New Rules on Mandatory COVID-19 Vaccinations: Applicability to Pharmacies
CMS Interim Final Rule on mandatory COVID-19 vaccinations for all facilities participating in Medicare and Medicaid potentially impacts pharmacies that provide services under a contract or arrangement with these facilities.
CMS Interim Final Rule (IFR)
On November 4, 2021, CMS issued its IFR (effective November 5, 2021) regarding mandatory COVID-19 vaccinations for all facilities participating in Medicare and Medicaid. The Background section of the IFR states its applicability to “21 types of providers and suppliers, ranging from hospitals and hospices to rural health clinics to long term care facilities.”
Pharmacies are not included in the list of providers and suppliers to which the vaccine mandate applies. Therefore, the IFR does not impact retail (customer walk-in) pharmacies that do not work with facilities that participate in Medicare or Medicaid programs.
However, the IFR potentially impacts pharmacies that provide services under a contract or arrangement with a facility that participates in Medicare or Medicaid programs. The IFR requires staff at facilities that participate in Medicare or Medicaid to be vaccinated. The initial dose must be received by December 6, 2021, and the second dose by January 4, 2021.
The IFR states that the vaccination requirements must apply to all staff who directly provide any care, treatment or other services for the facility or its patients. For such staff, COVID-19 vaccination is required as a condition for continued provision of services for the facility or its patients.
In addition to a facility’s employees, practitioners, and volunteers, the IFR broadly includes anyone who (1) provides services to the facility under a contract or an arrangement and (2) potentially comes in contact with the facility staff or patients. Thus, if a pharmacy delivers drugs to hospitals, SNFs and other facilities, the delivery employee will likely need to be vaccinated.
The CMS Rule does not apply to “one off” vendors, volunteers or professionals who infrequently provide ad-hoc, non-health care services. Lastly, the IFR does not prohibit facilities from extending the vaccination requirements beyond their staff.
OSHA Emergency Temporary Standard (ETS)
On November 4, 2021, OSHA issued its ETS regarding mandatory COVID-19 vaccinations for all private sector employers with 100 or more employees. Under the ETS, covered employers must implement and enforce a mandatory COVID-19 vaccination policy under which employees may either (1) become vaccinated or (2) undergo regular COVID-19 testing (at least once every 7 days for employees in the office each week) and wear a face covering.
Exceptions for medical (or disability) and sincerely held religious beliefs apply to the OSHA ETS. OSHA will begin enforcing the ETS on December 5, 2021. This is the date by which unvaccinated workers need to begin wearing masks. Employers must begin collecting tests from their unvaccinated workforce on January 5, 2022.
Defining 100 Employees
Employers must count all employees, including part-time workers, remote workers, minors, and temporary employees, in determining its threshold compliance responsibility. Employers cannot consider separate locations as separate workforces; the 100-employee threshold includes all employees in all locations.
For example, if corporation A owns 3 pharmacies (i.e., under a single tax ID number), each with 40 employees, then corporation A is subject to the OSHA ETS because it has a total of 120 employees. On the other hand, if John Smith owns 3 pharmacies under separate corporate entities (i.e., 3 different tax ID numbers) and each pharmacy has 40 employees, then none of the pharmacies are subject to the OSHA ETS.
A pharmacy that has fewer than 100 employees at the start of the OSHA ETS effective date is not subject to the ETS. However, if that pharmacy then hits the 100-employee threshold, the pharmacy becomes subject to the ETS for the duration of the standard, even if the employee count drops back under 100 employees.
The 100-employee threshold does not include independent contractors or workers provided by staffing agencies. Employers should be very careful when classifying workers as independent contractors, as the Department of Labor (DOL) and state agencies critically review these classifications and make determinations that workers are actually employees and not independent contractors.
PTO to Receive Vaccine
Employees are entitled to PTO for the time necessary to receive the COVID-19 vaccine. The amount of vaccine PTO available is defined as a “reasonable” amount of time, not to exceed 4 hours.
Employees are also entitled to PTO for the time necessary for recovery due to the adverse effects (AEs) of COVID-19 vaccination. Employers may not force employees to use vacation pay to cover an absence period arising due to AEs from receipt of the vaccine.
Verification of Vaccination Status
Employers must require employees to provide acceptable proof of vaccination, which includes: (1) a record of immunization from a health care provider or pharmacy; (2) a copy of the employee’s COVID-19 vaccination record card; (3) a copy of medical records documenting the vaccination; or (4) a copy of an immunization record from a public health, state, or tribal immunization system, or a copy of any other official documentation that contains the type of vaccine administered, date(s) of administration, and the name of the health care professional or clinic site that/who administered the vaccine.
These are considered medical records and should be stored in employees’ medical files (separate from their HR or disciplinary files).
Weekly Testing for Unvaccinated Employees
Employers are allowed to mandate their entire workforce to be vaccinated (except for any employees with disability, medical, or religious accommodations). However, under OSHA’s ETS, covered employers may provide a soft compliance option for unvaccinated employees in lieu of mandatory vaccination.
Under this approach, unvaccinated employees must provide the employer with a negative test result every 7 days for continuing access to the workplace. Unvaccinated employees who come into the workplace less than once every 7 days must only obtain a negative test result within 7 days prior to their return to the workplace.
Unvaccinated employees who work exclusively from home, or exclusively outside, are not required to submit to testing. Employees granted a religious, disability, or medical accommodation from the COVID-19 vaccination must still submit weekly negative COVID-19 tests, even though granted an accommodation from receiving the COVID-19 vaccine.
The testing requirement may be satisfied through a negative nucleic acid amplification test (NAAT), a rapid-result antigen test, or through other testing options approved by the FDA. Employees may not rely upon tests that are both self-administered and self-read. Instead, an authorized health care provider must administer the test, which likely includes pharmacists, though this is not explicitly stated in the regulations.
Employees who submit weekly negative COVID-19 tests in lieu of vaccination must wear masks in the workplace. Employers who allow for weekly COVID-19 testing in lieu of mandatory COVID-19 vaccinations are not required to pay for the cost of weekly COVID-19 testing.
However, OSHA reminds employers: “…Payment for testing may be required by other laws, regulations, or collective bargaining agreements or other collectively negotiated agreements.”
Face Covering Obligation
Unvaccinated employees must wear approved face coverings (beginning December 5, 2021) when indoors and when occupying a vehicle with others for work purposes. This policy must be enforced at all times, except: (1) when the employee is alone in a room with floor-to-ceiling walls and a closed door; (2) for a limited time period to allow the employee to drink and/or eat; (3) when the employee is wearing a respirator; or (4) where the employer can show that the use of face coverings is infeasible or creates a greater hazard.
OSHA will begin enforcing the ETS on December 5, 2021. This is the date by which unvaccinated workers need to begin wearing masks. Employers must begin collecting tests from their unvaccinated workforce on January 5, 2022.
Penalties for Non-Compliance
If an employer with 100 or more employees does not comply with the OSHA ETS, OSHA can penalize the employer for each individual violation. Each individual violation could lead to a fine of up to $14,000.
OSHA intends to penalize employers for each employee who is negatively impacted by the employer’s failure to comply and for each instance of “failing to protect” an employee. OSHA has stated it anticipates that the penalties will be large to achieve a deterrent effect.
Temporary Stay of Enforcement
On November 6, 2021, the Fifth Circuit Court of Appeals (the Federal Court of Appeals governing Louisiana, Mississippi, and Texas) issued a stay temporarily blocking OSHA’s ETS.
The Fifth Circuit ordered the Biden Administration to file initial legal papers by November 8, 2021, and requested responsive filings by November 9, 2021. The court is expected to move quickly to issue a final ruling on whether the new policy can be enforced.
We recommend that employers with 100 or more employees prepare for compliance with the ETS, even though it is currently stayed, especially given the short compliance deadlines in the rule. Further, even though it appears as though the stay applies nationwide, the Fifth Circuit may later clarify that its applicability is only to Texas, Mississippi, and Louisiana.
About the Authors
Jeffrey S. Baird, Esq., is Chairman of the Health Care Group at Brown & Fortunato, a law firm with a national health care practice based in Texas. He represents pharmacies, infusion companies, HME companies, manufacturers, and other health care providers throughout the United States.Mr. Baird is Board Certified in Health Law by the Texas Board of Legal Specialization and can be reached at (806) 345-6320 or email@example.com.
Brittany K. Hinton, Esq., is an attorney with the Labor and Employment Law Group at Brown & Fortunato. She represents clients in a wide range of employment litigation and agency matters, as well as in employment counseling throughout the United States.Ms. Hinton can be reached at (806) 345-6365 or firstname.lastname@example.org.