On November 5, 2021, the Centers for Medicare & Medicaid Services (CMS) issued an Interim Final Rule requiring vaccinations (“Vaccination IFR”). The Vaccination IFR can be found here. On June 21, 2021, the Occupations Safety and Health Administration (OSHA) issued an emergency temporary standard for healthcare settings (“Healthcare ETS”). The full text of the Healthcare ETS can be found here. Finally, healthcare employers with 100 or more employees must comply with the Emergency Temporary Standard for COVID-19 Vaccination and Testing (“Vaccination and Testing ETS”), which OSHA issued on November 5, 2021. The Vaccination and Testing ETS can be found here. This collection of regulations imposes numerous COVID-related obligations on healthcare employers. The most pertinent of those obligations will be discussed below.
The Vaccination IFR applies to Medicare and Medicaid-certified facilities—i.e., entities that are controlled by CMS’s health and safety regulations. This includes 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, and 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, and Long Term Care facilities. However, there are a few entities that are regulated by CMS that are exempt from the Vaccination IFR’s requirements, including Religious Nonmedical Health Care Institutions (RNHCIs), Organ Procurement Organizations (OPOs), and Portable X-Ray Suppliers.
In addition, various healthcare entities are not subject to CMS’s health and safety regulations and thus are not subject to the Vaccination IFR, such as Assisted Living Facilities, Group Homes, physicians’ offices, schools receiving Medicaid funding, and entities that have been designated as Home and Community-Based Services under 42 CFR § 441.300 et seq.
The Vaccination IFR applies to eligible staff working at a facility that participates in the Medicare and Medicaid programs, regardless of clinical responsibility or patient contact. It includes employees who perform their duties solely within a formal clinical setting, but not individuals who provide services 100 percent remotely and don’t have any direct contact with patients and other staff.
The Healthcare ETS applies to employees in hospitals, nursing homes, and assisted living facilities; emergency responders; home healthcare workers; and employees in ambulatory care facilities where suspected or confirmed COVID-19 patients are treated. The Healthcare ETS applies to support and medical-billing employees as well unless those employees aren’t working in a healthcare setting—e.g., off-site laundry, off-site medical billing, etc. The Healthcare ETC became effective on June 21, 2021, and compliance has been required since July 2021. In November 2021, OSHA determined that the requirements of the Healthcare ETS remain necessary to address the danger of COVID-19 in healthcare settings, and thus remain in effect today.
II. Vaccination Requirement under the Vaccination IFR
Under CMS’s Vaccination IFR, covered facilities must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. Employees are considered “fully vaccinated” if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19.
The regulation requires health care providers to establish a process or policy to fulfill the staff vaccination requirements over two phases. For Phase 1, which must be completed on or before December 5, 2021, covered employees must have received, at a minimum, the first dose of a primary series or a single dose COVID-19 vaccine prior to providing any care, treatment, or other services for the facility and/or its patients. For Phase 2, which must be completed by January 4, 2022, covered employees must complete the primary vaccination series. The regulation does not include testing requirements for unvaccinated staff. The Vaccination IFR requires staff vaccination only.
In addition to developing and implementing a plan to complete—and document—the two phases discussed above, healthcare facilities must develop and implement a process for tracking vaccination status (including boosters). Covered facilities must also develop a process to grant and track vaccination exemptions, including those based on applicable federal law (e.g., the ADA and Title VII of the Civil Rights Act), or recognized clinical contraindications to COVID-19 vaccines (click here to see information from the CDC regarding contraindications).
III. COVID-19 Plan
One of the main elements of the Healthcare ETS is the requirement that employers develop and implement a COVID-19 plan. Among other things, the plan must include: (1) a designated safety coordinator, (2) a workplace-specific hazard assessment, and (3) policies and procedures to minimize the risk of transmission of COVID-19 to employees. If the employer has more than 10 employees, the plan must be in writing. Employers must seek the input and involvement of non-managerial employees (and their representatives, if any) in the hazard assessment and the development and implementation of the COVID-19 plan. Employers have the flexibility to determine the best approach to accomplish the overall hazard assessment. However, the hazard assessment must include an evaluation of employees’ potential workplace exposure to all people present at the workplace, including patients, coworkers, employees of other entities, members of the public, clients, independent contractors, visitors, and other non-employees.
IV. Patient Screening and Management
The Healthcare ETS also includes provisions related to patient screening and management. In settings where direct patient care is provided, healthcare employers must: (1) limit and monitor points of entry, and (2) screen and triage all clients, patients, residents, delivery people, and other visitors, and other non-employees. Patient screening can take various forms depending on the design and size of the facility. However, OSHA has stated that asking questions about COVID-19 symptoms and illness is the minimum screening requirement. Questions can include confirming that individuals are abiding by any policies and procedures for wearing face coverings, as well as assessing individuals’ recent exposures to COVID-19. To conduct the screening, employers can contact patients, clients, residents, or other visitors by phone or video, prior to their arrival at the facility.
V. Personal Protective Equipment (PPE), Social Distancing, and Barriers
The Healthcare ETS requires employers to provide and ensure employees wear facemasks when indoors. In addition, when employees are exposed to people with suspected/confirmed COVID-19, the employer must provide and ensure employees use respirators. In addition to PPE, the Healthcare ETS requires social distancing and barriers, in certain situations. Employers must: (1) keep people at least 6 feet apart when indoors; and (2) where 6-foot distancing isn’t carried out, install cleanable/disposable solid barriers at each fixed work location in non-patient care areas. The barriers must be sized (e.g., height, width) and located so that they block face-to-face pathways between employees and other individuals, based on where each person would normally stand or sit. However, fully vaccinated workers are exempted from masking, distancing, and barrier requirements when in well-defined areas where there is no reasonable expectation that any person with suspected or confirmed COVID-19 will be present.
VI. Aerosol-Generating Procedures on a Person with Suspected or Confirmed
The Healthcare ETS contains requirements related to aerosol-generating procedures (AGPs). APGs are defined as medical procedures that generate aerosols that can be infectious and are of respirable size. They included procedures like open suctioning of airways, sputum induction, CPR, intubation/extubation, BiPAP/CPAP ventilation, and some dental procedures. When an APG is performed on a person with suspected or confirmed COVID-19, the employer must: (1) limit the number of employees present to only those essential for patient care; (2) ensure the procedure is performed in an airborne infection isolation room (if available); and (3) clean and disinfect surfaces after the procedure.
VII. Cleaning, Disinfection, and Ventilation
Employers must follow the CDC’s guidelines for cleaning and disinfection. The CDC’s cleaning/disinfecting guidelines can be found here. Employers must also ensure ventilation systems are being used in accordance with the manufacturer’s instructions and are rated MERV 13 or higher, if possible. The Healthcare ETS does not require the installation of new HVAC systems to replace or augment functioning systems.
VIII. Health Screening and Medical Management
In addition to screening patients/customers, healthcare employers must screen their employees. Employers must: (1) screen employees before each workday/shift; (2) require employees to promptly notify the employer when the employees are COVID-19 positive, suspected of having COVID-19, or experiencing certain symptoms; (3) notify certain employees within 24 hours when a person who has been in the workplace is COVID-19 positive; and (4) follow requirements for removing employees from the workplace. Employers have discretion in choosing whether to implement self-monitoring or in-person screening. An employer can also choose to utilize both methods. Employers with more than 10 employees must provide medical removal protection benefits in accordance with the standard to workers who must isolate or quarantine. Employers must also pay for the costs of the test itself. When providing notice about potential COVID-19 exposure, employers must protect infected employees’ identities.
IX. Vaccination, Training, and Anti-Retaliation
Under the Healthcare ETS, employers must provide reasonable time and paid leave for vaccinations and vaccine side effects. As stated above, the Vaccination IFR contains vaccination requirements for certain healthcare employers. In addition, under the Healthcare ETS, healthcare (and most other) employers with 100 or more employees must comply with the Vaccination and Testing ETS, including that standard’s vaccination requirements. So, even those healthcare facilities that aren’t covered by the CMS’s Vaccination IFR, are likely covered by the Vaccination and Testing ETS if they have 100 or more employees.
Under the Healthcare ETS, employers must provide training for employees related to COVID-19 transmission/infection. Employers must also inform employees of their rights to the protections provided under the ETS and employers may not discriminate against employees for exercising those rights.
X. No Cost to Employees
The Healthcare ETS requires that implementation of all requirements of the standard must be at no cost to employees. However, there are some exceptions. When the Healthcare ETS permits employees to use PPE beyond what is required by the ETS, the ETS does not require employers to pay for that PPE. So, for example, for employees who provide their own face shields, the employer is not required to reimburse the employees for the cost of those face shields.
XI. Recordkeeping and OSHA Notifications
Under the Healthcare ETS, OSHA imposes certain recordkeeping and notification obligations. Employers must establish a COVID-19 log. However, small employers with 10 or fewer employees are not required to comply with the recordkeeping requirement. Employers must report work-related COVID-19 fatalities and in-patient hospitalizations to OSHA.