Pharmacies May Fall Under CMS IFR and OSHA Rules for Mandated COVID-19 Vaccinations

The Centers for Medicare and Medicaid Services (CMS) and OSHA have issued new rules for mandated COVID-19 vaccinations, testing and mask wearing for certain employers beginning in December 2021.

A whitepaper by Brown & Fortunato, P.A. law firm outlines how these new rules could impact independent pharmacies.


CMS Interim Final Rule (IFR)

CMS issued its IFR regarding mandatory COVID-19 vaccinations for “all facilities” participating in Medicare and Medicaid. Affected facilities encompass 21 types ranging from hospitals and hospices to rural health clinics and long-term care facilities.

Although walk-in retail pharmacies are not included in the list of providers and suppliers impacted by the vaccine mandate, it potentially impacts pharmacy employees who provide services under contract or arrangement with affected facilities. The COVID-19 vaccination mandate may be required for pharmacy employees or contractors as a condition for continued services to the facilities if pharmacy staff come in contact with facility staff or patients (e.g. delivery drivers).

Pharmacies are advised to check with the facilities to which they provide products or services to see if the vaccination requirement will be extended beyond health care facilities staff. The IFR does not prohibit mandated facilities from extending the mandate.

OSHA Emergency Temporary Standard (ETS)

This OSHA Emergency Temporary Standard is under scrutiny by a federal court of appeals and is subject to a (potentially national) temporary stay of enforcement. However, employers should be aware of how the standard may affect them.

According to the ETS, starting December 5, 2021, a private sector facility with 100 or more employees must implement and enforce a mandatory COVID-19 vaccination policy. This could include pharmacies with 100 or more employees under one corporate entity (e.g. multiple stores under one entity).

The initial dose must be received by December 6, 2021 and the second dose by January 4, 2022. If an employee chooses not to get vaccinated for reasons such as medical, disability or religious reasons, they must submit to weekly COVID-19 testing. These tests must be performed by an authorized medical professional (not self-administered and self-read). Any unvaccinated pharmacy employees must wear a face covering while in the workplace.

Employees are entitled to PTO for up to four hours to receive the vaccine and, if needed, PTO for the time necessary to recover from side effects of the vaccine. Employers may not force employees to use vacation pay to cover this time.

Non-compliance of these standards may result in OSHA penalties and fines up to $14,000 per violation. Read the full whitepaper for more details.

Stay tuned for future updates on regulatory changes that may impact your pharmacy. You may also be interested in this pharmacy advisory article about compensation for delivery drivers

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