OSHA and CMS COVID-19 Vaccine Mandates: What Healthcare Providers Need to Know

Nov 10, 2021 | COVID-19 Legal Update, Legal & Regulatory Updates

On November 5, 2021 – nearly two months after being announced by President Biden – the federal government released workplace COVID-19 vaccination mandates in the form of an OSHA Emergency Temporary Standard (ETS) applicable to private workplaces with more than 100 employees and a CMS Interim Final Rule (IFR) applicable to health care staff in certain clinical settings.  Below is a brief summary of what healthcare providers and practices need to know:

OSHA Emergency Temporary Standard
The full text of the ETS can be found here, and its accompanying FAQ guidance here.  The ETS is currently subject to several lawsuits, including a temporary stay issued by the U.S. Court of Appeals for the Fifth Circuit.

Which Employers Are Subject to the ETS?
Employers with 100 or more employees are subject to the ETS.  Private workplaces of employers who have fewer than 100 employees in total are not subject to the ETS.  In addition, settings where any employee provides healthcare services or healthcare support services when subject to the IFR (see below) are not subject to the ETS.

What Policies Does the ETS Require Employers To Implement?
Employers subject to the ETS are required to develop, implement, and enforce either (a) a mandatory COVID-19 vaccination policy or (b) a policy allowing employees to elect either to get vaccinated or to undergo weekly COVID-19 testing and wear a face covering at the workplace.

What Is The Timeline for Implementing the ETS?
The ETS became effective immediately upon publication on November 5, 2021.  On or before December 5, 2021, employers subject to the ETS must comply with all requirements of the ETS except for testing employees who have not completed their entire primary vaccination doses.  On or before January 4, 2022, employers subject to the ETS must have implemented all requirements of the ETS, including testing for employees who have not received all doses required for primary vaccination.  Employers are not required to pay for the testing of their employees.

Are There Exemptions?
The ETS does not apply to employees who do not report to a workplace where other individuals such as coworkers or customers are present, employees while they are working from home, or employees who work exclusively outdoors.  In addition, an employer’s vaccination policy must include exemptions for those employees (1) for whom a vaccine is medically contraindicated, (2) for whom medical necessity requires a delay in vaccination, or (3) those legally entitled to a reasonable accommodation under federal civil rights laws because they have a disability or sincerely-held religious beliefs, practices, or observances that conflict with the vaccination requirement.

CMS Interim Final Rule
The full text of the IFR can be found here, and its accompanying FAQ guidance here.

Which Healthcare Providers Are Subject to the IFR?
The vaccination requirements under the IFR apply to all eligible staff working at a facility that participates in the Medicare/Medicaid program, regardless of clinical responsibility or patient contact.  These requirements, however, are limited to the following provider/supplier types:

  • Ambulatory Surgery Centers
  • Community Mental Health Centers
  • Comprehensive Outpatient Rehabilitation Facilities
  • Critical Access Hospitals
  • End-Stage Renal Disease Facilities
  • Home Health Agencies
  • Home Infusion Therapy Suppliers
  • Hospices
  • Hospitals
  • Intermediate Care Facilities for Individuals with Intellectual Disabilities
  • Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services
  • Psychiatric Residential Treatment Facilities
  • Programs for All-Inclusive Care for the Elderly Organizations
  • Rural Health Clinics/Federally Qualified Health Centers, and
  • Long Term Care facilities.

The IFR does not directly apply to independent physicians or clinicians.  However, the IFR may indirectly apply if physicians or other staff have admitting privileges or provide services at a qualifying healthcare facility, such as an ambulatory surgery center or hospital.

What are the Vaccination Requirements under the IFR?
Healthcare providers subject to the IFR must establish a process or policy to fulfill the following staff vaccine requirements.  On or before December 5, 2021, applicable staff must have received at least the first dose of a COVID-19 vaccine (or, have requested and been granted an exception).  On or before January 4, 2022, applicable staff must complete the primary vaccination series, unless an exception applies.   Unlike the ETS, the IFR requires staff vaccination and does not provide a COVID-19 testing alternative for unvaccinated staff.  New staff must be compliant as of the relevant implementation dates.  Documentation of booster shots is not needed.

Are There Exemptions?
CMS requires providers and suppliers subject to the IFR to allow for exemptions for staff with recognized medical conditions where vaccines are contraindicated and for religious beliefs.  Requirements for such exemptions should be addressed as part of the provider’s or supplier’s vaccination policies.  Notably, staff who previously had COVID-19 are not exempt from the vaccination requirements.

How Will The Rule Be Enforced?
CMS expects state survey agencies to conduct onsite compliance reviews.  Surveyors will review COVID-19 vaccination policies and procedures, the number of patient and staff COVID-19 cases over the preceding four weeks, and vaccination status.  Non-compliant facilities will be subject to a variety of penalties beginning in 2022, including civil monetary penalties, denial of payment, and termination from the Medicare and Medicaid programs.

Other Applicable Rules
CMS worked with OSHA to ensure regulations were complementary and ensured maximum coverage of staff across a multitude of settings.  There are situations in which the OSHA standard may also apply to staff not subject to the vaccination requirements under the IFR.  If facilities are not certified under CMS, then the OSHA rule may apply.  The IFR pre-empts any state law prohibiting vaccine mandates.

What Comes Next?
As with other legal and regulatory developments during the COVID-19 pandemic, the circumstances surrounding the implementation and enforcement of the ETS and the IFR are rapidly evolving.  It is possible for both OSHA and CMS to makes changes to the new regulations, as well as to supplement its FAQ guidance.  As noted above, there are several legal challenges making their way through the federal courts and several states, including Tennessee, have passed legislation that directly contradicts the requirements of the ETS and/or the IFR.

We have been advising medical groups to continue preparations to comply with the applicable rule until the lawsuits and challenges are resolved, and are available to help groups develop policies that comply with the rules.  Stay tuned.

The COVID-19 pandemic and response is an evolving situation.  All levels of government are engaged in the process of preparing new legislation, regulations and orders both to stem the spread of the virus and to provide relief to employers and employees.   We will continue to monitor the situation and provide updates as applicable, especially as such updates affect healthcare providers and their practices