Florida v. Dep't of Health & Human Servs., 120621 FED11, 21-14098-JJ
| Judge | Before ROSENBAUM, JILL PRYOR, and LAGOA, Circuit Judges. Lagoa, Circuit Judge, dissenting: |
| Court | U.S. Court of Appeals — Eleventh Circuit |
| Docket Number | 21-14098-JJ |
| Parties | STATE OF FLORIDA, Plaintiff-Appellant, v. DEPARTMENT OF HEALTH AND HUMAN SERVICES, SECRETARY OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES, UNITED STATES OF AMERICA, U.S. CENTERS FOR MEDICARE AND MEDICAID SERVICES, ADMINISTRATOR OF THE CENTERS FOR MEDICARE AND MEDICAID, Defendants-Appellees. |
| Date | 06 December 2021 |
Appeal from the United States District Court for the Northern District of Florida D.C. Docket No. 3:21-cv-02722-MCR-HTC
Before ROSENBAUM, JILL PRYOR, and LAGOA, Circuit Judges.
CORRECTED
OPINION
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ROSENBAUM and JILL PRYOR, Circuit Judges.
On November 5, 2021, the Secretary of Health and Human Services issued an interim rule that requires facilities that provide health care to Medicare and Medicaid beneficiaries to ensure that their staff, unless exempt for medical or religious reasons, are fully vaccinated against COVID-19. See Omnibus COVID-19 Health Care Staff Vaccination, 86 Fed. Reg. 61, 555 (Nov. 5, 2021) (the "interim rule"). Under the interim rule, covered staff must receive their first dose of a two-dose vaccine or a single-dose vaccine by December 6, 2021, or request an exemption by that date. Non-exempt covered staff must receive their second dose of a two-dose vaccine by January 4, 2021.
Florida brought this lawsuit challenging the interim rule. In the district court, Florida requested a preliminary injunction to bar the interim rule's enforcement, which the district court denied. Florida has appealed the district court's order denying its motion
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for a preliminary injunction. This case was presented to us on Florida's Time-Sensitive Motion for Injunction Pending Appeal. After careful review, we denied the motion yesterday. Because of the time constraints involved, though we denied the motion yesterday, the attached opinion explains the reasons for our ruling as of the time that we denied the motion yesterday.
I.
FACTUAL BACKGROUND
A. In Response to the Ongoing COVID-19 Public Health Crisis, the Secretary Issued the Interim Rule Mandating Vaccines for Healthcare Workers at Medicare and Medicaid Facilities.
The United States is currently facing a public health emergency as the result of a novel corona virus, which causes the disease COVID-19. See 86 Fed. Reg. at 65, 519. In the United States, more than 44 million individuals have been infected with COVID-19 and over 720, 000 have died. See id. COVID-19 is the "deadliest disease in American history." Id.
The Secretary recently took steps in administering the Medicare and Medicaid programs to protect Americans from the risks associated with COVID-19. Tens of millions of Americans receive health care through these federally funded programs. See Azar v. Allina Health Servs., 139 S.Ct. 1804, 1808 (2019). Medicare, which is funded entirely by the federal government, covers individuals who are over age 65 or who have specified disabilities. See id. Medicaid, which is funded by the federal government and the States,
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covers eligible low-income individuals, including those who are elderly, pregnant, or disabled. See Garrido v. Dudek, 731 F.3d 1152, 1153-54 (11th Cir. 2013).
Medicare and Medicaid beneficiaries receive health care services from a variety of entities including hospitals, skilled nursing facilities, home-health agencies, and hospices (collectively, "facilities"). To participate in the programs, a facility must enter into a provider agreement for the applicable program and demonstrate that it meets the conditions for participation. See 42 U.S.C. §§ 1395cc(a), 1396a(a)(27).
For both the Medicare and Medicaid programs, Congress charged the Secretary with ensuring that participating facilities protect the health and safety of their patients. For example, the Medicare statute authorizes payment for "hospital services," id. § 1395d(a), defining a "hospital" as an institution that meets requirements "the Secretary finds necessary in the interest of the health and safety of individuals who are furnished services in the institution. See id. § 1395x(e)(9); see also id. § 1395i-3(d)(4)(B) (imposing a similar requirement for skilled nursing facilities). Likewise, the Medicaid statute requires that facilities meet health and safety standards "as the Secretary may find necessary." Id. § 1396r(d)(4)(B), 1396d(1)(1). In addition, the Medicaid statute incorporates by cross reference analogous Medicare standards that grant the Secretary such authority. See id. § 1396d(h), (1)(1), (o).
Regulations establish detailed conditions of participation in the Medicare and Medicaid programs. Among other things,
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facilities must have effective "infection prevention and control pro-gram[s]" in place to "help prevent the development and transmission of communicable disease and infections." 42 C.F.R. § 483.80. See also id. §§ 416.51, 482.42.
On November 5, the Secretary promulgated an interim rule to amend the infection-control regulations for facilities that participate in Medicare or Medicaid. As described above, this interim rule generally requires that facilities certified to participate in Medicare or Medicaid ensure their staff are fully vaccinated against COVID-19, unless an employee is exempt for medical or religious reasons. See 86 Fed. Reg. at 61, 555, 61, 561, 61, 572. If a provider fails to comply with the vaccine-mandate requirement, it may be subjected to enforcement remedies, including civil monetary penalties, the denial of payment for new admissions, or termination of its Medicare or Medicaid provider agreement. Id. at 61, 574.
The Secretary issued the interim rule because he found that requiring the vaccination of staff against COVID-19 was "necessary for the health and safety of individuals to whom care and services are furnished." Id. at 61, 561. Even though many health care workers have been vaccinated against COVID-19, the Secretary found that vaccination rates remain too low at many health care facilities. Id. at 61, 559. Unvaccinated staff continue to pose a significant threat to patients because the virus that causes COVID-19 is highly transmissible and dangerous. Id. at 61, 557. The Secretary cited data reflecting that the virus spreads readily among health care workers and from health care workers to patients and that such spread is
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more likely when health care workers are unvaccinated. Id. In addition, the Secretary found that due to the same factors that qualified them for enrollment (age, disability, and/or poverty), patients covered by Medicare or Medicaid are "more susceptible" than the general population "to severe illness or death" if they contract COVID-19. Id. at 61, 609.
The Secretary identified other ways that unvaccinated staff can jeopardize patients' access to medical care and services. Id. at 61, 558. Fearing exposure to the virus, some patients have refused care by unvaccinated staff, which limits the ability of providers to meet the health care needs of their patients. Id. Other individuals forgo medical care altogether to avoid the possibility of being exposed to COVID-19. Id. And when staff members are exposed to or infected with COVID-19, they are absent from work, which further disrupts patients' access to medical care. Id. at 61, 559.
In issuing the interim rule, the Secretary considered that requiring vaccinations could cause some health care workers to leave their jobs rather than be vaccinated. But after reviewing empirical evidence, the Secretary concluded that this concern was overstated and outweighed by countervailing considerations. Id. at 61, 569. Among other things, the Secretary cited evidence showing that after a large hospital system in Texas imposed a vaccine mandate, 99.5% of its staff received the vaccine. Id. Only a very small number of workers-153 out of more than 26, 000 (or 0.6%)-resigned rather than receive the vaccine. Id. Similarly, after a Detroit-based health system instituted a vaccine mandate, it reported that 98% of
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its 33, 000 workers were fully or partially vaccinated or in the process of obtaining a religious or medical exemption, with less than one percent of staff receiving an exemption. Id.
Before issuing the interim rule, the Secretary also considered whether any alternatives to a vaccine mandate would adequately protect the health and safety of Medicare and Medicaid patients at the facilities. See id. at 61, 613-14. One of these alternatives was to limit a vaccination requirement to health care workers who had not previously been infected with COVID-19. Id. at 61, 614. But the Secretary rejected this alternative because uncertainties remained about "the strength and length" of immunity for individuals who had previously been infected. Id. A second alternative was to require daily or weekly testing of unvaccinated individuals. But the Secretary rejected this alternative because the evidence showed that "vaccination was a much more effective infection control measure" than requiring testing alone. Id. Ultimately, the Secretary concluded that the vaccine mandate was "the minimum regulatory action necessary" to protect health and safety. Id. at 61, 613.
The Secretary determined that the vaccine mandate requirement should go into effect immediately, even though the agency had not previously given the public notice or an opportunity to comment. The Secretary found good cause for bypassing the notice-and-comment procedure generally required by 5 U.S.C. § 553 because (1) patients in facilities funded by Medicare and Medicaid were more likely than the general population to suffer severe illness or death from COVID-19; (2) there had already been over half
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a million cases of COVID-19 among health care staff; (3) COVID-19 infection rates among health care staff increased when the Delta variant emerged, and (4) COVID-19 cases were expected to spike in the winter, which is also flu season, creating the risk of combined infections. Id. at 61, 557-59, 61, 583-84. Any...
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