A group of Republican state attorneys general announced on Nov. 10 that they had filed suit against the Biden Administration in response to the rule issued by the federal Centers for Medicare and Medicaid Services (CMS) on Nov. 4 that will require employees and staff members of virtually all patient care organizations that receive Medicare or Medicaid reimbursement, to become vaccinated for COVID-19 by Jan. 4.
In a press release posted to the CMS website on Nov. 4, the agency stated that “The Biden-Harris Administration is requiring COVID-19 vaccination of eligible staff at health care facilities that participate in the Medicare and Medicaid programs. The emergency regulation issued by the Centers for Medicare & Medicaid Services (CMS) today protects those fighting this virus on the front lines while also delivering assurances to individuals and their families that they will be protected when seeking care. The press release quoted CMS Administrator Chiquita Brooks-LaSure as stating that “Ensuring patient safety and protection from COVID-19 has been the focus of our efforts in combatting the pandemic and the constantly evolving challenges we’re seeing. Today’s action addresses the risk of unvaccinated health care staff to patient safety and provides stability and uniformity across the nation’s health care system to strengthen the health of people and the providers who care for them,” Brooks LaSure said in a statement contained in the press release on that date.
On Nov. 10, ten Republican state attorneys general sued to stop the mandate. The attorneys general of Missouri, Nebraska, Arkansas, Kansas, Iowa, Wyoming, Alaska, South Dakota, North Dakota, and New Hampshire jointly filed a lawsuit in the U.S. District Court for the Eastern District of Missouri in St. Louis.
"Placing this additional mandate on healthcare facilities and employees will exacerbate this problem and will likely lead some facilities – particularly those in underserved, rural areas – to close due to an inability to hire sufficient staff," Kansas Attorney General Derek Schmidt said in a statement.
As Reuters’ Ahmed Aboulenein wrote on Nov. 11, “The lawsuit said the federal mandate intruded on states' police power and is unlawful under the Administrative Procedures Act because there was no comment period before its release.” CMS had stated that the interim final rule covers over 10 million people and applies to around 76,000 healthcare providers including hospitals, nursing homes, and dialysis centers. An interim final rule is effective immediately without the standard comment period that follows publication. There is a 60-day comment period following its publication, however. Providers that fail to comply with the mandate could lose access to Medicare and Medicaid funds. Medicare serves people 65 and older and the disabled. Medicaid serves the poor.
Aboulenein wrote that “The lawsuit said the CMS rule was heavy handed and did not take local factors and conditions into account.”
And as The Washington Post’s Reis Thebault, María Luisa Paúl, Andrew Jeong, and Annabelle Timsit wrote on Nov. 11, “The plaintiffs argue that CMS “acted arbitrarily and capriciously” in implementing the rule and did not give enough consideration to the impact it would have on the shortage of health-care workers in the states. They ask the court to reject the vaccine mandate under the Administrative Procedure Act. It’s the latest legal challenge to a set of emergency public health rules issued by the Biden administration during the pandemic, including a vaccine-or-testing requirement for private businesses with more than 100 employees, which would take effect Jan. 4. On Saturday, that Biden order was temporarily blocked by a federal appeals court as part of a separate lawsuit.”
CMS has said there have not been widespread resignations within healthcare providers that have already mandated vaccines, including 41 percent of U.S. hospitals, and that applying the mandate to all healthcare settings ensures staff cannot quit one setting to seek jobs in another. "With many employers already mandating vaccination, and with nearly all local (and distant) healthcare employers requiring vaccination under this rule, we expect that such effects will be minimized," the agency said in introducing the rule.
The administration says it is confident that its requirement, which includes penalties of nearly $14,000 per violation, will withstand legal challenges in part because its safety rules pre-empt state laws.
The same state attorneys general had announced a lawsuit on Nov. 5 challenging the OSHA vaccine mandate rule as well. As a CBS News report published on that date noted, “Under new regulations by the Occupational Safety and Health Administration, companies with more than 100 employees must require their workers to be vaccinated against COVID-19 or be tested for the virus weekly and wear masks on the job. The requirement is to kick in January 4. Failure to comply could result in penalties of nearly $14,000 per violation.”
Regarding that previous announcement, White House Deputy Press Secretary Karine Jean-Pierre said during a November 8 White House press briefing that “The administration clearly has the authority to protect workers, and actions announced by the President are designed to save lives and stop the spread of COVID-19. And as DOJ said, they will be defending these lawsuits.” Jean-Pierre repeated that assertion on Thursday, now referring as well to the CMS mandate.
In the text of the lawsuit, the ten state attorneys general write that “That IFC, also referred to as the ‘CMS vaccine mandate,’ imposes an unprecedented federal vaccine mandate on nearly every full-time employee, part-time employee, volunteer, and contractor working at a wide range of healthcare facilities receiving Medicaid or Medicaid funding. The CMS vaccine mandate threatens with job loss millions of healthcare workers who risked their lives in the early days of the COVID-19 pandemic to care for strangers and friends in their communities. The Plaintiff States seek to end this dragooning of our States’ healthcare heroes. Critically, the CMS vaccine mandate also threatens to exacerbate an alarming shortage of healthcare workers, particularly in rural communities, that has already reached a boiling point. Indeed, the circumstances in the Plaintiff States—facts that CMS, which skipped notice-and comment rulemaking, did not fully consider—foreshadow an impending disaster in the healthcare industry. By ignoring the facts on the ground and unreasonably dismissing concerns about workforce shortages, the CMS vaccine mandate jeopardizes the healthcare interests of rural Americans. This case,” they wrote, “illustrates why the police power over compulsory vaccination has always been the province of—and still properly belongs to—the States. Vaccination requirements are matters that depends on local factors and conditions. Whatever might make sense in New York City, St. Louis, or Omaha could be decidedly counterproductive and harmful in rural communities like Memphis, Missouri or McCook, Nebraska. Federalism allows States to tailor such matters in the best interests of their communities. The heavy hand of CMS’s nationwide mandate does not. This Court should thus set aside that rule as unlawful agency action under the Administrative Procedure Act (“APA”), 5 U.S.C. §§ 701–706.”
But both administration officials and other legal experts cast doubt on the validity of the arguments in both cases. With regard to the lawsuit against OSHA, Seema Nanda, Solicitor for the U.S. Department of Labor, said in a statement on Friday that the federal Occupational Safety and Health Act gives OSHA the authority to act quickly during an emergency if it finds workers are subject to a grave danger. The agency contends its temporary rule also preempts any state or local bans on employers’ ability to require vaccines. “We are fully prepared to defend this standard in court,” Nanda said.
And in their Nov. 5 report, the Associated Press’s David A. Lieb, Geoff Mulvihill, and Andrew DeMillo quoted Lawrence Gostin, a professor at Georgetown University Law Center and director of the World Health Organization’s center on health law, as affirming the fact that the half-century-old law that created OSHA gives it the power to set minimum workplace safety measures. “I think that Biden is on rock-solid legal ground,” he told the AP.
Meanwhile, with regard to the CMS rule, The New York Times’s Reed Abelson wrote on Nov. 10 that “Federal officials said they could not comment on pending litigation. In a statement, the Centers for Medicare & Medicaid Services said that “there is no question that staff in any health care setting who remain unvaccinated pose both direct and indirect threats to patient safety and population health.” But she also wrote that “Legal experts said the agency generally had the ability to establish rules governing the organizations that it pays to deliver care. ‘C.M.S. has very broad authority to regulate Medicare-certified providers,’” Katrina A. Pagonis, a lawyer specializing in regulatory issues for Hooper, Lundy & Bookman, told Abelson. And she quoted Erin J. McLaughlin, a labor and employment lawyer for the Pittsburgh-based Buchanan, Ingersoll & Rooney, as stating that the rule was “essentially a condition of participation” in federally funded programs. The administration invoked the Supremacy Clause in the Constitution to pre-empt state and local laws when issuing the rule, McLaughlin added.
In its press release announcing the interim final rule, CMS noted that “CMS is taking necessary action to establish critical safeguards for the health of all people, their families, and the providers who care for them. CMS knows that everyone working in health care wants to do what is best to keep their patients safe. Yet, unvaccinated staff pose both a direct and indirect threat to the very patients that they serve. Vaccines are a crucial scientific tool in preserving and restoring efficient operations across the nation’s health care system while protecting individuals. This new requirement presents an opportunity to continue driving down COVID-19 infections, stabilize the nation’s health care system, and ensure safety for anyone seeking care.”
And the agency noted that the following types of patient care organizations are covered by the new rule: “The requirements apply to: Ambulatory Surgical Centers, Hospices, Programs of All-Inclusive Care for the Elderly, Hospitals, Long Term Care facilities, Psychiatric Residential Treatment Facilities, 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.”
This is a developing story; Healthcare Innovation will update this story as new developments emerge.