One year ago, the Center for Medicare & Medicaid Services (CMS) issued an interim final rule
requiring 15 types of health-care facilities that receive Medicare or
Medicaid funding to ensure that their more than 10 million employees
were vaccinated against Covid-19. This was one of multiple Biden
administration mandates covering, in addition to medical workers,
private employees at large firms (the OSHA mandate covering 84 million
workers), federal contractors (one-fifth of the national workforce), 3.5
million federal employees, and Head Start employees, contractors, and
volunteers. The administration designed these mandates to force American
workers to choose between vaccination or their jobs. Federal courts
have enjoined all of them except for the medical-worker one, which the
Supreme Court allowed to continue. The administration withdrew the OSHA rule for private employees after the Court found that it exceeded OSHA’s statutory authority to address workplace hazards.
Now a coalition of 22 states, led by Montana attorney general Austin
Knudsen, has made a convincing case for repealing the medical-worker
vaccine mandate. The states, relying on a section of the Administrative Procedure Act that gives “an interested person the right to petition for the issuance, amendment, or repeal of a rule,” have filed a petition
seeking repeal with the Department of Health and Human Services (HHS)
and CMS (the part of HHS with primary responsibility for overseeing the
Medicare program and the federal role in the Medicaid program).
Many of these states had previously challenged the rule as part of
two separate lawsuits—one led by Missouri and the other by Louisiana.
District courts in Missouri and Louisiana each found the rule defective
and preliminarily enjoined enforcement. The government applied for an
emergency stay of those injunctions, and the Supreme Court consolidated
the two separate cases. A 5–4 Court majority concluded
that the statute gave the HHS secretary authority “to promulgate, as a
condition of a facility’s participation in the programs, such
‘requirements as [he] finds necessary in the interest of the health and
safety of individuals who are furnished services in the institution.’”
That authority would include measures to prevent transmission of
communicable diseases and infections within those facilities.
The Court stayed the two district court injunctions, thereby allowing
enforcement of the mandate while litigation to resolve the cases moved
through the lower courts. That litigation continues in the district
courts. In doing so, the Court relied on a finding by the HHS secretary
that “a COVID–19 vaccine mandate will substantially reduce the
likelihood that healthcare workers will contract the virus and transmit
it to their patients.”
The new petition rehashes several legal arguments that, regardless of
their merits, were made to and rejected by the narrow Supreme Court
majority. But the petition is more effective in arguing that changed
scientific circumstances undermine the HHS secretary’s justification
that vaccinating staff protects patients. It claims that the medical
evidence supporting the mandate was weak when the rule was issued and
has become even less convincing as newer, more transmissible variants
have become the predominant circulating viruses.
The rationale for imposing the mandate was that vaccines would
protect medical workers from becoming infected and that, even if they
were infected, vaccines would make them less likely to transmit the
virus to residents and patients at medical facilities. But the initial
vaccine trials were primarily focused
on determining whether the vaccines protected against symptomatic
Covid-19 infection, not against all transmission. They did not account
for post-vaccination, mild, or asymptomatic infections, nor did they
study secondary transmission.
In addition, the trials were conducted before the advent of newer, more transmissible viruses. By August 2021, nearly all U.S. cases were the newer Delta variant, which was associated with diminished effectiveness of vaccines
against infection and illness, leading to increased numbers of
breakthrough infections in fully vaccinated people and onward
transmission to others.
Furthermore, it has long been apparent that protection against
infection, regardless of the variant, wanes with time after vaccination.
By six to 12 months post-vaccination, protection against infection is
half or less of the protection in the first one to two months.
The Delta variant remained prevalent in November 2021 when CMS issued
the vaccine mandate but was on the way to being supplanted by the far
more transmissible Omicron and its subvariants. By December, Omicron was
predominant and led to a rapid rise in daily case numbers in the U.S.,
even among the vaccinated. And the CDC had already acknowledged
over the summer of 2021 that “[a]nyone with Omicron infection,
regardless of vaccination status or whether or not they have symptoms,
can spread the virus to others.”
By the time the Supreme Court issued its January 2022 decision
allowing the vaccine mandate to be imposed, the vaccines had little or
no effectiveness in limiting Covid infection and onward transmission.
The government does not dispute the vaccines’ waning effectiveness.
In a September 2022 hearing before the full Fifth Circuit Court of
Appeals (sitting en banc) that dealt with the federal employee
mandate, the administration’s attorney said that when the mandate was
issued last year, vaccines were thought to be effective against Covid-19
transmission and would protect employees from getting infected. “The
fact is that the science has changed,” he conceded.
“There are new variants and that particular rationale is somewhat
eroded, but there are still significant rationales at play here in terms
of preventing serious illness for federal employees, which has a clear
nexus to the federal workplace in terms of productivity and efficiency.”
While protecting employees themselves from serious illness may or may
not suffice for the purposes of a federal employee mandate (the Fifth
Circuit has not ruled yet), it does not satisfy the statutory authority
cited by the Supreme Court in upholding the medical-worker mandate to
issue requirements “necessary in the interest of the health and safety
of individuals who are furnished services in the institution.”
While I would hope that medical workers get vaccinated to protect
themselves from serious Covid illness, it is now hard to justify forcing
them to do so in the name of patient protection. More effective
infection-control measures are now being utilized in medical facilities.
Continuing a vaccine mandate on pain of employment termination risks
worsening nationwide medical staffing shortages. Hospital systems across
the nation are experiencing shortages of physicians, nurses, technicians, respiratory therapists, and other hard-to-fill jobs. On average, 25 percent of the nation’s nursing homes report insufficient numbers
of nurses and aides, and in many states the percentage is higher.
Twenty-four states report that 30 percent or more of their facilities
lack adequate staffing, and the top four states (Alaska, Minnesota,
Maine, and Wyoming) exceed 60 percent.
Moreover, continuing a nationwide mandate ignores the fact that state
and local governments—which historically and under the Constitution’s
principles of federalism have been the locus of public health
decision-making—are better able to assess local conditions and determine
the most appropriate policies for limiting disease transmission in
their facilities. Similarly, private institutions can and have imposed
mitigation measures, including vaccine mandates, for their facilities
when conditions warranted them.
The time has come for HHS and the Biden administration to follow the
science and retract all vaccine mandates still being adjudicated in
various federal courts. The federal government’s legal authority to
impose any of them has always been dubious, and now there is no longer
any scientific or medical justification for such autocratic and
potentially counterproductive measures.
