, 2020-September 30, 2022). 

Broken down, that means that each time the HHS Secretary extends the PHE for 90 days, federal taxpayers shell out at least $4.5 billion in additional Medicaid spending. This does not count increased federal Medicaid costs for Covid, which CBO noted in its 2020 estimate, was “likely to be substantial.” (See Section 6008.)

Conclusion

On Biden’s first full day in office, January 21, 2021, the number of new Covid-19 cases in the U.S. was 189,648, according to the CDC. 

On January 14, 2022, the day Secretary Becerra once again extended the emergency, the number of U.S new reported cases was 874,087, according to the CDC. 

Secretary Becerra’s latest PHE designation lists eight, 90-day renewals after HHS’s first January 2020 determination—two Administrations and nine emergency health declarations in all.

Will our state of Covid-19 emergency ever end?

Further Reading

Public Health Emergency:

Biden Administration’s Letter, dated January 22, 2021, notifying governors the PHE was expected to last all of 2021

Public Health Emergency Declarations

Coronavirus Disease 2019 (COVID-19) EUA – Archived Information, FDA 

Emergency Authorities Under the National Emergencies Act, Stafford Act, and Public Health Service Act, Updated July 14, 2020, CRS. 

“Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 A Notice by the Health and Human Services Department on 03/17/2020”, Federal Register

Preliminary Estimate of the Effects of H.R. 6201, the Families First Coronavirus Response Act,” which became Public Law 116-127, CBO

Public Health Service Act, Section 319, Public Health Emergencies Fact Sheet, Association of State and Territorial Health Officials

“HHS Renews COVID-19 Public Health Emergency Through July 19, 2021; Additional Renewals Are Expected,” May 4, 2021, JDsupra

“Medicaid’s Federal Medical Assistance Percentage (FMAP),” Updated July 29, 2020, CRS

CDC “COVID Data Tracker”

 

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