On November 4, 2021, the Biden administration and the Centers for Medicare and Medicaid Services (CMS) at the Department of Health and Human Services (HHS) issued an interim final rule requiring healthcare worker vaccinations. The interim rule comes just weeks after CMS’ new rule requiring vaccinations for nursing home employees, and extends similar requirements to a wide array of healthcare industry employees. These new rules are just one part of a broader spectrum of regulations, including new OSHA regulations.

To make it easy for businesses and workers to comply, the administration announced that the deadline for workers to receive their shots will be the same for the OSHA rule, the CMS rule, and the previously announced federal contractor vaccination requirement. Across all three requirements, workers will need to be fully vaccinated by January 4, 2022. OSHA has also clarified that it will not apply its new rule to workplaces covered by either the CMS rule or the federal contractor vaccination requirement. And, both OSHA and CMS are making clear that their new rules preempt any inconsistent state or local laws, including laws that ban or limit an employer’s authority to require vaccination, masks, or testing.

The implementing regulations will be effective on the day they are published in the Federal Register.  There will then be a 60-day comment period during which interested stakeholders may, through various avenues, submit comments.

In order to meet the new requirement, 17 million workers at over 76,000 healthcare facilities across the country must receive either two doses of the Pfizer or Moderna vaccines, or one dose of the Johnson & Johnson vaccine by January 4, 2022. The interim rule does not require additional doses or booster shots.

The regulations will be implemented in two phases. For Phase 1, within 30 days after the regulation is published, staff at all healthcare facilities covered by the regulation must have received, at a minimum, the first dose of a two-dose vaccine 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, within 60 days after the regulation is published, staff at all healthcare provider and supplier types covered by the regulation must be fully vaccinated. Exceptions are made for those who have been granted exemptions from the COVID-19 vaccine or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC.   

The interim rule makes clear that it preempts all conflicting state or local laws as applied to Medicare- and Medicaid-certified providers and suppliers, including laws that ban or limit an employer’s authority to require vaccinations, masks, or COVID-19 testing. This includes state and local laws that may regulate employers with fewer than 100 employees, notwithstanding that the requirements in past directives have only applied to employers with more than 100 employees.  It also states in the preamble that it is meant to be complementary to the OSHA Emergency Temporary Standard (ETS).  Therefore, some providers may be subject to the OSHA ETS and the interim CMS rule although they have different purposes. 

Which employers are covered?

The interim rule applies to healthcare services, support or suppliers that are regulated under CMS standards.  Such “facilities” include, but are not limited to:

• Hospitals
• Ambulatory surgery centers
• Dialysis facilities
• Home health agencies
• Clinics, rehabilitation agencies, and public agencies as providers of outpatient physical therapy and speech-language pathology services
• Psychiatric residential treatment facilities
• Long-term care facilities including nursing homes
• Programs of all-inclusive care for the elderly
• Home infusion therapy suppliers
• Rural health clinics
• End-stage renal disease facilities

The interim rule affects only Medicare- and Medicaid-certified providers and suppliers. It does not directly apply to other healthcare entities, such as physician offices, that are not regulated by CMS.  

Which individuals are covered?

The interim rule applies to all current and future employees at covered facilities, regardless of whether the employee holds a clinical or non-clinical position. The requirements are not limited to those staff who perform duties within a formal clinical setting.

This policy builds on the recent vaccination requirement for nursing facilities and expands vaccination requirements to all workers and staff at CMS-regulated facilities. Beyond doctors, nurses, and medical staff, the mandate includes students, trainees, volunteers, and those who are not involved in direct patient, resident, or client care.  It also applies to home healthcare workers working in patients’ homes. 

Notably, the policy also applies to anyone who provides treatment or services to the facility under contract or other arrangements.  In order to comply with the new mandate, employers and administrators must ensure that all contractors servicing the facility are vaccinated. This rule applies to both clinical and non-clinical contractors, such as hospice and dialysis staff, physical therapists, occupational therapists, mental health professionals, and social workers.

It is possible, however, that entities not covered by this rule may still be subject to the other state or federal COVID-19 vaccination requirements, including OSHA’s ETS.

How does this affect accommodations?

The interim rule expressly acknowledges that facilities should continue to make accommodations for employees with a disability, medical condition, or sincerely held religious belief, practice or observance in accordance with the Equal Employment Opportunity Commission (EEOC) guidelines. This means that, in some instances, employers may be required to provide appropriate accommodations, to the extent required by federal law, for employees who request and receive exemptions from vaccination because of a disability, medical condition, or sincerely held religious belief, practice, or observance.

The interim rule further specifies that providers and suppliers must have a process for collecting and evaluating exemption requests, including tracking and securing documentation of information provided by those who have requested the exemption, the facility’s decision on the request, and any accommodation that is provided. Requests for exemptions based on applicable federal law must be documented and evaluated in accordance with the applicable federal law and each facility’s policies and procedures.

For religious exemptions, the interim rule directs employers to the EEOC Compliance Manual on Religious Discrimination for information on evaluating and responding to such requests.

Employers are responsible for ensuring that individuals covered by the interim rule are vaccinated by the January 4, 2022 deadline.

Do employers have to offer paid time off for vaccination?

The interim rule does not address or require offering paid time off for vaccinations, so employers should refer to state law or OSHA’s ETS, if applicable, in determining whether they will offer paid time off for vaccination.

We will provide additional updates on the interim rule and general industry guidance in the days ahead.