New OSHA and CMS rules outline vaccination requirements for health care workers

On Nov. 4, the Biden Administration announced the details of two policies to help fight COVID-19 by expanding vaccination requirements, which will affect health care workers in certain settings.

First, the Occupational Safety and Health Administration (OSHA) is requiring employers with 100 or more employees to ensure that each of their workers is fully vaccinated or undergoes testing for COVID-19 on at least a weekly basis. The rule also requires that these employers provide paid time off for employees to get vaccinated and ensure all unvaccinated workers wear a face mask in the workplace. (Update: On Nov. 6, the U.S. Court of Appeals for the Fifth Circuit issued a stay freezing the new rule.)

Second, the Centers for Medicare & Medicaid Services (CMS) is requiring that health care workers at certain facilities that participate in Medicare and Medicaid be fully vaccinated. (See the CMS Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule.) The rule only applies to Medicare and Medicaid-certified provider and supplier types that are regulated under the Medicare health and safety standards known as Conditions of Participation (CoPs), Conditions for Coverage (CfCs), or Requirements.

Certain health care settings are excluded, such as the following:

• Physicians' offices (with fewer than 100 employees),
• Assisted living facilities,
• Group homes.

Affected facilities include the following:

• Hospitals,
• Hospices,
• Rural health clinics/federally qualified health centers,
• Critical access hospitals,
• Home health agencies,
• Long-term care facilities,
• Indian Health Service facilities,
• Ambulatory surgical centers,
• Comprehensive outpatient rehabilitation facilities,
• Clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services,
• Community mental health centers,
• End-stage renal disease facilities,
• Home infusion therapy suppliers,
• Intermediate care facilities for individuals with intellectual disabilities,
• Programs of all-inclusive care for the elderly,
• Psychiatric residential treatment facilities.

When do the vaccine mandates apply?

Facilities covered by these regulations must establish a process or plan for tracking and documenting staff vaccinations and ensure the following:

• By Dec. 5, 2021, all eligible staff have received the first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine prior to providing any care, treatment, or other services,
• By Jan. 4, 2022, all eligible staff have received the necessary shots to be fully vaccinated — two doses of Pfizer or Moderna, or one dose of Johnson & Johnson.

Are there any exemptions?

The regulation allows exemptions based on recognized medical conditions or religious beliefs, observances, or practices. Contraindications include a severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a component of the COVID-19 vaccine, or a known diagnosed allergy to a component of the vaccine. The CDC recommends vaccination for most people with underlying medical conditions.

Facilities must develop a process or plan for providing exemptions in alignment with federal law and must implement additional precautions for staff who are exempt from vaccination (e.g., testing, physical distancing, source control).

Who must be vaccinated?

The vaccine requirement applies to the following individuals:

• Eligible staff (facility employees, licensed physicians and other providers, students, trainees, and volunteers), regardless of clinical responsibility or patient contact,
• Individuals who provide care, treatment, or other services for the facility and/or its patients under contract or other arrangements,
• All staff who interact with other staff, patients, residents, clients, or PACE program participants in any location beyond the formal clinical setting (such as homes, clinics, other sites of care, administrative offices, and off-site meetings).

Does the requirement apply to physicians with admitting privileges in a hospital?

Yes, physicians admitting or treating patients in person within a facility subject to the CMS health and safety regulations must be vaccinated for the facility to be compliant.

View more Frequently Asked Questions from CMS about the requirements.

While the vaccination of workers is largely supported in health care, hospital and clinic leaders may worry that mandates could exacerbate staffing shortages. Some organizations are filling staffing gaps in the short-term by cross-training nonclinical staff to ease the burden on clinical staff or tapping medical students. Practices should also consider staff-retention strategies (see "Five Ways to Retain Good Staff"), as well as these tips for countering vaccine hesitancy among health care workers.

— Tracey Allen-Ehrhart, director for the AAFP's Center for Career and Practice, and Brandi White, FPM managing editor

Posted on Nov. 4, 2021, by FPM staff