Missouri, et al. v. Biden, et al., No. 21-cv-01329 (E.D. Mo.). Complaint filed November 20, 2021.


Ten states have joined in challenging the action of the United States Department of Health and Human Services (HHS), Centers for Medicare and Medicaid Services (CMS) in promulgating an Interim Final Rule with Comment Period (IFC) that conditions health care providers’ receipt of federal funding and reimbursement on employee or contractor vaccination against COVID-19.  

Providers and Employees Threatened. Health care providers whose employees fail to comply with the federally mandated demand that all health care workers be vaccinated against Covid-19 may lose federal funding,   As vaccination refusal will threaten employer compliance with the federal measure, unvaccinated employees may lose their jobs.

Exacerbation, Not Mitigation.  The states submit that this sweeping federal incursion on health care administration threatens to exacerbate an already extant crisis in health care provision, which crisis only deepened during the COVID-19 pandemic, forcing states to undertake drastic measures to ameliorate the deadly synergies of two crises which individually would have sufficed to cause health care services to crater. 

          To the extant shortage of workers and threat of harm from viral infection the federal government has added a compliance burden that, the states contend, violates the interests of the states, the healthcare providers and entities within the states, and the healthcare workers who must submit to vaccination or face termination. 

State Standing.  Having brought their complaint in the United States District Court for the Eastern District of Missouri, the states and their attorneys general assert standing premised on exercise of parens patriae powers or statutory authorizations. 

Effective Immediately.  The Interim Final Rule, also called  the CMS vaccine mandate, became effective on publication on publication in the Federal Register on November 5th.  Its protocol demands at least partial vaccination compliance by the first week of December, a deadline that only compounds the problems the rule has caused, the states note.  

          Most significantly, the states argue, the Interim Final Rule is not merely factually detrimental to the provision of health care services, the rule itself and the manner in which the rule was crafted is in violation of central components of the Administrative Procedures Act (APA) and the United States Constitution.

The CMS Vaccine Mandate Makes Matters Worse.  The complaining states assert that the sweeping federal incursion on providers’ rights will exacerbate and extant shortage of workers.  The federal scheme is an unconstitutional abridgment of rights traditionally reserved to the states, and is not only legally flawed but also is, as a practical matter, administratively disastrous, as the health care needs of densely populated urban areas are markedly varied from those of rural settings.  

The CMS vaccine mandate must be set aside.  The states ask that the federal court declare the CMS vaccine rule be declared invalid constitutionally and in violation of the Administrative Procedures Act (APA) and other statutes, and that its enforcement be enjoined.

Not an overnight development.  Healthcare workforce shortages predate the COVID-19 pandemic by decades, the states recount.  Nursing shortages, already critical, have been made all the more so by the demands for urgent and other care precipitated by the pandemic. Many nursing professionals feel they cannot continue to work as they have been.  Many have been attracted to positions offering better working conditions are higher compensation. 

          Staffing shortages threaten the capacity of hospitals to administer care.  To address pandemic care needs, states relaxed standards for the provision of services, permitted workers to work without vaccination, and expanded telehealth services.

          The states are critical of the implementation of the administrative rule per see where doing so represents and Executive Branch about face from federal non-involvement in vaccination to a nationwide push for COVID-19 vaccination compliance that threatens workers with loss of employment and provider entities with loss of available federal funding.   

Reaching beyond providers.  Where health care workers cannot work, providers will be unable to provide services, and the patient public will be denied care.  Each of these outcomes, the states observe, is contrary to sound policies of health care delivery.

A diverse panoply of providers under a single rubric.   There are fifteen categories of Medicare and Medicaid providers, encompassing urban and rural clinics, hospitals, long-term care facilities, and home health agencies. 

          CMS reports that nearly all hospitals within the United States are connected in some measure to Medicare and Medicaid.  Although CMS has recognized the diverse purposes and practices of these categories of providers and suppliers, CMS has embroidered on all covered providers and suppliers the measures applicable to long-term care facilities, the states observe. 

          Moreover, CMS appears to recognize the adverse consequences of the vaccine mandate:  failure to comply will threaten health care workers with loss of employment, which in turn will deepen an already critical worker shortage, which in turn will impact access to care.

No comment.  The states point out that there has never before been a federal vaccination mandate, and that the newly-effective rule is unsound on multiple grounds.  The states notes that CMS abandoned the comment period ordinarily required for rules of the magnitude of the unprecedented healthcare vaccine mandate.  Moreover, CMS has failed to locate with accuracy its authority to promulgate the vaccine mandate.

Unauthorized rule-making. The states argue that there is no statutory authority for the CMS vaccine mandate, and that none of the authorities cited by the CMS as authorizing the mandate do so.  This legally unsupported rule will cause the states great economic harm, particularly as states will not only be threatened with loss of federal resources but the states’ own administrative resources have been conscripted to serve the federal government. 

Hindsight unavailing.  The states submit that the CMS has relied on post-hoc rationalizations to support the rule, an impermissible approach which renders the measure arbitrary, capricious, and not in accordance with law. 

Constitutionally intrusive.  The states argue that compulsory vaccination is traditionally a power reserved to the states.  The federal expansion of power over the states violates the Tenth Amendment, the states submit.

Doctrinally unsound.  The states argue that the CMS vaccine mandate is unsound as it is a measure of national breadth and depth that is not supported by clear Congressional directive, and thus runs afoul of the major questions doctrine.   Similarly, the co of a Congressional articulation of an intelligible guiding principle, the CMS vaccine rule violates principles of non-delegation.

Outside professional bounds.  The states observe that the CMS vaccine mandate is precluded by the Social Security Act, which forbids supervision or control over the practice and provision of medicine and medical services.

Procedurally flawed.  The states submit that the Administrative Procedures Act (APA) is not inaptly named, and that no sound excuse exists for CMS’ failure to adhere to notice and comment procedures which permit interested persons’ participation in administrative processes.  

          CMS not only failed to adhere to these processes but its rule became effective on publication with initial compliance to be completed within thirty days.  Additionally, CMS failed to comply with the sixty-day pre-publication requirement of the Social Security Act.  

Input not sought.  CMS failed to confer with the states concerning the mandate as it is required to do.

Unconstitutional conditions imposed.   The federal government may not impose conditions on funding unrelated to the programs impacted or without notice to the states that vaccination would be required in order to obtain federal funds.  

State resources conscripted.  In enacting measures which threaten providers’ finances through demands on employees, the states observe that is is an infringement on state powers for the federal government to demand that state administrative resources be expended in service of federal aims.

Declaratory and injunctive relief sought: looking forward. The states have requested declaratory and injunctive relief which would nullify the CMS vaccine mandate and prohibit its enforcement.  At this writing the federal court has not issued any orders relating to the case, although in light of the abbreviated time frame for compliance with the CMS vaccine mandate, it is anticipated that there will be activity related to this case soon.  

Missouri, et al. v. Biden, et al., No. 21-cv-01329 (E.D. Mo.) Complaint






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