Court filing
Brief - Scotus
Full text
Nos. 21A240 & 21A241
In the Supreme Court of the United States
JOSEPH R. BIDEN, JR., PRESIDENT OF THE UNITED
STATES OF AMERICA, ET AL.,
Applicants,
v.
STATE OF MISSOURI, ET AL.,
Respondents.
XAVIER BECERRA, SECRETARY OF HEALTH AND HUMAN
SERVICES, ET AL.,
Applicants,
v.
STATE OF LOUISIANA, ET AL.,
Respondents.
On Applications for Stays
MOTION OF FORMER SECRETARIES OF
HEALTH AND HUMAN SERVICES, FORMER
ADMINISTRATORS OF THE CENTERS FOR
MEDICARE AND MEDICAID SERVICES,
AND OTHER FORMER FEDERAL HEALTH
OFFICIALS FOR LEAVE TO FILE BRIEF AS
AMICI CURIAE AND BRIEF AS AMICI CURIAE
IN SUPPORT OF APPLICANTS
ANDREW J. PINCUS
Counsel of Record
Mayer Brown LLP
1999 K Street, NW
Washington, DC 20006
(202) 263-3000
apincus@mayerbrown.com
Counsel for Amici Curiae
i
MOTION OF FORMER SECRETARIES OF
HEALTH AND HUMAN SERVICES,
FORMER ADMINISTRATORS OF THE
CENTERS FOR MEDICARE AND MEDICAID
SERVICES, AND OTHER FORMER FEDERAL
HEALTH OFFICIALS FOR LEAVE TO FILE
BRIEF AS AMICI CURIAE
IN SUPPORT OF APPLICANTS
Donald M. Berwick, Sylvia M. Burwell, Margaret
A. Hamburg, Tom Scully, Kathleen Sebelius, Donna
Shalala, Andrew M. Slavitt, and Bruce C. Vladeck re-
spectfully move under Rule 37.2(b) of the Rules of this
Court for leave to file the attached brief as amici cu-
riae in support of Applicants Joseph R. Biden, Jr., et
al., and Xavier Becerra, et al.
Applicants took no position on the filing of this
brief. Respondents consented to the filing of a timely
amicus brief.
Amici are former Secretaries of Health and Hu-
man Services (HHS), former Administrators of the
Centers for Medicare and Medicaid Services (CMS),
and another former senior federal health official ap-
pointed by Presidents Clinton, George W. Bush, and
Obama. They are:
Donald M. Berwick, Administrator, Centers for
Medicare and Medicaid Services, 2010-2011
Sylvia M. Burwell, Secretary of Health and Hu-
man Services, 2014-2017
Margaret A. Hamburg, Commissioner, Food and
Drug Administration, 2009-2015
Tom Scully, Administrator, Centers for Medicare
and Medicaid Services, 2001-2004
ii
Kathleen Sebelius, Secretary of Health and Hu-
man Services, 2009-2014
Donna Shalala, Secretary of Health and Human
Services, 1993-2001
Andrew M. Slavitt, Acting Administrator, Centers
for Medicare and Medicaid Services, 2015-2017
Bruce C. Vladeck, Administrator, Health Care Fi-
nancing Administration (predecessor of Centers
for Medicare and Medicaid Services), 1993-1997.
These cases involve challenges to a rule promul-
gated by the Department of Health and Human Ser-
vices that requires certain employees of health care
providers that receive federal funds under the Medi-
care and Medicaid programs to be vaccinated against
COVID-19. See Medicare and Medicaid Programs:
Omnibus COVID-19 Health Care Staff Vaccination
(Rule), 86 Fed. Reg. 61555 (Nov. 5, 2021).
COVID-19 has produced the deadliest—and most
widespread—health crisis in our nation’s history.
This disease is particularly severe for older Amer-
icans and individuals who suffer from pre-existing
conditions. Those are the very groups most likely to
seek health care, and therefore interact with employ-
ees of health care providers such as hospitals and
nursing homes. The Rule seeks to protect the health
and safety of these individuals—who receive health
care under the Medicare and Medicaid programs—by
minimizing the risk that health care workers will con-
tract COVID-19 and infect their patients.
As a result of their lengthy combined experience—
totaling 32 years of government service—amici have
significant expertise regarding the issues presented in
these cases regarding the agencies’ statutory author-
iii
ity, the considerations that should be taken into ac-
count in promulgating rules pursuant to that author-
ity, and the health issues raised by COVID-19.
Because of the unprecedented nature of the
COVID-19 threat, the question before the Court—
whether the Rule should be permitted to take effect—
is extraordinarily important. Permitting the filing of
the attached brief would give the Court the benefit of
amici’s experience and expertise, and in addition pro-
vide information not brought to the Court’s attention
by Applicants.
For the foregoing reasons, amici respectfully re-
quest that they be allowed to file the attached brief as
amici curiae.
Respectfully submitted.
ANDREW J. PINCUS
Counsel of Record
Mayer Brown LLP
1999 K Street, NW
Washington, DC 20006
(202) 263-3000
apincus@mayerbrown.com
Counsel for Amici Curiae
DECEMBER 2021
iv
TABLE OF CONTENTS
Page
MOTION OF FORMER SECRETARIES OF
HEALTH AND HUMAN SERVICES,
FORMER ADMINISTRATORS OF THE
CENTERS FOR MEDICARE AND
MEDICAID SERVICES, AND OTHER
FORMER FEDERAL HEALTH OFFICIALS
FOR LEAVE TO FILE BRIEF AS AMICI
CURIAE IN SUPPORT OF APPLICANTS ............... i
TABLE OF AUTHORITIES.......................................vi
INTEREST OF THE AMICI CURIAE .......................1
SUMMARY OF ARGUMENT .....................................3
ARGUMENT ...............................................................5
The Court Should Allow The Health Care
Worker Vaccination Rule To Take Effect..............5
A. COVID-19 Continues To Pose Unique
Threats In The Health Care Context...............5
B. There Is a Broad Expert Consensus In
Favor Of Mandatory Vaccination For
Health Care Workers...................................... 12
C. The Vaccination Rule Is A Valid
Exercise Of The Department’s
Regulatory Authority. .................................... 14
1. The Department’s statutory
authority plainly encompasses
infection-control requirements,
including a vaccination requirement. ....... 14
2. The Secretary’s determination that a
vaccination requirement is necessary
to protect patients’ health and safety
is not arbitrary or capricious. ................... 18
v
TABLE OF CONTENTS—continued
Page
3. The Secretary’s decision to make the
rule immediately effective is
supported by good cause. .......................... 23
CONCLUSION .......................................................... 25
vi
TABLE OF AUTHORITIES
Page(s)
Cases
FCC v. Prometheus Radio Project,
141 S. Ct. 1150 (2021) ................................ 5, 19, 23
Florida v. Department of Health and
Human Services,
No. 21- 14098, 2021 WL 5768796
(11th Cir. Dec. 6, 2021) .................................. 18, 24
Jacobson v. Massachusetts,
197 U.S. 11 (1905) ................................................ 17
Klaassen v. Trustees of Ind. Univ.,
7 F.4th 592 (7th Cir. 2021) .................................. 17
Sorenson Communications Inc. v. FCC,
755 F.3d 702 (D.C. Cir. 2014) .............................. 23
South Dakota v. Dole,
483 U.S. 203 (1987) .............................................. 18
Statutes, Rules and Regulations
5 U.S.C. § 553(b) ........................................................ 23
42 U.S.C. § 1395 ........................................................ 18
42 U.S.C. § 1395d(a) .................................................. 16
42 U.S.C. § 1395i-3(d)(4)(B) ...................................... 16
42 U.S.C. § 1395x(e)(9) .......................................... 4, 16
vii
TABLE OF AUTHORITIES—continued
Page(s)
42 U.S.C. § 1395cc(b)(2) ............................................ 15
42 U.S.C. § 1395hh(b)(2)(C) ...................................... 23
42 U.S.C. § 1396a ...................................................... 15
42 U.S.C. § 1396d(h).................................................. 16
42 U.S.C. § 1396d(l)(1) .............................................. 16
42 U.S.C. § 1396d(o) .................................................. 16
42 U.S.C. § 1396r(d)(4)(B) ......................................... 16
Rule 37.6 ...................................................................... 1
42 C.F.R. § 416.51 ..................................................... 17
42 C.F.R. § 418.60 ..................................................... 17
42 C.F.R. § 482.42 ..................................................... 17
42 C.F.R. § 483.80 ..................................................... 17
42 C.F.R. § 484.70(b) ................................................. 17
42 C.F.R. § 485.640 ................................................... 17
42 C.F.R. § 485.725 ................................................... 17
42 C.F.R. § 494.30 ..................................................... 17
viii
TABLE OF AUTHORITIES—continued
Page(s)
Medicare and Medicaid Programs;
Omnibus COVID-19 Health Care
Staff Vaccination, 86 Fed. Reg.
61555 (Nov. 5, 2021) .................................... passim
Other Authorities
AARP, New AARP Analysis Shows
Nursing Homes Vaccination Rates
Still Well Short of Benchmark as
COVID Cases Trend Upwards (Aug.
12, 2021), https://press.aarp.-
org/2021-8-12-New-AARP-Analysis-
Shows-Nursing-Homes-Vaccination-
Rates-Still-Well-Short-of-
Benchmark-as-COVID-Cases-Trend-
Upwards ............................................................... 20
Bridget Balch, Amer. Ass’n of Medical
Colleges, Another pandemic holiday:
Can we gather safely this year? (Dec.
14, 2021),
https://www.aamc.org/news-
insights/another-pandemic-holiday-
can-we-gather-safely-year ..................................... 9
Julie Bosman, Amy Harmon and Albert
Sun, As U.S. Nears 800,000 Virus
Deaths, 1 of Every 100 Older
Americans Has Perished, N.Y. Times
(Dec. 13, 2021) ........................................................ 7
ix
TABLE OF AUTHORITIES—continued
Page(s)
Centers for Disease Control and
Prevention, COVID Data Tracker
(visited Dec. 19, 2021),
https://covid.cdc.gov/covid-data-
tracker/#datatracker-home .................................... 5
Centers for Disease Control and
Prevention, Daily Trends in Number
of COVID-19 Cases in The US
Reported to CDC (last accessed Dec.
21, 2021), https://covid.cdc.gov/covid-
data-tracker/#trends_dailycases ..................... 9, 10
Centers for Disease Control and
Prevention, Delta Variant: What We
Know About The Science (Aug. 26,
2021),
https://www.cdc.gov/coronavirus/201
9-ncov/variants/delta-variant.html ....................... 6
Centers for Disease Control and
Prevention, Influenza (Flu) -
Background and Epidemiology (Aug.
26, 2021),
https://www.cdc.gov/flu/professionals
/acip/background-epidemiology.htm...................... 9
x
TABLE OF AUTHORITIES—continued
Page(s)
Centers for Disease Control and
Prevention, People With Certain
Medical Conditions (Dec. 14, 2021),
https://www.cdc.-
gov/coronavirus/2019-ncov/need-
extra-precautions/people-with-
medical-conditions.html ........................................ 7
Centers for Disease Control and
Prevention, The Possibility of
COVID-19 after Vaccination:
Breakthrough Infections (Nov. 9,
2021),
https://www.cdc.gov/coronavirus/201
9-ncov/vaccines/effectiveness/why-
measure-effectiveness/breakthrough-
cases.html ............................................................... 8
Centers for Disease Control and
Prevention, Prevalent
Hospitalizations of Patients with
Confirmed COVID-19, United States
(last accessed Dec. 21, 2021),
https://covid.cdc.gov/covid-data-
tracker/#hospitalizations ..................................... 10
xi
TABLE OF AUTHORITIES—continued
Page(s)
Centers for Disease Control and
Prevention, Science Brief: COVID-19
Vaccines and Vaccination (Sept. 15,
2021),
https://www.cdc.gov/coronavirus/201
9-ncov/science/science-briefs/fully-
vaccinated-people.html .......................................... 8
Centers for Disease Control and
Prevention, Vaccination to Prevent
COVID-19 Outbreaks with Current
and Emergent Variants - United
States, 2021 (July 27, 2021),
https://emergency.cdc.gov/han/2021/
han00447.asp) ...................................................... 11
CMS, Fast Facts (Nov. 2021),
https://www.cms.gov/Research-
Statistics-Data-and-
Systems/Statistics-Trends-and-
Reports/CMS-Fast-Facts (Medicare
data for calendar year 2020;
Medicaid data for fiscal year 2020) ..................... 15
CMS, National Health Expenditure
Data, https://www.cms.gov/Research-
Statistics-Data-and-
Systems/Statistics-Trends-and-
Reports/NationalHealthExpendData/
NHE-Fact-Sheet ................................................... 15
xii
TABLE OF AUTHORITIES—continued
Page(s)
Clare L. Gordon, et al., Staff to staff
transmission as a driver of
healthcare worker infections with
COVID-19, 26 Infection, Disease &
Health 276, 277 (Nov. 2021) ................................ 11
Joint Statement in Support of COVID-
19 Vaccine Mandates for All Workers
in Health and Long-Term Care
(Sept. 2021),
https://www.acponline.org/acp_policy
/statements/joint_statement_covid_v
accine_mandate_2021.pdf .................................... 14
Michael Klompas, et al., The Case for
Mandating COVID-19 Vaccines for
Health Care Workers, Annuals of
Internal Medicine (July 13, 2021),
https://www.acpjournals.org/doi/10.7
326/M21-2366)........................................................ 6
xiii
TABLE OF AUTHORITIES—continued
Page(s)
Kanoko Matsuyama, Omicron Four
Times More Transmissible Than
Delta in New Study, Bloomberg (Dec.
8, 2021),
https://www.bloomberg.com/news/art
icles/2021-12-09/omicron-four-times-
more-transmissible-than-delta-in-
japan-study#:~:-
text=The%20omicron%20variant%20
of%20Covid,about%20-
the%20new%20strain's%20contagiou
sness ....................................................................... 6
Mayo Clinic, Fully vaccinated? Get the
Facts (Dec. 16, 2021),
https://www.mayoclinic.org/coronavir
us-covid-19/fully-vaccinated .................................. 8
Brian E. McGarry, et al.,
Correspondence - Nursing Home
Staff Vaccination and Covid-19
Outcomes, The New England
Journal of Medicine (Dec. 8, 2021),
https://www.nejm.org/doi/full/10.105
6/NEJMc2115674 ................................................. 11
xiv
TABLE OF AUTHORITIES—continued
Page(s)
Amy McKeever, COVID-19 surpasses
1918 flu as deadliest pandemic in
U.S. history, National Geographic
(Sept. 21, 2021),
https://www.nationalgeographic.com/
history/article/covid-19-is-now-the-
deadliest-pandemic-in-us-history .......................... 5
Multisociety statement on coronavirus
disease 2019 (COVID-19) vaccination
as a condition of employment for
healthcare personnel (July 13, 2021),
https://www.ncbi.nlm.nih.gov/pmc/ar
ticles/PMC8376851/ ....................................... 12, 13
Dave Muoio, Fierce Healthcare, How
many employees have hospitals lost
to vaccine mandates? Here are the
numbers so far (Nov. 23, 2021),
https://www.fiercehealthcare.com/ho
spitals/how-many-employees-have-
hospitals-lost-to-vaccine-mandates-
numbers-so-far ..................................................... 22
xv
TABLE OF AUTHORITIES—continued
Page(s)
Lionel Piroth, et al., Comparison of the
characteristics, morbidity, and
mortality of COVID-19 and seasonal
influenza: a nationwide, population-
based retrospective cohort study, The
Lancet (Dec. 17, 2020),
https://www.thelancet.com/journals/l
anres/article/PIIS2213-
2600(20)30527-0/fulltext ........................................ 6
Scott C. Roberts, et al., Correlation of
healthcare worker vaccination with
inpatient healthcare-associated
coronavirus disease 2019 (COVID-
19), Infection Control & Hospital
Epidemiology (Sept. 21, 2021),
https://doi.org/10.1017/ice.2021.414 .................... 11
Mitch Smith, Doctors and Nurses Are
‘Living in a Constant Crisis’ as Covid
Fills Hospitals, N.Y. Times (Dec. 17,
2021) ..................................................................... 10
Earl Strum, et al., Healthcare workers
benefit from second dose of COVID-
19 mRNA vaccine: Effects of partial
and full vaccination on sick leave
duration and symptoms (preprint,
posted Nov. 21, 2021),
https://doi.org/10.1101/2021.-
11.17.21266479 .................................................... 20
xvi
TABLE OF AUTHORITIES—continued
Page(s)
Yan Xie, et al., Comparative evaluation
of clinical manifestations and risk of
death in patients admitted to
hospital with covid-19 and seasonal
influenza: cohort study, BMJ (Dec.
15, 2020),
https://www.bmj.com/content/bmj/37
1/bmj.m4677.full.pdf .............................................. 6
BRIEF OF FORMER SECRETARIES OF
HEALTH AND HUMAN SERVICES,
FORMER ADMINISTRATORS OF THE
CENTERS FOR MEDICARE AND MEDICAID
SERVICES, AND OTHE FORMER FEDERAL
HEALTH OFFICIALS AS AMICI CURIAE IN
SUPPORT OF APPLICANTS
INTEREST OF THE AMICI CURIAE1
Amici curiae are former Secretaries of Health and
Human Services (HHS), former Administrators of the
Centers for Medicare and Medicaid Services (CMS),
and another senior former federal health official ap-
pointed by Presidents Clinton, George W. Bush, and
Obama. They are:
Donald M. Berwick, Administrator, Centers for
Medicare and Medicaid Services, 2010-2011
Sylvia M. Burwell, Secretary of Health and Hu-
man Services, 2014-2017
Margaret A. Hamburg, Commissioner, Food and
Drug Administration, 2009-2015
Tom Scully, Administrator, Centers for Medicare
and Medicaid Services, 2001-2004
Kathleen Sebelius, Secretary of Health and Hu-
man Services, 2009-2014
1 Pursuant to Rule 37.6, amici affirm that no counsel for a party
authored this brief in whole or in part and that no person other
than amici and their counsel made a monetary contribution to
its preparation or submission. Counsel of record for all parties
received notice of amici’s intention to file this brief more than 10
days prior to the due date for respondents’ brief. Applicants take
no position on the filing of this brief. Respondents consented to a
timely-filed amicus brief.
2
Donna Shalala, Secretary of Health and Human
Services, 1993-2001
Andrew M. Slavitt, Acting Administrator, Centers
for Medicare and Medicaid Services, 2015-2017
Bruce C. Vladeck, Administrator, Health Care Fi-
nancing Administration (predecessor of Centers
for Medicare and Medicaid Services), 1993-1997.
This case involves a challenge to a rule issued by
the Centers for Medicare and Medicaid Services—a
component of the Department of Health and Human
Services. As a result of their lengthy combined expe-
rience leading these and other federal health agen-
cies—totaling 32 years of government service—amici
have significant expertise in the issues presented re-
garding the agencies’ statutory authority, the consid-
erations that should be taken into account in promul-
gating rules pursuant to that authority, and the
health issues raised by COVID-19. They file this brief
to assist the Court in its consideration of these ex-
tremely important questions by explaining why the
rule at issue in these cases is a lawful and reasonable
exercise of the Department’s authority.
3
SUMMARY OF ARGUMENT
COVID-19 has produced the deadliest—and most
widespread—health crisis in our nation’s history. Un-
fortunately, as recent reports document, that crisis is
not over.
A significant percentage of Americans remain un-
vaccinated, and unvaccinated individuals face a
greater risk of infection and a greater chance of seri-
ous illness or death—and also have been found more
likely to transmit the disease to others. Cold weather
in many parts of the country, combined with holiday
travel and gatherings, increase the risk of virus trans-
mission. And the new Omicron variant’s very substan-
tial increased transmissibility, together with uncer-
tainty about the severity of infections that result, com-
pounds the problem.
This disease is particularly severe for older Amer-
icans and individuals who suffer from pre-existing
conditions. Those are the very groups most likely to
seek health care, and therefore interact with employ-
ees of health care providers such as hospitals and
nursing homes.
For these reasons, it is critically important to min-
imize the risk that health care workers will contract
COVID-19.
There is a consensus of medical experts that the
best way to accomplish this goal is to require health
care workers to be vaccinated. That is the recommen-
dation of the Centers for Disease Control and Preven-
tion and it is the position adopted by 60 organizations
that together represent virtually the entire health
care profession in the United States.
4
Multiple studies have found that transmission of
COVID-19 from health care workers to patients and
to fellow workers is more likely when workers are not
vaccinated than when they are vaccinated. In addi-
tion, vaccinated workers are less likely to become in-
fected and, if they do, suffer shorter and less severe
illnesses—reducing absences and therefore increasing
the availability of health care services.
Against this background, the Secretary acted law-
fully and reasonably in adopting the rule requiring
vaccination of health care workers at facilities that re-
ceive Medicare and Medicaid funds. See Medicare and
Medicaid Programs; Omnibus COVID-19 Health Care
Staff Vaccination (Rule), 86 Fed. Reg. 61555 (Nov. 5,
2021).
To begin with, the governing statutes expressly
authorize the Secretary to impose conditions on recip-
ients of Medicare funds that he “finds necessary in the
interest of the health and safety of” patients. E.g., 42
U.S.C. § 1395x(e)(9). And the Secretary has similar
statutory authority under the Medicaid law. HHS has
long exercised that authority to require health care
providers to take actions to reduce the risk of patient
infection—and the broad, unrestricted statutory text
easily encompasses a vaccination requirement.
The Secretary’s decision to require vaccination to
address COVID-19’s unprecedented threat rests on an
entirely reasonable assessment of the relevant consid-
erations that is neither arbitrary nor capricious. He
also carefully considered possible alternatives and
particularly assessed the risk that a vaccination re-
quirement could produce staff shortages. Finally, the
Secretary concluded that good cause permitted the
rule to take effect without prior notice and comment.
5
These determinations, which rest on the assess-
ment of scientific evidence and balancing of policy con-
siderations squarely within the Secretary’s expertise,
are well within the “zone of reasonableness” permitted
for agency action. Because the Secretary “reasonably
considered the relevant issues and reasonably ex-
plained the decision,” FCC v. Prometheus Radio Pro-
ject, 141 S. Ct. 1150, 1158 (2021), the Court should al-
low the rule to take effect.
ARGUMENT
The Court Should Allow The Health Care
Worker Vaccination Rule To Take Effect.
A. COVID-19 Continues To Pose Unique
Threats In The Health Care Context.
COVID-19 is, by far, the deadliest disease in
American history—with more than 802,000 deaths in
our country, compared to 675,000 Americans killed by
the 1918 flu.2 That extraordinary death toll results
from multiple factors.
First, the virus is highly contagious—and the
newer SARS-CoV-2 variants are increasingly conta-
gious. For example, a person infected with the original
variant would on average infect two additional people,
but someone infected with the Delta variant will infect
2 Centers for Disease Control and Prevention, COVID Data
Tracker (visited Dec. 19, 2021), https://covid.cdc.gov/covid-data-
tracker/#datatracker-home; Amy McKeever, COVID-19 sur-
passes 1918 flu as deadliest pandemic in U.S. history, National
Geographic (Sept. 21, 2021), https://www.nationalgeo-
graphic.com/history/article/covid-19-is-now-the-deadliest-pan-
demic-in-us-history.
6
an average of five additional people.3 Early reports in-
dicate that that the new Omicron variant is dramati-
cally more transmissible than Delta.4
Second, the adverse health effects resulting from
a SARS-CoV-2 infection, and the length of the illness,
are much more severe than for other viruses, such as
the flu.5
Third, older Americans and individuals with com-
promised immune systems are especially vulnerable
to the disease. Thus, “[s]eventy-five percent of people
3 Centers for Disease Control and Prevention, Delta Variant:
What We Know About The Science (Aug. 26, 2021),
https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-vari-
ant.html.
4 Kanoko Matsuyama, Omicron Four Times More Transmissible
Than Delta in New Study, Bloomberg (Dec. 8, 2021),
https://www.bloomberg.com/news/articles/2021-12-09/omicron-
four-times-more-transmissible-than-delta-in-japan-study#:~:-
text=The%20omicron%20variant%20of%20Covid,about%20-
the%20new%20strain's%20contagiousness (“The omicron vari-
ant of Covid-19 is 4.2 times more transmissible in its early stage
than delta, according to a study by a Japanese scientist who ad-
vises the country’s health ministry.”).
5 COVID-19 “is resulting in much higher morbidity and mortality
than seasonal flu.” Rule, 86 Fed. Reg. at 61569 (citing Lionel
Piroth, et al., Comparison of the characteristics, morbidity, and
mortality of COVID–19 and seasonal influenza: a nationwide,
population-based retrospective cohort study, The Lancet (Dec. 17,
2020), https://www.thelancet.com/journals/lanres/arti-
cle/PIIS2213-2600(20)30527-0/fulltext; Yan Xie, et al., Compara-
tive evaluation of clinical manifestations and risk of death in pa-
tients admitted to hospital with covid–19 and seasonal influenza:
cohort study, BMJ (Dec. 15, 2020), https://www.bmj.com/con-
tent/bmj/371/bmj.m4677.full.pdf; Michael Klompas, et al., The
Case for Mandating COVID–19 Vaccines for Health Care Work-
ers, Annuals of Internal Medicine (July 13, 2021),
https://www.acpjournals.org/doi/10.7326/M21-2366).
7
who have died of the virus in the United States — or
about 600,000 of the nearly 800,000 who have per-
ished so far—have been 65 or older. One in 100 older
Americans has died from the virus. For people
younger than 65, that ratio is closer to 1 in 1,400.”6
And people with nineteen different pre-existing medi-
cal conditions “are more likely to get severely ill from
COVID-19”—which could require hospitalization, in-
tensive care, or a ventilator, and could lead to death.7
Fourth, a significant percentage of Americans re-
main unvaccinated, and unvaccinated individuals
face a greater risk of infection, and a greater chance
6 Julie Bosman, Amy Harmon and Albert Sun, As U.S. Nears
800,000 Virus Deaths, 1 of Every 100 Older Americans Has Per-
ished, N.Y. Times (Dec. 13, 2021), https://www.ny-
times.com/2021/12/13/us/covid-deaths-elderly-americans.html?.
See also Rule, 86 Fed. Reg. at 61566 (citing statistics demonstrat-
ing that “[a]ge remains a strong risk factor for severe COVID-19
outcomes”).
7 Centers for Disease Control and Prevention, People With Cer-
tain Medical Conditions (Dec. 14, 2021), https://www.cdc.-
gov/coronavirus/2019-ncov/need-extra-precautions/people-with-
medical-conditions.html. These medical conditions are: cancer,
chronic kidney disease, chronic liver disease, chronic lung dis-
eases, dementia or other neurological conditions, diabetes (type
1 or type 2), Down syndrome, heart conditions, HIV infections,
weakened immune system, mental health conditions, overweight
and obesity, pregnancy, sickle cell disease or thalassemia, smok-
ing (current or former), organ or blood stem cell transplant,
stroke or cerebrovascular disease, substance use disorder (such
as alcohol, opioid, or cocaine use disorder), and tuberculosis.
8
of serious illness.8 Unvaccinated individuals who be-
come infected also have been found to be more likely
to transmit the disease to others.9
The coming months will be a challenging time for
our country. Cold weather in many parts of the nation
means that people are likely to spend more time in-
8 The CDC has determined that “[a]vailable evidence suggests
the currently approved or authorized COVID-19 vaccines are
highly effective against hospitalization and death for a variety of
strains”—and cites numerous studies. Centers for Disease Con-
trol and Prevention, Science Brief: COVID-19 Vaccines and Vac-
cination (Sept. 15, 2021), https://www.cdc.gov/coronavirus/2019-
ncov/science/science-briefs/fully-vaccinated-people.html. Vac-
cinated individuals can suffer “breakthrough” infections, but
“the risk of infection remains much higher for vaccinated than
unvaccinated people”; “[f]ully vaccinated people with a vaccine
breakthrough infection are less likely to develop serious illness
than those who are unvaccinated”; and “[e]ven when fully vac-
cinated people develop symptoms, they tend to be less severe
symptoms than in unvaccinated people. This means they are
much less likely to be hospitalized or die than people who are not
vaccinated.” Centers for Disease Control and Prevention, The
Possibility of COVID-19 after Vaccination: Breakthrough Infec-
tions (Nov. 9, 2021), https://www.cdc.gov/coronavirus/2019-
ncov/vaccines/effectiveness/why-measure-effectiveness/break-
through-cases.html.
9 Vaccinated people are much less likely to become infected. And,
as the CDC has explained, vaccinated individuals who become
infected “have the potential to spread the virus to others, alt-
hough at much lower rates than unvaccinated people.” Science
Brief: COVID-19 Vaccines and Vaccination, supra n. 8. See also
Mayo Clinic, Fully vaccinated? Get the Facts (Dec. 16, 2021),
https://www.mayoclinic.org/coronavirus-covid-19/fully-vac-
cinated (“[p]eople with vaccine breakthrough infections may
spread COVID-19 to others. However, it appears that vaccinated
people spread COVID-19 for a shorter period than do unvac-
cinated people”).
9
doors, which increases the risk of virus transmis-
sion.10 Large gatherings and travel—both welcome
features of the holiday season—also significantly in-
crease transmission risk.11 And these problems are
compounded by recent demonstrations of the Omicron
variant’s very substantial increased transmissibility
and uncertainty about the severity of infections that
result.
The number of new infections in recent weeks has
already increased dramatically—a ten-fold increase
compared to six months ago.12 Even the short-term in-
crease is significant: more than 55% since November
10 “Respiratory virus infections typically circulate more fre-
quently during the winter months, with peaks in pneumonia and
influenza deaths typically during winter months” and “the U.S.
experienced a large COVID–19 wave in the winter of 2020.” Rule,
86 Fed. Reg. at 61584; see also Centers for Disease Control and
Prevention, Influenza (Flu) – Background and Epidemiology
(Aug. 26, 2021), https://www.cdc.gov/flu/professionals/acip/back-
ground-epidemiology.htm (“[p]eak activity most commonly oc-
curs during the winter”).
11 Bridget Balch, Amer. Ass’n of Medical Colleges, Another pan-
demic holiday: Can we gather safely this year? (Dec. 14, 2021),
https://www.aamc.org/news-insights/another-pandemic-holiday-
can-we-gather-safely-year (discussing risks posed by travel and
gatherings).
12 The seven-day average of the number of infections was 11,812
on June 17, 2021, and 128,142 on December 17, 2021. Centers
for Disease Control and Prevention, Daily Trends in Number of
COVID-19 Cases in The US Reported to CDC (last accessed Dec.
21, 2021), https://covid.cdc.gov/covid-data-tracker/#trends_dai-
lycases.
10
2.13 Hospitalizations due to COVID have also in-
creased dramatically.14
These realities have significant consequences for
the nation’s health care system.
Health care workers are very likely to come into
contact with older Americans and those with preexist-
ing conditions. Nursing home residents all fall into at
least one of those categories, and often both. And in-
dividuals seeking treatment at hospitals and other
health care centers are disproportionately older and
sicker, and also more likely to suffer from pre-existing
conditions.15
Multiple studies have found that transmission of
COVID-19 from health care workers to patients is
more likely when workers are not vaccinated than
when they are vaccinated.16
13 Ibid. (70,779 on November 2 and 128,142 on December 17).
14 The seven-day average of the number of hospitalized patients
was 43,260 on November 17, 2021, and 61,008 on December 17,
2021—an increase of 20% in just one month. Centers for Disease
Control and Prevention, Prevalent Hospitalizations of Patients
with Confirmed COVID-19, United States (last accessed Dec. 21,
2021), https://covid.cdc.gov/covid-data-tracker/#hospitalizations;
see also Mitch Smith, Doctors and Nurses Are ‘Living in a Con-
stant Crisis’ as Covid Fills Hospitals, N.Y. Times (Dec. 17, 2021)
(“[t]he highly contagious Omicron variant arrives in the United
States at a moment when there is little capacity left in hospitals,
especially in the Midwest and Northeast, where case rates are
the highest”).
15 Rule, 86 Fed. Reg. at 61568 (explaining why “individuals seek-
ing health care services are more likely to fall into the high-risk
category”).
16 One study found “that case rates among [nursing home] facility
residents are higher in facilities with lower vaccination coverage
11
Also, health care workers spend considerable time
in close proximity to one another—both when per-
forming their duties and when in rest areas. Staff-to-
staff transmission has been identified as a significant
cause of COVID-19 infection.17 In addition to the
threat to health care workers who become infected,
among staff”—residents in “facilities in which vaccination cover-
age of staff is 75 percent or lower experience higher rates of pre-
ventable COVID–19.” Rule, 86 Fed. Reg. at 61558 (citing Centers
for Disease Control and Prevention, Vaccination to Prevent
COVID-19 Outbreaks with Current and Emergent Variants —
United States, 2021 (July 27, 2021), https://emer-
gency.cdc.gov/han/2021/han00447.asp). Another study, at Yale
New Haven Hospital, found that health care units with more
than one COVID-19 case “had lower staff vaccination rates.”
Ibid. (citing Scott C. Roberts, et al., Correlation of healthcare
worker vaccination with inpatient healthcare-associated corona-
virus disease 2019 (COVID–19), Infection Control & Hospital Ep-
idemiology (Sept. 21, 2021), https://doi.org/10.1017/ice.2021.414).
The Secretary discussed a number of additional studies. 86 Fed.
Reg. at 61558 & nn. 39-41 & 43. And more recent studies reach
the same conclusion. For example, an analysis of nursing home
data found a greater rate of patient infections in facilities with
low staff vaccination rates, compared to infections in counties
with higher vaccination rates. Estimates based on the model
“suggest that if all the nursing homes in our sample had been in
the highest quartile of staff vaccination coverage (82.7% on aver-
age), 4775 cases among residents (29% of the total during the
study window), 7501 cases among staff (29% of the total), and
703 Covid-19–related deaths among residents (48% of the total)
could possibly have been prevented.” Brian E. McGarry, et al.,
Correspondence – Nursing Home Staff Vaccination and Covid-19
Outcomes, The New England Journal of Medicine (Dec. 8, 2021),
https://www.nejm.org/doi/full/10.1056/NEJMc2115674.
17 Clare L. Gordon, et al., Staff to staff transmission as a driver
of healthcare worker infections with COVID-19, 26 Infection, Dis-
ease & Health 276, 277 (Nov. 2021) (79% of health care worker
infections acquired at hospital found to result from staff-to-staff
transmission).
12
transmission among health care workers increases
the risk to patients, and also requires all exposed in-
dividuals to quarantine—reducing available staff at a
time when health care providers are already stretched
to, and often beyond, their capacity to serve patients
due to the increase in COVID-19 cases.
For these reasons, it is critically important to min-
imize to the greatest extent possible the risk that
health care workers will contract COVID-19.
B. There Is a Broad Expert Consensus In
Favor Of Mandatory Vaccination For
Health Care Workers.
The strong consensus view of expert medical or-
ganizations is that best way to protect patients, health
care workers, and the nation’s health care system is
for health care workers to be vaccinated against
COVID-19.
Seven organizations representing epidemiologists
and others expert in infectious diseases stated in July
2021 that “vaccination should be a condition of em-
ployment for all healthcare personnel in facilities in
the United States” except for those with medical con-
traindications and “and other exemptions as specified
by federal or state law.”18 They identified three “ben-
efits of a fully vaccinated workforce”—“(1) reducing
18 Multisociety statement on coronavirus disease 2019 (COVID-
19) vaccination as a condition of employment for healthcare per-
sonnel (July 13, 2021), https://www.ncbi.nlm.nih.gov/pmc/arti-
cles/PMC8376851/. This statement was issued by the Society for
Healthcare Epidemiology of America, the Society for Post-Acute
and Long-Term Care Medicine, the Association for Professionals
in Epidemiology and Infection Control, the HIV Medicine Asso-
ciation, the Infectious Diseases Society of America, the Pediatric
13
the risk of transmission within healthcare facilities
among [healthcare personnel] and patients, from the
community to healthcare facilities, and from
healthcare facilities to the community; (2) maintain-
ing a healthy workforce and supporting [healthcare
personnel] wellness; and (3) maintaining the trust-
worthiness of [healthcare personnel] and healthcare
institutions.”19
The organizations observed that “[h]istorically,
the most effective strategies for managing viral ill-
nesses (eg, measles, rubella, and influenza) have been
by vaccination.”20 But they concluded that “[p]rior ex-
perience and current information suggest that a suffi-
cient vaccination rate is unlikely to be achieved with-
out making COVID-19 vaccination a condition of em-
ployment.”21 They explained that “[t]he experience to
date with voluntary influenza vaccination, as opposed
to influenza vaccination as a condition of employment,
suggests that without requiring COVID-19 vaccina-
tion, target coverage,” which requires greater-than-
90% coverage, “will rarely be achieved”—because
“[c]ompliance among those who were required by their
employer to receive the vaccination was 94.4%, com-
pared to 69.6% among those without vaccination as a
condition of employment.”22
An additional 53 organizations—that together
represent essentially the entire health care profession
Infectious Diseases Society, and the Society of Infectious Dis-
eases Pharmacists.
19 Id. at 4.
20 Id. at 2.
21 Id. at 1.
22 Id. at 5.
14
in the United States—have reached the same conclu-
sion. They “advocate that all health care and long-
term care employers require their workers to receive
the COVID-19 vaccine. This is the logical fulfillment
of the ethical commitment of all health care workers
to put patients as well as residents of long-term care
facilities first and take all steps necessary to ensure
their health and well-being.”23
C. The Vaccination Rule Is A Valid Exercise
Of The Department’s Regulatory Author-
ity.
The rule falls within HHS’s statutory authority to
establish conditions for health care providers that re-
ceive Medicare and Medicaid funds; the Secretary’s
determination is eminently reasonable; and the Sec-
retary properly made the rule effective immediately.
1. The Department’s statutory authority
plainly encompasses infection-control re-
quirements, including a vaccination re-
quirement.
Medicare and Medicaid are huge federal pro-
grams. The government’s expenditures in calendar
23 Joint Statement in Support of COVID-19 Vaccine Mandates for
All Workers in Health and Long-Term Care (Sept. 2021),
https://www.acponline.org/acp_policy/statements/joint_state-
ment_covid_vaccine_mandate_2021.pdf.
The statement was joined by the American Medical Associa-
tion, American College of Surgeons, American College of Physi-
cians, National Medical Association, and many other physician
specialty societies. Other signing organizations include the
American Nursing Association and a number of other organiza-
tions representing nurses; and organizations representing phar-
macists and other medical professionals.
15
year 2020 totaled nearly $1.2 trillion.24 Medicare pro-
vides health care for 62.8 million Americans 65 or
older and certain younger disabled individuals; Medi-
caid covers 76.5 million low-income Americans, in-
cluding many who are disabled or elderly.25
Given the very large number of Americans whose
health is dependent on these programs (over 40% of
the country), it is not surprising that Congress has
conferred upon the Department of Health and Human
Services broad authority to impose conditions on the
recipients of this enormous amount of federal funds—
to ensure that the government’s money is properly uti-
lized and that the beneficiaries of these important pro-
grams are properly protected. That authority plainly
includes the power to impose requirements to protect
patients against infection, such as the vaccination
rule at issue in this case.
Providers of health care services are eligible for
payment under the Medicare and Medicaid statutes
only if they meet the conditions for participation in
those programs. 42 U.S.C. § 1395cc(b)(2); 42 U.S.C. §
1396a. The statutes expressly authorize the Secretary
to impose conditions to protect the health and safety
of patients receiving services paid for by those pro-
grams.
24 CMS, National Health Expenditure Data,
https://www.cms.gov/Research-Statistics-Data-and-Sys-
tems/Statistics-Trends-and-Reports/NationalHealthEx-
pendData/NHE-Fact-Sheet.
25 CMS, Fast Facts (Nov. 2021), https://www.cms.gov/Research-
Statistics-Data-and-Systems/Statistics-Trends-and-Re-
ports/CMS-Fast-Facts (Medicare data for calendar year 2020;
Medicaid data for fiscal year 2020).
16
Thus, the Medicare law authorizes payments for
“hospital services,” 42 U.S.C. § 1395d(a), and imposes
a number of requirements in defining the “hospital”
that is eligible to receive such payments, see id. §
1395x(e). One such requirement is that the hospital
must “meet such * * * requirements as the Secretary
finds necessary in the interest of the health and safety
of individuals who are furnished services in the insti-
tution.” Id. § 1395x(e)(9).
Similar authority applies to the other categories
of health care providers that receive payments under
Medicare. See, e.g., 42 U.S.C. § 1395i-3(d)(4)(B) (“[a]
skilled nursing facility must meet such other require-
ments relating to the health, safety, and well-being of
residents * * * as the Secretary may find necessary”);
id. § 1395k(a)(2)(F)(i) (ambulatory surgical center
must “meet[] health, safety, and other standards spec-
ified by the Secretary in regulations”); id. §
1395x(p)(4)(A)(v) (outpatient physical therapy ser-
vices); id. § 1395x(aa)(2)(K) (rural health clinics); id. §
1395x(cc)(2)(J) (comprehensive outpatient rehabilita-
tion facilities); id. § 1395x(dd)(2)(G) (hospice facili-
ties).
And the government has similar statutory author-
ity under the Medicaid law. 42 U.S.C. § 1396r(d)(4)(B)
(requiring nursing homes to “meet such other require-
ments relating to the health and safety of residents or
relating to the physical facilities thereof as the Secre-
tary may find necessary”); see also, e.g., 42 U.S.C. §§
1396d(h), 1396d(l)(1), 1396d(o) (incorporating Medi-
care standards for various categories of health care
providers).
The agency has used this authority to require
health care providers to take a variety of actions to
address and reduce the risk of patient infection. See,
17
e.g., 42 C.F.R. § 483.80 (requiring long term care facil-
ities to maintain an “infection prevention and control
program” to “help prevent the development and trans-
mission of communicable diseases and infections” and
specifying particular standards to prevent transmis-
sion of viruses); 42 C.F.R. § 482.42 (specifying require-
ments for “active hospital-wide programs for the sur-
veillance, prevention, and control of [healthcare-asso-
ciated infections] and other infectious diseases”); 42
C.F.R. § 485.640 (same for critical access hospitals);
42 C.F.R. § 484.70(b) (same for home health agencies);
42 C.F.R. § 416.51 (same for ambulatory surgical ser-
vices); 42 C.F.R. § 418.60 (same for hospice care); 42
C.F.R. § 494.30 (same for end-stage renal disease fa-
cilities); 42 C.F.R. § 485.725 (same for outpatient
physical therapy and speech-language pathology ser-
vices).
The Department has not previously imposed a
vaccination requirement, but the broad statutory
text—authorizing requirements the Secretary “finds
necessary in the interest of the health and safety” of
patients—plainly encompasses such a requirement.
Certainly there is no basis for reading that unquali-
fied language to exclude a vaccination requirement.
See also Jacobson v. Massachusetts, 197 U.S. 11, 28
(1905) (holding that vaccination requirement falls
within a State’s police power “to protect the public
health and secure the public safety”).
Indeed, “vaccination requirements, like other pub-
lic-health measures, have been common in this na-
tion.” Klaassen v. Trustees of Ind. Univ., 7 F.4th 592,
593 (7th Cir. 2021). Congress’s expansive grant of
“health and safety” authority to protect patients re-
ceiving care under the Medicare and Medicaid pro-
grams cannot reasonably be read to prevent the
18
agency from adopting a measure that States have
found necessary to protect the health and safety of
their citizens.
Finally, 42 U.S.C. § 1395, which bars federal “su-
pervision or control over the practice of medicine or
the manner in which medical services are provided,”
does not bar the imposition of a vaccination require-
ment—any more than it bars the infection control
measures required under long-established CMS regu-
lations. The vaccination regulation says nothing about
how medical services are provided to patients or how
doctors and nurses practice medicine. Accord, Florida
v. Department of Health and Human Services, No. 21-
14098, 2021 WL 5768796, at *12 (11th Cir. Dec. 6,
2021).26
2. The Secretary’s determination that a vac-
cination requirement is necessary to pro-
tect patients’ health and safety is not arbi-
trary or capricious.
The parties challenging the rule also argue that it
is arbitrary and capricious. But this Court has made
26 The Missouri district court stated (21A240 App. 9a) that clear
congressional authorization is required because the rule inter-
feres with traditional state authority. The statutory text here is
clear; but that requirement does not apply because the rule
simply sets the terms for the use of federal funds. “Congress may
attach conditions on the receipt of federal funds, and has repeat-
edly employed the power ‘to further broad policy objectives by
conditioning receipt of federal moneys upon compliance by the
recipient with federal statutory and administrative directives.’”
South Dakota v. Dole, 483 U.S. 203, 206 (1987) (citation omitted)
(upholding condition on State’s use of federal funds). There can
be no dispute that the condition here relates to a federal policy
objective—protection of patient health and safety—that is tied
directly to the purpose of the federal programs.
19
clear that judicial review under this standard is “def-
erential”—“a court may not substitute its own policy
judgment for that of the agency. A court simply en-
sures that the agency has acted within a zone of rea-
sonableness and, in particular, has reasonably consid-
ered the relevant issues and reasonably explained the
decision.” Prometheus Radio Project, 141 S. Ct. at
1155. The Secretary’s determinations satisfy that
standard.
To begin with, the Secretary reasonably deter-
mined that COVID-19’s unique threat justifies a vac-
cination requirement. He based that decision on:
The virus’s high transmissibility and the of-
ten-severe consequences of infection—partic-
ularly for the older Americans covered by
Medicare and the disabled Americans covered
by both Medicare and Medicaid—and the risk
posed by new variants, Rule, 86 Fed. Reg. at
61556-57, 61566, 61568, 61609;
Significant levels of infection among health
care workers and patients, id. at 61559,
61585;
The expert consensus supporting vaccination,
id. at 61565;27
27 See pages 12-14, supra. The Secretary also pointed out that
AARP, an organization representing 38 million older Americans,
advocated mandatory vaccination for nursing home workers. 86
Fed. Reg. at 61565 & n.124. AARP explained that “more than
186,000 residents and staff of nursing homes and other long-term
care facilities have died from COVID-19 – representing around
30% of deaths, even though less than 1% of the population lives
in these facilities”; that “[o]nly one-quarter of nursing homes had
at least 75% of staff vaccinated, which is the benchmark goal the
20
Studies showing staff-to-patient transmission
is higher when health care workers are not
vaccinated, id. at 61557, 61559, 61566,
61583;28
The effectiveness of the vaccine in preventing
infection, id. at 61558, 61583, 61585-86;
Low vaccination rates among health care
workers, and significant variation of vaccina-
tion rates across geographic regions and types
of facilities, id. at 61559, 61566, 61584-85; and
The beneficial effect of vaccination in alleviat-
ing staff shortages, id. at 61558-59, 61608.29
The Secretary also assessed possible alternative
approaches. For example, he explained that studies
had found that already-existing protective measures
industry has set”; and that “the vaccination rates vary dramati-
cally by state and location. Staff vaccination rates ranged from a
low of 44% in Louisiana to 87% in Hawaii.” AARP, New AARP
Analysis Shows Nursing Homes Vaccination Rates Still Well
Short of Benchmark as COVID Cases Trend Upwards (Aug. 12,
2021), https://press.aarp.-org/2021-8-12-New-AARP-Analysis-
Shows-Nursing-Homes-Vaccination-Rates-Still-Well-Short-of-
Benchmark-as-COVID-Cases-Trend-Upwards.
28 See also note 16, supra. The Secretary also observed that vac-
cination is more effective that other measures in preventing
staff-to-patient flu infections. Rule, 86 Fed. Reg. at 61557-58.
29 Additional studies confirm that vaccinated health care workers
are less likely to be infected, and miss fewer days of work if they
are. See, e.g., Earl Strum, et al., Healthcare workers benefit from
second dose of COVID-19 mRNA vaccine: Effects of partial and
full vaccination on sick leave duration and symptoms (preprint,
posted Nov. 21, 2021), https://doi.org/10.1101/2021.-
11.17.21266479.
21
were not effective in preventing staff-to-patient trans-
mission. 86 Fed. Reg. at 61557, 61559, 61566, 61583.
He “considered requiring daily or weekly testing of un-
vaccinated individuals,” but—after “review[ing] scien-
tific evidence on testing”—found vaccination a “more
effective infection control measure.” Id. at 61614. And
he rejected the option of exempting previously-in-
fected health care workers because of “uncertainties
about * * * the strength and length of this immunity
compared to people who are vaccinated,” and also
cited the CDC recommendation that previously-in-
fected individuals get vaccinated. Ibid.; see also id. at
61559.
These determinations fall well within the “zone of
reasonableness” established by the arbitrary-and-ca-
pricious standard. That is particularly true because
they rest on the assessment of scientific evidence and
policy considerations squarely within the Secretary’s
expertise.
Finally, the Missouri district court erred in con-
cluding (21A240 App. 25a-31a) that the Secretary did
not adequately consider the risk that a vaccination re-
quirement could produce staff shortages.
The Secretary specifically addressed that concern,
stating that “there might a certain number of health
care workers who choose to” leave their jobs rather
than be vaccinated. Rule, 86 Fed. Reg. at 61569. But
he explained that “many COVID-19 vaccination man-
dates have already been successfully initiated in a va-
riety of health care settings, systems and states.” Ibid.
And he cited examples of health care systems that had
22
adopted vaccination requirements with 99.5%, 99%,
and 95% compliance. Id. at 61569 & nn. 156-59.30
The Secretary further stated that “COVID-related
staff shortages are occurring absent the rule due to
numerous factors, such as infection, quarantine and
staff illness,” that would be reduced dramatically as a
result of the rule. He determined that, accordingly,
“there is no reason to think” that resignations due to
the vaccination requirement “will be a net minus even
in the short term” even though there may be “some
short-term disruption of current levels for some pro-
viders or suppliers in some places.” 86 Fed. Reg. at
61608-09. That is especially true, the Secretary added,
because of the large “magnitude of normal turnover”
of health care employees—which he estimated at
more than 25% annually. Ibid.
The Secretary also explained that “[t]he current
patchwork of regulations undermines the efficacy of
COVID–19 vaccine mandates [adopted by individual
hospital or nursing home systems or States] by en-
couraging unvaccinated workers to seek employment
at providers that do not have such patient protections,
30 Information released after issuance of the rule provides addi-
tional support for the Secretary’s conclusion: numerous health
care providers from throughout the country have reported ex-
tremely high rates of compliance with vaccination requirements.
See Dave Muoio, Fierce Healthcare, How many employees have
hospitals lost to vaccine mandates? Here are the numbers so far
(Nov. 23, 2021), https://www.fiercehealthcare.com/hospi-
tals/how-many-employees-have-hospitals-lost-to-vaccine-man-
dates-numbers-so-far (compiling data, with links to the compa-
nies’ reports, with the overwhelming majority of providers re-
porting greater than 95% compliance and most with compliance
in excess of 98%). Of course, this report does not compile infor-
mation on the countervailing benefits realized from staff vaccina-
tion—in terms of reduced sick and quarantine leave.
23
exacerbating staffing shortages, and creating dispari-
ties in care across populations.” Rule, 86 Fed. Reg. at
61584. The rule prevents such a “race to the bottom”
by putting all Medicare and Medicaid health care pro-
viders on an equal footing.
The Secretary concluded that “the COVID-19 vac-
cine requirements [imposed by the rule] will result in
nearly all health care workers being vaccinated,
thereby benefitting all individuals in health care set-
tings.” Id. at 61569.
That determination, too, falls squarely within the
Secretary’s authority—especially given the predictive
nature of the judgment. The Secretary “reasonably
considered the relevant issue[] and reasonably ex-
plained the decision.” Prometheus Radio Project, 141
S. Ct. at 1155.
3. The Secretary’s decision to make the rule
immediately effective is supported by good
cause.
The Administrative Procedure Act (APA) permits
an agency to issue immediately-effective rules if the
agency finds “good cause” that “notice and public pro-
cedure thereon are impracticable, unnecessary, or
contrary to the public interest.” 5 U.S.C. § 553(b); see
also 42 U.S.C. § 1395hh(b)(2)(C) (incorporating the
APA standard).
That standard is satisfied here, because the rule
addresses an imminent threat to patients’ life and
health. See Sorenson Communications Inc. v. FCC,
755 F.3d 702, 706 (D.C. Cir. 2014) (“[W]e have ap-
proved an agency’s decision to bypass notice and com-
ment where delay would imminently threaten life.”);
Rule, 86 Fed. Reg. at 61612 (estimating significant
“patient and resident benefits” in terms of hundreds
24
or thousands of “lives saved” each month); Florida,
2021 WL 5768796, at *14 (upholding good cause de-
termination).
The Missouri district court stated that the
agency’s “good cause claim is undermined by its own
delay in promulgating the mandate.” 21A240 App.
13a. But the Secretary correctly explained, in detail,
why it would not have been proper to act earlier.
COVID vaccines were authorized for health care
workers in December 2020, and the agency chose ini-
tially “to encourage rather than mandate vaccination,
believing that” education campaigns and other actions
would produce a high level of vaccination. Rule, 86
Fed. Reg. at 61583. But the Secretary found that vac-
cination levels are “insufficient to protect the health
and safety of individuals receiving health care ser-
vices” under Medicare and Medicaid, * * * particularly
given the advent of the Delta variant and the poten-
tial for new variants” (ibid.)—a potential recently re-
alized with Omicron. See also id. at 61584 (listing
multiple factors supporting conclusion that delay
“would contribute to negative health outcomes for pa-
tients, including loss of life”—including insufficient
level of vaccination, risk of new variants, strain on the
health care system from Delta variant, full licensure
of vaccines by FDA, and additional evidence regarding
the efficacy and safety of vaccines).
Given the Secretary’s expertise on these matters,
that assessment is more than sufficient to establish
good cause.
25
CONCLUSION
The applications for stays should be granted.
Respectfully submitted.
ANDREW J. PINCUS
Counsel of Record
Mayer Brown LLP
1999 K Street, NW
Washington, DC 20006
(202) 263-3000
apincus@mayerbrown.com
Counsel for Amici Curiae
DECEMBER 2021
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