Lawsuits challenging the CMS Interim Final Rule (IFR) on COVID-19 vaccine requirements for healthcare workers and Occupational Safety and Health Administration’s (OSHA) COVID-19 Emergency Temporary Standards on Health Care Employment and Vaccinations and Testing for Large Employers (ETS) continue to be filed in various jurisdictions nationwide. On November 4, 2021, CMS issued an IFR requiring staff at 21 types of healthcare facilities and service providers that participate in Medicare or Medicaid programs to be fully vaccinated against COVID-19 by January 4, 2022. More information about the IFR can be found here. The first challenge to the CMS rule was filed by ten separate states in the Eastern District of Missouri on November 10, 2021. Another complaint was filed by twelve different states in the Western District of Louisiana on November 15, 2021. Other states have followed with individual complaints, including Texas on November 15, 2021 in the Northern District of Texas, and Florida in the Northern District of Florida on November 17, 2021.

All of the complaints make similar arguments, including:

• The vaccine mandates exceed CMS’s statutory authority to “make and publish such rules and regulations, not inconsistent with this chapter, as may be necessary to the efficient administration of the functions with which [he] is charged under” the acts governing the Medicare and Medicaid programs, as well as the other statutory grants of authority pointed to in the CMS rule;

• The vaccine mandate violates 42 U.S.C. §1395, which provides that nothing in the Social Security Act “shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency, or person;”

• The vaccine mandate violates the Administrative Procedure Act (APA) because the IFR was issued without notice and the opportunity to comment under 42 U.S.C. §1395hh(b)(1);

• The vaccine mandate violates the Congressional Review Act (CRA) requiring rules to be submitted to Congress for an opportunity to pass a resolution disapproving the rule and “major rules” must receive a report from the Government Accountability Office before it becomes effective; and

• The vaccine mandate is arbitrary and capricious under the APA.

The complaints seek injunctive and declaratory relief setting aside the IFR.

OSHA ETS AND LAWSUITS

On November 5, 2021, OSHA issued the ETS. As we previously reported, the ETS requires, among other things, that private employers with 100 or more employees develop, implement, and enforce COVID-19 testing and vaccination policies. Lawsuits have been filed in all 12 regional circuits by numerous states, employers, unions, and other petitioners seeking to set aside the ETS, and on November 12, 2021 a panel of the Fifth Circuit Court of Appeals issued a 22 page opinion granting the petitioners’ request to stay the ETS pending review.

On November 12, 2021, pursuant to 29 U.S.C. § 2112(a)(3), the Judicial Panel on Multidistrict Litigation issued an order consolidating the petitions and randomly selected the Sixth Circuit Court of Appeals to handle the consolidated cases.

Many of the petitioners in the now-consolidated Sixth Circuit case moved for initial en banc review, which would bypass a panel entirely and put the case before the entire Circuit Court. The Circuit’s En Banc Coordinator has directed OSHA to file a consolidated response to those petitioners by November 30, 2021. OSHA has since announced that it will suspend all implementation activities while the litigation unfolds.