To Vaccinate or Not Vaccinate -That is the Question

Executive Orders are actions by the President.  Legally they have equal force of Congressional action or established laws.  Executive Orders stay in force until a date specified by the order or until the order is revoked by the current or any future President.  Orders commonly assign rule-making related to the order to another government agency.  Orders are typically not in effect until such rules are published in the Federal Register.

There are three Executive Orders in 2021 you need to be aware of.

1. Executive Order “Protecting Worker Health and Safety” https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/21/executive-order-protecting-worker-health-and-safety/  (January 2021) This order shifted the regulatory authority for actions related to the COVID-19 pandemic to OSHA and required they develop national standards for pandemic response.  Those standards were released in several OSHA policies throughout 2021 (explained later).  The most important standard will be reviewed under “How Does This Apply to Me”
2. Executive Order “Requiring Coronavirus Disease 2019 Vaccination for Federal Employees” https://www.whitehouse.gov/briefing-room/presidential-actions/2021/09/09/executive-order-on-requiring-coronavirus-disease-2019-vaccination-for-federal-employees/  (June 2021) Unless you are an employee of the Federal government, this Order does not apply to you.
3. Executive Order “Path Out of the Pandemic” https://www.whitehouse.gov/covidplan/ (September 2021) This is the order containing new rules related to required vaccinations for employees who work for businesses with greater than 100 employees and certain healthcare workers.  The specifics of this order will be reviewed under “How Does This Apply to Me?”

Healthcare guidelines are typically issued by OHSA or CDC but may also include other Federal agencies.  CDC is more of an advisory agency while OSHA has enforcement power (see special note “Civic Lesson” below). It should be noted that of potentially more concern would be an employer’s liability from private action (employees and/or patients) which would likely be determined in court on the basis of compliance with established guidelines and/or other rules.  In healthcare, we have essentially non-binding recommendations under CDC and binding guidelines under OSHA – although following both would be highly recommended.  OSHA guidelines are totally focused on establishing and maintaining a safe environment for patients and patrons of a business.  All practices should be compliant with mandated OSHA guidelines through extensive written policies.

As directed by the Executive Order Path Out of the Pandemic, a specific guideline was issued by Health and Human Services (CMS).

Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination

https://www.federalregister.gov/public-inspection/2021-23831/medicare-and-medicaid-programs-omnibus-covid-19-health-care-staff-vaccination

This guideline establishes the requirements for covered providers in relation to vaccination of healthcare workers.  Details will be reviewed under “How Does This Apply to Me?”

Emergency Temporary Standards (ETS)

Under Executive or Congressional order, a government agency may be directed to establish rules specific to an issue deemed to be of significant national concern.  These standards apply only to the specific issue cited and remain in force until a stated expiration, until Congress revokes them or until the current or any future President revokes them.

OSHA “Emergency Temporary Standard for Healthcare” (published and in force June 21, 2021)  https://www.osha.gov/coronavirus/ets

This established the general requirements for healthcare employers, including optometrists, in their interaction with employees and patients.  Details will be reviewed under “How Does This Apply to Me?”

OSHA “COVID-19 Vaccination and Testing; Emergency Temporary Standard” (published and in force November 4, 2021)

https://www.federalregister.gov/documents/2021/11/05/2021-23643/covid-19-vaccination-and-testing-emergency-temporary-standard

This established the requirements for large businesses and other healthcare entities to comply with the Executive Order mandating vaccinations.

Again, details will be reviewed in “How Does This Apply to Me”

There are three common questions associated with all these guidelines and standards.

“Does OSHA have the authority to make these rules?”

The answer is unequivocally YES.  The Department of Labor granted OSHA possibly to most extensive powers of any government agency.  Specific to healthcare, OSHA has “unlimited discretion to devise means to achieve a congressionally mandated goal” (wow…huh?).  In establishing these “means”, they do not have to base their decisions on “proven evidence” and are not required to consider any economic impact their decisions may have on the economy, businesses or individuals (more wow!).  Note later in the review of the newly released OSHA Emergency Temporary Standard, OSHA did not even come close to imposing their powers related to this issue.

“Does OSHA supersede state law?

Yes and no.  States have the rights to establish their own worker safety policies (in effect their own OSHA).  States that have their own such laws include Alaska, Arizona, California, Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, Nevada, New Mexico, North Carolina, Oregon, Puerto Rico, South Carolina, Tennessee, Utah, Vermont, Virginia, Washington, and Wyoming (covers both public and private entities) and six that cover only state and local government employees including Connecticut, Illinois, Maine, New Jersey, New York, and the Virgin Islands.  For these states, they have the right to establish any policies that are equal to or more restrictive than Federal OSHA.  For the remaining 28 states, they are bound by Federal OSHA and Federal OSHA policies supersede any and all actions, policies, orders or laws of those states.  Under the newly released Emergency Temporary Standards, states who have their own worker safety laws have 30 days to submit their vaccination plans to Federal OSHA for approval.  Legal challenge of this long-standing Federal authority will likely fall on deaf ears.

“Why were most of the rules related to healthcare providers shifted to HHS/CMS and not simply mandated by OSHA”

As discussed later, OSHA stated concerns in their authority to make a mandated vaccination policy for healthcare workers that went beyond the already established in the June ETS, escaping challenging by issuing a “soft” guidance.  The “out” was a 100-page explanation of how the existing guidelines were likely sufficient.  To create guidance that had teeth in it, the healthcare worker policy was shifted to HHS/CMS who stated in their policy their authority to take a wide range of actions against violators up to and including withholding payments for services rendered.  The effect of this was significantly diminished by the guidance being applied to only a small segment of the healthcare industry (see details in “How Does This Apply to Me?”).

This ETS was published and finalized on June 21, 2021, and is reviewed on the PCS website here.  This standard is simple.  As a healthcare employer, you have two choices:

1. Perform a standard COVID-19 screening on all patients and visitors who enter your facility and abide by CDC guidelines for preventing the spread of COVID-19; or,
2. You are obligated to adhere to extensive regulations in your business – you do NOT want to do this.

This standard is still in place and not affected by the newly released standards.

In general, this guideline will NOT apply to most practicing optometrists. The rule applies to only certain providers in certain practice settings.  These include

• Ambulatory Surgical Centers (ASCs)
• Hospices
• Psychiatric residential treatment facilities (PRTFs)
• Programs of All-Inclusive Care for the Elderly (PACE)
• Hospitals
• Long Term Care (LTC) Facilities, including Skilled Nursing Facilities (SNFs) and Nursing  Facilities (NFs)
• Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID)
• Home Health Agencies (HHAs)
• Comprehensive Outpatient Rehabilitation Facilities (CORFs)
• Critical Access Hospitals (CAHs)
• Clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical  therapy and speech-language pathology services
• Community Mental Health Centers (CMHCs)
• Home Infusion Therapy (HIT) suppliers
• Rural Health Clinics (RHCs)/Federally Qualified Health Centers (FQHCs)
• End-Stage Renal Disease (ESRD) Facilities

If you are not employed by one of these practice entities, this guideline does not apply. It does not apply to most optometrists practicing in a private practice situation.

If this guideline does apply to you, the specifics are as follows.

What exactly is required?

The guideline requires that all healthcare providers who are providers in the CMS program under one of the healthcare settings noted above to be vaccinated against COVID-19 or obtain an allowed exemption.

Does the rule apply to staff of healthcare providers or just the doctors?

It applies to both.  There are no exemptions for staff based on their specific job description or statement of minimal contact with patients or other employees.

Are there exemptions from the mandate? 

The guideline defers to the Equal Employment Opportunity Commission and other applicable Federal agencies for these policies.  In general, an individual may request and receive an exemption from the vaccination and mask requirements based on disability, medical condition, or sincerely held religious belief, practice, or observance.  In most cases, employers should obtain statements from a physician or other healthcare provider noting the employee has a disability or medical exemption.  The statement does not have to and should not contain the specific reasons for the disability or medical exemption.  The recognized clinical contraindications for vaccination may be found at https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws.  For religious exemption, employers should obtain a written attestation from the employee stating why their religious beliefs create an exemption.  The EEOC clearly states that employers do not have the authority to challenge a stated religious exemption.

This guideline contains NO exemption based on routine testing or prior diagnosis of COVID-19.

When does the guideline take effect?  

 Implementation dates were not specified in the rule.  The anticipated implementation is expected to occur in two phases.

Phase 1 – full implementation by December 6, 2021: Individuals must have received the first dose, or only dose as applicable, of a COVID-19 vaccine, or have requested or been granted an exemption to the vaccination requirements.

Phase 2 – full implementation by January 4, 2022.  Individuals must ensure that the primary vaccination series has been completed and that staff are fully vaccinated, except for those staff have been granted exemptions.

What if one of the impacted health care settings does not follow this mandate? 

HHS is formulating a plan to oversee compliance with this guideline that should be released in the near future.  They state they will use all necessary means under their power to force compliance including civil monetary penalties, denial of payment for new admissions, and/or termination of the Medicare/Medicaid provider agreement.

Likely against the desires of the current Administration, OSHA elected to impose what is referred to as “soft standard”, specifically stating they are refusing to call the standard a mandate.

Who does the standard apply to?

The standard applies to:

• Employers with more than 100 employees (defined as all full or part-time and working at ALL locations owned by the employer)
• For franchisor-franchisee arrangements, if the franchisee is an independently owned and operated business, the franchisee counts only the employees at their specifically owned and operated location(s)

Healthcare employers/workers in compliance with prior OSHA standard CFR 1910.502 (Emergency Temporary Standard for Healthcare – explained earlier) are exempt from this standard.  Note that healthcare employers with more than 100 employees were NOT included in this standard and therefore are still subject to the standard.  This will still include a large number of optometrists working in industry, academia, corporate employment, and most private equity arrangements.

What does the standard require?

• All applicable employers must form a written COVID-19 vaccination plan in compliance with the requirements of the standard.
• All applicable employers must determine the vaccination status of each employee. Acceptable forms of documentation include:
  • Record of immunization from a healthcare provider or pharmacy
  • Copy of COVID-19 Vaccination Record Card
  • Copy of medical records documenting vaccination
  • Copy of immunization records from public, health, state or tribal agency
  • Other official documentation showing dates, types of vaccination and provider who administered the vaccination
  • Statement from an employee stating specifically their vaccination status, inability to provide other acceptable documentation, and declaration their attestation is true and accurate
• Provide up to four hours paid leave to be vaccinated and application of reasonable time off for potential side effects from the vaccination
• Requirement that all non-vaccinated employees with exemption wear face masks while in the practice or if riding in a vehicle to an/or frorm work with another employee
• Removal of any employee who fails to be vaccinated refuses to routine testing, or refuses to provide an acceptable exemption

Are there exemptions to the standard?

Exemptions include the stated EEOC exemptions (disability, medical or religious – all discussed earlier) but also allow for a reasonable delay in compliance also based on temporary medical necessity).  Employees also may decline vaccination but must agree to routine (once a week) testing.  Testing costs can be assigned to the employee and the employee is obligated to present documentation of testing to the employer weekly or will be considered out of compliance and removed from the practice.

What tests are acceptable?

Under this ETS, the test must be (1) approved or authorized by the FDA (2) administered as instructed by the manufacturer, AND (3) not both self-administered and self-read by the employee unless in the presence of the employer.  Antibody tests do not qualify under this ETS.

What if the employee tests positive?

Regardless of vaccination status, any employee who tests positive may not be allowed in the practice until established CSC return-to-work requirements are met.

When does the standard take effect?

This ETS is in effect as of November 5, 2021.  Vaccination requirements must be met by January 4, 2022. All non-vaccinated employees must wear face masks effective immediately.

What else do we know about the standard?

This standard supersedes all state orders, laws, or mandates unless states with a worker safety plan submit their plan that is either equal to or more stringent than the ETC.  Applicable states have 30 days to submit their plan for approval.