On January 13, 2022, the Supreme Court of the United States issued a ruling paving the way for the Biden administration's vaccine mandate for health care workers to go into effect nationwide.1 The vaccine mandate, issued in the form of an interim final rule by the Centers for Medicare and Medicaid Services (CMS), was supposed to go into effect December 6, 2021, but was subsequently barred from going into effect in 24 states2 by injunctions issued by District Courts in Louisiana and Missouri. With its January 13, 2022 ruling, the Supreme Court "stayed" those injunctions, meaning that the rule will now go into effect in those states, pending the outcome of the substantive litigation about the administration's authority to issue the mandate working its way up through the federal judicial system, including possibly back to the high court.
The Secretary of Health and Human Services (HHS) had issued the CMS Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule on November 5, 2021, as we previously reported, requiring Medicare and Medicaid-certified suppliers, providers, and their staff to become vaccinated for COVID-19, subject to religious and medical exemptions. Hospitals, Hospice, Community Mental Health Centers, and Comprehensive Outpatient Rehabilitation Facilities are some of the types of facilities that are required to implement policies to ensure their staff, current and new, who provide care, treatment, or other services for the facility and/or its patients become vaccinated against COVID-19. Notably, the CMS vaccine mandate did not contain a testing exemption, unlike the administration's simultaneously announced OSHA rule, which contained a "vax or test" requirement.
In its per curiam opinion today, the Supreme Court ruled that the CMS vaccine mandate falls within the authorities conferred upon the HHS Secretary by Congress. It first noted that the HHS Secretary has general statutory authority to promulgate regulations "as may be necessary to the efficient administration of the functions with which [he] is charged," including the function of ensuring healthcare providers protect their patients' health and safety, and further noted that Congress authorized the HHS Secretary to promulgate such regulations as "the Secretary finds necessary in the interest of the health and safety of individuals who are furnished services." A version of this statutory authority exists for nearly all of the facilities that fall within the mandate, and is also the source of the conditions of participation of Medicare and Medicaid with which facilities must comply to be eligible to receive Medicare and Medicaid funds. Thus, the Supreme Court ruled that the CMS vaccine mandate "fits neatly within the language of the statute" that authorizes the HHS Secretary to impose these conditions of participation on the receipt of Medicaid and Medicare.
In so doing, the Court analogized the vaccine mandate to a condition of participation requiring certain providers to maintain and enforce an infection prevention and control program "to help prevent the development and transmission of communicable diseases and infections," as well as numerous conditions of participation that address the safe and effective provision of healthcare, as well as those that relate to the qualifications of healthcare workers themselves. The Court also recognized that the mandate goes further than other conditions of participation have in the past to address infection control, while underscoring that the HHS Secretary has never had to regulate "an infection problem of this scale and scope before." Moreover, the Court noted that Medicare and Medicaid conditions of participation have not historically included vaccine mandates because state requirements ordinarily require vaccination for diseases such as hepatitis B, influenza, and measles, mumps, and rubella.
At base, the Court found that CMS acted within a zone of reasonableness in issuing its interim final rule, which was supported by 73 pages of supporting reasoning on everything from the 35% or more unvaccinated staff at many facilities at the time the rule was issued, to the fact that COVID-19 can spread rapidly among healthcare workers and from them to patients and that such spread is more likely in unvaccinated healthcare workers, to the fact that Medicare and Medicaid patients are elderly and often disabled or otherwise in poor health and thus COVID-19 transmission to them is acutely dangerous, to the fact that fear of exposure to COVID-19 from unvaccinated healthcare staff could lead to patients themselves forgoing or failing to seek medically necessary care, in turn creating additional risks to patient health and safety. From all of this, the HHS Secretary determined that a COVID-19 mandate "will substantially reduce the likelihood that healthcare workers will contract the virus and transmit it to their patients," and therefore concluded that the mandate is "necessary to promote and protect patient health and safety" during the ongoing pandemic. With this ruling, the Court concluded that the HHS Secretary acted within his statutory authority in imposing such a vaccine requirement to participate in Medicare and Medicaid.
Late last month, CMS also announced its intention to reinstate its vaccine mandate in the 25 states that were not the subject of the above litigation, and that the compliance dates therefore were modified such that staff must be vaccinated with the first dose of the COVID-19 vaccine by January 27, 2022, and that healthcare staff must be vaccinated with a second dose by February 28, 2022. Presumably, with today's ruling, these dates will become effective in all states subject to the litigation as well.
Please note that the U.S. Supreme Court today also issued a stay of the OSHA Emergency Temporary Standard relating to mandated vaccination for employees.
1 The CMS vaccine mandate continues to be enjoined in Texas by the Northern District of Texas, and Florida has asked for an en banc rehearing in the 11th Circuit after a 3-judge panel refused to enjoin the CMS vaccine mandate there pending appeal, although Medicare and Medicaid providers are currently required to comply with the CMS vaccine mandate.
2 These states include: Alabama, Alaska, Arizona, Arkansas, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Utah, West Virginia, and Wyoming.
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