This week, the Biden administration released two new requirements related to vaccination:
- OSHA Emergency Temporary Standard (ETS, aka employers with more than 100 employees will be required to have a COVID-19 vaccine mandate or testing requirement)
- CMS Interim Final Rule (IFR, impacting Medicare and Medicaid-certified facilities and (some) providers, requiring COVID-19 vaccinations)
The links above will take you to text of the rules.
*Background*
On September 9th, the Biden administration announced a new federal strategy to address the COVID-19 pandemic. To increase vaccination rates, the administration announced a number of new initiatives intended to drive higher vaccination rates through employers:
- New requirement for federal employees to receive the COVID-19 vaccine (no testing opt-out)
- Similar requirement for federal contractors to receive the COVID-19 vaccine (no testing opt-out)
- New requirement for health care providers accepting Medicare and Medicaid payments to mandate COVID-19 vaccines for employees as a Condition of Participation in the program
- New Emergency Temporary Standard (ETS) issued by the Department of Labor’s Occupational Safety and Health Administration (OSHA) that would require employers with more than 100 employees to mandate either COVID-19 vaccinations or weekly testing for employees, as well as masking requirements for the unvaccinated.
Today, we now have the OSHA ETS and the CMS IFR.
*OSHA ETS*
The Occupational Safety and Health Administration (OSHA) is a part of the Department of Labor, with a stated mission to “ensure safe and healthful working conditions for workers by setting and enforcing standards and by providing training, outreach, education and assistance.” OSHA has the legal authority to issue ETSs in situations where “employees are exposed to a ‘grave danger’ and immediate action is necessary to protect those employees from such danger.” Given this legal mechanism, the temporary standard spends a good deal of time making the case for grave danger.
What employers does this ETS apply to?
The short answer – employers that have more than 100 employees. The long answer –
- All workers across all total workplaces, employees across all of their U.S. locations, regardless of employees’ current vaccination status or where they perform their work, including part-time workers (excluding contractors). For instance…
- For a single corporate entity with multiple locations, all employees at all locations are counted for purposes of the 100-employee threshold for coverage under this ETS.
- In a traditional franchisor-franchisee relationship in which each franchise location is independently owned and operated, the franchisor and franchisees would be separate entities for coverage purposes, such that the franchisor would only count “corporate” employees, and each franchisee would only count employees of that individual franchise.
- In other situations, two or more related entities may be regarded as a single employer for OSH Act purposes if they handle safety matters as one company, in which case the employees of all entities making up the integrated single employer must be counted.
- On a typical multi-employer worksite such as a construction site, each company represented – the host employer, the general contractor, and each subcontractor – would only need to count its own employees, and the host employer and general contractor would not need to count the total number of workers at each site.
- All workers, regardless of whether some are carved out from the requirements of the standard, count in the headcount to determine if the ETS applies to the employer.
What employees of a covered employer are impacted?
All employees, including those who may have been previously infected by COVID-19, except –
- Workers who do not report to a workplace where other individuals are present or who telework from home
- Workers who perform their work exclusively outdoors
- Workers for whom a vaccine is medically contraindicated
- Workers for whom medical necessity requires a delay in vaccination
- Workers are legally entitled to a reasonable accommodation under federal civil rights laws because they have a disability or sincerely-held religious beliefs, practices, or observances that conflict with the vaccination requirement.
- Workers covered by the other recently issued federal vaccine mandates
What are covered employers required to do?
Covered employers are required to develop, implement, and enforce a mandatory COVID-19 vaccination policy AND/OR establish, implement, and enforce a policy allowing employees who are not fully vaccinated to elect to undergo weekly COVID-19 testing and wear a face covering at the workplace.
- If a mandatory vaccination policy is implemented, employers are required to determine the vaccination status of each employee, obtain acceptable proof of vaccination, maintain records of each employee’s vaccination status, and maintain a roster of each employee’s vaccination status. Employers are also required to support vaccination by providing employees reasonable time, including up to four hours of paid time, to receive each vaccination dose, and reasonable time and paid sick leave to recover from side effects experienced following each dose.
Fully vaccinated for the purpose of the ETS means:
- A single dose of the Janssen (Johnson & Johnson) COVID-19 vaccine
- Two doses of the Pfizer-BioNTech COVID-19 or Moderna COVID-19 vaccine
- Vaccines listed by the World Health Organization (WHO) for emergency use
- Vaccines given as part of a clinical trial
This means no boosters and no extra doses for immunocompromised individuals are required for the purpose of this rule.
- If a testing strategy is implemented, employers must ensure that each employee who is not fully vaccinated is tested for COVID-19 at least weekly (if in the workplace at least once a week) or within 7 days before returning to work (if away from the workplace for a week or longer). The tests used must be:
- cleared, approved, or authorized by the FDA
- administered in accordance with the authorized instructions; and
- not both self-administered and self-read, unless observed by the employer or an authorized telehealth proctor.
Each employee who is not fully vaccinated is required to wear a face-covering when indoors or when occupying a vehicle with another person for work purposes, except in certain limited circumstances. (Employers must not prevent any employee, regardless of vaccination status, from voluntarily wearing a face-covering unless it creates a serious workplace hazard).
Who pays for testing?
Just because the testing is mandated, employers are not required to pay for any costs associated with testing (but they can voluntarily assume the costs). Employer payment for testing may be required by other laws, regulations, or collective bargaining agreements or other collectively negotiated agreements.
It’s important to note here that earlier in the year, the administration released guidance regarding insurance coverage for COVID-19 testing (FAQ attached). That guidance upholds the position that insurers are not required to pay for tests other than those for individual diagnosis. Said another way – the FFCRA/CARES language requiring coverage of testing does not apply to coverage of testing for things like surveillance initiatives and work requirements.
Bottom line – employers can make employees pay to cover the cost of testing.
When does this take effect?
The ETS is in effect immediately upon publication. Its requirements are broken out into two phases:
- Phase 1 – Within 30 days after publication, employers must comply with all requirements, other than testing for employees who are not fully vaccinated.
- Phase 2 – Within 60 days after publication, employers must comply with all requirements, including testing for employees who are not fully vaccinated.
Doing the math – that means that if a company is going to issue a vaccine mandate, all workers must be fully vaccinated by January 4th.
Documentation
Employers are required to provide employees:
- information about the requirements of the ETS and workplace policies and procedures established to implement the ETS
- the CDC document “Key Things to Know About COVID-19 Vaccines”
- information about protections against retaliation and discrimination
- information about laws that provide for criminal penalties for knowingly supplying false statements or documentation
Employers are required to report work-related COVID-19 fatalities to OSHA within 8 hours of learning about them, and work-related COVID-19 in-patient hospitalizations within 24 hours of the employer learning about the hospitalization.
Employees are entitled to their COVID-19 vaccine documentation, any COVID-19 test results, and aggregate number of fully vaccinated employees vs the total number of employees at that workplace.
Impact on State Laws Prohibiting Employer’s Vaccine, Mask, and Testing Mandates
OSHA’s FAQs make clear that the ETS preempts states from “adopting and enforcing workplace requirements relating to the occupational safety and health issues of vaccination, wearing face coverings, and testing for COVID-19,” unless approved by OSHA as a separate state plan. OSHA “intends for the ETS to preempt and invalidate any State or local requirements that ban or limit an employer’s authority to require vaccination, face covering, or testing.”
*CMS Interim Final Rule*
The IFR changes the Medicare and Medicaid program’s Conditions of Participation (CoPs), Conditions for Coverage (CfCs), and Requirements for Participation. Broadly, these conditions and requirements outline specific criteria that certain facilities and providers must meet to receive payment under the Medicare and Medicaid programs. Through this IFR, these health care facilities and providers are now required to have a process or policy in place ensuring that all applicable staff are vaccinated against COVID-19. The Administration announced that it anticipates this rule will cover more than 17 million workers at approximately 76,000 health care facilities, including hospitals and long-term care facilities.
What facilities and providers are impacted?
- 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
- 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
- Long Term Care facilities
- Indian Health Service facilities
What facilities are not impacted?
- Religious Nonmedical Health Care Institutions (RNHCIs)
- Organ Procurement Organizations (OPOs)
- Portable X-Ray Suppliers
- Medicaid Home and Community-based Services
- Assisted Living Facilities or Group Homes
- Physician’s Offices
What workers are impacted?
The requirements in the IFR apply to all “staff working at a facility that participates in the Medicare and Medicaid programs, regardless of clinical responsibility or patient contact…This includes facility employees, licensed practitioners, students, trainees, and volunteers. Additionally, this also includes individuals who provide care, treatment, or other services for the facility and/or its patients under contract or other arrangement.”
This requirement includes staff that work at locations outside so the formal clinical setting (such as homes, clinics, other sites of care, administrative offices, off-site meetings, etc.), as well as physicians admitting and/or treating patients in-person to one of the included facilities.
The requirement does NOT apply to individuals that –
- telework 100% of the time
- have a recognized medical condition for which vaccines are contraindicated (as a reasonable accommodation under the Americans with Disabilities Act (ADA))
- have a religious belief, observance, or practice (established under Title VII of the Civil Rights Act of 1964) (more on that below)
Facilities that grant medical or religious accommodations are expected to minimize the risk of transmission of COVID-19 to at-risk individuals.
When does this take effect?
The IFR is in effect immediately upon publication. Its requirements are broken out into two phases:
- Phase 1 – Within 30 days after the regulation is published, staff must have received at least the first dose or a single dose COVID-19 vaccine “prior to staff providing any care, treatment, or other services for the facility and/or its patients.”
- Phase 2 – Within 60 days after the regulation is published, staff must be fully vaccinated.
What is considered vaccinated?
- A single dose Janssen (Johnson & Johnson) COVID-19 Vaccine
- Two doses of the Pfizer-BioNTech COVID-19 or Moderna COVID-19 Vaccine
- Vaccines listed by the World Health Organization (WHO) for emergency use
- Vaccines given as part of a clinical trial
This means no boosters and no extra doses for immunocompromised individuals for the purpose of this rule.
Are there alternatives to vaccination to comply?
No. Testing protocols, prior infection, or positive antibody tests cannot be substituted for vaccination.
How will this new requirement be enforced?
In short, the same way all other CoPs and CfC’s are enforced.
In long…“CMS works directly with the State Survey Agencies to regularly review compliance with Medicare/Medicaid regulations across multiple health care settings. CMS expects state survey agencies to conduct onsite compliance reviews of these requirements in two ways:
- State survey agencies would assess all facilities for these requirements during the standard recertification survey.
- State survey agencies would assess vaccination status of staff on all complaint surveys.”
“While onsite, surveyors will review 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. This information, in addition to interviews and observations, will be used to determine the compliance of the provider or supplier with these requirements. Additionally, Accrediting Organizations will be required to update their survey processes to assess facilities they accredit for compliance with vaccination regulations.”
With regards to reporting, hospitals and Long-Term Care facilities (nursing homes) are still expected to comply with other federal reporting requirements with regards to vaccination rates and COVID-19 rates. Facilities participating in the Inpatient, PPS-Exempt Cancer, Long Term Care Hospital, Inpatient Rehabilitation, and Inpatient Psychiatric Quality Reporting Programs must collect data on the new COVID-19 Vaccination Coverage among Health Care Professionals measure from October 1, 2021 to December 31, 2021 and quarterly thereafter
*Contractors Guidance*
The administration issued additional guidance for federal contractors on September 24.
- What defines a contract/contractor? – “Contractor” is defined in Section 5 of the EO, and the guidance points to the Department of Labor’s proposed rule, “Increasing the Minimum Wage for Federal Contractors,” 86 Fed. Reg. 38,816, 38,887 (July 22, 2021). The Administration notes that if the definition shifts in the final rule, the definition will shift in the application of the mandate. The requirements also apply to subcontractors (except for subcontracts) and the contractor is on the hook for making sure the rules are followed.
- Who is covered? – The guidance specifies that the new mandate applies to all full-time and part-time employees of the contractor who work at a “covered location” (a “location controlled by a covered contractor at which any employee of a covered contractor working on or in connection with a covered contract is likely to be present during the period of performance for a covered contract,” excluding a person’s home). This means that even if employees are not working on the government contract, the mandate still applies to them.
- What does “fully vaccinated” mean? – “People are considered fully vaccinated for COVID-19 two weeks after they have received the second dose in a two-dose series, or two weeks after they have received a single-dose vaccine. There is currently no post-vaccination time limit on fully vaccinated status; should such a limit be determined by the Centers for Disease Control and Prevention, that limit will be considered by the Task Force and OMB for possible updating of this Guidance.” Said another way – no boosters are needed to comply right now.
- Compliance Deadlines and Timing – Contractors must have employees fully vaccinated no later than December 8, 2021. (This week’s announcement updated the timeline for contractors to align them with the January 4, 2022, deadline)
- For contracts awarded prior to October 15, where performance is ongoing, the vaccine requirements “must be incorporated at the point at which an option is exercised or an extension is made.”
- For contracts awarded between October 15 and November 14, agencies must include the requirement in the solicitation and are encouraged to include it in contracts awarded during this time period but “are not required to do so unless the solicitation for such contract was issued on or after October 1.”
- For contracts awarded on or after November 14 – the vaccine mandates must be included.
- Contractors must ensure employees are fully vaccinated within 60 days of beginning work on a covered contract or at a covered workplace.
- How to prove vaccination status – “[A] covered contractor must review its covered employees’ documentation to prove vaccination status.” Said another way – attestation is not an option, and the guidance gives options for what papers count.
- Are there alternative to vaccination to comply? – No. Testing protocols, prior infection, or positive antibody tests cannot be substituted for vaccination.
- How to deal with noncompliant employees? – The Administration issued additional guidance in the form of FAQs, saying the “covered contractor should determine the appropriate means of enforcement with respect to its employee…who refused to be vaccinated.” The guidance further suggests providing counseling and education, followed by additional disciplinary measures.
*Religious Exemptions*
The question of religious exemptions falls to the Equal Employment Opportunity Commission (EEOC) is “responsible for enforcing federal laws that make it illegal to discriminate against a job applicant or an employee because of the person’s race, color, religion, sex (including pregnancy, transgender status, and sexual orientation), national origin, age (40 or older), disability or genetic information.”
Most employers with at least 15 employees are covered by EEOC laws (20 employees in age discrimination cases). Most labor unions and employment agencies are also covered. The laws apply to all types of work situations, including hiring, firing, promotions, harassment, training, wages, and benefits.” In other words – the EEOC is there to protect workers against discrimination by employers.
Many employers are establishing vaccine and testing mandates, and we now have an ETS from OSHA requiring employers with over 100 employees to impose such mandates or testing regimens. For many of the entities that have already imposed mandates, the ETS, and IFR, there are religious exemptions.
EEOC offered a few clarifications on what religious exemptions mean in Section L of their “what you should know” document last month that is worth revisiting in light of today’s announcements:
- “Employees and applicants must inform their employers if they seek an exception to an employer’s COVID-19 vaccine requirement due to a sincerely held religious belief, practice, or observance.”
- “Title VII requires employers to consider requests for religious accommodations but does not protect social, political, or economic views, or personal preferences of employees who seek exceptions to a COVID-19 vaccination requirement.”
- “Employers that demonstrate ‘undue hardship’ are not required to accommodate an employee’s request for a religious accommodation.”
If you are an employer with a vaccine mandate, or contemplating a mandate, or gearing up for the OHSA ETS, we suggest you give Section L a read.
*General Points of Clarification*
What about State laws prohibiting vaccine mandates?
The administration notes in its FAQs that under the Supremacy Clause of the U.S. Constitution, federal regulations pre-empt state laws to the contrary (aka U.S. Const. art. VI § 2). Thanks for the history lesson.
This is a lot of mandates, which one applies to my circumstance?
The administration notes…
“If facilities are not certified under the Medicare and Medicaid programs and therefore not regulated by the CoPs, then the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors or OSHA COVID-19 Healthcare Emergency Temporary Standard apply. The OSHA COVID-19 Employer Emergency Temporary Standard (for facilities with greater than 100 employees) applies to employers that are not subject to the preceding two regulations. Facilities should review the inclusion criterion for these regulations and comply with all applicable requirements”
*What’s next?*
The CMS comment period officially closes on January 4, 2022, and the ETS comment period closes December 4, 2021.
There will be lawsuits. Additionally, many large employers have pegged their mandates to these announcements, so expect those to roll out in the weeks to come.