What do these new regulations do?

Two new rules were released on Nov. 4, 2021, which carry out an Executive Order issued by President Biden in September 2021. These rules, issued by the Department of Health and Human Services and the Occupational Safety and Health Administration, outline new vaccine mandates that must be implemented in select practices. Please note, some states have additional requirements for health care workers. Doctors should ensure they are aware of any state requirements that may exist.

1. One rule issued by the Department of Health and Human Services (HHS) outlines a vaccine mandate for Medicare- and Medicaid-enrolled providers and suppliers. As the AOA had anticipated, these rules do not impact physician offices. If you are a Medicare- or Medicaid-enrolled physician and you provide care to Medicare and Medicaid patients outside of a physician’s office (e.g. ambulatory surgical center, hospital) please review the information below in Section 1 for further details.
2. One rule issued by the Occupational Safety and Health Administration (OSHA) outlined a vaccine mandate for certain employers who have more than 100 employees. Jan. 13, 2022 update: The Supreme Court stopped implementation of the OSHA vaccination-or-testing requirement on employers with more than 100 employees.

Major take aways

• If you are a Medicare- or Medicaid-enrolled doctor of optometry who only provides care to these patients in a physician’s office, this mandate from HHS does not impact you.

Section 1

HHS rule: Medicare- and Medicaid-enrolled providers and suppliers vaccine mandate

Who do these new regulations impact?

This mandate impacts Medicare- and Medicaid-enrolled providers, such as doctors of optometry who work in these settings:

• Ambulatory surgical centers (ASCs).
• Hospices.
• Psychiatric residential treatment facilities (PRTFs).
• Programs of All-Inclusive Care for the Elderly (PACE).
• Hospitals (acute care hospitals, psychiatric hospitals, hospital swing beds, long term care hospitals, children’s hospitals, transplant centers, cancer hospitals, and rehabilitation hospitals/inpatient rehabilitation facilities).
• Long term care (LTC) facilities, including skilled nursing facilities (SNFs) and nursing facilities (NFs), generally referred to as nursing homes.
• 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.

Are there exemptions for the mandate?

Yes, this rule defers to other federal employment laws which allow for employees to request and receive exemption from vaccination because of a disability, medical condition or sincerely held religious belief, practice or observance.

The HHS notes that employers must also follow federal laws protecting employees from retaliation for requesting an exemption on account of religious belief or disability status. For more information about these situations, employers can consult the Equal Employment Opportunity Commission’s website.

The HHS refers to recognized clinical contraindications to receiving a COVID-19 vaccine.

Does this mandate apply to staff working at one of the health care settings covered by the rule?

Yes. This rule indicates that facilities impacted by the rule must develop and implement policies and procedures under which all staff are vaccinated for COVID-19, regardless of clinical responsibility or patient contact. The rule delineates individuals anticipated to be covered by the mandate: facility employees; licensed practitioners; students, trainees and volunteers; and individuals who provide care, treatment or other services for the facility and/or its patients, under contract or other arrangement.

Does the mandate impact individuals who work for an impacted health care setting, but work remotely?

No.

What about people who work at an impacted health setting but only go there infrequently?

This rule would not impact those individuals. The HHS indicates, “providers and suppliers are not required to ensure the vaccination of individuals who infrequently provide ad hoc non-health care services (such as annual elevator inspection), or services that are performed exclusively off-site, not at or adjacent to any site of patient care (such as accounting services), but they may choose to extend COVID-19 vaccination requirements to them if feasible. Other individuals who may infrequently enter a facility or site of care for specific limited purposes and for a limited amount of time, but do not provide services by contract or under arrangement, may include delivery and repair personnel. We believe it would be overly burdensome to mandate that each provider and supplier ensure COVID-19 vaccination for all individuals who enter the facility. However, while facilities are not required to ensure vaccination of every individual, they may choose to extend COVID-19 vaccination requirements beyond those persons that we consider to be staff as defined in this rulemaking.”

If an individual has already had COVID-19 are they required to follow this mandate?

The HHS has recognized that a significant number of health care staff have already had COVID-19, but notes that evidence indicates their infection-induced immunity, also called “natural immunity,” is not equivalent to receiving the COVID-19 vaccine.

When do the mandates take effect?

HHS has given facilities some flexibility to meet the new requirements, including an additional 60 days to get employees fully vaccinated. The agency also said it will hold off on any enforcement action, as long as 90% of the workforce is vaccinated and the facility has a plan to immunize its remaining workers.

What kind of documentation must be retained to show vaccination status?

The HHS is requiring that providers and suppliers track and securely document the vaccination status of each staff member, including those for whom there is a temporary delay in vaccination, such as recent receipt of monoclonal antibodies or convalescent plasma. Vaccine exemption requests and outcomes must also be documented.

What are examples of acceptable forms of proof of vaccination?

• CDC COVID-19 vaccination record card (or a legible photo of the card).
• Documentation of vaccination from a health care provider or electronic health record.
• State immunization information system record.

Will this mandate go away after the public health emergency (PHE) ends?

The HHS expects this mandate to remain relevant for some time beyond the end of the formal PHE.

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

The HHS is planning to advise and train state surveyors on how to assess compliance with the new requirements among providers and suppliers. Those who do not comply may be subject to enforcement remedies imposed by the HHS depending on the level of noncompliance and the remedies available under federal law (for example, civil money penalties, denial of payment for new admissions or termination of the Medicare/Medicaid provider agreement). The HHS will closely monitor the status of staff vaccination rates, provider compliance and any other potential risks to patient, resident, client and PACE program participant health and safety.

Does this rule require weekly testing for those who are unvaccinated?

No. The HHS considered requiring daily or weekly testing of unvaccinated individuals. The agency believes vaccination is a more effective infection control measure but will continue to take comments on this issue.