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Federal Vaccine Mandates: Key Takeaways and Action Steps for Employers


On November 5, 2021, the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) published its much-anticipated COVID-19 Vaccination and Testing; Emergency Temporary Standard (ETS). On the same day, the Centers for Medicare & Medicaid Services (CMS) published its Interim Final Rule on vaccination of staff members at health care facilities that participate in Medicare and Medicaid programs. The latest in a string of vaccine-related requirements promised by the federal government, the ETS and the Interim Final Rule were first announced by President Biden on September 9, 2021—as two of the six prongs underpinning his sweeping “Path out of the Pandemic” COVID-19 Action Plan. Two additional prongs—those requiring vaccination for all executive branch employees and federal contractors—have also seen some developments in recent weeks.

Summarized below are important takeaways for employers with respect to these new vaccine-related requirements. Though legal challenges are already underway and more are expected, especially with respect to OSHA’s ETS, employers should take immediate steps to ensure compliance. Indeed, for covered health care facilities that have not implemented a vaccination requirement, the CMS Interim Final Rule requires quick action to implement a policy requiring all care providers to have received at least the first vaccine dose by December 6, 2021.

Please watch for registration information for our webinar on Tuesday, November 16 at 11am CT covering OSHA's ETS and the CMS's Interim Final Rule.

OSHA’s Emergency Temporary Standard

Does the ETS Apply to My Business?

Except as provided below, all private employers with 100 or more employees are covered under this ETS. In determining whether an employer has 100 or more employees, employers should count employees firm- or corporate-wide—not just those who work at a single location. Both full- and part-time workers should be counted, but workers properly classified as independent contractors should not be counted. In the case of franchise companies, when a franchise location is independently owned and operated, the franchisor and franchisee are considered separate entities; thus, employees should be counted separately for purposes of the ETS. However, if two or more entities handle safety matters as one company, the entities may be regarded as a single employer, and all employees should be counted together for purposes of this ETS. Additionally, employers that fluctuate above and below the 100-employee threshold are covered for the full term of the ETS, as of the first date on which they hit the coverage threshold.

Workplaces covered under the Safer Federal Workforce Task Force guidance for federal contractors and health care facilities subject to OSHA’s previously-issued Emergency Temporary Standard are not covered by this ETS. However, some health care facilities may eventually be covered by this ETS if OSHA’s previously-issued standard for health care facilities expires prior to the expiration of the ETS. The ETS does not specifically address whether it will apply to employers who are also covered by the CMS’s Interim Final Rule.

Finally, though some states, including Montana, Texas, Arkansas, and West Virginia, have passed laws prohibiting employers from requiring vaccines at all or under certain circumstances, the ETS, by its terms, preempts all contrary state laws. Therefore, employers are advised to follow OSHA’s standard unless and until an applicable court decision requires otherwise.

Are Any Employees Not Covered by the ETS?

Notably, the requirements of the ETS do not apply to employees in three instances: (1) when the employee works where no coworkers or customers are present; (2) when the employee works exclusively from home; and (3) when the employee works exclusively outdoors.

What Type of Policy Am I Required to Implement?

Covered employers are required to establish, implement, and enforce one of two policies: (1) a policy mandating that each employee must become fully vaccinated; or (2) a policy mandating that each employee must either choose to become fully vaccinated or provide proof of weekly testing and wear a face covering.

How Do I Find Out if My Employees are Vaccinated?

One critical aspect of an employer’s policy under this ETS is the requirement that employers obtain, document, and maintain information regarding their employees’ vaccination status. Employers must require each vaccinated person to provide acceptable proof of vaccination, which includes:

  • a record of immunization from a health care provider or pharmacy,
  • a copy of the employee’s COVID-19 Vaccination Record Card,
  • a copy of medical records documenting the vaccination,
  • a copy of immunization records from a public health, state, or tribal immunization information system, or
  • a copy of another official document that contains the type of vaccine received, date of receipt, and location of administration of the vaccine.

If an employee is unable to produce any of the above proof, the employee may provide a signed statement attesting to vaccination status, including the following language: “I declare (or certify, verify, or state) that this statement about my vaccination status is true and accurate. I understand that knowingly providing false information regarding my vaccination status on this form may subject me to criminal penalties.”

Employers who have already collected and tracked all employees’ vaccination statuses prior to the effective date of the ETS do not have to recollect the information—even if the employer previously accepted a method of proof that does not comply with the ETS’s requirements.

Am I Required to Pay for Employee Vaccination and Testing?

In addition to mandating vaccinations or testing/masking, the ETS requires employers to give paid time off to employees who need to receive their COVID vaccines or recover from vaccine-related side effects. Specifically, employers are required to provide up to four hours of paid time off for an employee to receive each dose of the COVID vaccine, which must be in addition to any other paid leave benefits that employees have accrued. Additionally, employers must provide reasonable paid sick leave to recover from side effects an employee may experience after receiving each dose of the vaccine. For leave to recover from post-vaccine side effects, employers may require employees to use paid leave (e.g., paid sick leave, vacation time) already provided by the employer.

However, the ETS does not require employers to compensate unvaccinated employees for time spent receiving weekly COVID tests. Employers also do not have to provide paid time off for employees recovering from COVID or those following CDC recommendations to isolate after a positive test or diagnosis of COVID. However, employers should follow their state and local laws or collectively negotiated agreements regarding paid sick leave.

The ETS likewise does not require employers to pay for weekly COVID tests for unvaccinated individuals. However, OSHA notes that employers "may be required to pay for testing to comply with other laws, regulations, collective bargaining agreements, or other collectively negotiated agreements." Accordingly, in states where employers are obligated to pay for employee expenses incurred in the course of employment (e.g., Illinois, California, Montana) and/or pay for medical examinations required for employment (e.g., Wisconsin, Illinois), employers should consider whether state law, or any other applicable authority, requires them to pay for COVID tests.

Are Vaccine Exemptions Available Under the ETS?

The ETS exempts employees from the requirement to become fully vaccinated under three circumstances: (1) a medical contraindication applies to the employee; (2) a medical necessity requires a delay in vaccination; or (3) the employee is legally entitled to a reasonable accommodation under federal civil rights laws because they have a disability or a sincerely held religious belief, practice, or observance that conflicts with the vaccination requirement.

Previously, we have advised employers to offer reasonable accommodations to employees with disabilities or sincerely held religious beliefs that would prevent them from getting vaccinated. The ETS provides a built-in accommodation for many of these employees: the weekly testing option. That said, employers should still offer an exemption process to consider whether reasonable accommodations would be appropriate in order to comply with Title VII, the ADA, and state and local laws.

Recently, the EEOC updated its guidance for analyzing religious exemptions under Title VII. Employers reviewing exemption requests should balance the need for an accommodation with any undue hardship that providing the accommodation—or many accommodations if faced with an influx of requests—would impose. Relevant factors for whether the accommodation would pose an undue hardship include the type of workplace, the nature of the employee’s duties, the number of employees who are fully vaccinated, the number of other employees seeking an accommodation, and the risk of spread of COVID-19 to other employees or the public.

What Protocols Must Unvaccinated Employees Follow?

Under the ETS, employers who choose not to mandate vaccination must require regular COVID testing by all unvaccinated employees. If an employee reports to work at least once every seven days, he or she must be tested at least once every seven days, and provide documentation of the test result no later than seven days following the last test result provided. If an employee does not report to work during a period of seven days or more, that employee must be tested within seven days prior to returning to the workplace, and provide documentation of the test result upon return.

The chosen COVID-19 test must be one that is cleared, approved, or authorized by the FDA. This includes tests currently in an Emergency Use Authorization. Tests must be administered in accordance with the authorized instructions. Notably, self-administered tests are not permitted unless administration is observed by the employer or an authorized telehealth proctor.

Employers must also require unvaccinated employees to wear face coverings while indoors and when occupying a vehicle with another person for work purposes. Unvaccinated employees do not need to wear a mask when alone in a room with floor to ceiling walls and a closed door, while eating and drinking, or for a limited time for identification or security purposes. Additionally, employees may be exempt from wearing a mask when employers can show that it would be infeasible or would create a greater hazard than the risks of transmitting and becoming infected by COVID.

What Happens if One of My Employees Tests Positive for COVID?

Each covered employer, in its vaccination policy, must require employees to promptly give the employer notice of a positive COVID test or diagnosis, regardless of the employees’ vaccination status. Employers must then immediately remove such employee from the workplace until the employee receives a negative test, meets the “return to work” criteria set forth by the CDC, or receives a recommendation to return to work by a licensed healthcare provider.

When Is the Deadline to Comply With the ETS?

By December 6, 2021, covered employers must comply with the ETS, except for the testing-related regulations. This means, for example, that by December 6, 2021, employers must have enacted a policy to provide the required paid time off for vaccination, follow the specified protocols for when an employee tests positive for COVID-19, and require unvaccinated employees to wear face coverings in certain circumstances. Employers have until January 4, 2022 to ensure that employees have completed their vaccine regimens, or are being tested weekly. Employers who previously implemented mandatory vaccination policies should update those policies to conform to the ETS requirements for newly hired employees and for current employees in the event the employer established a full-vaccination deadline that is after January 4.

How Long Will the ETS Remain In Place?

OSHA anticipates that the ETS will be in effect for six months (i.e., until May 5, 2022). However, OSHA may update the ETS depending on how the pandemic evolves during that time.

Am I Obligated to Notify My Employees of the ETS Requirements?

Covered employers are required to inform each employee about the requirements of the ETS, the employer’s policies, and OSHA rules regarding discrimination for reporting OSHA violations. Further, employers must provide all employees with the document “Key Things to Know about COVID-19 Vaccines.” Additionally, employers must report work-related COVID fatalities and hospitalizations to OSHA within specified timeframes.

Who Will Enforce the ETS?

Much like it already does for its other regulations, OSHA will enforce this ETS through its authority to investigate complaints and conduct workplace inspections. OSHA can issue penalties—including fines of nearly $14,000 for a single serious violation—for noncompliance with their workplace standards. For additional information, see OSHA’s list of FAQs.

Likely Legal Challenges Ahead

The ETS process is an exception to the usual formal rulemaking procedure, allowing OSHA to skip the usual notice and comment period. An ETS can only be issued upon a finding of “grave danger” to workers, and it may only remain in effect for six months from its publication date of November 5, 2021. However, during the six-month period, OSHA may work to develop a permanent rule that would replace the ETS upon its expiration. Here, OSHA has determined that occupational exposure to SARS-CoV-2, including the Delta variant, presents a grave danger to unvaccinated workers in the U.S.

Prior to the June 2021 Healthcare ETS, OSHA had only used the ETS process nine times, of which six were challenged, resulting in only one standard withstanding scrutiny. This OSHA ETS was immediately challenged on many fronts in lawsuits from Republican state attorneys general, companies, and other organizations seeking to block it. Indeed, the day after the ETS was issued, the Fifth Circuit placed the mandate on hold pending further litigation. Here, there are several contemporaneous lawsuits, and the federal rules for multi-circuit litigation call for these cases to be consolidated and heard by one court that is initially chosen by a lottery. As for the nature of the challenges, they include the 100-employee threshold, which could be deemed arbitrary, and is not an employee threshold that appears in any other OSHA regulation. Another ground for challenge is that the ETS is too broad, unlike the June 2021 ETS that was specific to the healthcare industry. This ETS applies to all general industry, and challengers will argue that it was not designed to limit the virus where needed.

CMS’s Interim Final Rule

Which Employers/Employees Are Covered, and What Is the Basic Requirement?

Also on November 5, 2021, CMS published its highly-anticipated Interim Final Rule on vaccination of staff members at health care facilities that participate in Medicare and Medicaid programs. This means that hospitals, ambulatory care centers, long term care facilities, home health agencies, and many other facilities must quickly mandate vaccines. Specifically, the Interim Final Rule provides that covered facilities must establish policies ensuring that: (Phase 1): by December 6, 2021, all eligible staff have received at least the first dose of a two-dose vaccine or a single-dose vaccine, prior to providing any care, treatment, or other services for the facility or its patients; and, (Phase 2): by January 4, 2022, all eligible staff have received both doses of a two-dose vaccine or a single-dose vaccine.

Because health care employees are being held to a higher standard, there is no testing alternative. Unless the staff receive a medical- or religious-based exemption, they must be vaccinated. Individuals subject to a covered health care facility’s vaccination policy include all current staff members, as well as any new staff member who provides care, treatment, or other services for the facility or its patients. This broad grouping of individuals includes employees, medical staff, anyone holding clinical privileges, licensed practitioners, students, trainees, volunteers, board members, and those who provide care, treatment, or other services for the facility or its patients under contract or other arrangements. However, staff members who provide services fully remotely (e.g., via telehealth) are not subject to the vaccination requirements.

Notwithstanding the above, CMS recognizes that many infrequent services and tasks in or for a health care facility are conducted by "one off" vendors and other professionals. Facilities are not required to ensure the vaccination of individuals who infrequently provide ad hoc non-health care services (e.g., plumber, elevator inspector). When determining whether to require COVID-19 vaccination of an individual who provides non-health care services on an ad-hoc basis, facilities should consider the frequency of presence, the type of services provided, and the proximity to patients and staff.

Do Exemption Requests Need to Be Accommodated?

CMS requires facilities to allow for exemptions requested by staff with recognized medical conditions for which vaccines are contraindicated, or with sincerely held religious beliefs the prevent compliance. Facilities should process exemption requests as part of their policies and procedures. CMS requires covered entities to ensure that requests for exemptions are properly documented and evaluated in accordance with applicable federal law.

CMS requires facilities to develop a process for implementing additional precautions for any staff who are not vaccinated due to a medical or religious accommodation, in order to mitigate the transmission and spread of COVID.

How Will CMS Enforce This Rule and What Are the Effects of Non-Compliance?

CMS has advised that it will ensure compliance with its Interim Final Rule through established survey and enforcement processes. If a covered facility does not meet the requirements, it will be cited as being non-compliant and have an opportunity to cure defects. The remedy for non-compliance among health care facilities ranges from civil monetary penalties, to denial of payment, to termination. See CMS’s list of FAQs for additional information.

Unanswered Questions

While the above-summarized guidance provides some clarity on workplace vaccination mandates promised weeks ago, it also leaves many unanswered questions for employers. Most notably, with respect to OSHA’s ETS, the following remains unclear:

  • Whether employers will have to pay for testing and/or require face coverings be worn for unvaccinated individuals who receive a religious or medical exemption (e.g., pursuant to federal or state law);
  • Whether employers will have to pay employees for time spent testing (e.g., pursuant to the Fair Labor Standards Act or state law); and,
  • How OSHA will enforce this standard, given its limited resources.

Regardless, employers should immediately begin preparing written policies that comply with OSHA’s ETS. Additionally, employers who have previously implemented such policies should review and revise them as necessary. Finally, covered employers should immediately begin requesting and collecting proof of vaccination. Employers who permit employees to get weekly COVID tests should similarly start planning for how employees will access such tests and report test results.

Quarles & Brady remains your best source for the most up-to-date guidance on the rapidly developing vaccine frontier. If you are seeking assistance developing your policies and exemption process or if you have any further questions, please contact your local Quarles & Brady attorney, or:

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