Federal vaccine mandates more questions than answers



President Biden’s announcement of the “Path out of the Pandemic” should not have come as a complete surprise to employers given the various previous announcements including mandating vaccines for federal employees, the OSHA ETS for healthcare workers (which provides time off to receive vaccinations among a wide array of other requirements), and the announcement that long-term care employees would be required to be vaccinated.

The outlines of the new plan are fairly broad with directions to OSHA to create and enact new regulations to mandate vaccinations for employers with 100 or more employees.  This will be done by an OSHA Emergency Temporary Standard which will be similar to the one already in place for healthcare workers mandating PPE and similar items. Dentons colleagues Julie Vanneman and Chad Wissinger have some great takeaways on OSHA for US Employers

Vaccinations for federal workers and contractors as well as healthcare workers will also be mandated. For healthcare, this will be a combination of CMS and OSHA regulations. The plan requires a number of actions including masking and that employers with 100 or more employees provide paid time off to receive vaccinations including to address limited post-vaccine reactions.

However, like any sweeping announcement, there are more questions than there are answers. Critical questions still need to be answered.  

When is this all taking effect? 


Federal employee mandates were first announced in July 2021 so the follow-up deadline is fairly short. For long-term care employers, who already had a pending vaccine mandate, CMS had stated that the anticipated regulations would be published sometime in September. With the new OSHA ETS on mandates, various statements have been made from “soon” to “in several weeks.”

There is also a question of how long employers will have to create their programs and bring themselves into compliance. Employers should assume that this will be sooner rather than later and start thinking about compliance issues now as it can be difficult to develop a program. 

Some first steps include determining the number of vaccinated employees. If you don’t already have one, creating a process to collect vaccination cards as part of the employee health record, and where appropriate, providing additional education to help employees understand vaccines and the vaccine process.  Various physicians, clinics, and others may be able to help with education. 

Who exactly is enforcing this? 

There are likely to be a series of industry-dependent enforcement mechanisms. For healthcare, this would include a combination of CMS regulations and OSHA, as well as DIA and others. For non-healthcare employees, this would be primarily through the anticipated OSHA ETS. 

It’s been noted that failure to comply with these requirements under the pending OSHA ETS could result in fines of $14,000 per incident and employers should remember that OSHA fines compound and accumulate very quickly. CMS can stop payment to a healthcare facility for failure to comply with its programs and practices and most of the agencies can impose correction plans on non-compliant employers. Other agencies, such as OFCCP, may also become involved for federal contractors.

Who is a federal contractor? 

Federal contractors are typically entities or individuals who have a contract with the United States and can include subcontractors even if those subcontracts don’t directly have a contract with the government. Some descriptions can be found in Executive Order 11246 which specifically relates to contractors who do over $10,000 in government business annually. Employers will need to assess whether or not they are simply participatory in government programs, such as many groups that receive grants or even federal insurance, or if they are involved in procurement or services contracts with the government. This is an individualized assessment.

Will there be exceptions to this rule? 

For healthcare employers, it seems unlikely that there will be exceptions based on employer size given some of the previous government long-term care statements.  For those who would come exclusively under the proposed OSHA ETS (employers with 100 or more employees), smaller employers are exempt. However, as many smaller employers have already begun to find out, if you contract a provided service for larger companies, you may already be subject to a vaccine mandate with larger companies refusing to allow you on-site if your employees are not vaccinated.  This “ripple effect” is part of the purposes of the proposed ETS. 

What about the ADA and religious exemptions? 

The EEOC has previously indicated that employers could mandate vaccines for their employees (even without a federal mandate) although they had to offer exemptions for bona fide healthcare reasons or religious beliefs. Exemptions can be a complex process and need to be evaluated appropriately given the current state of the law.  However, employers should note that wholesale exemptions where every employee is given a healthcare or religious exemption are very likely not to be considered compliance with the law unless you are a religious institution. 

Can I use the honor system to determine if employees have been vaccinated? 

It seems unlikely that the honor system would be sufficient to show compliance with a mandated vaccine program. In all likelihood, employers will have to collect other documentation such as vaccine cards and that documentation will need to be kept as an employee health record.  It is not clear at the current time whether such a record is kept as part of a standard employee health record or an OSHA record. There may be different time requirements for how long you keep records depending on this categorization. 

What about the testing option?  

Testing is an area where there are some extremely large unanswered questions.  If you, as an employer, are allowed to opt-out of a vaccine mandate as a whole, presumably you are going to have to pay for the mandatory weekly testing which will be required under the ETS as well as the time employees spend testing.  If you don’t test on site this could include some travel time as well.  This was a complex issue for many long-term care facilities at the height of the first and second wave of the pandemic when CMS mandated COVID testing, sometimes twice a week. 

What about testing if you have an exemption?

This is also an excellent question that needs clarification from the federal government.  If an employee qualifies for an exemption, presumably, they will still need to be tested, but who pays for that regular testing if the company has a vaccine program in place? Prior to the new academic year, a number of colleges announced if students were unvaccinated, they would have to pay for their own mandatory testing.  It’s not clear who bears the cost.

What about employees who work remotely?  

That’s a wait-and-see. We don’t know what the regulations will say about remote employees. However, employers should remember that just because you work remotely doesn’t mean you are actually remote. These employees may come to the office for occasional meetings, to pick up equipment, to attend a holiday or other parties, to meet co-workers for lunch, and a wide array of things that employers encourage to improve teamwork when employees work remotely. 

What else?

There are also a number of other questions that seem unlikely to be answered at least by an initial ETS. The devil, or in this case, compliance is always in the details. Other questions will include but are certainly not limited to what about employees who only periodically report to work, or if they are remote and unvaccinated how will testing be managed? What type of tests will be appropriate and are employers required to store test results and if so, for long? 

The big picture

Finally, as we’ve learned from every other local, state, or federal program or rule through the pandemic, even once regulations are issued, there will be ongoing questions that you need to address and clarifications for individual business practices. Some initial steps you can take now:

  • Assess how much of your workforce is vaccinated
  • Survey to see if those who are not vaccinated would like additional information about vaccines or the vaccine process as well as providing ongoing education
  • Think about potential compliance problems and how you could address them with a vaccine program

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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