Large Employers, Health Care Providers, and Federal Government Contractors - What Do the Federal COVID-19 Mandates Mean to You?

As we have reported since the COVID-19 pandemic began, it has created numerous and unprecedented requirements for employers to navigate.  Now, pursuant to OSHA’s COVID-19 Vaccination and Testing Emergency Temporary Standard (“ETS”), President Biden’s Executive Order 14042 for federal government contractors (the “Executive Order”), and the Centers for Medicare and Medicaid Services (“CMS”) emergency regulation, many employers may be required to implement policies requiring their employees to be fully vaccinated from COVID-19, with few exceptions.  However, litigation has halted the implementation of the ETS for now, and challenges have been filed to the legality of the Executive Order and the CMS emergency regulation.

Below, please find summaries of the ETS, the Executive Order, and the CMS regulation, including employer requirements, penalties, and the status of complex litigation challenging each.

  1. OSHA ETS

On November 5, 2021, OSHA published the ETS requiring COVID-19 vaccinations or weekly COVID-19 testing for employees at workplaces with 100 or more employees.  There has been some pushback on the ETS, and several lawsuits have been filed claiming that the ETS is unconstitutional.  As a result of the pending litigation, OSHA has suspended activities that would implement or enforce the ETS.  Although it is unclear if or when the ETS will be implemented and enforced in the future, it is still important for employers to know what the requirements are, how they can comply, and what the deadline is for compliance so they can continue to prepare to follow the requirements if the ETS is upheld and enforced.

What does the ETS require and who must comply?

Generally, a private employer with 100 or more employees must comply with the ETS, should it go into effect.  However, states or U.S. territories that operate under their own OSHA-approved workplace safety and health programs will have a certain amount of time to create their own “equally effective plans” or adopt the ETS.  Employers should check with the laws of their state or their legal counsel to determine if the ETS, or other state mandated plan, will apply.

The ETS has many requirements.  First, employers must establish a policy mandating all employees become fully vaccinated against COVID-19 or, in the alternative, a policy allowing employees to either become fully vaccinated against COVID-19 or submit to weekly COVID-19 testing and wear a face covering in the workplace (when indoors or when in a vehicle if other employees are present).  The ETS applies to all employees except those who do not report to a workplace where other individuals are present, such as employees working from home and employees who work exclusively outdoors.

If the employer chooses a vaccine mandate (rather than the vaccine or mask/test option) an employee may be eligible for an exception from the vaccine mandate as a reasonable accommodation due to medical reasons or a sincerely held religious belief, practice, or observance that prevent them from being vaccinated.  In that case, the employee would still be subject to the masking and weekly testing requirements of the ETS, unless they are further eligible for a reasonable accommodation from the masking or COVID-19 testing requirements.

The ETS’s weekly testing requirements mandate that each unvaccinated employee be tested every 7 days, or within 7 days before returning to work if away from the workplace for a week or more.  Although the ETS does not require employers to pay for testing, most insurance does not cover regular COVID-19 testing.  Accordingly, employers must decide whether the employee will bear that cost.  Another uncertainty is whether nonexempt employees must be compensated for their time spent getting tested if testing is done outside of their normal working hours.

Employers also must determine the vaccination status of each employee, obtain acceptable proof of vaccination, and maintain records of each employee’s vaccination status.  Covered employers who opt for a policy permitting employees to either be fully vaccinated or provide proof of weekly testing must also obtain each employee’s weekly COVID-19 test results no less than every seven days.  If an employee has been away from the workplace more than seven days, the employee must provide the employer with COVID-19 test results from a test taken no more than seven days prior to returning to the workplace.  Employers are also required to keep a roster of each employee and his or her vaccination status.  Please see The COVID-19 Log for more information on this requirement.

There are more requirements for employers.  Employers must require employees to promptly provide notice to the employer when the employee receives a positive COVID-19 test or is diagnosed with COVID-19 and employers must immediately remove any COVID-19 positive employee from the workplace.  Employers must also provide employees with information about the ETS and workplace policies and procedures, vaccine efficacy and safety, protections against retaliation for exercising rights related to COVID-19 safety standards (such as requesting time off for vaccination/recovery and requesting personal protective equipment, among others), and the laws and penalties for supplying false information.  OSHA has prepared a notice for this purpose, located here.

It doesn’t end there.  Employers must report work-related COVID-19 fatalities to OSHA within 8 hours of learning about such fatality, and work-related COVID-19 inpatient hospitalizations within 24 hours.  Upon request, employers also have an obligation to provide OSHA, within four (4) business hours of the request, with (i) the employer’s written policy for vaccination/testing and (ii) the aggregate number of fully vaccinated employees and total number of employees at the workplace.  For any other records required to be maintained, covered employers have until the end of the next business day after a request to provide the records to OSHA.

Employers must also make individual employee’s COVID-19 vaccination documentation and any COVID-19 test results available either to the employee, or anyone with the written authorization of the employee, for examination or inspection by the end of the next business day following the request.  All vaccination records and rosters as well as testing records are considered confidential employee medical records under OSHA regulations and must be maintained as such.  They must not be disclosed except as required by ETS or other federal law.  Note that OSHA’s standard 30-year retention requirement is not applicable to these records and rosters.  Rather, they must be maintained and preserved while the ETS remains in effect.  However, should OSHA eventually issue a permanent standard, these records may then be subject to the normal 30-year retention rule.

Penalties

OSHA may fine a covered employer that does not comply with the ETS up to $13,653 for each violation of the standard.  Employers that willfully or repeatedly violate the standard can be fined up to $136,532 for repeated violations.  

Litigation Challenging ETS 

The future of ETS is far from certain.  On November 12, 2021, the U.S. Court of Appeals for the Fifth Circuit issued an order upholding its initial November 6, 2021, opinion, ordering a temporary stop of the ETS.  The ruling noted that a permanent injunction for the mandate is likely because the law’s applicability is both overinclusive and underinclusive.  The Court found a conflict between the notion that the ETS was required due to the danger posed by COVID-19, but only applied it to workplaces with 100 or more employees, and not to smaller employers – and that OSHA made that choice based on the functional ability of larger employers to cope with the mandate, not relative danger.  Additionally, the court criticized the ETS for not trying to account for differences in workplaces “that have more than a little bearing on workers’ varying degrees of susceptibility to the supposedly ‘grave danger’ the [ETS] purported to address.”  The Court suggested, for example, that a 28-year-old truck driver is less vulnerable to COVID-19 than a 62-year-old prison janitor by virtue of their different working circumstances.  The Court held that the mandate fails to address “much of the reality and common sense” of these scenarios.  The Court also noted that the mandate raises constitutional concerns that OSHA exceeded its statutory authority.

The Court ordered that OSHA take no steps to implement or enforce the ETS until further court order.  Accordingly, OSHA confirmed that it has suspended activities related to the implementation and enforcement of ETS pending future developments in the litigation.

Multidistrict Litigation

Now, we turn our attention to the Sixth Circuit, which “won the lottery” to hear the consolidated multidistrict litigation challenging the ETS.  Specifically, when petitions for review of federal agency actions are filed in several federal circuit courts, one court of appeals, chosen at random, will hear all the consolidated cases.  Accordingly, the challenges to the ETS pending in 11 federal jurisdictions will be consolidated and heard by the Sixth Circuit Court of Appeals.    

What happens next?

The Sixth Circuit Court of Appeals will ultimately have the power to modify or lift the order by the Fifth Circuit.  However, regardless of the Sixth Circuit’s holding, the U.S. Supreme Court may ultimately decide the fate of the ETS.  

What are the deadlines?

The ETS was set to require employers to comply with all requirements by December 5th, except for the masking/testing requirement, which was to be implemented by January 4th.  Due to the pending litigation these dates are on “hold.”

Given the potential penalties at stake for noncompliance and with the January 4th deadline for compliance looming, we recommend that employers should not wait to hear from the Sixth Circuit or U.S. Supreme Court and should instead prepare to comply if the ETS is upheld.  We will continue to monitor the litigation and keep our clients apprised as it progresses.

For more information, OSHA’s ETS Fact Sheet and Frequently Asked Questions are available on OSHA’s website.

  1. The Executive Order

In September 2021, President Biden issued a vaccine mandate for covered employees of federal government contractors.  This Executive Order has dual provisions – for both “covered contractor employees” and the physical workplaces in which the work is performed. 

What does the Executive Order require and who must comply?

Pursuant to the Executive Order, all employees who qualify as “covered contractor employees” must be vaccinated against COVID-19, unless they are legally entitled to an accommodation from the vaccination requirement due to medical reasons or a sincerely held religious belief, practice, or observance.  The Executive Order does not permit a mask/test alternative.

“Covered contractor employees” include those working directly on or in support of a contract requiring compliance with the Executive Order (whether the contract is new, extended, or renewed), whether the employee works on a full-time, part-time, or remote basis, as well as employees of the contractor or affiliates of the contractor who do not work on or in support of covered contracts, but who work in the same physical workplace as those who do.  (“In support of” refers to back-office functions like human resources, payroll, legal, or billing, among others.) 

Covered contractor employees must provide or show documentation to their employer verifying their vaccination status.  If the employer retains that documentation, it must be maintained as confidential medical information in accordance with the Americans with Disabilities Act (“ADA”).  In addition, covered contractors should review and resolve requests for accommodation pursuant to EEOC guidance on the ADA and Title VI of the Civil Rights Act of 1964. 

In addition to the vaccination requirements, compliance requirements for masking and physical distancing apply to physical workplaces under the control of the covered contractor where work on or in support of a covered contract is performed, including outdoor workplaces.  These requirements apply to all employees (and employees of affiliated entities) working in physical locations where work on or in support of covered contracts is performed, even if the employees are not themselves working on or in support of covered contracts.  Employees may also be eligible for medical or religious accommodation from masking requirements.

Masking and physical distancing requirements will vary depending on whether the physical workplace is in an area of low, moderate, or high transmission, and must be adjusted if the transmission rates vary.  Notice posting is required to inform employees and visitors of requirements.  Covered federal contractors are required to designate a compliance officer to ensure and enforce compliance with requirements and to determine the transmission status of the area in which the physical workplace is located on a weekly basis. 

The duty to comply with the masking and physical distancing requirements of the Executive Order applies as soon as a clause requiring compliance is incorporated into a covered contract.  The Executive Order has a complicated phase-in requirement for contractor compliance.  Pursuant to the Executive Order:

  • Contracts entered, extended, or renewed, or options exercised, on or after November 14, 2021, are required to incorporate the compliance clause, at which point contractors are required to comply with all requirements of the Executive Order. 
  • For contracts awarded prior to October 15, 2021, where performance is ongoing, the requirements must be incorporated at the point at which an option is exercised or an extension or renewal of the contract is made.
  • Between October 15 and November 14, 2021, agencies were required to include the clause in the solicitation and were encouraged to include the clause in contracts awarded during this time but are not required to do so unless the solicitation for such contract was issued on or after October 15.

Despite the phase-in requirement, however, contracting agencies are pressuring federal contractors who would not yet be subject to the Executive Order to agree to mid-term contract modifications for compliance.  Compliance requirements will apply at most levels of performance of the federal government contract and covered prime contractors are required to “flow down” the compliance obligations to their subcontractors.

Penalties.

Failure to comply with federal contracting requirements may result in a variety of penalties, up to and including possible termination of a contract, nonrenewal, or debarment.

What is the deadline? 

The Executive Order requires all “covered contractor employees” to be fully vaccinated against COVID-19 by January 18, 2022, unless they are legally entitled to an accommodation.  (Meaning, that employees have completed the primary vaccination series by January 4, 2022.)  There is no grace period for new employees hired after January 18, 2022, or compliance requirements taking effect after that date: all covered contract employees must be fully vaccinated as of the first period of work on a contract requiring compliance. 

Resources 

Due to the complexity of federal government contracting and compliance with this Executive Order, this article provides only basic compliance information.  Detailed guidance and FAQ regarding the applicability and implementation of the Executive Order have been issued by the Safer Federal Workforce Task Force and may be found at https://www.saferfederalworkforce.gov/contractors/.  Please note that these guidance materials are updated regularly.

  1. CMS Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule

CMS also issued emergency regulations requiring COVID-19 vaccination of eligible staff at health care facilities that participate in the Medicare and Medicaid programs.  The emergency regulation went into effect on November 5, 2021.

What does the emergency regulation require and who must comply?

Covered facilities must establish a policy ensuring that all covered staff members have received the first dose of a two-dose COVID-19 vaccine, or a one-dose COVID-19 vaccine, by December 6, 2021, prior to providing any care, treatment, or other services and that they must be “fully vaccinated” by January 4, 2022.  CMS considers staff fully vaccinated if it has been two weeks or more since they completed a primary vaccination series for COVID-19.  This requirement applies to all individuals working at a facility that participates in the Medicare and Medicaid programs regardless of clinical responsibility or patient contact – including all facility employees, licensed practitioners, students, trainees, and volunteers.

The requirement applies to the following Medicare and Medicaid-certified provider and supplier types: ambulatory surgery centers, community mental health centers, comprehensive outpatient rehabilitation facilities, critical access hospitals, end-stage renal disease facilities, home health agencies, home infusion therapy suppliers, hospices, hospitals, intermediate care facilities for individuals with intellectual disabilities, clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services, psychiatric residential treatment facilities (PRTFs) programs for all-inclusive care for the elderly organizations (PACE), rural health clinics/federally qualified health centers, and long-term care facilities.  The mandate does not apply to any health care entities that CMS does not regulate.

The mandate further requires that covered facilities track and securely document the vaccination status of each staff member, kept in a confidential manner, and stored separately from an employee’s personnel file.

On November 10, 2021, ten states filed suit against CMS in the U.S. District Court for the Eastern District of Missouri seeking to halt the rule from being implemented.  Another twelve states filed a federal lawsuit on November 14th in the U.S. District Court for the Western District of Louisiana and in the U.S. District Court for the Northern District of Texas.  The lawsuits claim the interim final rule exceeds CMS’ statutory authority, violates the Administrative Procedure Act and other laws, and is unconstitutional, and seeks to stop the agency from imposing the vaccine mandate.  These lawsuits are still pending and, as of the date of publication of this article, no stay of enforcement has been entered.

What is the deadline?

All eligible staff must be fully vaccinated by January 4, 2022.

Penalties.

For nursing homes, home health agencies, and hospice facilities (beginning in 2022), penalties for noncompliance include civil monetary penalties, denial of payment, and even termination from the Medicare and Medicaid program as a final measure.  The remedy for noncompliance among hospitals and certain other acute and continuing care providers is termination of the covered facility’s Medicare/Medicaid provider agreement; however, CMS’s goal is to bring health care facilities into compliance.  Termination would generally occur only after providing a facility with an opportunity to make corrections and come into compliance.

Resources.

Detailed guidance and FAQ regarding applicability and implementation may be found at the following links: Frequently asked questions and Federal Register.  Additionally, the American Health Care Association has developed a policy and procedures template.

  1.  Acceptable Forms of Proof of Vaccination Status

Examples of acceptable forms of proof of vaccination for all the above mandates include:

  • A copy of the COVID-19 vaccination record card;
  • A copy of medical records documenting the vaccination;
  • Documentation of vaccination from a health care provider or electronic health record;
  • A copy of immunization records from a public health, state, or tribal immunization information system; or
  • The immunization record from a health care provider or pharmacy.
  1. What Employers Should Do
  • The OSHA ETS and updated guidance from White House clarify that the OSHA ETS only applies to workplaces that are not covered by the Executive Order or the CMS mandate.  Employers should determine which rule (if any) applies to them.
  • Given the heavy penalties for noncompliance, employers who may be subject to the OSHA ETS should prepare to comply with its requirements.  At this point, this includes choosing whether to implement a vaccine mandate, or a vaccine or mask/test option, preparing a policy and distributing it to employees, surveying employees for vaccination status and preparing a roster, collecting the necessary documentation from employees, and planning for providing paid time off and sick leave to employees getting and recovering from vaccinations.  Employers should also decide who will pay for testing, and review with legal counsel whether nonexempt employees are entitled to be paid for time spent getting tested outside of work hours.
  • Employers who are currently subject to the Executive Order must identify their covered contractor employees and covered contract workplaces, implement the required workplace safety measures, ensure that all covered contractor employees are fully vaccinated by January 18, 2022, or that requests for accommodation are being reviewed, ensure that new hires are complying with the vaccine requirement (or are accommodated), and that compliance personnel have been designated to implement and enforce the workplace safety protocols.  Employers who obtain vaccination records must ensure that they are maintained as confidential medical records.
  • Employers who are subject to the CMS mandate must establish a process or policy to fulfil the staff vaccination requirement as soon as possible to ensure that staff have received, at a minimum, the first dose of a primary series or single dose COVID-19 vaccination by December 6, 2021, and be fully vaccinated by January 4, 2022.  CMS expects state survey agencies to regularly review compliance by reviewing the facility’s COVID-19 vaccination policies and procedures, the number of resident and staff COVID-19 cases over the last 4 weeks, and a list of all staff and their vaccination status.  Accordingly, covered facilities should prepare to satisfy all recordkeeping requirements.