UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF FLORIDA
PENSACOLA DIVISION
STATE OF FLORIDA,
Plaintiff,
v. Case No. 3:21-cv-2722
DEPARTMENT OF HEALTH AND
HUMAN SERVICES; XAVIER
BECERRA, in his official capacity as
Secretary of the Department of Health
and Human Services; The UNITED
STATES OF AMERICA; CHIQUITA
BROOKS-LASURE, in her official
capacity as Administrator of the Centers
for Medicare and Medicaid; THE
CENTERS FOR MEDICARE AND
MEDICAID,
Defendants.
_________________________________/
COMPLAINT FOR TEMPORARY RESTRAINING
ORDER, PRELIMINARY AND PERMANENT
INJUNCTIVE RELIEF, AND DECLARATORY RELIEF
INTRODUCTION
1. Many American workers were able to stay home at the peak of the
pandemic. But our healthcare workers were on the front lines, risking their lives to
keep us safe. Working conditions were tough, exacerbating an already worsening
staffing shortage.
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 1 of 36
2
2. While these same workers continue to bravely discharge their duties,
President Biden is now telling over 10 million of them that they must get vaccinated
or lose their jobs. In his words, any resistance to this mandate—even by those with
natural immunity—is claiming the “freedom to kill [others] with [their] COVID.”
1
3. This action is unprecedented. As the federal government concedes, it
has “not previously required” mandatory vaccination for the healthcare industry. See
Medicare and Medicaid Programs: Omnibus COVID-19 Health Care Staff
Vaccination, 86 Fed. Reg. 61,555 (Nov. 5, 2021) (the mandate). In fact, the federal
government has “not previously required” mandatory vaccination for any private
industry. Just months ago, the Biden Administration made clear that mandating
vaccines is “not the role of the federal government.”
2
4. It is also reckless. The healthcare industry is in the throes of what “some
are calling the worst U.S. health-care labor crisis in memory.”
3
Indeed, pandemic-
related burnout has created critical staffing shortages nationwide. Compounding the
problem, many healthcare employees do not want to take the COVID-19 vaccine,
particularly in small, rural areas already short on personnel. Combined, these factors
1
CNN Presidential Town Hall With President Joe Biden, CNN (Oct. 21, 2021),
https://transcripts.cnn.com/show/se/date/2021-10-21/segment/01.
2
Press Briefing by Press Secretary Jen Psaki, July 23, 2021, The White House (July 23, 2021),
https://www.whitehouse.gov/briefing-room/press-briefings/2021/07/23/press-briefing-by-press-
secretary-jen-psaki-july-23-2021/.
3
Carey Goldberg & Jonathan Levin, Vaccine Mandates Hit Amid Historic Health-Care Staff
Shortage, Bloomberg (Oct. 2, 2021), https://www.bloomberg.com/news/articles/2021-10-
02/vaccine-mandates-hit-amid-historic-health-care-staff-shortage.
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 2 of 36
3
have created a powder keg, and healthcare officials fear a vaccine mandate could
spark an exodus of workers from the industry. Given these severe conditions, even
a minor loss of staff could have a “disastrous impact” on patient care.
4
5. Against this backdrop, the federal government previously determined
that less-intrusive safety regulations were appropriate to combat the spread of
COVID-19 in healthcare facilities. E.g., Medicare and Medicaid Programs; COVID-
19 Vaccine Requirements for Long-Term Care (LTC) Facilities and Intermediate
Care Facilities for Individuals With Intellectual Disabilities (ICFs-IID) Residents,
Clients, and Staff, 86 Fed. Reg. 26,306 (May 13, 2021); Occupational Exposure to
COVID-19; Emergency Temporary Standard, 86 Fed. Reg. 32,376 (June 21, 2021).
6. But as healthcare workers grappled with the deeply personal decision
of whether to take a vaccine, President Biden’s “patience . . .w[ore] thin,” and he
grew “ang[ry] at those who haven’t gotten vaccinated.”
5
Unwilling to wait any
longer, on September 9, 2021, President Biden announced several administrative
actions aimed at mandating vaccines, which together affect roughly 100 million
Americans.
6
4
Health care group worried vaccine mandate will impact Missouri nursing homes, Fox 2 Now
(Nov. 5, 2021), https://fox2now.com/news/health-care-group-worried-vaccine-mandate-will-
impact-missouri-nursing-homes/.
5
Remarks by President Biden on Fighting the COVID-19 Pandemic, The White House (Sept. 9,
2021), https://www.whitehouse.gov/briefing-room/speeches-remarks/2021/09/09/remarks-by-
president-biden-on-fighting-the-covid-19-pandemic-3/.
6
Id.
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 3 of 36
4
7. As relevant here, he announced that the Department of Health &
Human Services (HHS) would issue a rule requiring vaccination for all employees
working in Medicare- or Medicaid-participating facilities.
7
On November 5, 2021,
the Centers for Medicare and Medicaid (CMS), an HHS component, did so. See 86
Fed. Reg. at 61,555.
8. In its effort to fast-track the President’s agenda, however, CMS
exceeded its statutory authority and flouted key procedural safeguards that Congress
enacted to protect the public from hasty and reactive decision-making.
9. To start, CMS lacks the power to issue an industry-wide vaccination
mandate. The statutes it relies on do not provide it such sweeping authority. In fact,
CMS is forbidden from exerting this level of control over the healthcare industry.
See 42 U.S.C. § 1395.
10. Lack of authority aside, CMS also failed to fulfill its statutory duty “to
consult with appropriate State agencies” in developing the mandate, see 42 U.S.C.
§ 1395z—a grievous dereliction of duty given that CMS has never before mandated
vaccination and thus lacks an understanding of how its mandate will affect the States.
11. Making matters worse, CMS sidestepped the notice and comment
process set out in the Administrative Procedure Act (APA). See 5 U.S.C. § 553. And
7
Biden-Harris Administration to Expand Vaccination Requirements for Health Care Settings,
CMS (Sept. 9, 2021), https://www.cms.gov/newsroom/press-releases/biden-harris-administration-
expand-vaccination-requirements-health-care-settings.
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 4 of 36
5
though it claims “good cause” to do so, see id. § 553(b)(B), its primary
justifications—the two-year-old COVID-19 pandemic and the Delta variant—do not
satisfy the exceedingly high and exceptional “good cause” standard.
12. On top of all this, CMS acted arbitrarily and capriciously in issuing the
mandate. See 5 U.S.C. § 706(2)(A). It fails to adequately consider the viability of
less-intrusive measures like testing, the harmful effects the mandate will have on the
healthcare staffing crisis and vaccine-education efforts, the effects of natural
immunity and new COVID-19 treatments, the reliance interests of healthcare
employers and employees, and the incongruence between its vaccine requirement
and its stated goal of protecting patients and staff. It also fails to connect the statistics
driving its mandate with most of the facilities covered by it or to sufficiently justify
its extreme departure from the federal government’s prior practices.
13. Finally, the mandate violates the Spending Clause—which requires that
conditions on federal funds be unambiguous—by changing the terms of an
agreement Florida has with the federal government midstream and without notice.
14. Because CMS’s rushed and unlawful mandate threatens to defund the
State’s medical facilities, bleed them of vital staff, hamper the quality of their
medical care, and harm both Florida’s economy and the health of its citizens, Florida
seeks immediate relief from this Court.
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 5 of 36
6
PARTIES
15. Plaintiff State of Florida is a sovereign State and has the authority and
responsibility to protect its public fisc and the health, safety, and welfare of its
citizens. It is also the operator of medical-service providers that receive Medicare or
Medicaid funding. And its health agency—the Agency for Health Care
Administration (AHCA)—administers Florida’s Medicaid plan and assists CMS in
regulating facilities that participate in Medicare.
16. Defendants are the United States, appointed officials of the United
States government, and United States governmental agencies responsible for the
issuance and implementation of the challenged administrative actions.
17. Florida sues Defendant the United States of America under 5 U.S.C.
§§ 702–703 and 28 U.S.C. § 1346.
18. Defendant CMS issued the mandate and is a component of HHS.
19. Defendant Chiquita Brooks-LaSure is the Administrator of CMS. She
is sued in her official capacity.
20. Defendant HHS oversees CMS.
21. Defendant Xavier Becerra is the Secretary of HHS. He is sued in his
official capacity.
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 6 of 36
7
JURISDICTION AND VENUE
22. The Court has subject matter jurisdiction pursuant to
28 U.S.C. §§ 1331, 1346, 1361 and 5 U.S.C. §§ 702–03.
23. The Court is authorized to award the requested declaratory and
injunctive relief under 5 U.S.C. § 706, 28 U.S.C. §§ 1361, 2201–02, the Constitution,
and the Court’s equitable powers.
24. Venue lies in this district pursuant to 28 U.S.C. § 1391(e)(1) because
the State of Florida is a resident of every judicial district in its sovereign territory,
including this judicial district (and division). See California v. Azar, 911 F.3d 558,
570 (9th Cir. 2018).
8
And because medical facilities receive Medicare and Medicaid
funding in this district and division, a substantial part of the events or omissions
giving rise to Florida’s claims occurred here.
FACTUAL BACKGROUND
The Medicare and Medicaid Schemes
25. Medicare and Medicaid are federal programs that pay medical expenses
for certain individuals.
8
Accord Alabama v. U.S. Army Corps of Eng’rs, 382 F. Supp. 2d 1301, 1329 (N.D. Ala. 2005);
see also Atlanta & F.R. Co. v. W. Ry. Co. of Ala., 50 F. 790, 791 (5th Cir. 1892) (explaining that
“the state government . . . resides at every point within the boundaries of the state”).
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 7 of 36
8
26. Medicare is an insurance program.
9
It provides health-insurance
coverage to individuals who are at least 65-years-old and are entitled to monthly
Social Security benefits, and to disabled individuals who meet certain requirements.
42 U.S.C. § 1395 et seq. CMS administers the program on behalf of the Secretary of
HHS. See Pharm. Rsch. & Mfrs. of Am. v. Walsh, 538 U.S. 644, 651 n.3 (2003).
27. Medicaid is an assistance program.
10
It pays medical bills for low-
income individuals. 42 U.S.C. § 1396 et seq. It is “the primary federal program for
providing medical care to indigents at public expense.” Mem’l Hosp. v. Maricopa
Cnty., 415 U.S. 250, 262 n.19 (1974). The program is administered jointly by the
States and the federal government through a “contract[ual]” relationship. NFIB v.
Sebelius, 567 U.S. 519, 577 (2012). Federal funds are distributed to qualifying
States, which administer their Medicaid programs pursuant to federal requirements.
28. To be eligible to receive payments from either Medicare or Medicaid,
participating medical-care providers must enter into agreements with the federal
government or the administering State in which they agree to comply with federally
imposed conditions of participation, coverage, or certification. E.g., 42 U.S.C.
9
What is the difference between Medicare and Medicaid, HHS,
https://www.hhs.gov/answers/medicare-and-medicaid/what-is-the-difference-between-medicare-
medicaid/index.html.
10
Id.
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 8 of 36
9
§§ 1395cc(b)(2), 1396a(a)(33)(B). Some requirements are created by statute. E.g.,
42 U.S.C. § 1395x. Others are created by CMS regulations. E.g., 42 C.F.R. part 482.
29. To ensure compliance with these conditions, CMS contracts with state
health agencies to “survey” participating medical-care providers. 42 U.S.C.
§§ 1395aa(a), 1396a(a)(33)(B). Florida is no exception—AHCA surveys
participating providers on behalf of CMS.
Current State of the Healthcare Industry
30. The COVID-19 pandemic has placed tremendous strain on the nation’s
healthcare industry, creating perhaps the “worst U.S. health-care labor crisis in
memory.”
11
As of October 1, 2021, about 16% of U.S. hospitals had “critical staffing
shortages.”
12
In some places, as many as 25% of beds are going unfilled because the
facilities lack adequate staffing.
13
And rural areas are bearing a disproportionate
share of the burden, making up 60% of staffing shortages nationwide
14
despite
serving less than 20% of the population.
15
11
Carey Goldberg & Jonathan Levin, Vaccine Mandates Hit Amid Historic Health-Care Staff
Shortage, Bloomberg (Oct. 2, 2021), https://www.bloomberg.com/news/articles/2021-10-
02/vaccine-mandates-hit-amid-historic-health-care-staff-shortage.
12
Id.
13
Id.
14
Aallyah Wright, Rural Hospitals Can’t Find the Nurses They Need to Fight COVID, Stateline
(Sept. 1, 2021), https://www.pewtrusts.org/en/research-and-
analysis/blogs/stateline/2021/09/01/rural-hospitals-cant-find-the-nurses-they-need-to-fight-covid.
15
Rural Report: Challenges Facing Rural Communities and the Roadmap to Ensure Local Access
to High-quality, Affordable Care, American Hospital Association at 2,
https://www.aha.org/system/files/2019-02/rural-report-2019.pdf.
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 9 of 36
10
31. A chief driver of the crisis is employee burnout, which has reached
“epidemic proportions.”
16
In one study, “[a]n overwhelming 55% of frontline-health
care workers reported burnout (defined as mental and physical exhaustion from
chronic workplace stress).”
17
Almost 30% have considered “leaving the medical
field” altogether,
18
and over 500,000 have done so already.
19
32. Another driver is money. Drawn by lucrative salary raises—some
approaching 800%—many healthcare workers have left in-house staffs for contract
staffing agencies.
20
Depleted by these losses, healthcare providers have been forced
to turn to these very agencies to fill their staffing gaps, paying “well above normal”
for their services.
21
This staffing arms race has hit healthcare providers across the
board,
22
but it has been especially difficult for small rural hospitals that cannot afford
16
Dharam Kaushik, Medical burnout: Breaking bad, AAMC (June 4, 2021),
https://www.aamc.org/news-insights/medical-burnout-breaking-bad.
17
Id.
18
Id.
19
Mallory Hackett, Healthcare lost 17,500 jobs in September amid ongoing labor shortage,
Healthcare Finance (Oct. 11, 2021), https://www.healthcarefinancenews.com/news/healthcare-
lost-17500-jobs-september-amid-ongoing-labor-shortage.
20
Leticia Miranda, Rural hospitals losing hundreds of staff to high-paid traveling nurse jobs, NBC
News (Sept. 15, 2021), https://www.nbcnews.com/business/business-news/rural-hospitals-losing-
hundreds-staff-high-paid-traveling-nurse-jobs-n1279199.
21
Bertha Coombs, Regulations slow urgent hiring of doctors and nurses amid coronavirus
outbreak, staffing firms say, CNBC (Mar. 28, 2020),
https://www.cnbc.com/2020/03/28/coronavirus-regulations-slow-hiring-of-doctors-and-nurses-
staffing-firms-say.html.
22
Hospitals and Health Systems Face Unprecedented Financial Pressures Due to COVID-19,
American Hospital Association (May 2020), https://www.aha.org/guidesreports/2020-05-05-
hospitals-and-health-systems-face-unprecedented-financial-pressures-due.
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 10 of 36
11
to pay inflated contract staffing rates or increase salaries to keep their employees in-
house.
23
33. Florida has not been immune to this staffing emergency. For example,
92% of long term care facilities in Florida face a staffing crunch; for 75% of them,
it is “the number one concern.”
24
And Florida’s vacancy rate for nurses is 11%—
more than a full percentage point above the national average.
25
34. Compounding the staffing crisis, many healthcare workers, both
nationally and in Florida, do not want to receive the COVID-19 vaccine. A
nationwide survey found that 25% of nurses had personal concerns about taking the
vaccine.
26
In Florida, data published just a few months ago found that between 40–
50% of hospital employees had not been vaccinated.
27
And in rural areas—which
23
Leticia Miranda, Rural hospitals losing hundreds of staff to high-paid traveling nurse jobs (Sept.
15, 2021), https://www.nbcnews.com/business/business-news/rural-hospitals-losing-hundreds-
staff-high-paid-traveling-nurse-jobs-n1279199.
24
Jake Stofan, Health care industry asking Florida lawmakers to address chronic staffing
shortages, WFLA (Nov. 1, 2021), https://www.wfla.com/news/florida/health-care-industry-
asking-florida-lawmakers-to-address-chronic-staffing-shortages/.
25
Id.
26
Christopher O’Donnell, Tampa Bay hospitals push COVID vaccine – but won’t mandate it for
their workers, Tampa Bay Times (Sept. 3, 2021),
https://www.tampabay.com/news/health/2021/09/03/tampa-bay-hospitals-push-covid-shot-but-
wont-mandate-it-for-their-workers/.
27
Liz Crawford, AHCA: 42% of Florida hospital workers weren’t vaccinated, as of June 4, WTSP
(July 22, 2021), https://www.wtsp.com/article/news/health/coronavirus/vaccine/hospital-workers-
not-vaccinated/67-9e842ff1-e5b0-4f1f-8f9f-ccfec865ccbf; David Bauerlein, UF Health
Jacksonville finding widespread vaccine hesitancy among its own staff, Jacksonville.com (July 23,
2021), https://www.jacksonville.com/story/news/2021/07/23/uf-health-ceo-says-overcoming-
vaccine-hesitancy-challenge-among-staff/8075987002/.
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 11 of 36
12
have the most “dire” staffing shortages of all
28
—the statistics are even bleaker. One
study found that in 30% of rural hospitals nationwide, less than half of the staff have
received a COVID-19 vaccine.
29
35. This confluence of factors has left many healthcare administrators
worried that a vaccine mandate could push the industry over the edge. They fear
“many employees [will] quit rather than comply”—a “huge concern” given current
staffing deficiencies.
30
The concern is not merely speculative: In some places, triple-
digit numbers of workers have resigned or been fired for refusing to take a vaccine.
31
One Florida-based administrator estimates that a mandate would cause him to “lose
10 to 15 percent of [his] staff.”
32
But this estimate is on the low end: A recent survey
found that 37% of unvaccinated workers would leave their jobs if their employers
28
Aallyah Wright, Rural Hospitals Can’t Find the Nurses They Need to Fight COVID, Stateline
(Sept. 1, 2021), https://www.pewtrusts.org/en/research-and-
analysis/blogs/stateline/2021/09/01/rural-hospitals-cant-find-the-nurses-they-need-to-fight-covid.
29
Tamara Keith, Why Lagging COVID Vaccine Rate At Rural Hospitals ‘Needs To Be Fixed Now’,
NPR (May 4, 2021), https://www.npr.org/2021/05/04/993270974/why-lagging-covid-vaccine-
rate-at-rural-hospitals-needs-to-be-fixed-now.
30
Christopher O’Donnell, Tampa Bay hospitals push COVID vaccine – but won’t mandate it for
their workers, Tampa Bay Times (Sept. 3, 2021),
https://www.tampabay.com/news/health/2021/09/03/tampa-bay-hospitals-push-covid-shot-but-
wont-mandate-it-for-their-workers/.
31
Dan Diamond, 153 people resigned or were fired from a Texas hospital system after refusing to
get vaccinated, The Washington Post (June 22, 2021),
https://www.washingtonpost.com/health/2021/06/22/houston-methodist-loses-153-employees-
vaccine-mandate/.
32
Hannah Mitchell, ‘Like hand-to-hand combat’: Florida health system battles vaccine hesitancy
1 employee at a time, Becker’s Hospital Review (Nov. 4, 2021),
https://www.beckershospitalreview.com/hospital-management-administration/like-hand-to-hand-
combat-florida-health-system-battles-vaccine-hesitancy-1-employee-at-a-time.html.
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 12 of 36
13
mandated vaccination or weekly testing.
33
And if mandatory vaccination is the only
option, 72% say they will quit.
34
36. Employee flight does not just hamper the healthcare industry’s capacity
to fight COVID-19, but to address other healthcare risks as well. As the CEO of one
Florida health system put it: “If today I said, ‘everybody’s required to take the
vaccine or you’re terminated,’ then I have a problem being able to take care of people
who show up to our ER with strokes, or chest pains, or medical admissions or
surgical admissions.”
35
And as CMS concedes, 86 Fed. Reg. at 61,612, given the
already-severe staffing shortage in the healthcare industry, “[e]ven a small fraction
of” so-called “recalcitrant unvaccinated employees” could “disrupt facility
operations,” id., and have a “disastrous impact” on patient care.
36
37. To be sure, encouraging vaccination of healthcare workers is good
policy. Indeed, such measures have proven effective in Florida. To cite one example,
33
Liz Hamel et al., KFF COVID-19 Vaccine Monitor: October 2021, KFF (Oct. 28, 2021),
https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-october-
2021/.
34
Id.
35
Jacqueline LaPointe, Hospitals Staffing Shortages a Concerns with Mandatory Vaccinations,
Revcycle Intelligence (July 26, 2021), https://revcycleintelligence.com/news/hospital-staffing-
shortages-a-concern-with-mandatory-vaccinations.
36
Health care group worried vaccine mandate will impact Missouri nursing homes, Fox 2 Now
(Nov. 5, 2021), https://fox2now.com/news/health-care-group-worried-vaccine-mandate-will-
impact-missouri-nursing-homes/.
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 13 of 36
14
a healthcare system raised staff vaccination rates by 10% through vaccination-
education strategies.
37
38. Mandates, however, are another matter altogether. In addition to the
issues already discussed, they may even “chill” individuals who might otherwise
take the vaccine voluntarily.
38
The Federal Government’s Response to the COVID-19 Pandemic
39. In January 2020, HHS declared the COVID-19 pandemic a public
health emergency. Though public health emergency designations naturally expire
after 90 days, 42 U.S.C. § 247d, HHS has renewed the designation each time it was
set to expire.
39
40. Almost a year ago, in December 2020, COVID-19 vaccines began to
become available to the general public. On December 11, 2020, the Food & Drug
Administration (FDA) authorized the emergency use of the two-dose Pfizer-Biotech
vaccine. A week later, FDA did the same for the two-dose Moderna vaccine. On
37
Hannah Mitchell, ‘Like hand-to-hand combat’: Florida health system battles vaccine hesitancy
1 employee at a time, Becker’s Hospital Review (Nov. 4, 2021),
https://www.beckershospitalreview.com/hospital-management-administration/like-hand-to-hand-
combat-florida-health-system-battles-vaccine-hesitancy-1-employee-at-a-time.html.
38
Bailey LeFever, Majority of Florida’s long-term care staffers refused coronavirus vaccine,
Tampa Bay Times (Apr. 1, 2021), https://www.tampabay.com/news/health/2021/04/01/majority-
of-floridas-long-term-care-staffers-refused-coronavirus-vaccine/.
39
COVID-19 Public Health and Medical Emergency Declarations and Waivers, PHE (Apr. 16,
2021), https://www.phe.gov/emergency/events/COVID19/Pages/2019-Public-Health-and-
Medical-Emergency-Declarations-and-Waivers.aspx.
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 14 of 36
15
February 27, 2021, FDA did the same for the one-dose Johnson & Johnson vaccine.
40
And almost immediately, healthcare workers became eligible to take the vaccine.
41
41. Despite these authorizations and the longstanding public health
emergency declaration, the federal government never sought to mandate
vaccinations to fight COVID-19 in any sector, let alone the healthcare sector. Rather,
it opted for less-intrusive measures. In May 2021, for instance, CMS issued an
interim final rule (IFR) that required long term care facilities and intermediate care
facilities for individuals with intellectual disabilities to educate staff and residents
about the vaccine and make the vaccine available to them. 86 Fed. Reg. at 26,306
(May IFR). This, in CMS’s view, was “necessary to help protect the health and
safety” of residents. Id. Mandatory vaccination, however, was not required.
42. Similarly, in June 2021, the Occupational Health and Safety
Administration (OSHA) issued a COVID-19 Healthcare Emergency Temporary
Standard (ETS), which aimed to protect healthcare workers from occupational
exposure to COVID-19. 86 Fed. Reg. at 32,376 (June ETS). Under the June ETS—
which remains in effect—covered healthcare employers must implement measures
like transmission-based precautions, personal protective equipment, and physical
40
Carl Zimmer et al., Coronavirus Vaccine Tracker, The New York Times,
https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html.
41
Maggie Fox, Some Americans should start getting the first Covid-19 vaccine today. It will take
months before everyday people get the shots, CNN (Dec. 14, 2020),
https://www.cnn.com/2020/12/14/health/covid-vaccine-timeline/index.html (reporting that
healthcare workers would be eligible for vaccination in December 2020).
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 15 of 36
16
distancing. Id. at 32,426–57. The June ETS also requires employers to provide paid
leave for employees to receive COVID-19 vaccines. Id. at 32,599. But like CMS’s
May IFR, the June ETS did not mandate vaccination.
The Biden Administration’s Actions
43. Despite pushing the envelope in numerous ways during the COVID-19
pandemic, e.g., Ala. Ass’n of Realtors v. HHS, 141 S. Ct. 2485, 2486 (2021); Florida
v. Becerra, 8:21-cv-839, 2021 WL 2514138 (M.D. Fla. June 18, 2021), the Biden
Administration at first drew a hard line on vaccine mandates: In its view, mandating
vaccines was “not the role of the federal government.”
42
44. Not long after, though, the President’s “patience” with the unvaccinated
“w[ore] thin,” prompting him to announce three new administrative actions aimed
at compelling much, if not most, of the adult population in the United States to
receive a COVID-19 vaccine.
43
45. First, the President announced that he would issue an executive order
requiring all executive branch employees and federal contractors to be vaccinated.
44
42
Press Briefing by Press Secretary Jen Psaki, July 23, 2021, The White House (July 23, 2021),
https://www.whitehouse.gov/briefing-room/press-briefings/2021/07/23/press-briefing-by-press-
secretary-jen-psaki-july-23-2021/.
43
Remarks by President Biden on Fighting the COVID-19 Pandemic, The White House (Sept. 9,
2021), https://www.whitehouse.gov/briefing-room/speeches-remarks/2021/09/09/remarks-by-
president-biden-on-fighting-the-covid-19-pandemic-3/.
44
Id.
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 16 of 36
17
46. Second, the President announced that the Department of Labor would
develop an emergency rule mandating that private employers with 100 or more
employees require their employees to become fully vaccinated or submit to weekly
testing.
45
47. Finally, as relevant here, the President announced that the federal
government would publish a rule mandating vaccines for employees who work at
healthcare facilities that accept Medicare and Medicaid.
46
Even though he stated a
month earlier that HHS would only require nursing homes to vaccinate their
employees,
47
he expanded this mandate, announcing that the rule would require all
participating facilities to have their employees vaccinated.
48
The Mandate
48. CMS published that regulation—the mandate—on November 5, 2021.
86 Fed. Reg. at 61,555.
45
Id.
46
Id.
47
FACT SHEET: President Biden to Announce New Actions to Protect Americans from COVID-
19 and Help State and Local Leaders Fight the Virus, The White House (Aug. 18, 2021),
https://www.whitehouse.gov/briefing-room/statements-releases/2021/08/18/fact-sheet-president-
biden-to-announce-new-actions-to-protect-americans-from-covid-19-and-help-state-and-local-
leaders-fight-the-virus/.
48
Biden-Harris Administration to Expand Vaccination Requirements for Health Care Settings,
CMS (Sept. 9, 2021), https://www.cms.gov/newsroom/press-releases/biden-harris-administration-
expand-vaccination-requirements-health-care-settings.
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 17 of 36
18
49. The mandate directs participating facilities
49
to ensure that covered
employees
50
submit to COVID-19 vaccination, unless the employees are eligible for
a religious or medical exemption. Id. at 61,572.
50. The mandate deploys “a common set of provisions for each”
participating facility; there are “no substantive regulatory differences across
settings.” Id. at 61,570.
51. It operates in two phases. Phase 1 requires that covered employees
receive either the first dose of a two-dose vaccine or the sole dose of a single-dose
vaccine by December 6, 2021. Id. at 61,573. Phase 2 requires that covered employees
receive the second dose of a two-dose vaccine by January 4, 2022. Id.
52. To comply with the mandate, a participating facility must implement a
“process for tracking and securely documenting the COVID-19 vaccination status
49
Participating facilities subject to the mandate include: ambulatory surgical centers; hospices;
psychiatric residential treatment facilities; programs of all-inclusive care for the elderly; hospitals;
long term care facilities, including skilled nursing facilities and nursing facilities, generally
referred to as nursing homes; intermediate care facilities for individuals with intellectual
disabilities; home health agencies; comprehensive outpatient rehabilitation facilities; critical
access hospitals; clinics, rehabilitation agencies, and public health agencies as providers of
outpatient physical therapy and speech-language pathology services; community mental health
centers; home infusion therapy suppliers; rural health clinics/federally qualified health centers; and
end-stage renal disease facilities. 86 Fed. Reg. at 61,569–70.
50
Covered employees subject to the mandate include: facility employees; licensed practitioners;
students, trainees, and volunteers; and individuals who provide care, treatment, or other services
for the facility and/or its patients, under contract or other arrangement. 86 Fed. Reg. 61,570. The
requirements also extend to staff who provide care outside of a formal clinical setting and to “any
individual that performs their duties at any site of care, or has the potential to have contact with
anyone at the site of care.” Id. at 61,570–71. Employees working 100% remotely are exempt. Id.
at 61,571.
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 18 of 36
19
of all staff,” including booster-shot status. 42 C.F.R. § 416.51(c)(3)(iv)–(v). It must
also “track[] and securely document[]” all exemptions. Id. § 416.51(c)(3)(vi)–(vii).
And it must implement “[c]ontingency plans” for all persons who are “not fully
vaccinated.” Id. § 416.51(c)(3)(x).
53. As for enforcement, CMS intends to issue “interpretive guidelines” that
outline “enforcement remedies” CMS can pursue against participating facilities that
do not comply. 86 Fed. Reg. at 61,574. These will include “civil money penalties,
denial of payments for new admissions, or termination of the Medicare/Medicaid
provider agreement.” Id. A senior White House official has made clear that CMS
“will not hesitate to use [its] full enforcement authority” to carry out the mandate.
51
54. CMS, however, does not intend to enforce the mandate alone—it
expects the States to help. Consistent with their contracts with CMS, see 42 U.S.C.
§ 1395aa(a), States must verify that healthcare facilities operating in their borders
comply with the mandate. CMS plans to “advise and train State surveyors on how
to assess compliance with the new requirements” and how to review “the entity’s
records of staff vaccinations.” 86 Fed. Reg. at 61,574. It will also “instruct surveyors
51
Background Press Call on OSHA and CMS Rules for Vaccination in the Workplace, The White
House (Nov. 3, 2021), https://www.whitehouse.gov/briefing-room/press-
briefings/2021/11/04/background-press-call-on-osha-and-cms-rules-for-vaccination-in-the-
workplace/.
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 19 of 36
20
to conduct interviews staff [sic] to verify their vaccination status,” and will tell
surveyors how they “should cite” facilities “when noncompliance is identified.” Id.
55. CMS “expect[s]” its vaccine mandate “to remain relevant for some time
beyond the end” of the declared public health emergency and anticipates retaining
the mandate “as a permanent requirement for facilities.” Id. at 61,574.
56. The mandate has “near-universal applicability” to healthcare staff,
covering an estimated 10.3 million employees. Id. at 61,603. By CMS’s own
estimate, about 2.4 million of these employees are unvaccinated. Id. at 61,607. And,
as CMS concedes, the mandate’s chief aim is to coerce these unvaccinated
employees to submit to vaccination upon pain of unemployment. See id. (“The most
important inducement will be the fear of job loss, coupled with the examples set by
fellow vaccine-hesitant workers who are accepting vaccination more or less
simultaneously”); id. at 61,608 (“[I]t is possible there may be disruptions in cases
where substantial numbers of health care staff refuse vaccination and are not granted
exemptions and are terminated, with consequences for employers, employees, and
patients.”).
CMS’s Failure to Consult or Engage in Notice and Comment
57. CMS concedes that this is new ground for the agency. By its own
admission, it has “not previously required” mandatory vaccinations as a condition
for participation in Medicare or Medicaid. Id. at 61,567. In fact, the federal
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 20 of 36
21
government has never required any private industry to submit to mandatory
vaccination.
58. Despite this marked departure from prior practice, though, CMS did not
“consult” with “appropriate State agencies” before issuing its Mandate, as it is
required to do under 42 U.S.C. § 1395z. Id. at 61,567. In CMS’s view, the
consultation statute does not require that it consult before publishing a rule. Id. And
even if it did, says CMS, there is no agency with which it would be “appropriate” to
consult before publishing the rule “[g]iven the urgent need” for a mandate here. Id.
59. Similarly, CMS did not engage with interested stakeholders through the
notice and comment process. Id. at 61,583 (citing 5 U.S.C § 553(b); 42 U.S.C
§ 1395hh(b)(1)). Instead, it found for “good cause” that it would “be impracticable
and contrary to the public interest . . . to undertake normal notice and comment
procedures.” Id. at 61,586. It supported its good-cause determination based
primarily on the COVID-19 pandemic, the Delta variant, and the upcoming flu
season. See id. at 61,583–84.
CMS’s Justifications for the Mandate
60. In justifying its mandate, CMS offers internally inconsistent reasoning
and fails to adequately consider data that undermined its decision.
61. To start, CMS claims to consider “concerns about health care workers
choosing to leave their jobs rather than be vaccinated,” yet it ultimately finds that
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 21 of 36
22
the mandate was justified given that there is “insufficient evidence to quantify and
compare adverse impacts on patient and resident care associated with temporary
staffing losses due to mandates and absences due to quarantine for known COVID-
19 exposures and illness.” Id. at 61,569.
62. This lack of data, however, is not cause to issue an industry-wide
mandate; it is cause to exercise restraint in issuing such a mandate.
63. As CMS concedes, there “might be a certain number of health care
workers who choose” to leave the medical field because of the mandate. Id. at
61,569. And because it is “unknown . . . how rapidly those quitting rather than being
vaccinated could be replaced,” id. at 61,612, CMS admits that current “endemic staff
shortages . . . may be made worse if any substantial number of unvaccinated
employees leave health care employment altogether,” id. at 61,607. Indeed, given
the already “critical staffing shortage,” id. at 61,559, CMS acknowledges that
worker resignations need not even be substantial to do damage: If “[e]ven a small
fraction of” those CMS pejoratively labels “recalcitrant unvaccinated employees”
quit, it “could disrupt facility operations.” Id. at 61,612. In some cases, this impact
will be “disastrous,”
52
especially in rural areas, which, as CMS admits, are “having
greater problems with employee vaccination.” Id. at 61,613.
52
Health care group worried vaccine mandate will impact Missouri nursing homes, Fox 2 Now
(Nov. 5, 2021), https://fox2now.com/news/health-care-group-worried-vaccine-mandate-will-
impact-missouri-nursing-homes/.
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 22 of 36
23
64. Along with this, CMS recognizes that the “providers and suppliers
regulated under this rule are diverse in nature, management structure, and size.” Id.
at 61,602. Even so, CMS relies mostly on facts and figures involving long term care
facilities—providers who serve mostly elderly and often immunocompromised
patients—to justify applying the mandate to other Medicare- and Medicaid-certified
providers. See, e.g., id. at 61,585 (discussing “case rates among [long term care]
facility residents,” and claiming, without citation that those facilities’ “experience may
generally be extrapolated to other settings”). CMS does so despite conceding that
“[a]ge remains a strong risk factor for severe COVID-19 outcomes,” id. at 61,566,
and that “risk of death from infection from an unvaccinated 75- to 84-year-old person
is 320 times more likely than the risk for an 18- to 29-years old person,” id. at 61,610
n.247.
65. CMS also claims to have “considered requiring daily or weekly testing
of unvaccinated individuals” instead of mandatory vaccination. Id. at 61,614. But it
rejects this alternative in about a sentence, concluding that vaccination is a “more
effective infection control measure.” Id. OSHA, by contrast, issued a vaccine
mandate on the same day that includes a weekly testing alternative. See COVID-19
Vaccination and Testing; Emergency Temporary Standard, 86 Fed. Reg. 61,402,
61,450 (Nov. 5, 2021). Indeed, despite concluding that testing is “not as effective as
vaccination,” OSHA permitted testing because it is “still effective” and because
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 23 of 36
24
OSHA had concerns about imposing a “strict vaccination mandate with no
alternative” on such short notice given the potential “economic and health impacts”
of such a decision.
53
Id. at 61,433, 61,436.
66. CMS further “considered whether it would be appropriate to limit
COVID-19 vaccination requirements to staff who have not previously been infected
by SARS-CoV-2.” 86 Fed. Reg. at 61,614. Yet it decides against that option because
it does not think that “natural immunity” is “equivalent to receiving the COVID-19
vaccine.” Id. at 61,559. Elsewhere, however, CMS recognizes the value of natural
immunity when it states that each day 100,000 people are “recover[ing] from
infection,” that they “are no longer sources of future infections,” and that their natural
immunity “reduce[s] the risk to both health care staff and patients substantially.” Id.
at 61,604 (emphasis added). And indeed, a highly reported study from Israel found
that “natural immunity confers longer lasting and stronger protection” against the
Delta variant than vaccination.
54
67. CMS claims that the mandate is needed to protect patients from
COVID-19 infection, yet it does not require that patients be vaccinated and
53
OSHA also could not establish a “grave danger” to most healthcare workers because it found
that its June ETS adequately protects against COVID-19 risk. 86 Fed. Reg. at 61,421. CMS does
not acknowledge this finding.
54
See Sivan Gazit et al., Comparing SARS-CoV-2 natural immunity to vaccine-induced immunity:
reinfections versus breakthrough infections, medRxiv (Aug. 24, 2021),
https://www.medrxiv.org/content/10.1101/2021.08.24.21262415v1.
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 24 of 36
25
recognizes that “the effectiveness of the vaccine to prevent disease transmission by
those vaccinated [is] not currently known.” Id. at 61,615.
Irreparable Harm to Florida
68. The mandate places Florida in an untenable position. On the one hand,
if Florida refuses to comply with the mandate, its state-run facilities that participate
in Medicare and Medicaid will be subject to fines and lose millions of dollars in
funding. On the other hand, if Florida complies with the mandate, its facilities will
lose critical staff, exacerbating an already-severe staffing crisis. To weather the
staffing dip, its facilities will either need to pay exorbitant premiums to contract
staffing agencies or provide a diminished quality of patient care. They will also bear
the cost of ensuring that their employees have complied with the mandate, which
they cannot recover in a suit against the federal government. See Chiles v.
Thornburgh, 865 F.2d 1197, 1209 (11th Cir. 1989); Odebrecht Const., Inc. v. Sec’y,
Fla. Dep’t of Transp., 715 F.3d 1268, 1289 (11th Cir. 2013). And adding insult to
injury, compliance will make Florida complicit in an unlawful policy that it
fundamentally opposes, undermining its sovereignty.
69. Florida’s AHCA also faces an equally untenable choice. It is obligated
by contract and the mandate to survey participating facilities to verify compliance
with the mandate. If it refuses to comply, it stands to lose millions in federal funding.
And if it submits, it will be forced to expend additional resources while carrying out
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 25 of 36
26
CMS’s compliance checks, which it again cannot recover in a suit against the federal
government. See Chiles, 865 F.2d at 1209.
70. Further, the mandate will require private healthcare facilities in Florida
to bear the administrative cost of ensuring compliance with the mandate, which they
too cannot recover. Id. They will also lose employees who refuse to submit to
vaccination, further straining the resources of those facilities, injuring the public
health, and taxing Florida’s economy.
71. Finally, the Florida Legislature is currently contemplating legislation
that would prohibit vaccine mandates.
55
This legislation is likely to pass within the
next few days. Once it does, Florida will face an additional sovereign injury.
CLAIMS
COUNT 1
Agency action that is not in accordance with law
and is in excess of authority, in violation of the APA
72. Florida repeats and incorporates by reference ¶¶ 1–71.
73. Under the APA, a court must “hold unlawful and set aside agency
action” that is “not in accordance with law,” “in excess of statutory . . . authority, or
55
Governor DeSantis Joined By President Simpson and Speaker Sprowls to Announce Legislative
Agenda for Special Session of the Florida Legislature, Florida Governor’s Office (Nov. 8, 2021),
https://www.flgov.com/2021/11/08/governor-desantis-joined-by-president-simpson-and-speaker-
sprowls-to-announce-legislative-agenda-for-special-session-of-the-florida-legislature/.
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 26 of 36
27
limitations, or short of statutory right,” or “without observance of procedure required
by law.” See 5 U.S.C. § 706(2)(A), (C)–(D).
74. The mandate is contrary to law for at least two reasons.
75. First, the mandate violates 42 U.S.C. § 1395z because it was issued
without required consultation with the States.
76. Under § 1395z, CMS “shall consult with appropriate State agencies and
recognized national listing or accrediting bodies” in “carrying out [its] functions”
relating to “determination of conditions of participation” for many healthcare
providers subject to the mandate. 42 U.S.C. § 1395z.
56
CMS did not do so.
77. Second, the mandate exceeds CMS’s statutory authority.
78. Indeed, Congress speaks clearly when it “authoriz[es] an agency to
exercise powers of vast economic and political significance.” Ala. Ass’n of Realtors,
141 S. Ct. at 2489. And courts apply a presumption that Congress “preserves the
constitutional balance between the National Government and the States.” Bond v.
United States, 572 U.S. 844, 862 (2014). But nothing in the several provisions that
govern Medicaid and Medicare clearly authorizes a vaccine mandate.
56
Specifically, the consultation requirement applies to conditions of participation for hospitals
under § 1395x(e)(9), psychiatric hospitals under § 1395x(f)(4), skilled nursing facilities under
§§ 1395x(j) and 1395i-3, home health agencies under § 1395x(o)(6), comprehensive outpatient
rehabilitation facilities under § 1395x(cc)(2), hospices under § 1395x(dd)(2), critical access
hospitals under §§ 1395x(mm)(1) and 1395i-4(e), and ambulatory surgical centers under
§ 1395k(a)(2)(F)(i).
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 27 of 36
28
79. To the contrary, § 1395 makes clear that no federal officer may
“exercise any supervision or control” over (a) “the practice of medicine or the
manner in which medical services are provided,” (b) “the selection, tenure, or
compensation of any officer or employee of any institution, agency, or person
providing health services,” or (c) “the administration or operation of any such
institution, agency, or person.” 42 U.S.C. § 1395. The mandate does just that.
80. For these reasons, the mandate is contrary to law.
COUNT 2
Failure to conduct notice and comment in violation of the APA
81. Florida repeats and incorporates by reference ¶¶ 1–71.
82. The APA requires notice of, and comment on, agency rules that “affect
individual rights and obligations.” Chrysler Corp. v. Brown, 441 U.S. 281, 303
(1979); see 5 U.S.C. §§ 553, 706(2)(D). The Medicare and Medicaid schemes track
these requirements. See 42 U.S.C § 1395hh(b)(1).
83. CMS concedes that it did not engage in notice and comment. 86 Fed.
Reg. at 61,583. Instead, it invokes the “good cause” exception, which permits an
agency to waive notice and comment when it finds for “good cause” that the process
is “impracticable, unnecessary, or contrary to the public interest.” Id. at 61,583
(citing 5 U.S.C § 553(b)(B)). This standard is notoriously difficult to satisfy. See
Mack Trucks, Inc. v. EPA, 682 F.3d 87, 93 (D.C. Cir. 2012).
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 28 of 36
29
84. CMS relies on the COVID-19 pandemic for good cause, along with
related circumstances like the Delta variant. Id. at 61,583–84. Of course, no one
contests the seriousness of the COVID-19 pandemic. But after almost two years,
COVID-19 is a persistent feature of life and cannot itself constitute good cause. See
Becerra, 2021 WL 2514138, at *45; Regeneron Pharms., Inc. v. HHS, 510 F. Supp.
3d 29, 48 (S.D.N.Y. 2020). To hold otherwise would effectively repeal notice and
comment requirements for the duration of the pandemic.
85. In fact, CMS’s own delay is what caused its so-called emergency.
Vaccines have been available to healthcare workers for nearly a year. 86 Fed. Reg.
at 61,584.
57
But until now, CMS made no efforts to mandate vaccination. “Good
cause cannot arise as a result of the agency’s own delay.” Nat. Res. Def. Council v.
Nat’l Highway Traffic Safety Admin., 894 F.3d 95, 114 (2d Cir. 2018). And CMS
waited nearly three additional months between announcing the mandate and
publishing it.
86. CMS’s other good-cause justifications fare no better. Most prevalent, it
cites the possibility for a “more severe” flu season as support for good cause given
the risks of “coinfection” and increased “stress” on the healthcare system. See 86
57
Maggie Fox, Some Americans should start getting the first Covid-19 vaccine today. It will take
months before everyday people get the shots, CNN (Dec. 14, 2020),
https://www.cnn.com/2020/12/14/health/covid-vaccine-timeline/index.html (reporting that
healthcare workers would be eligible for vaccination in December 2020).
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 29 of 36
30
Fed. Reg. at 61,584. Yet in the next breath, CMS admits that “the intensity of the
upcoming 2021–2022 influenza season cannot be predicted” and that “influenza
activity during the 2020–2021 season was low throughout the U.S.” Id.
87. Moreover, notice and comment is needed to bolster the “fairness,
wisdom, and political legitimacy” of a rule of this magnitude. Becerra, 2021 WL
2514138, at *45 (quoting Hickman & Pierce, Administrative Law Treatise § 5.10
(6th ed. 2020)).
88. For these reasons, notice and comment was required.
COUNT 3
Arbitrary and capricious agency action in violation of the APA
89. Florida repeats and incorporates by reference ¶¶ 1–71.
90. Under the APA, a court must “hold unlawful and set aside agency
action” that is “arbitrary [or] capricious.” 5 U.S.C. § 706(2)(A). The mandate is
arbitrary and capricious for several reasons.
91. First, the mandate does not adequately consider the alternative of
testing requirements. See DHS v. Regents of the Univ. of Cal., 140 S. Ct. 1891, 1913
(2020). CMS claims to have “considered requiring daily or weekly testing of
unvaccinated individuals” instead of mandatory vaccination. 86 Fed. Reg. at 61,614.
But it dismisses this alternative in a cursory sentence, proclaiming that vaccination
is a “more effective infection control measure.” Id.
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 30 of 36
31
92. Second, CMS fails to “articulate a satisfactory explanation” for why its
mandate is “rational” given that unvaccinated workers may flee the industry. Motor
Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983).
93. Third, CMS fails to adequately consider the impact its mandate will
have on vaccination-education efforts. In Florida, those efforts have had great
success, sometimes raising vaccination rates by ten percent.
58
Yet CMS fails to
consider to what extent its mandate will “chill” individuals who might otherwise
take the vaccine voluntarily.
94. Fourth, CMS does not rationally connect its statistics to most of the
healthcare facilities covered by its mandate. Indeed, CMS recognizes that the
“providers and suppliers regulated under this rule are diverse in nature, management
structure, and size.” Id. at 61,602. Still, CMS relies mostly on facts and figures
involving long term care facilities—providers that serve mostly elderly or
immunocompromised patients—to justify applying the mandate to other providers.
See, e.g., id. at 61,585.
95. Fifth, CMS does not consider the rate at which “game-changing”
COVID-19 treatments minimize the more-serious health risks of COVID-19. Nor
58
Hannah Mitchell, ‘Like hand-to-hand combat’: Florida health system battles vaccine hesitancy
1 employee at a time, Becker’s Hospital Review (Nov. 4, 2021),
https://www.beckershospitalreview.com/hospital-management-administration/like-hand-to-hand-
combat-florida-health-system-battles-vaccine-hesitancy-1-employee-at-a-time.html.
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 31 of 36
32
does CMS consider the viability of state-by-state approaches to mandatory
vaccination, despite acknowledging that, in some States, COVID-19 cases “are
trending downward.” Id. at 61,583–84.
96. Sixth, CMS concludes that prior COVID-19 infection should not
qualify a covered employee for an exemption from the mandate because it is not
equivalent to receiving a COVID-19 vaccine. Id. at 61,559, 61,614. Elsewhere,
however, CMS recognizes the value of natural immunity. See id. at 61,604 (finding
natural immunity “reduce[s] the risk to both health care staff and patients
substantially”); id. (noting that those who recover are “in very rare cases still
infectious”).
97. Seventh, CMS inconsistently claims the mandate will protect patients
while recognizing, in its cost-benefit analysis, that “the effectiveness of the vaccine
to prevent disease transmission by those vaccinated [is] not currently known.” E.g.,
86 Fed. Reg. at 61,569, 61,615.
98. Eighth, CMS fails to consider the interests of millions of healthcare
workers who pursued their careers without knowing they would be subject to
mandated vaccination. Regents, 140 S. Ct. at 1913. And it ignores the reliance
interests of healthcare employers, including the States, who ordered their affairs
under the assumption that Medicaid and Medicare dollars would be available
without this onerous condition.
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 32 of 36
33
99. Ninth, the mandate is the product of political pressure, not measured
judgment. Aera Energy LLC v. Salazar, 642 F.3d 212, 220 (D.C. Cir. 2011). The
true impetus is clear: facing a scandal over his actions in Afghanistan, dismal
approval numbers on his COVID response, and an inability to advance his legislative
agenda, President Biden succumbed to pressure to control the healthcare decisions
of millions. He did so even though his Administration had assured the public that
vaccine mandates are “not the role of the federal government.”
59
100. Finally, CMS fails to adequately explain its extreme departure from its
prior practice of not mandating vaccines. See E. Bay Sanctuary Covenant v. Trump,
349 F. Supp. 3d 838, 858 (N.D. Cal. 2018); accord Regents, 140 S. Ct. at 1913.
101. For these reasons, the mandate is arbitrary and capricious.
COUNT 4
Violation of the Spending Clause
102. Florida repeats and incorporates by references ¶¶ 1–71.
103. The mandate is also an unconstitutional condition on Florida’s receipt
of federal funds.
“[I]f Congress intends to impose a condition on the grant of federal moneys,
it must do so unambiguously,” so “States [can] exercise their choice knowingly.”
59
Press Briefing by Press Secretary Jen Psaki, July 23, 2021, The White House (July 23, 2021),
https://www.whitehouse.gov/briefing-room/press-briefings/2021/07/23/press-briefing-by-press-
secretary-jen-psaki-july-23-2021/.
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 33 of 36
34
Pennhurst State Sch. & Hosp. v. Halderman, 451 U.S. 1, 17 (1981). Here, Florida
agreed to a lucrative contract, paying millions in federal funds, to enforce Medicare
and Medicaid requirements on healthcare providers. When it agreed to do so,
however, it was given no notice that it would have to enforce vaccination
requirements. Florida now faces the untenable choice of refusing to enforce the
mandate, and losing millions, or acquiescing. But the Spending Clause does not
allow the government to put Florida to this choice—any conditions must have been
disclosed to Florida from the beginning. Pennhurst, 451 U.S. at 17; cf. NFIB, 567
U.S. at 584.
104. For this reason, the mandate violates the Spending Clause.
COUNT 5
Declaratory judgment that the Biden Administration’s policy is unlawful
105. Florida repeats and incorporates by reference ¶¶ 1–71.
106. For the same reasons described in Counts 1–4, Florida is entitled to a
declaratory judgment that Defendants are violating the law.
PRAYER FOR RELIEF
For these reasons, Florida asks the Court to:
a) Hold unlawful and set aside the mandate.
b) Issue a temporary restraining order and preliminary and permanent
injunctive relief enjoining Defendants from enforcing the mandate.
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 34 of 36
35
c) Issue declaratory relief declaring Defendants’ actions unlawful.
d) Award Florida costs and reasonable attorney’s fees.
e) Award such other relief as the Court deems equitable and just.
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 35 of 36
36
Respectfully submitted,
Ashley Moody
ATTORNEY GENERAL
John Guard (FBN 374600)
CHIEF DEPUTY ATTORNEY GENERAL
James H. Percival (FBN 1016188)
DEPUTY ATTORNEY GENERAL OF LEGAL POLICY
Henry C. Whitaker (FBN 1031175)
SOLICITOR GENERAL
Daniel Bell (FBN 1008587)
CHIEF DEPUTY SOLICITOR GENERAL
/s/ David M. Costello
David M. Costello (FBN 1004952)
ASSISTANT SOLICITOR GENERAL
Natalie Christmas (FBN 1019180)
ASSISTANT ATTORNEY GENERAL OF LEGAL POLICY
Jason H. Hilborn (FBN 1008829)
DEPUTY SOLICITOR GENERAL
Office of the Attorney General
The Capitol, Pl-01
Tallahassee, Florida 32399-1050
(850) 414-3300
(850) 410-2672 (fax)
david.costell[email protected]
Counsel for the State of Florida
Case 3:21-cv-02722-MCR-HTC Document 1 Filed 11/17/21 Page 36 of 36
UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF FLORIDA
PENSACOLA DIVISION
STATE OF FLORIDA,
Plaintiff,
v. Case No. 3:21-cv-2722
DEPARTMENT OF HEALTH AND
HUMAN SERVICES, et al.,
Defendants.
_________________________________/
FLORIDA’S MOTION FOR A TEMPORARY
RESTRAINING ORDER OR PRELIMINARY INJUNCTION
Even before the COVID-19 pandemic, the healthcare industry faced a worker
shortage. The pandemic has made it far worse. Over half-a-million employees have
left the industry since the pandemic began, with hundreds more departing each day.
Rural America has been hit hardest. Despite this crisis, the Biden Administration has
given frontline healthcare workers an unrelenting ultimatum: submit to mandatory
COVID vaccination or lose your job.
For a myriad of reasons, many healthcare workers in Florida will refuse the
vaccine and be forced into unemployment, triggering a cascade of harmful effects
across the State. Healthcare staffing rates will plummet, especially in rural areas.
Florida will struggle to care for its disabled; its veterans will find it harder to obtain
admission to nursing homes; prisoners will face delays in obtaining emergency
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 1 of 37
2
medical services; the mentally incompetent will spend more time in jail as treatment
facilities work through the backlog; and the sick and vulnerable will receive inferior
care.
These ills would have been readily apparent had the federal government
followed the procedural protections designed to prevent this type of hasty decision-
making. Had the Administration, for example, consulted with the States as required
by law, Florida would have informed the government of the terrible effects the
mandate would have. Similarly, had the government conducted notice and
comment—rather than deploying an implausible “good cause” finding—the public
would have explained the many drawbacks of the mandate.
Instead, the Biden Administration published an interim final rule on
November 5 that requires covered employees to receive their first dose by December
6. To prevent the many harms that will accompany that deadline, Florida requests a
preliminary injunction before December 6 and a temporary restraining order if the
Court cannot afford preliminary relief by then.
BACKGROUND
Medicare and Medicaid
Medicare and Medicaid are federal programs that pay medical expenses for
certain individuals. Medicare is an insurance program that covers medical bills for
elderly and disabled individuals; Medicaid is an assistance program that pays
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 2 of 37
3
medical bills for low-income individuals.
1
The Centers for Medicare & Medicaid
Services (CMS) primarily administers Medicare and partners with States to
administer Medicaid. See Douglas v. Indep. Living Ctr. of S. Cal., Inc., 565 U.S.
606, 610 (2012) (discussing CMS’s role in Medicaid); Cape Cod Hosp. v. Sebelius,
630 F.3d 203, 205 (D.C. Cir. 2011) (discussing CMS’s role in Medicare).
To be eligible to receive payments from either Medicare or Medicaid,
participating providers must agree to comply with federally imposed conditions of
participation, coverage, or certification. E.g., 42 U.S.C. §§ 1395cc(b)(2),
1396a(a)(33)(B). Some requirements are created by statute. E.g., id. § 1395x. Others
are created by CMS regulations. E.g., 42 C.F.R. part 482.
To ensure compliance with these conditions, CMS contracts with state health
agencies to “survey” participating providers. 42 U.S.C. §§ 1395aa(a),
1396a(a)(33)(B). Florida is no exception—its Agency for Health Care
Administration (AHCA) surveys participating providers on behalf of CMS. Ex. 1
¶¶ 5–7.
1
What is the difference between Medicare and Medicaid, HHS,
https://www.hhs.gov/answers/medicare-and-medicaid/what-is-the-difference-between-medicare-
medicaid/index.html.
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 3 of 37
4
Current State of the Healthcare Industry
Reeling from the COVID-19 pandemic, the healthcare industry is facing the
“worst U.S. health-care labor crisis in memory.”
2
Frontline workers—who
unwaveringly faced the worst days of the pandemic—are experiencing
unprecedented levels of exhaustion and fatigue, with almost 30% considering
leaving the medical field
3
and over 500,000 having done so already.
4
Further
exacerbating this crisis, many have left healthcare facilities for private staffing
companies that can promise higher wages,
5
causing many facilities to turn to these
private companies to fill the gaps—often paying an exorbitant premium.
6
All this has put the healthcare industry on life support. For example, last
month about 16% of U.S. hospitals reported “critical staffing shortages.”
7
In some
2
Carey Goldberg & Jonathan Levin, Vaccine Mandates Hit Amid Historic Health-Care Staff
Shortage, Bloomberg (Oct. 2, 2021), https://www.bloomberg.com/news/articles/2021-10-
02/vaccine-mandates-hit-amid-historic-health-care-staff-shortage.
3
Dharam Kaushik, Medical burnout: Breaking bad, AAMC (June 4, 2021),
https://www.aamc.org/news-insights/medical-burnout-breaking-bad.
4
Mallory Hackett, Healthcare lost 17,500 jobs in September amid ongoing labor shortage,
Healthcare Finance (Oct. 11, 2021), https://www.healthcarefinancenews.com/news/healthcare-
lost-17500-jobs-september-amid-ongoing-labor-shortage.
5
Leticia Miranda, Rural hospitals losing hundreds of staff to high-paid traveling nurse jobs, NBC
News (Sept. 15, 2021), https://www.nbcnews.com/business/business-news/rural-hospitals-losing-
hundreds-staff-high-paid-traveling-nurse-jobs-n1279199.
6
Bertha Coombs, Regulations slow urgent hiring of doctors and nurses amid coronavirus
outbreak, staffing firms say, CNBC (Mar. 28, 2020),
https://www.cnbc.com/2020/03/28/coronavirus-regulations-slow-hiring-of-doctors-and-nurses-
staffing-firms-say.html.
7
Carey Goldberg & Jonathan Levin, Vaccine Mandates Hit Amid Historic Health-Care Staff
Shortage, Bloomberg (Oct. 2, 2021), https://www.bloomberg.com/news/articles/2021-10-
02/vaccine-mandates-hit-amid-historic-health-care-staff-shortage.
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 4 of 37
5
places, as many as 25% of beds are going unfilled because the facilities lack adequate
staffing.
8
And rural areas are bearing a disproportionate share of the burden, making
up 60% of staffing shortages nationwide
9
despite serving less than 20% of the
population.
10
Florida has not been immune to this crisis. For instance, 92% of long term
care facilities in Florida face a staffing crunch; for 75% of them, it is “the number
one concern.”
11
And Florida’s vacancy rate for nurses is 11%—more than a full
percentage point above the national average.
12
A vaccine mandate threatens to make these dire conditions worse. As of a few
months ago, 40–50% of hospital employees in Florida had not been vaccinated.
13
And in rural areas, the statistics are even bleaker, with some reports showing that
8
Id.
9
Aallyah Wright, Rural Hospitals Can’t Find the Nurses They Need to Fight COVID, Stateline
(Sept. 1, 2021), https://www.pewtrusts.org/en/research-and-
analysis/blogs/stateline/2021/09/01/rural-hospitals-cant-find-the-nurses-they-need-to-fight-covid.
10
Rural Report: Challenges Facing Rural Communities and the Roadmap to Ensure Local Access
to High-quality, Affordable Care, American Hospital Association at 2,
https://www.aha.org/system/files/2019-02/rural-report-2019.pdf.
11
Jake Stofan, Health care industry asking Florida lawmakers to address chronic staffing
shortages, WFLA (Nov. 1, 2021), https://www.wfla.com/news/florida/health-care-industry-
asking-florida-lawmakers-to-address-chronic-staffing-shortages/.
12
Id.
13
Liz Crawford, AHCA: 42% of Florida hospital workers weren’t vaccinated, as of June 4, WTSP
(July 22, 2021), https://www.wtsp.com/article/news/health/coronavirus/vaccine/hospital-workers-
not-vaccinated/67-9e842ff1-e5b0-4f1f-8f9f-ccfec865ccbf; David Bauerlein, UF Health
Jacksonville finding widespread vaccine hesitancy among its own staff, Jacksonville.com (July 23,
2021), https://www.jacksonville.com/story/news/2021/07/23/uf-health-ceo-says-overcoming-
vaccine-hesitancy-challenge-among-staff/8075987002/.
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 5 of 37
6
30% of rural hospitals nationwide have less than half of their employees
vaccinated.
14
Healthcare administrators are already preparing for the fallout of a vaccine
mandate. One Florida-based administrator estimates that a mandate would cause him
to “lose 10 to 15 percent of [his] staff.”
15
Indeed, a recent study confirms his fears,
reporting that 37% of unvaccinated workers would leave their jobs if their employers
mandated vaccination or weekly testing and 72% would leave if the only option were
vaccination.
16
The Biden Administration’s Actions
On September 9, 2021, President Biden announced three sweeping and
unprecedented initiatives aimed at compelling roughly two-thirds of American
workers to receive a COVID-19 vaccine.
17
Florida has already challenged two of the
initiatives—the Occupational Safety and Health Administration (OSHA) mandate
and the federal contractor mandate—and challenges the third here.
14
Tamara Keith, Why Lagging COVID Vaccine Rate At Rural Hospitals ‘Needs To Be Fixed Now’,
NPR (May 4, 2021), https://www.npr.org/2021/05/04/993270974/why-lagging-covid-vaccine-
rate-at-rural-hospitals-needs-to-be-fixed-now.
15
Hannah Mitchell, ‘Like hand-to-hand combat’: Florida health system battles vaccine hesitancy
1 employee at a time, Becker’s Hospital Review (Nov. 4, 2021),
https://www.beckershospitalreview.com/hospital-management-administration/like-hand-to-hand-
combat-florida-health-system-battles-vaccine-hesitancy-1-employee-at-a-time.html.
16
Liz Hamel et al., KFF COVID-19 Vaccine Monitor: October 2021, KFF (Oct. 28, 2021),
https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-october-
2021/.
17
Remarks by President Biden on Fighting the COVID-19 Pandemic, The White House (Sept. 9,
2021), https://www.whitehouse.gov/briefing-room/speeches-remarks/2021/09/09/remarks-by-
president-biden-on-fighting-the-covid-19-pandemic-3/.
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 6 of 37
7
On November 5, 2021, as directed by the President, CMS published an interim
final rule titled “Omnibus COVID-19 Health Care Staff Vaccination.” 86 Fed. Reg.
61,555 (Nov. 5, 2021). The mandate directs participating facilities to ensure that
covered employees submit to COVID-19 vaccination unless the employees are
eligible for a religious or medical exemption. Id. at 61,570–73. Whether employees
opt for a single-dose or double-dose vaccine, they must receive their first shot by
December 6. Id. at 61,573. Participating facilities must track vaccination status of
their employees. Id. at 61,572.
In the mandate, CMS claims to have considered “concerns about health care
workers choosing to leave their jobs rather than be vaccinated,” yet ultimately finds
there is “insufficient evidence to quantify and compare” that effect with “absences
due to quarantine for known COVID-19 exposures and illness.” Id. at 61,569. CMS
concedes there “might be a certain number of health care workers who choose” to
leave the medical field because of the mandate. Id. And CMS admits that current
“endemic staff shortages . . . may be made worse if any substantial number of
unvaccinated employees leave health care employment altogether.” Id. at 61,607.
CMS also recognizes that participating facilities range dramatically in
“nature, management structure, and size.” Id. at 61,602. Even so, CMS relies mostly
on facts and figures involving long term care facilities—providers who primarily
serve elderly or immunocompromised patients—to justify applying the mandate to
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 7 of 37
8
other providers. See, e.g., id. at 61,585 (discussing “case rates among [long term care]
facility residents,” and claiming, without citation, that those facilities’ “experience
may generally be extrapolated to other settings”).
CMS claims to have “considered requiring daily or weekly testing of
unvaccinated individuals” instead of mandatory vaccination but, in a single sentence,
concludes that vaccination is a “more effective infection control measure.” Id. at
61,614. The OSHA mandate, in contrast, includes a weekly testing alternative. See
COVID-19 Vaccination and Testing; Emergency Temporary Standard, 86 Fed. Reg.
61,402, 61,450 (Nov. 5, 2021). Indeed, despite concluding that testing is “not as
effective as vaccination,” OSHA permitted testing because it is “still effective” and
because OSHA had concerns about imposing a “strict vaccination mandate with no
alternative” on such short notice given the potential “economic and health impacts”
of such a decision.
18
Id. at 61,433, 61,436.
CMS similarly claims to have considered limiting vaccination requirements
to those who have not been infected with COVID-19, but cursorily concludes that
prior infection is not equivalent to vaccination. 86 Fed. Reg. at 61,614. Even so,
CMS recognizes that those who recover are “in very rare cases still infectious.” Id.
18
OSHA also could not establish a “grave danger” to most healthcare workers because it found
that a rule it passed in June—which requires precautionary measures but does not mandate
vaccines—is adequate to protect against COVID-19 risk. 86 Fed. Reg. at 61,421. CMS did not
acknowledge this finding.
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 8 of 37
9
at 61,604. And indeed, a highly reported study from Israel found that “natural
immunity confers longer lasting and stronger protection” against the Delta variant
than vaccination.
19
All these considerations brushed aside, CMS barrels through to its ultimate
conclusion that a vaccine mandate is the only measure adequate to combat the
pandemic. Id. at 61,560 (“[W]e are compelled to require staff vaccinations for
COVID-19.”). While the mandate relies on the existence of a declared public health
emergency to justify much of its reasoning, CMS admits that this is not its true basis,
previewing that the mandate will be “a permanent requirement for facilities.” Id. at
61,574.
Despite the unprecedented nature of mandatory vaccinations—indeed, CMS
acknowledges that it has “not previously required” vaccinations as a condition for
participation—CMS issued the mandate as an interim final rule without notice and
comment. Id. at 61,567. In support of “good cause” to dispense with notice and
comment, CMS’s points to the “strain on the health care system” caused by the
pandemic, id. at 61,584, the “emergence of the Delta variant,” id. at 61,583, and the
upcoming flu season, id. at 61,584. CMS admits, however, that vaccines first became
19
See Sivan Gazit et al., Comparing SARS-CoV-2 Natural Immunity to Vaccine-Induced Immunity:
Reinfections Versus Breakthrough Infections, medRxiv (2021 preprint),
https://www.medrxiv.org/content/10.1101/2021.08.24.21262415v1.
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 9 of 37
10
available in December 2020—almost a year ago—and that “health care workers
were among the first groups provided access to vaccinations.” Id. at 61,584.
CMS also declined to comply with its statutory obligation to consult with
appropriate state agencies. See 42 U.S.C. § 1395z. But unlike for notice and
comment, there is no “good cause” exception to that requirement. Despite attempting
to regulate countless state agencies, CMS concludes that there is no “entity with
which it would be appropriate to engage in these consultations in advance of issuing”
the mandate. 86 Fed. Reg. at 61,568.
Eventually, CMS intends to issue “interpretive guidelines” that outline
“enforcement remedies” for facilities that do not comply with the mandate. Id. at
61,574. Remedies will include “civil money penalties, denial of payments for new
admissions, or termination of their Medicare/Medicaid provider agreement.” Id. A
senior White House official has made clear that CMS “will not hesitate to use [its]
full enforcement authority” to carry out the mandate.
20
CMS, however, does not intend to enforce the mandate alone—it expects the
States to help. Consistent with their contracts with CMS, see 42 U.S.C. § 1395aa(a);
20
Background Press Call on OSHA and CMS Rules for Vaccination in the Workplace, The White
House (Nov. 3, 2021), https://www.whitehouse.gov/briefing-room/press-
briefings/2021/11/04/background-press-call-on-osha-and-cms-rules-for-vaccination-in-the-
workplace/.
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 10 of 37
11
Ex. 1 ¶¶ 5–6, 11, States must verify that healthcare facilities operating in their
borders comply with the mandate. 86 Fed. Reg. at 61,574.
Irreparable Harm to Florida
If Florida does not comply with the mandate, it faces civil penalties and loss
of funding for state-run facilities. For example, Medicare-Medicaid accounts for
roughly a quarter of the funding for State Veterans Nursing Homes run by Florida’s
Department of Veterans’ Affairs. Ex. 5 10. Moreover, individuals insured by
Medicare and Medicaid would lose access to these facilities. If the Department of
Health were to lose funding for its qualified health centers, for instance, patients in
lower-income and rural areas would need to travel up to 60 miles for prenatal
services. Ex. 3 ¶¶ 12, 14.
The harm to Florida extends beyond its own healthcare facilities. The Florida
Department of Corrections relies on private hospitals to provide emergency medical
services to inmates. Ex. 4 ¶¶ 7–9, 19–20. At these hospitals, corrections officers must
be present to protect the safety of medical personnel and other patients. Id. ¶¶ 10–
11. But the mandate requires vaccination of these officers before they can enter the
hospital. Id. ¶¶ 4, 13. The Department of Corrections expects the mandate to cause
delays in obtaining emergency medical services for inmates, which could be
catastrophic to prisoner health and subject the Department to liability for Eighth
Amendment violations. Id. ¶¶ 16–18.
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 11 of 37
12
If Florida instead chooses to comply with the mandate, it similarly faces
irreparable harm. Healthcare facilities across the state are suffering from staffing
shortages. Ex. 4 12; Ex. 2 10; Ex. 5 9; Ex. 6 ¶¶ 16, 29. This is especially true
in Florida’s rural areas, which have an inherently limited workforce. Ex. 2 ¶ 10; Ex.
6 ¶¶ 6, 16, 29; supra at 5–6. And since many Florida employees would leave if faced
with mandatory vaccination, compliance would decrease already limited staff
numbers. Ex. 6 18 (staff survey suggests a ten percent loss of staff if mandate takes
effect).
Resulting staff shortages pose two problems for Florida. First, facilities would
be forced to turn to private contractors to fill staffing gaps at a much higher cost. Ex.
5 ¶¶ 9, 11; Ex. 6 ¶¶ 15, 21. Second, if facilities were unable to curb the staffing
shortage, they would be unable to provide the same level of care. Florida’s
Department of Veterans’ Affairs, for instance, may need to reduce occupancy at its
facilities, forcing veterans onto a waiting list for critical services. Ex. 5 12. The
Department of Children and Families, meanwhile, would be unable to provide
effective treatment programs or safe environments for the mentally incompetent,
meaning they would remain imprisoned until a vacancy arises. Ex. 2 11–14. At the
same time, the Department of Health would need to “cancel[] or significantly
delay[]” many healthcare services in rural areas. Ex. 3 19. And the Agency for
Persons with Disabilities would need to decrease emphasis on direct care and shift
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 12 of 37
13
employees to different roles, risking even greater employee burnout and providing
less tailored methods of treatment. Ex. 6 ¶¶ 21, 25.
In some cases, a decrease in staff would even put the facilities in jeopardy of
failing to comply with state and federal legal requirements, like patient-staff ratios.
See id. ¶¶ 11–13 (citing 42 C.F.R. § 483.430(c)–(d)), 20. Failure to provide adequate
care could also place facilities at risk of emergency action for Immediate Jeopardy—
a CMS enforcement mechanism that could result in fines or complete exclusion from
the Medicaid-Medicare programs. See id. ¶¶ 9–10 (citing 42 C.F.R. part 442).
Adding insult to injury, the mandate also requires AHCA to ensure
compliance at public and private facilities statewide. Ex. 1 ¶ 5. AHCA thus faces an
untenable choice between losing federal funds or allocating resources to enforce the
unlawful mandate. Id. ¶¶ 9–11.
Because Defendants imposed a deadline of December 6 for individuals to
receive a vaccination and for facilities to have policies in place to track employee
vaccination status, Florida’s irreparable harm is imminent.
ARGUMENT
A plaintiff seeking a temporary restraining order or preliminary injunction
must establish (1) “that he is likely to succeed on the merits,” (2) “that he is likely
to suffer irreparable harm in the absence of preliminary relief,” (3) “that the balance
of equities tips in his favor,” and (4) “that an injunction is in the public interest.”
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 13 of 37
14
Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7, 20 (2008); accord Schiavo ex rel.
Schindler v. Schiavo, 403 F.3d 1223, 1225–26 (11th Cir. 2005) (explaining that the
same standard applies to temporary restraining orders).
21
I. FLORIDA IS LIKELY TO SUCCEED ON THE MERITS OF ITS CLAIMS.
a. The challenged actions are contrary to law and in excess of statutory
authority.
Under the Administrative Procedure Act (APA), courts must “hold unlawful
and set aside agency action” that is “not in accordance with law,” “in excess of
statutory . . . authority, or limitations, or short of statutory right,” or “without
observance of procedure required by law.” See 5 U.S.C. § 706(2)(A), (C)–(D).
Because the mandate violates multiple statutes, CMS has “gone beyond what
Congress has permitted it to do.” City of Arlington v. FCC, 569 U.S. 290, 298 (2013).
i. CMS failed to consult with appropriate state agencies before
issuing the mandate.
Under § 1395z, CMS “shall consult with appropriate State agencies and
recognized national listing or accrediting bodies” in “carrying out [its] functions”
relating to “determination of conditions of participation” for many healthcare
providers subject to the mandate. 42 U.S.C. § 1395z.
22
CMS also “may consult with
21
Upon filing, Florida will notify the U.S. Department of Justice and the U.S. Attorney for the
Northern District of Florida via email.
22
Specifically, the consultation requirement applies to conditions of participation for hospitals
under 42 U.S.C. § 1395x(e)(9), psychiatric hospitals under § 1395x(f)(4), skilled nursing facilities
under §§ 1395x(j) and 1395i-3, home health agencies under § 1395x(o)(6), comprehensive
outpatient rehabilitation facilities under § 1395x(cc)(2), hospices under § 1395x(dd)(2), critical
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 14 of 37
15
appropriate local agencies.” Id. CMS did not do so. Instead, CMS does not
“understand the statute to impose a temporal requirement to do so in advance of the
issuance of” the mandate. 86 Fed. Reg. at 61,567.
The problem for CMS, however, is that the text of § 1395z requires the
consultation to occur before new conditions are promulgated. The statute describes
the required consultation as “relating to determination of conditions of participation
by providers of services.” 42 U.S.C. § 1395z (emphasis added). A “determination”
is “[t]he act of deciding something officially.” Determination, Black’s Law
Dictionary (11th. ed. 2019). The provision’s title confirms this meaning by referring
to “[c]onsultation with State agencies . . . to develop conditions of participation.” 42
U.S.C. § 1395z (emphasis added). Consultation after the conditions have been set,
as CMS did here, thus violates § 1395z.
CMS also attempts to justify its dereliction by asserting that there is no state
agency that is “appropriate” for CMS to consult with. 86 Fed. Reg. at 61,567. Yet
CMS misunderstands the meaning of “appropriate” in the statutory phrase requiring
it to “consult with appropriate State agencies.” 42 U.S.C. § 1395z. The word
“appropriate” merely expresses that certain state agencies—those connected with
Medicare and Medicaid—are the agencies that CMS must consult with. It does not
access hospitals under §§ 1395x(mm)(1) and 1395i-4(e), and ambulatory surgical centers under
§ 1395k(a)(2)(F)(i).
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 15 of 37
16
invite CMS to decide for itself whether consultation is “appropriate” given the
circumstances. If consultation with state agencies were optional, or at CMS’s
discretion, Congress would not have used the mandatory “shall” to describe
consultation with state agencies and the discretionary “may” to describe consultation
with local agencies. See Jennings v. Rodriguez, 138 S. Ct. 830, 844 (2018) (“Unlike
the word ‘may,’ which implies discretion, the word ‘shall’ usually connotes a
requirement.”); NFIB v. Sebelius, 567 U.S. 519, 544 (2012) (“Where Congress uses
certain language in one part of a statute and different language in another, it is
generally presumed that Congress acts intentionally.”).
Because the government failed to consult with States, including Florida, the
mandate violates § 1395z.
ii. The mandate exceeds CMS’s statutory authority.
Congress speaks clearly when it “authoriz[es] an agency to exercise powers
of vast economic and political significance.” Ala. Ass’n of Realtors v. HHS, 141 S.
Ct. 2485, 2489 (2021). And courts apply a presumption that Congress “preserves the
constitutional balance between the National Government and the States.” Bond v.
United States, 572 U.S. 844, 862 (2014). Moreover, Spending Clause legislation,
like the Medicare and Medicaid programs, is “binding on States only insofar as it is
‘unambiguous.’” Wos v. E.M.A. ex rel. Johnson, 568 U.S. 627, 654 (Roberts, C.J.,
dissenting) (quoting Pennhurst State Sch. & Hosp. v. Halderman, 451 U.S. 1, 17
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 16 of 37
17
(1981)). CMS’s position, however, wrongly assumes that Congress would authorize
a vaccine mandate for an entire industry—treading on the police powers of the
States—in a “cryptic . . . fashion.” FDA v. Brown & Williamson Tobacco Corp., 529
U.S. 120, 160–61 (2000).
CMS first cites its general rulemaking powers. See 86 Fed. Reg. at 61,567
(citing 42 U.S.C. §§ 1302(a), 1395hh(a)(1)). But these provisions merely authorize
the Secretary of HHS to “make and publish such rules and regulations . . . as may be
necessary to the efficient administration of the functions with which [he] is charged
under” the Social Security Act, 42 U.S.C. § 1302(a), and to “prescribe such
regulations as may be necessary to carry out the administration of the” Medicare
program, id. § 1395hh(a)(1). These provisions raise two problems for CMS.
First, “necessary” is a “word of limitation” and is synonymous with
“required,” “indispensable,” and “essential.” Vorcheimer v. Phila. Owners Assoc.,
903 F.3d 100, 105 (3d Cir. 2018); accord In re Microsoft Corp. Antitrust Litig., 355
F.3d 322, 327 (4th Cir. 2004). And nothing about the mandate is “essential” for the
“efficient administration” of Medicaid or “to carry out the administration” of
Medicare. Id. §§ 1302(a), 1395hh(a)(1). In short, CMS appears to assume that the
word “necessary” is far more capacious than its plain meaning.
Second, the two general grants of rulemaking authority cannot grant CMS this
authority on their own. Instead, CMS must identify the specific statutes governing
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 17 of 37
18
Medicare and Medicaid that it believes it is “administ[ering]” or “carry[ing] out. Id.
Attempting to do so, CMS runs through a variety of provisions, each of which is
specific to particular categories of facilities. 86 Fed. Reg. at 61,567. None of these
provisions authorizes the mandate.
As a preliminary matter, the significant variances provision-to-provision call
into question the wisdom—as well as the legality—of issuing a singular mandate
applicable to so many different facilities. In any event, none of these provisions
authorize the mandate. And to prevail, CMS would need to identify adequate
statutory authority for each type of facility, which it certainly cannot do.
CMS points to several provisions that merely define certain types of services.
See 86 Fed. Reg. at 61,567 (citing 42 U.S.C. §§ 1396d(h)(1)(B)(i), 1396d(d)(1),
1395x(iii)(3)(D)(i)(IV), 1395x(aa)(2)(K), 1395x(p)(4)(A)(v), 1395x(ff)(3)(B)(iv),
1395x(e)(9), 1395x(dd)(2)(G), 1395x(cc)(2)(J), 1395x(o)(6)). For example, one
defines a “qualified home infusion therapy supplier” to include an entity that “meets
such other requirements as the Secretary determines appropriate.” Id.
§ 1395x(iii)(3)(D)(i)(IV). But even assuming Congress buried a grant of authority
in a definitional provision—rather than merely acknowledging that the Secretary
may impose requirements by some separate authority—this provision says nothing
about vaccine mandates and is far too nebulous to satisfy the clear statement rule
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 18 of 37
19
applicable here. See Whitman v. Am. Trucking Ass’ns, 531 U.S. 457, 468 (2001)
(explaining that Congress does not “hide elephants in mouseholes”).
CMS also points to provisions governing the criteria for certification of a
facility, preconditions for facilities to receive payment, and types of services
provided. See 42 U.S.C. §§ 1395i-4(e), 1395i-3(d)(4)(B), 1395bbb, 1395rr(b)(1)(A),
1395k(a)(2)(F)(i), 1395eee(f), 1396u-4(f). To illustrate, one provision states that “[a]
skilled nursing facility must meet such other requirements relating to the health,
safety, and well-being of residents or relating to the physical facilities thereof as the
Secretary may find necessary.” Id. § 1395i-3(d)(4)(B). Again, this language does not
clearly authorize an industry-wide vaccine mandate.
If anything, the statute forecloses CMS’s position. Section 1395 makes clear
that no federal officer may “exercise any supervision or control” over (a) “the
practice of medicine or the manner in which medical services are provided,” (b) “the
selection, tenure, or compensation of any officer or employee of any institution,
agency, or person providing health services,” or (c) “the administration or operation
of any such institution, agency, or person.” 42 U.S.C. § 1395. The mandate does just
that. It seeks to compel participating facilities to require employees to receive a
vaccine, track and gather data about employee vaccination status, and terminate
employees who refuse to comply. 86 Fed. Reg. at 61,571–72.
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 19 of 37
20
Given the clear statement rule that applies to CMS’s sweeping mandate, and
the clarification provided by § 1395, the mandate exceeds CMS’s authority.
b. Defendants failed to conduct notice and comment.
The APA requires notice of, and comment on, agency rules that “affect
individual rights and obligations.” Chrysler Corp. v. Brown, 441 U.S. 281, 303
(1979); see 5 U.S.C. §§ 553, 706(2)(D). The Medicare and Medicaid schemes track
these requirements. See 42 U.S.C § 1395hh(b)(1).
CMS concedes that it did not engage in notice and comment. 86 Fed. Reg. at
61,583. Instead, it invokes the “good cause” exception, which permits an agency to
waive notice and comment when it finds for “good cause” that the process is
“impracticable, unnecessary, or contrary to the public interest.” Id. (citing 5 U.S.C
§ 553(b)(B)). This standard is notoriously difficult to satisfy. See Mack Trucks, Inc.
v. EPA, 682 F.3d 87, 93 (D.C. Cir. 2012).
CMS relies on the COVID-19 pandemic for good cause, along with related
circumstances like the Delta variant. 86 Fed. Reg. at 61,583–84. Of course, no one
contests the seriousness of the COVID-19 pandemic. But after almost two years,
COVID-19 is a persistent feature of life and cannot itself constitute good cause. See
Florida v. Becerra, 8:21-cv-839, 2021 WL 2514138, at *45 (M.D. Fla. June 18,
2021); Regeneron Pharms., Inc. v. HHS, 510 F. Supp. 3d 29, 48 (S.D.N.Y. 2020).
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 20 of 37
21
To hold otherwise would effectively repeal notice and comment requirements for
the duration of the pandemic.
Tellingly, CMS invoked many of the same concerns to justify a finding of
good cause in an interim final rule published six months ago, namely the existence
of a public health emergency, the need to protect vulnerable patient populations, and
strain on the healthcare industry. See Medicare and Medicaid Programs; COVID-19
Vaccine Requirements for Long-Term Care (LTC) Facilities and Intermediate Care
Facilities for Individuals with Intellectual Disabilities (ICFs-IID) Residents, Clients,
and Staff, 86 Fed. Reg. 26,306, 26,320–21 (May 13, 2021). If the same conditions
were present nearly six months ago, it strains credulity to assert them now. See
Chamber of Commerce v. SEC, 443 F.3d 890, 908 (D.C. Cir. 2006) (“The [good
cause] exception excuses notice and comment in emergency situations.” (emphasis
added)).
In fact, CMS’s own delay is what caused its so-called emergency. Vaccines
have been available to healthcare workers for nearly a year. 86 Fed. Reg. at 61,584.
23
But until now, CMS made no efforts to mandate vaccination. “Good cause cannot
23
Maggie Fox, Some Americans should start getting the first Covid-19 vaccine today. It will take
months before everyday people get the shots, CNN (Dec. 14, 2020),
https://www.cnn.com/2020/12/14/health/covid-vaccine-timeline/index.html (reporting that
healthcare workers would be eligible for vaccination in December 2020).
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 21 of 37
22
arise as a result of the agency’s own delay,” Nat. Res. Def. Council v. Nat’l Highway
Traffic Safety Admin., 894 F.3d 95, 114 (2d Cir. 2018).
Further undercutting CMS’s good cause is its nearly three-month delay
between announcing the mandate and publishing it. See Regeneron, 510 F. Supp. 3d
at 48 (CMS’s two-month delay “suggest[ed] a lack of urgency” that belied a finding
of good cause). President Biden first announced a CMS vaccine mandate on August
18, gave specifics about the one here on September 9, and finally published the
mandate on November 5. CMS therefore took longer to issue the mandate than
participating facilities have to meet its terms. This delay “suggests a lack of urgency”
incompatible with a genuine finding of good cause. Id.
On top of this, CMS does not appear to believe its own good-cause rationale.
To underscore that the pandemic justifies good cause, CMS relies heavily on the
declared public health emergency. E.g., 86 Fed. Reg. at 61,583. Yet CMS disclaims
the public health emergency as justification for the mandate and makes clear that the
mandate will continue to apply even after the public health emergency terminates.
See id. at 61,574. Put differently, that the mandate is a lasting one, rather than a
limited measure during a public health emergency, contradicts CMS’s good-cause
explanation.
CMS’s other good-cause justifications fare no better. Most prevalent, it cites
the possibility for a “more severe” flu season as support for good cause given the
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 22 of 37
23
risks of “coinfection” and increased “stress” on the healthcare system. See id. at
61,584. Yet in the next breath, CMS admits that “the intensity of the upcoming
2021–2022 influenza season cannot be predicted” and that “influenza activity during
the 2020–2021 season was low throughout the U.S.” Id.
Moreover, notice and comment is needed to bolster the “fairness, wisdom, and
political legitimacy” of a rule of this magnitude. Becerra, 2021 WL 2514138, at *45
(quoting Hickman & Pierce, Administrative Law Treatise § 5.10 (6th ed. 2020)). The
“more expansive the regulatory reach of” a rule, “the greater the necessity for public
comment” to allow those affected to be heard. Am. Fed’n of Gov’t Emp. v. Block,
655 F.2d 1153, 1156 (D.C. Cir. 1981). And there is no overlooking the magnitude
of this rule. CMS has “not previously required” mandatory vaccination for the
healthcare industry. 86 Fed. Reg. at 61,567. In fact, no federal agency has ever
mandated vaccination for a private industry. The mandate represents a sea change in
prior practices, meaning that CMS lacks historical perspective about the effect its
mandate will have. See Harris v. McRae, 448 U.S. 297, 308–09 (1980).
And indeed, the notice and comment process is even more vital in the context
of Medicare and Medicaid. These programs “touch[] the lives of nearly all
Americans,” and are two of the “largest federal program[s]” in the country. See Azar
v. Allina Health Servs., 139 S. Ct. 1804, 1808 (2019). Even “minor changes” to the
way the programs are administered “can impact millions of people and billions of
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 23 of 37
24
dollars in ways that are not always easy for regulators to anticipate.” Id. at 1816.
“Recognizing this reality,” id. at 1808, Congress doubled the standard 30-day
comment period for changes to the “substantive legal standard” affecting the
payment for services. 42 U.S.C. § 1395hh(a)(2), (b)(1); see also id.
§ 1395hh(e)(1)(B)(i) (providing for a 30-day delay in effective date for retroactive
applications). That provision applies here, and so good cause should be especially
difficult to establish.
The Biden Administration claims this is a “once-in-a-generation pandemic.”
24
But it is equally true that this is a once-in-a-generation mandate. Notice and
comment was required.
c. The mandate is arbitrary and capricious.
Under the APA, a court must “hold unlawful and set aside agency action” that
is “arbitrary [or] capricious.” 5 U.S.C. § 706(2)(A). The mandate is arbitrary and
capricious for several reasons.
First, the mandate does not adequately consider the alternative of testing
requirements. See DHS v. Regents of the Univ. of Cal., 140 S. Ct. 1891, 1913 (2020).
CMS claims to have “considered requiring daily or weekly testing of unvaccinated
individuals” instead of mandatory vaccination. 86 Fed. Reg. at 61,614. But it
24
Press Briefing by Press Secretary Jen Psaki, July 27, 2021, The White House (July 27, 2021),
https://www.whitehouse.gov/briefing-room/press-briefings/2021/07/27/press-briefing-by-press-
secretary-jen-psaki-july-27-2021/.
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 24 of 37
25
dismisses this alternative in a cursory sentence, proclaiming that vaccination is a
“more effective infection control measure.” Id. This mere lip service to a less-
restrictive alternative—one that OSHA found “effective” given the short timeframe
and the unknown “economic and health impacts” of a strict vaccine mandate, 86 Fed.
Reg. at 61,433, 61,436—is insufficient. So is CMS’s failure to grapple with OSHA’s
finding that it could not establish any “grave danger” to most healthcare workers so
long as they complied with the COVID-19 precautions outlined in OSHA’s June
ETS. Id. at 61,421.
Second, CMS fails to “articulate a satisfactory explanation” for why its
mandate was “rational” given that unvaccinated workers may flee the industry.
Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983).
Despite recognizing that there “might be a certain number of health care workers
who choose” to resign because of the mandate, 86 Fed. Reg. at 61,569, CMS rejects
these concerns in a single sentence, concluding that it had “insufficient evidence to
quantify and compare adverse impacts on patient and resident care associated with
temporary staffing losses” and “absences due to quarantine for known COVID-19
exposures and illness,” id. A lack of data, however, is not reason to issue an industry-
shaking vaccine mandate; it is reason to refrain from issuing such a mandate.
In any event, CMS ignores much to reach its cursory conclusion. A week
before it issued its rule, a survey found that 72% of unvaccinated workers would quit
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 25 of 37
26
rather than vaccinate.
25
CMS itself cites at least one instance where triple-digit
numbers of workers resigned or were fired for refusing to take a vaccine. Id. at
61,569 n.155 (citing a report that 153 employees of Houston Methodist Hospital quit
following its vaccination mandate).
26
As CMS recognizes, “if any substantial
number of unvaccinated employees leave health care employment altogether,” the
already “endemic staff shortages . . . may be made worse.” Id. at 61,607. And this
will have a particularly acute impact on healthcare in rural areas, which, as CMS
admits, are “having greater problems with employee vaccination.” Id. at 61,613.
Glazing over these problems, however, does not make them disappear and does not
satisfy the reason-giving requirements of the APA. See Regents, 140 S. Ct. at 1913.
Third, CMS fails to adequately consider the impact its mandate will have on
vaccination-education efforts. In Florida, those efforts have had great success,
sometimes raising vaccination rates by ten percent.
27
Yet CMS does not consider to
what extent its mandate would “chill” individuals who might otherwise take the
25
Liz Hamel et al., KFF COVID-19 Vaccine Monitor: October 2021, KFF (Oct. 28, 2021),
https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-october-
2021/.
26
Dan Diamond, 153 people resigned or were fired from a Texas hospital system after refusing to
get vaccinated, The Washington Post (June 22, 2021),
https://www.washingtonpost.com/health/2021/06/22/houston-methodist-loses-153-employees-
vaccine-mandate/.
27
Hannah Mitchell, ‘Like hand-to-hand combat’: Florida health system battles vaccine hesitancy
1 employee at a time, Becker’s Hospital Review (Nov. 4, 2021),
https://www.beckershospitalreview.com/hospital-management-administration/like-hand-to-hand-
combat-florida-health-system-battles-vaccine-hesitancy-1-employee-at-a-time.html.
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 26 of 37
27
vaccine voluntarily, a key factor OSHA considered in establishing its employer
vaccine mandate. See 86 Fed. Reg. at 61,436 (reasoning that the testing aspect of the
vaccine mandate “would elicit more effective employee participation”).
Fourth, CMS fails to rationally connect its statistics to most of the healthcare
facilities covered by its mandate. Indeed, CMS recognizes that the “providers and
suppliers regulated under this rule are diverse in nature, management structure, and
size.” 86 Fed. Reg. at 61,602. Still, CMS relies mostly on facts and figures involving
long term care facilities—providers that serve mostly elderly or
immunocompromised patients—to justify applying the mandate to other providers.
See, e.g., id. at 61,585 (discussing “case rates among [long term care] facility
residents,” and claiming, without citation, that those facilities’ “experience may
generally be extrapolated to other settings”). At the same time, CMS concedes that
“[a]ge remains a strong risk factor for severe COVID-19 outcomes.” Id. at 61,566.
In short, the statistics that it claims justify its action do not represent most facilities
caught within the mandate.
Fifth, CMS does not consider the rate at which “game-changing” COVID-19
treatments minimize the more-serious health risks of COVID-19. Nor does CMS
consider the viability of state-by-state approaches to mandatory vaccination, despite
acknowledging that, in many states, COVID-19 cases “are trending downward.” Id.
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 27 of 37
28
at 61,583–84. This is particularly true in Florida, which had the lowest number of
COVID-19 cases in the nation at the start of November 2021.
28
Sixth, CMS concludes that prior COVID-19 infection could not qualify a
covered employee for an exemption from the mandate because it was not equivalent
to receiving a COVID-19 vaccine. Id. at 61,559–60, 61,614. Elsewhere, however,
CMS recognizes the value of natural immunity. See id. at 61,604 (finding natural
immunity “reduce[s] the risk to both health care staff and patients substantially”);
id. (noting that those who recover are “in very rare cases still infectious”). CMS is
in good company in acknowledging natural immunity. Many experts have reached
the same conclusion, e.g., United States v. Arencibia, No. 18-294, 2021 WL
2530209, at *4 (D. Minn. June 21, 2021),
29
including the authors of a highly reported
study from Israel, which concluded that “natural immunity confers longer lasting
28
David Schutz, Florida Has Lowest COVID Cases Per Capita in US, Data Shows, South Florida
Sun Sentinel (Oct. 28, 2021), https://www.sun-sentinel.com/coronavirus/fl-ne-florida-covid-19-
lowest-case-rate-in-nation-20211028-gvcy2hxdnngufnv3vpwm23yuae-story.html.
29
Accord Yair Goldberg et al., Protection of Previous SARS-CoV-2 Infection Is Similar to That of
BNT162b2 Vaccine Protection: A Three-Month Nationwide Experience from Israel, medRxiv
(2021 preprint), https://www.medrxiv.org/content/10.1101/2021.04.20.21255670v1 (concluding
that the “overall estimated level of protection from prior . . . infection” was comparable to that
from vaccination); Nabin K. Shrestha et al., Necessity of COVID-19 Vaccination in Previously
Infected Individuals, medRxiv, (2021 preprint),
https://www.medrxiv.org/content/10.1101/2021.06.01.21258176v2 (concluding that those with
natural immunity are “unlikely to benefit from COVID-19 vaccination”); Galit Perez et al., A 1 to
1000 SARS-Cov-2 Reinfection Proportion in Members of a Large Healthcare Provider in Israel:
A Preliminary Report, medRxiv, (2021 preprint), https://www.medrxiv.org/content/
10.1101/2021.03.06.21253051v1 (finding that approximately 1/1000 of participants in a study of
persons who previously tested positive for COVID-19 were reinfected).
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 28 of 37
29
and stronger protection against infection . . . caused by the Delta variant.”
30
CMS’s
unexplained inconsistency in agency position renders the mandate “arbitrary and
capricious.” Encino Motorcars, LLC v. Navarro, 136 S. Ct. 2117, 2126 (2016).
Seventh, CMS inconsistently claims the mandate will protect patients while
recognizing, in its cost-benefit analysis, that “the effectiveness of the vaccine to
prevent disease transmission by those vaccinated [is] not currently known.” E.g., 86
Fed. Reg. at 61,569, 61,615.
If the benefits of the mandate are so uncertain, CMS
should not assume that they outweigh the substantial costs Florida has identified.
Eighth, CMS fails to consider the interests of millions of healthcare workers
who pursued their careers without knowing they would be subject to mandated
vaccination. Regents, 140 S. Ct. at 1913. And it ignores the reliance interests of
healthcare employers, including the States, who ordered their affairs under the
assumption that Medicaid and Medicare dollars would be available without this
onerous condition. Cf. NFIB, 567 U.S. at 584 (“A State could hardly anticipate that
Congress’s reservation of the right to ‘alter’ or ‘amend’ the Medicaid program
included the power to transform it so dramatically.”).
Ninth, the mandate is the product of political pressure, not measured
judgment. Aera Energy LLC v. Salazar, 642 F.3d 212, 220 (D.C. Cir. 2011). The
30
See Sivan Gazit et al., Comparing SARS-CoV-2 Natural Immunity to Vaccine-Induced Immunity:
Reinfections Versus Breakthrough Infections, medRxiv (2021 preprint),
https://www.medrxiv.org/content/10.1101/2021.08.24.21262415v1.
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 29 of 37
30
true impetus is clear: facing a scandal over his actions in Afghanistan, dismal
approval numbers on his COVID response, and an inability to advance his legislative
agenda, President Biden succumbed to pressure to control the healthcare decisions
of millions. He did so even though his Administration had assured the public that
vaccine mandates are “not the role of the federal government.”
31
And even a month
before announcing the mandate, the Administration said that CMS would be
promulgating a much narrower mandate directed only at nursing homes.
32
These
“sudden[] revers[als]” of course “create[] the plausible inference that political
pressure may have caused the agency to take action it was not otherwise planning to
take,” Connecticut v. Dep’t of Interior, 363 F. Supp. 3d 45, 64–65 (D.D.C. 2019),
which justifies setting the action aside, Aera Energy, 642 F.3d at 220; Dep’t of
Commerce v. New York, 139 S. Ct. 2551, 2576 (2019) (“Accepting contrived reasons
would defeat the purpose of [judicial review.]”).
Finally, CMS fails to adequately explain its extreme departure from its prior
practice of not mandating vaccines. See E. Bay Sanctuary Covenant v. Trump, 349
F. Supp. 3d 838, 858 (N.D. Cal. 2018); accord Regents, 140 S. Ct. at 1913. The
31
Press Briefing by Press Secretary Jen Psaki, July 23, 2021, The White House (July 23, 2021),
https://www.whitehouse.gov/briefing-room/press-briefings/2021/07/23/press-briefing-by-press-
secretary-jen-psaki-july-23-2021/.
32
FACT SHEET: President Biden to Announce New Actions to Protect Americans from COVID-
19 and Help State and Local Leaders Fight the Virus, The White House (Aug. 18, 2021),
https://www.whitehouse.gov/briefing-room/statements-releases/2021/08/18/fact-sheet-president-
biden-to-announce-new-actions-to-protect-americans-from-covid-19-and-help-state-and-local-
leaders-fight-the-virus/.
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 30 of 37
31
closest CMS comes is to suggest that mandatory vaccination is not extraordinary
given that “many health care workers already comply with employer or State
government vaccination requirements.” 86 Fed. Reg. at 61,567. But that does not
explain such a monumental shift by the federal government. It shows only that the
Biden Administration has lost track of the difference between a limited federal
government of enumerated powers and the rights reserved to private individuals and
the States—a distinction fundamental to our Constitution.
For these reasons, the mandate is arbitrary and capricious.
d. The challenged actions violate the Spending Clause.
“[I]f Congress intends to impose a condition on the grant of federal moneys,
it must do so unambiguously,” so “States [can] exercise their choice knowingly.”
Pennhurst, 451 U.S. at 17. Here, Florida agreed to a lucrative contract, paying
millions in federal funds, to enforce Medicare and Medicaid requirements on
healthcare providers. Ex. 1 ¶¶ 5, 9. When it agreed to do so, however, it was given
no notice that it would have to enforce vaccination requirements. Florida now faces
the untenable choice of refusing to enforce the mandate, and losing millions, or
acquiescing. But the Spending Clause does not allow the government to put Florida
to this choice—any conditions must have been disclosed to Florida from the
beginning. Pennhurst, 451 U.S. at 17; cf. NFIB, 567 U.S. at 584.
For this reason, the mandate violates the Spending Clause.
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 31 of 37
32
II. FLORIDA HAS STANDING AND IS IRREPARABLY HARMED BY THE
CHALLENGED ACTIONS.
States are entitled to “special solicitude” in establishing standing.
Massachusetts v. EPA, 549 U.S. 497, 520 (2007); see also Alfred L. Snapp & Son,
Inc. v. Puerto Rico ex rel. Barez, 458 U.S. 592, 607 (1982) (recognizing the States’
“quasi-sovereign interest in the health and well-being—both physical and
economic—of its residents”). Moreover, a “state has standing to sue in its sovereign
capacity when it has suffered an economic injury” or must “expend[] any of its
resources.” Chiles v. Thornburgh, 865 F.2d 1197, 1208 (11th Cir. 1989). Florida has
standing to challenge an allegedly illegal agency action that “may adversely impact”
its “economy” and “thereby injur[e]” Florida. Alabama v. U.S. Army Corps of
Eng’rs, 424 F.3d 1117, 1130 (11th Cir. 2005) (emphasis added).
Economic harm caused by federal agency action also establishes irreparable
harm. These harms “cannot be undone through monetary remedies,” Ferrero v.
Associated Materials Inc., 923 F.2d 1441, 1449 (11th Cir. 1991), because the United
States has sovereign immunity, Odebrecht Const., Inc. v. Sec’y, Fla. Dep’t of
Transp., 715 F.3d 1268, 1289 (11th Cir. 2013).
33
And sovereign injury—such as
preemption of state law or interference with state policy—is also irreparable harm
33
The procedural harm from the failure to provide notice and comment may also be irreparable.
See Becerra, 2021 WL 2514138, at *47.
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 32 of 37
33
because it likewise cannot be addressed through monetary remedies.
34
See Kansas
v. United States, 249 F.3d 1213, 1227–28 (10th Cir. 2001).
As explained above, supra at 11–13, Florida faces each of these harms absent
this Court’s intervention.
III. THE BALANCE OF THE EQUITIES AND PUBLIC INTEREST FAVOR
PRELIMINARY INJUNCTIVE RELIEF.
The equities and public-interest factors merge for federal-government action.
Nken v. Holder, 556 U.S. 418, 435 (2009). Both favor an injunction here. “Forcing
federal agencies to comply with the law is undoubtedly in the public interest.” Cent.
United Life, Inc. v. Burwell, 128 F. Supp. 3d 321, 330 (D.D.C. 2015). Moreover,
“[t]here is clearly a robust public interest in safeguarding prompt access to health
care.” Whitman-Walker Clinic, Inc. v. DHS, 485 F. Supp. 3d 1, 61 (D.D.C. 2020)
(citing New York v. DHS, 969 F.3d 42, 87–88 (2d Cir. 2020), and California v. Azar,
911 F.3d 558, 582 (9th Cir. 2018)). “The effect on the health of the local economy
is [also] a proper consideration in the public interest analysis.” All. for the Wild
Rockies v. Cottrell, 632 F.3d 1127, 1138 (9th Cir. 2011). And it is “against
34
The Florida legislature is currently contemplating legislation that would prohibit vaccine
mandates. See Governor DeSantis Joined By President Simpson and Speaker Sprowls to Announce
Legislative Agenda for Special Session of the Florida Legislature, Florida Governor’s Office (Nov.
8, 2021), https://www.flgov.com/2021/11/08/governor-desantis-joined-by-president-simpson-
and-speaker-sprowls-to-announce-legislative-agenda-for-special-session-of-the-florida-
legislature/. This legislation is likely to pass within the next few days. Once it does, Florida will
face an additional sovereign injury.
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 33 of 37
34
the public interest to force a person out of a job.” Vencor, Inc. v. Webb, 829 F. Supp.
244, 251 (N.D. Ill. 1993).
CONCLUSION
For the foregoing reasons, the Court should preliminarily enjoin Defendants
from enforcing, implementing, or giving any effect to the mandate. If the court
cannot reach a decision by December 6, 2021, it should enter a temporary restraining
order by that date.
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 34 of 37
35
Respectfully submitted,
Ashley Moody
ATTORNEY GENERAL
John Guard (FBN 374600)
CHIEF DEPUTY ATTORNEY GENERAL
James H. Percival (FBN 1016188)
DEPUTY ATTORNEY GENERAL OF LEGAL POLICY
Henry C. Whitaker (FBN 1031175)
SOLICITOR GENERAL
Daniel Bell (FBN 1008587)
CHIEF DEPUTY SOLICITOR GENERAL
/s/ David M. Costello
David M. Costello (FBN 1004952)
ASSISTANT SOLICITOR GENERAL
Natalie Christmas (FBN 1019180)
ASSISTANT ATTORNEY GENERAL OF LEGAL POLICY
Jason H. Hilborn (FBN 1008829)
DEPUTY SOLICITOR GENERAL
Office of the Attorney General
The Capitol, Pl-01
Tallahassee, Florida 32399-1050
(850) 414-3300
(850) 410-2672 (fax)
david.costello@myfloridalegal.com
Counsel for the State of Florida
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 35 of 37
36
CERTIFICATE OF COMPLIANCE
This motion complies with the requirements of Local Rule 7.1(F) because it
contains 7,648 words.
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 36 of 37
37
CERTIFICATE OF SERVICE
I hereby certify that on this 17th day of November, 2021, a true and correct
copy of the foregoing was filed with the Court’s CM/ECF system and furnished by
US Mail to:
Xavier Becerra, Secretary
U.S. Department of Health and Human
Services
200 Independence Avenue, S.W.
Washington, DC 20201
U.S. Centers for Medicare and
Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
United States of America
c/o United States Attorney’s Office
Northern District of Florida
Tallahassee Headquarters
Civil Process Clerk
111 North Adams Street
4
th
Floor, U.S. Courthouse
Tallahassee, FL 32301
Chiquita Brooks-LaSure, Administrator
U.S. Centers for Medicare and
Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
U.S. Department of Health and Human
Services
200 Independence Avenue, S.W.
Washington, DC 20201
U.S. Department of Justice
Justice Management Division
950 Pennsylvania Ave., N.W.
Room 1111
Washington, DC 20530
/s/ David M. Costello
Assistant Solicitor General
Case 3:21-cv-02722-MCR-HTC Document 2 Filed 11/17/21 Page 37 of 37