Healthcare Law

• Publication year: 2022

Healthcare Law

Kathryn Dunnam Harden

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Healthcare Law

Kathryn Dunnam Harden^*

I. Introduction

This Article serves as a review of significant healthcare developments in the United States Court of Appeals for the Eleventh Circuit during this past Survey period. Specifically, this Article will cover cases, legislation, and trends involving COVID-19, healthcare fraud, and reproductive rights.

II. COVID-19 Regulation and Litigation

The COVID-19 pandemic has now stretched over two years and has "overtaken the 1918 influenza pandemic as the deadliest disease in American history."¹ The federal government, along with the individual states, have sought to issue numerous regulations and legislation to address the novel and deadly disease. COVID-19 has proved to be politically polarizing, and the various efforts to address the disease have been met with opposition. Recent regulatory efforts by the federal government are detailed below.

Effective November 5, 2021, the Occupational Safety and Health Administration (OSHA) issued an "emergency temporary standard (ETS) to protect unvaccinated employees of large employers (100 or more employees) from the risk of contracting COVID-19 by strongly encouraging vaccination."² The rule required that "[c]overed employers must develop, implement, and enforce a mandatory COVID-19 vaccination policy, with an exception for employers that instead adopt a policy requiring employees to either get vaccinated or elect to undergo

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regular COVID-19 testing and wear a face covering at work in lieu of vaccination."³

In response, "[s]cores of parties—including States, businesses, trade groups, and nonprofit organizations—filed petitions for review, with at least one petition arriving in each regional Court of Appeals. The cases were consolidated in the Sixth Circuit, which was selected at random pursuant to 28 U.S.C. § 2112(a)."⁴ In a per curiam opinion, the Supreme Court of the United States ultimately granted the applications seeking a stay of OSHA's COVID-19 Vaccination and Testing ETS.⁵ The Court held that "[a]pplicants are likely to succeed on the merits of their claim that the Secretary lacked authority to impose the mandate," because the Occupational Safety and Health Act (The Act) does not plainly authorize the Secretary's mandate.⁶ In its reasoning, the Court emphasized that the Act "empowers the Secretary to set workplace safety standards, not broad public health measures."⁷ The Court contemplated that a permissible exercise of authority would be to "regulate occupation-specific risks related to COVID-19," such as COVID-19 researchers or "risks associated with working in particularly crowded or cramped environments."⁸ To require large employers, however, to implement mandatory vaccine measures was too broad an exercise of power.⁹

Although Congress has indisputably given OSHA the power to regulate occupational dangers, it has not given that agency the power to regulate public health more broadly. Requiring the vaccination of 84 million Americans, selected simply because they work for employers with more than 100 employees, certainly falls in the latter category.¹⁰

Effective January 26, 2022, OSHA withdrew its November 2021 ETS.¹¹ Thus, employers outside of the healthcare context are not required to implement mandatory vaccine policies.

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Other regulatory efforts have fared better. Effective November 5, 2021, the Secretary of Health and Human Services and Centers for Medicare and Medicaid Services issued a rule requiring that the non-exempt staff of healthcare facilities be vaccinated against COVID-19 in order to receive funding.¹² The vaccine mandate was sought in order "to help protect the health and safety of residents, clients, patients, PACE participants, and staff, and reflect lessons learned to date as a result of the COVID-19 public health emergency."¹³ Indeed, "[a]s of mid-October 2021, over 44 million COVID-19 cases, 3 million new COVID-19 related hospitalizations, and 720,000 COVID-19 deaths have been reported in the U.S."¹⁴

Multiple states, including two Eleventh Circuit states, Alabama and Georgia, signed onto Louisiana's Motion for Preliminary Injunction in order to enjoin the new vaccine mandate from taking effect.¹⁵ The United States District Court for the Western District of Louisiana granted the injunctive relief.¹⁶ A second United States district court, the United States District Court for the Eastern District of Missouri, likewise granted an injunction against the new vaccine mandate as sought by several different states.¹⁷ In both cases, the federal government then sought a stay of the injunctions in each respective United States court of appeals.¹⁸ The stays were denied by both the United States Court of Appeals for the Fifth Circuit and the United States Court of Appeals for the Eighth Circuit.¹⁹

The federal government then filed applications to stay those injunctions with the Supreme Court of the United States.²⁰ In a per curiam opinion, the Court ultimately granted the stays on January 13, 2022.²¹ The Court held that the "Secretary's rule falls within the

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authorities that Congress has conferred upon him."²² The Court reasoned:

After all, ensuring that providers take steps to avoid transmitting a dangerous virus to their patients is consistent with the fundamental principle of the medical profession: first, do no harm. It would be the "very opposite of efficient and effective administration for a facility that is supposed to make people well to make them sick with COVID-19."²³

In citing to the amici curiae briefs filed in the subject case, the Court further noted that "healthcare workers and public-health organizations overwhelmingly support the Secretary's rule."²⁴ "We accordingly conclude that the Secretary did not exceed his statutory authority in requiring that, in order to remain eligible for Medicare and Medicaid dollars, the facilities covered by the interim rule must ensure that their employees be vaccinated against COVID-19."²⁵ The Court disagreed with the States' remaining arguments, including the argument that the vaccine mandate was arbitrary and capricious.²⁶

Consistent with the Supreme Court, in December 2021, the United States Court of Appeals for the Eleventh Circuit upheld a district court's denial of Florida's request for an injunction barring enforcement of the vaccine mandate for healthcare staff.²⁷ In sum, in order to receive funding from Centers for Medicare and Medicaid Services, non-exempt healthcare staff must be vaccinated.

III. False Claims Act Update

This Survey period produced another significant development in the realm of Healthcare Fraud: Yates v. Pinellas Hematology & Oncology, PA.²⁸ The United States Court of Appeals for the Eleventh Circuit held that the Excessive Fines Clause of the Eighth Amendment does apply to non-intervened qui tam actions brought under the False Claims Act (FCA), a question previously left...