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BREAKING NEWS: Federal Agencies Release Guidance for Mandatory Vaccination and Testing for Healthcare Workers and Employers

Issue Brief

November 4, 2021

Today, the Centers for Medicare & Medicaid Services (CMS) released an interim final rule on mandatory vaccination for healthcare staff, while the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) announced an Emergency Temporary Standard (ETS) on COVID-19 Testing and Vaccination to reduce COVID-19 transmission in the workplace.

CMS Interim Final Rule

Under the new interim final rule issued by CMS, staff at healthcare facilities governed by the Medicare Conditions of Participation (COP) must be vaccinated for COVID-19. This includes most healthcare facilities in the country except for organ procurement requirements, religious nonmedical healthcare institutions, X-ray suppliers, assisted living facilities, community organizations, and physicians’ offices. CMS defines “staff” broadly to include all current and new staff that are on-site at healthcare facilities or who have contact with on-site staff at healthcare facilities. This would include swing staff, such as nurses who move between assisted living facilities and a hospital or physicians who operate their own offices but have hospital privileges. However, it does not include fully remote teleworkers. CMS noted that the mandate will apply to approximately 76,000 facilities and 17 million healthcare workers.

The new vaccination mandate requires all eligible facilities to have a plan for vaccinating staff, for providing any applicable religious and medical exemptions/exceptions, and for tracking vaccinations within the next 30 days. The timeline for vaccination is short – staff must have a first dose of a multi-dose vaccine or the single-dose vaccine by Dec. 5, 2021. Eligible staff must be fully vaccinated (i.e., have received all doses in a vaccine regimen, excluding boosters and not including the 14-day waiting period after the final dose) by Jan. 4, 2022. Staff that have previously contacted COVID-19 and may have natural immunity are not exempt from the vaccination requirements.

CMS surveyors and accrediting organizations will test compliance with the new COP. The expectation is that facilities will have a clear process for requesting medical or religious exemptions and will clearly document the reasons exemptions are granted or denied. CMS does not dictate the exact structure of facility exemption/exception policies and procedures. Additionally, facilities must have extra precautions, including testing, physical distancing, and assignment of staff to non-patient care areas, in place for unvaccinated staff who have been granted medical or religious exemptions. Finally, it is important to note that the new rule preempts any state laws barring mandatory vaccination requirements.

OSHA Emergency Temporary Standard

The ETS issued by OSHA requires covered employers to develop, implement, and enforce a mandatory COVID-19 vaccination policy. Employers will also be allowed to adopt a policy allowing employees to opt out of mandatory vaccination, but will be required to undergo regular COVID-19 testing and wear a face covering in the workplace. The ETS is effective immediately following publication, and employers must comply with most requirements within 30 days of publication and with testing requirements within 60 days of publication. Employer’s policies must follow the following guidelines:

  • Employers must provide paid time to workers to get vaccinated and allow for paid leave to recover from any side effects.

  • Employers must determine the vaccination status of each employee by obtaining acceptable proof of vaccination status from vaccinated employees and maintain records and a roster of each employee's vaccination status.
  • Employees must provide prompt notice if they test positive for COVID-19 or receive a COVID-19 diagnosis. Employers must then remove the employee from the workplace, regardless of vaccination status; employers must not allow them to return to work until they meet required criteria.
  • Employers must ensure each worker who is not fully vaccinated is tested for COVID-19 at least weekly (if the worker is in the workplace at least once a week) or within 7 days before returning to work (if the worker is away from the workplace for a week or longer).

  • Employers must ensure each employee who has not been fully vaccinated wears a face covering when indoors or when occupying a vehicle with another person for work purposes.

CMS’ interim final rule will accept comments on the interim final rule until early January, and OSHA’s ETS will also be open for comments. ASHP will continue to update members with the final rules or any significant changes.