Explaining the New COVID-19 Vaccination Requirement for Health Care Provider Staff
On November 5, 2021, the Centers for Medicare and Medicaid Services (CMS) published regulations that established the first ever federal vaccination requirements for health care provider staff.1 Drawing on its authority to establish patient health and safety standards, CMS’s regulations require health care providers that participate in the Medicare and/or Medicaid programs to ensure that their staff are fully vaccinated against COVID-19.2 The new rule applies to staff who provide any care, treatment, or other services for providers or patients, including contractors and volunteers. The first phase of the new regulations was to take effect on December 6, 2021, with staff required to have received their first vaccine dose or requested an exemption by that date.3 However, the new regulations have been put on hold by federal courts, and the pending lawsuits create uncertainty about whether the new requirements ultimately will be implemented.4 This issue brief examines the new regulations, explains the status of the pending litigation, and identifies issues to watch.
CMS says it decided to require health care staff to be vaccinated because its earlier efforts to simply encourage vaccination have been “insufficient” to protect patient health and safety. For example, CMS cites data showing that COVID-19 cases in nursing homes surged with the rise of the Delta variant. The nursing home staff vaccination rate is nearly 76% nationally as of November 2021, with substantial variation by region. CMS concluded that standard federal requirements across provider types are needed because the existing “patchwork” of state and employer requirements has not been enough to bring the pandemic under control in health care settings. CMS notes that the vaccines are safe and highly effective at preventing severe illness and death, and unvaccinated staff can strain the health care system by transmitting COVID-19 to patients and having to miss work if they are recovering from COVID-19 or quarantining after exposure. CMS acknowledges that some staff may leave their jobs because they do not want to receive the vaccine but cites examples of vaccine mandates adopted by health systems in Texas and Detroit and a long-term care parent corporation with 250 facilities as well as the New York state health care worker mandate, all of which resulted in high rates of compliance and few employee resignations.
In response to the new regulations, 26 states led by Republican officials filed four federal lawsuits challenging the new rules (Table 1). While the specific legal claims vary somewhat among the different cases, the states essentially raise four major arguments. First, the states challenge the process that CMS used to adopt the new rules, arguing that CMS did not have good cause to forgo public notice and comment under the Administrative Procedure Act (APA). The states also argue that CMS’s authority to establish health and safety regulations for Medicare and Medicaid providers does not allow it to adopt a “broad” vaccine requirement. And, they assert that CMS’s new rule is arbitrary and capricious under the APA because CMS did not appropriately consider factors such as potential staffing disruptions, the “limitations” of vaccines, and the “benefits” of natural immunity. Finally, the states contend that the new rules violate Constitutional principles about the appropriate balance between federal and state government power. For example, the states argue that the rules place “new” conditions on state receipt of federal funds in violation of the Constitution’s Spending Clause. The states also argue that the new rules improperly force states to administer federal regulations and unconstitutionally infringe on the states’ police powers to regulate for public health and safety.
|Table 1: State Lawsuits Challenging CMS COVID-19 Vaccine Requirement for Medicare and Medicaid Provider Staff, as of 12/12/21|
|Case Name||States Joining Lawsuit||Current Status|
|District Court||Appeals Court|
|MO v. Biden||10 states (AK, AR, IA, KS, MO, NE, NH, ND, SD, WY)||On 11/29/21, the court granted a preliminary injunction preventing CMS from enforcing the new rules in these 10 states while the lawsuit is pending.||CMS has appealed the preliminary injunction order to the 8th Circuit.
On 12/13/21, the 8th Circuit in a 2:1 order denied CMS’s motion to lift the preliminary injunction pending appeal.
|LA v. Becerra||14 states (AL, AZ, GA, ID, IN, KY, LA, MS, MT, OH, OK, SC, UT, WV)||On 11/30/21, the court granted a preliminary injunction preventing CMS from enforcing the new rules nationwide while the lawsuit is pending.*||CMS has appealed the preliminary injunction order to the 5th Circuit.|
|TX v. Becerra||1 state (TX)||On 12/3/21, the court put the case on hold, pending subsequent court action in the LA case.||N/A|
|FL v. HHS||1 state (FL)||On 11/20/21, the court denied FL’s motion for a preliminary injunction. On 12/1/21, the court issued an opinion reaffirming the preliminary injunction denial.||FL has appealed the preliminary injunction denial to the 11th Circuit.
On 12/6/21, the 11th Circuit in a 2:1 decision denied FL’s motion for an injunction pending appeal.
|NOTES: *The LA preliminary injunction applies nationwide except in the 10 states that are subject to the MO preliminary injunction.
SOURCE: KFF analysis of court documents.
Currently, CMS is unable to enforce the new rules nationwide, as a result of court orders, though circumstances may change as cases are appealed. To date, the 8th Circuit Court of Appeals has ruled that a Missouri federal court’s decision preventing CMS from enforcing the new rules should remain in place while the appeal in that case is pending. Additionally, a federal court in Louisiana has blocked the new rules, while the 11th Circuit Court of Appeals has affirmed a Florida federal court’s decision that the new regulations can be implemented while litigation is pending. (A fourth case in Texas federal court is on hold, pending further court action in the Louisiana case.) The Missouri court’s preliminary injunction blocking the new rules applies in the 10 states that brought that case. However, the Louisiana court went further, applying its preliminary injunction not only to the 14 states in the case before it but also to all other states (except the 10 states in the Missouri case). This means that the new rules are now on hold even in states that did not challenge them. The Louisiana decision also put the new rules on hold in Florida, despite the Florida court’s decision that the new rules should go into effect. However, as the 11th Circuit points out in its review of the Florida decision, the Louisiana decision could be changed when it is reviewed by the 5th Circuit on appeal. Specifically, the 11th Circuit found that it is reasonably likely that the 5th Circuit will conclude that the Louisiana court should not have applied its decision nationwide, even if the 5th Circuit ultimately upholds the Louisiana court’s decision to block the new rules in the 14 states that brought the Louisiana case.
Court decisions in the lawsuits to date demonstrate opposing views about the scope of CMS’s authority to respond to the pandemic and what constitutes the public’s interest (Table 2). The 11th Circuit’s decision defers to the agency’s expertise in the face of an unprecedented pandemic and notes that accepting Florida’s arguments in opposition would amount to substituting the state’s “views on epidemiology for the Secretary’s judgment about the best way to protect the public from infection.” By contrast, the Missouri and Louisiana courts fault the agency for not giving more credence to the arguments advanced by states that oppose CMS’s rule. When articulating the public’s interest in these issues, the 11th Circuit emphasizes the public’s interest in slowing COVID-19 spread and protecting patients from preventable infection, while the Missouri and Louisiana decisions emphasize the public’s interest in being free from vaccine requirements. The Louisiana court’s characterization of the public interest is notable in light of its ultimate decision to block the rule in states that are not part of the litigation. The Louisiana court says that it entered a nationwide ruling because there are “unvaccinated healthcare workers in other states who also need protection,” though it does not discuss other aspects of the public interest, which may favor the rule.
The fate of CMS’s new rules may ultimately be determined by the Supreme Court. The preliminary injunctions blocking implementation of the rules issued by Missouri and Louisiana courts currently are awaiting review on appeal by the 8th and 5th Circuits, respectively. If one or both appeals courts affirms the preliminary injunction, that decision would conflict with the 11th Circuit’s conclusion that the rule should not be blocked. A conflict among different appeals courts could increase the likelihood of the Supreme Court stepping in. As litigation to determine CMS’s authority to mandate health care provider vaccines as part of its pandemic response continues to play out, the emergence of the Omicron variant is raising new questions about the pandemic’s future course. This development likely will further challenge CMS as it seeks to adopt policies to bring the pandemic under control which ultimately could prove successful but may never be implemented if courts decide to limit the agency’s authority.
|Table 2: Comparison of Court Decisions About Whether to Preliminarily Enjoin CMS’s Health Care Provider Vaccine Rule, as of 12/12/21|
(affirming FL court’s denial of preliminary injunction)
|1. Is the state likely to succeed on the merits of its challenge to CMS’s rule?
(A) Did CMS have good cause to issue the rule as interim final and bypass public notice and comment?
(B) Is CMS’s rule within its authority to regulate Medicare and Medicaid as delegated by Congress?
(C) Is CMS’s rule arbitrary and capricious?
(D) Does the new rule inappropriately infringe on state power?
|(A) No. CMS took too long to issue the new rule for circumstances to be considered an emergency. The MO court also concluded that public health and safety is an insufficient reason to waive notice and comment, especially for an “unprecedented” new rule.
(B) No. Though Congress has given CMS “general” authority to issue regulations about Medicare and Medicaid patient health and safety, CMS needs “clear authorization” to adopt a vaccine mandate because this involves “powers of vast economic and political significance.”
(C) Yes. CMS acknowledges that the extent to which vaccines prevent COVID-19 spread and their long-term effectiveness are “unknown.” CMS should not have used evidence about COVID-19’s impact on long-term care facilities to extrapolate about effects on other providers that do not care for “vulnerable” patients. CMS’s rule is too broad because it acknowledges that children are less affected by COVID-19 but subjects pediatric facilities to the new rule. CMS did not appropriately consider alternatives such as testing or natural immunity or the harm the rule will cause by exacerbating worker shortages.
(D) The preliminary injunction decisions do separately analyze this issue in detail, though the LA court notes that the rule infringes on state power because it specifically preempts state law.
|(A) Yes. CMS provided a “detailed explanation” to justify good cause and the need for “urgency” due to the ongoing pandemic, the Delta variant, and the upcoming flu season, and determined that further delay would endanger patient health and safety.
(B) Yes. Federal law expressly authorizes CMS to establish Medicare and Medicaid provider health and safety standards. Congress did not need to be more specific because until now, vaccination has not been a political issue and instead has been regarded as a “common-sense measure designed to prevent healthcare workers, whose job it is to improve patients’ health, from making them sicker.”
(C) No. The court should defer to CMS’s decision about how to best protect patients, which is supported by “ample evidence.” CMS cites evidence showing that health care workers respond to mandates by getting vaccinated instead of leaving their jobs.
(D) While not separately analyzed by the 11th Circuit, the court notes that federal law preempts conflicting state law.
|2. Will the state experience irreparable harm without a preliminary injunction?||Yes. States are irreparably harmed if they cannot enforce laws that prohibit vaccine mandates, and their citizens will be harmed by the rule’s exacerbation of staffing shortages that may comprise patient safety and lead to facility closures and by the choice between job loss or vaccination.||No. CMS has authority to issue the new rule, and FL is not irreparably harmed because federal law preempts conflicting state law. FL’s evidence predicting new staffing shortages is “speculative” and “conclusory.”|
|3. Does the public interest favor a preliminary injunction?||Yes. The MO court found that, while the public has an interest in stopping COVID spread, it would “suffer little, if any, harm” if the rule is blocked. The LA court found that the “public interest is served by maintaining the liberty of individuals who do not want to take the COVID-19 vaccine.”||No. Barring enforcement of the new rule would harm the public’s interest in slowing COVID-19 spread and protecting patients from “infliction of a potentially deadly virus. . . by those who are supposed to be taking care of them,” which is preventable by vaccination.|
|NOTE: *The 8th Circuit issued an order keeping the MO preliminary injunction in place pending appeal but did not write an opinion.
SOURCE: KFF analysis of court documents.
The new rule applies to Medicare and Medicaid providers that are directly regulated by CMS and therefore does not reach all Medicaid providers, such as certain home and community-based services (HCBS) providers. The rule applies to nursing homes, hospitals, outpatient rehab facilities, federally qualified health centers, rural health centers, and home health agencies, among other provider types. Residents and staff of other HCBS providers, such as group homes, assisted living facilities, and day habilitation programs, face increased risk of serious illness or death from COVID-19, similar to their counterparts in nursing homes. But, because states (and not CMS) license and regulate these providers, CMS has not required them to comply with the new rule. States or individual providers could adopt staff vaccination mandates, and providers may be subject to other rules such as the Occupational Safety and Health Administration requirement for large employers (which also has been put on hold by courts) or state or local requirements.
CMS says that provider compliance with the new rule will be part of the existing oversight process through which state or federal inspectors review all Medicare and Medicaid program requirements. CMS envisions that inspectors will review facility policies and records and conduct staff interviews to verify vaccination status. CMS will provide guidance about oversight as well as penalties for noncompliance, which could include civil monetary penalties, denial of payment for new long-term care facility admissions, or termination of Medicare and/or Medicaid program participation.
The new rule also provides that staff must be fully vaccinated by January 4, 2022, or have been granted an exemption (based on disability or sincere religious belief) or temporary delay (based on CDC clinical guidelines). Providers also must implement “additional precautions” to mitigate COVID-19 transmission and adopt contingency plans to address staff who are not fully vaccinated.
Before the rule was put on hold by courts, CMS said that it would determine whether to make the new rule permanent based on public comments (due January 4, 2022) and the future course of the pandemic. The new rule is not tied to the duration of the COVID-19 public health emergency (PHE), and CMS expects that it will “remain relevant for some time beyond” the PHE end. Medicare interim final rules expire after three years unless they are finalized.