Vaccine Mandates: What’s Next for Health Care

*This Featured Article is contributed by AHLA's Labor and Employment Practice Group.

January 21, 2022

Adam R. Young , Seyfarth Shaw LLP
Bailey G. Green , Seyfarth Shaw LLP

OSHA Health Care ETS

On June 21, 2021, OSHA adopted a Healthcare Emergency Temporary Standard (Healthcare ETS), which sought to protect workers from COVID-19 in settings where they provide health care or health care support services. Under the OSH Act, an ETS is effective for six months and serves as a proposal for a permanent standard.

On December 27, 2021, OSHA announced that the final rule could not be completed within that timeframe and withdrew all non-recordkeeping portions of the Healthcare ETS. However, the recordkeeping portions of the ETS (i.e., the COVID-19 log and reporting provisions) remain in effect because they were adopted under a separate provision of the OSH Act. Health care facilities should ensure that they are continuing to comply with these reporting provisions, which require employers to report an employee COVID-19 case to OSHA even if more than 24 hours has elapsed between illness onset and hospitalization, and even if more than 30 days has elapsed between illness onset and a fatality.

Even though the federal OSHA Healthcare ETS partially expired in December, some state health care ETSs remain on the books (e.g., Tennessee) and other states are developing or enforcing state COVID-19 regulations (e.g., New York, Virginia, Washington State).

OSHA Vaccination and Testing ETS

On November 4, 2021, OSHA announced a vaccination and testing mandate for virtually all employers with 100 or more employees. The OSHA ETS required employers to ensure that all of their employees were either fully vaccinated or underwent weekly COVID-19 testing. Employers were required to maintain a roster of each employee’s vaccination status and preserve proof of vaccination for each employee who was fully or partially vaccinated. If an employee was not fully vaccinated, they were required to wear a mask while indoors. On January 13, 2022, the Supreme Court reinstated a stay of the regulation, effectively blocking the ETS for the foreseeable future. While a final ruling on the merits is outstanding, a similar outcome would be expected at the Supreme Court.

With both ETSs nullified, we can expect that OSHA will continue to enforce COVID-19 hazards at workplaces through the General Duty Clause, respiratory protection standard, and recordkeeping standard. Health care facilities should ensure that they are addressing all COVID-19 hazards and remaining in compliance with the remaining federal and state COVID-19 regulations and guidance.

CMS Vaccine Mandate

On November 5, 2021, the Secretary of the Department of Health and Human Services announced that, in order to receive Medicare and Medicaid funding, participating health care facilities had to ensure that their staff are vaccinated against COVID-19. Although the CMS rule provides for employees to seek exemptions on disability or religious grounds, it does not permit a testing option for those who prefer not to vaccinate. Accordingly, the CMS rule requires a “hard” vaccine mandate, with no opt-out.

Following the announcement of the rule, two U.S. district courts enjoined enforcement of the rule in 24 states. On January 13, 2022, the Supreme Court issued a 5-4 decision permitting enforcement of the CMS rule nationwide. The Court ruled that the Secretary did not exceed his statutory authority by requiring that facilities covered by the rule enforce the vaccine mandate. Rather, the statute gave clear authority to condition CMS funds “in the interest of health and safety.”

Now, the Eastern District of Missouri’s November 29, 2021, order granting a preliminary injunction is stayed pending disposition of the government’s appeal in the Eighth Circuit and the disposition of the government’s petition for writ of certiorari (if sought). The same is true for the Western District of Louisiana’s November 30, 2021, order granting a preliminary injunction, which also is stayed during the government’s appeal in the Fifth Circuit and the disposition of the government’s petition for writ of certiorari. If a writ is denied, the respective stay is automatically terminated. To the extent that a writ is granted, the Supreme Court’s order shall terminate upon its judgment on the respective appeal.

It should also be noted that after the Eastern District of Missouri and the Western District of Louisiana issued their preliminary injunctions, the Northern District of Texas issued a preliminary injunction against the CMS Vaccine Mandate on December 15, 2021. As a result, the Texas preliminary injunction was not considered in the Supreme Court’s January 13, 2022, decision and remained in place. However, following the Supreme Court’s decision, the Northern District of Texas, on January 18, 2022, dismissed the action, resulting in the mandate being enforceable nationwide. The remainder of this article addresses the compliance requirements and deadlines following these developments.

At this time, the Court’s ruling enables CMS to enforce its vaccine mandate rule as a condition of participation in Medicaid and Medicare funding, which covers more than 17 million health care workers. Specifically, the rule applies to the following health care facilities:

Ambulatory Surgical Centers
Hospices
Psychiatric residential treatment facilities
Programs of All-Inclusive Care for the Elderly
Hospitals (acute care hospitals, psychiatric hospitals, hospital swing beds, long term care hospitals, children's hospitals, transplant centers, cancer hospitals, and rehabilitation hospitals/inpatient rehabilitation facilities)
Long Term Care Facilities, including Skilled Nursing Facilities and Nursing Facilities, generally referred to as nursing homes
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
End-Stage Renal Disease Facilities

It is important to note that this rule is based on the contract between the facilities and CMS—not geography. State law is not relevant in determining compliance. In fact, the rule expressly preempts the applicability of any state or local law that provides for exemptions to the extent such law provides broader exemptions than provided for by the federal law and are inconsistent with the rule.

Due to the injunctions granted in the Eastern District of Missouri, the Western District of Louisiana, and the Northern District of Texas, however, health care providers will face different compliance deadlines depending on their state. States impacted by the injunctions will have more time to comply with the CMS Vaccine Mandate. On January 14, 2022, CMS issued a memorandum with new deadlines for the 24 states where the CMS mandate had been enjoined. Following the dismissal of the action in Texas, CMS on January 20, 2022 issued another memorandum with new deadlines applicable to that state. The following states, where the CMS mandate had previously been enjoined, have delayed compliance deadlines:

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
Wyoming
Texas

The remaining states must comply with the deadlines provided in CMS’ December 28, 2021 memorandum. Below is a summary of the the requirements and deadlines established in CMS’ December 28, 2021, January 14, 2022, and January 20, 2022 memorandums.

Compliance Deadlines for States Not Impacted by the Preliminary Injunctions

Employers in the states not listed above must observe the requirements established in the December 28, 2021 CMS memorandum. By January 27, 2022, covered providers must demonstrate (1) that policies and procedures for ensuring all facility staff are vaccinated or received an exemption have been implemented and (2) 100% of staff have received at least one dose of the COVID-19 vaccine, or have a pending request for, or have been granted, an exemption, or have been identified as needing a temporary delay in receipt of vaccine. A delay, as recommended by the Centers for Disease Control and Prevention (CDC), may be necessary if a staff member has recently had COVID-19. If less than 100% of staff are vaccinated, the facility will be in non-compliance under the rule and will receive a notice of non-compliance. However, if the facility can show that 80% of its staff are vaccinated and has a plan to achieve 100% vaccination within 60 days, it would not be subject to additional enforcement actions. On January 27, 2022, federal, state, accreditation organizations, and CMS-contracted surveyors will also begin surveying for compliance with these requirements as part of initial certification, standard recertification or reaccreditation, and complaint surveys.

By February 28, 2022, facilities must ensure that all policies and procedures are developed and implemented for ensuring that all staff, regardless of clinical responsibility or patient contact, are fully vaccinated. If less than 100% of staff are vaccinated, the facility will be in non-compliance under the rule and will receive a notice of non-compliance. However, if the facility can show that 90% of its staff are vaccinated and has a plan to achieve 100% vaccination within 30 days, it would not be subject to additional enforcement actions. Finally, by March 28, 2022, facilities failing to maintain compliance with the 100% standard may be subject to enforcement actions. If any health care facilities in the 15 categories listed above have not begun to implement the necessary measures to fall within compliance of the CMS mandate, now is the time to begin.

Compliance Deadlines for State Impacted by the Preliminary Injunctions

Employers in the states impacted by the Missouri and Louisiana injunctions must comply with the requirements detailed in the January 14, 2022 CMS memorandum. By February 14, 2022, covered providers must demonstrate that (1) they implemented the policies and procedures for ensuring all facility staff are vaccinated or received an exemption and (2) 100% of staff have received at least one dose of the COVID-19 vaccine, or have a pending request for, or have been granted, an exemption, or have been identified as needing a temporary delay in receipt of vaccine. A delay, as recommended by the CDC, may be necessary if a staff member recently contracted COVID-19. If less than 100% of staff are vaccinated, the facility will be in non-compliance under the rule and will receive a notice of non-compliance. However, if the facility can show that 80% of its staff are vaccinated and has a plan to achieve 100% vaccination within 60 days, it would not be subject to additional enforcement actions. Facilities that do not meet these parameters could be subject to additional enforcement actions depending on the severity of the deficiency and the type of facility.

On February 14, 2022, federal, state, accreditation organizations, and CMS-contracted surveyors will also begin surveying for compliance with these requirements as part of initial certification, standard recertification or reaccreditation, and complaint surveys.

Within 60 days or by March 15, 2022, facilities must ensure that all policies and procedures are developed and implemented for ensuring that all staff, regardless of clinical responsibility or patient contact, are fully vaccinated. If less than 100% of staff are vaccinated, the facility will be in non-compliance under the rule and will receive a notice of non-compliance. However, if the facility can show that 90% of its staff are vaccinated and has a plan to achieve 100% vaccination within 30 days, it would not be subject to additional enforcement actions. Finally, within 90 days or by April 14, 2022, facilities failing to maintain compliance with the 100% standard may be subject to enforcement actions. If any health care facilities in the 15 categories listed above have not begun to implement the necessary measures to fall within compliance of the CMS mandate, now is the time to begin.

Employers in Texas must comply with similar requirements detailed in the January 20, 2022 CMS memorandum but with slightly later compliance deadlines.

The recent Supreme Court holdings finally provide clarity for health care providers; they should focus their efforts on developing and implementing the required policies and procedures by the deadlines established in the CMS Vaccine Mandate and on continuing to adhere to the reporting requirements in the Healthcare ETS. Health care facilities should continue to keep a watchful eye on both federal and state regulations to guarantee compliance with all laws and to ensure the safety of their employees.

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