Business of Medicine
OSHA and CMS COVID-19 Vaccine Mandates: What Healthcare Organizations Need to Know
UPDATE 12/03/21: As of 11/30/21, a federal district court in Louisiana issued a nationwide preliminary injunction against the Centers for Medicare & Medicaid Services (CMS) Interim Final Rule mandating vaccines for certain covered healthcare providers and facilities except in the 10 states that a federal court in Missouri also enjoined the day before. CMS has appealed both of those decisions and has filed motions for stays of the orders. In the meantime, like OSHA, CMS has suspended activities related to the implementation and enforcement of the rule pending future developments in the litigation.
UPDATE 11/12/21: As of 11/12/21 OSHA has suspended the implementation and enforcement of the Emergency Temporary Standard- we will post updates as they occur.
On November 5, 2021, the Occupational Safety and Health Administration (OSHA) and the Centers for Medicare & Medicaid Services (CMS) both published their interim final rules regarding COVID-19 vaccination mandates.
OSHA’s Emergency Temporary Standard (OSHA Rule) requires businesses with 100 or more employees (such as large physician practices) to implement a vaccine-or-testing mandate by January 4, 2022. But healthcare organizations with 100 or more employees will not be required to comply with the new OSHA Rule if the organization is still subject to OSHA’s Healthcare ETS, which was issued in June 2021 and is currently scheduled to expire in December 2021. Unless the Healthcare ETS is extended, it appears all healthcare organizations with 100 or more employees will be required to comply with the new OSHA Rule.
CMS’s Omnibus COVID-19 Health Care Staff Vaccination interim final rule (CMS Rule) requires that every employee be vaccinated and does not allow for a testing opt-out like the OSHA Rule. The CMS Rule will apply to virtually all Medicare-certified facilities (such as hospitals, ambulatory surgery centers, home health agencies and long-term care facilities). According to a recent statement from the White House, the CMS Rule will apply to more than 17 million healthcare employees at approximately 76,000 healthcare facilities.
However, the CMS Rule does not appear to apply to traditional outpatient physician practices that accept Medicare payments but have less than 100 employees. That means physician practices with less than 100 employees are not subject to either the OSHA Rule or the CMS Rule.
Physician practices with more than 100 employees are subject to the OSHA Rule and must implement a vaccine-or-testing mandate by January 4, 2022. Healthcare facilities (such as hospitals, ambulatory surgery centers, dialysis facilities, home health agencies and long-term care facilities) are subject to the CMS Rule, which requires mandatory vaccination for employees.
- Physician Practices <100 Employees: not subject to OSHA Rule or CMS Rule
- Physician Practices >100 Employees: Must comply with the OSHA Rule
- Medicare Certified Healthcare Facilities: Must comply with the CMS Rule
The enforceability of both the OSHA Rule and the CMS Rule is far from certain, as both are currently facing numerous legal challenges. But since both rules impose significant penalties for noncompliance, most healthcare organizations that are subject to either rule should strongly consider developing their implementation plans while awaiting judicial decisions.
Following is further information that can help you determine 1) whether your healthcare organization is subject to the OSHA Rule or the CMS Rule, 2) what requirements are imposed on your organization, and 3) potential repercussions for healthcare organizations that fail to comply with the new regulations.
Step 1: Determine whether your organization is subject to the OSHA Rule or the CMS Rule
Healthcare organizations subject to the OSHA Rule
Healthcare organizations with 100 or more employees are subject to the OSHA Rule. However, a few types of workers, such as employees who work 100% remotely or independent contractors, do not count towards the 100-employee threshold. More information on which employees count towards that threshold can be found on OSHA’s website.
Healthcare organizations subject to the CMS Rule
The CMS Rule mandates that Medicare-certified healthcare facilities, regardless of the number of employees, require all on-site workers to be fully vaccinated by January 4, 2022.
The CMS Rule applies to the following facilities:
- Ambulatory surgical centers
- Clinics (rehabilitation agencies and public health agencies as providers of outpatient physical therapy and speech-language pathology services)
- Community mental health centers
- Comprehensive outpatient rehabilitation facilities
- Critical access hospitals
- End-stage renal disease facilities
- Intermediate care facilities for individuals with intellectual disabilities
- Home health agencies
- Home infusion therapy suppliers
- Long-term care facilities
- Programs of all-inclusive care for the elderly
- Psychiatric residential treatment facilities
- Rural health clinics/federally qualified health centers
Step 2: Determine the requirements the OSHA Rule or CMS Rule imposes on your organization
OSHA Rule compliance requirements and dates
Healthcare organizations subject to the OSHA Rule must meet the following requirements by December 5, 2021:
Establish and implement a written policy requiring each employee to be fully vaccinated against COVID-19, or establish a policy allowing employees to choose whether to be fully vaccinated or tested for COVID-19 at least every seven days and wear face coverings.
Determine the vaccination status of each employee.
Obtain “acceptable proof” of vaccination status. Acceptable proof can be a vaccination card, pharmacy or medical records or records from any public immunization system.
Create and maintain a roster of employee vaccination status, which must be preserved while the OSHA Rule is in effect.
Provide support for vaccination of employees.
Require that employees provide prompt notice of a positive COVID-19 test.
Require employees who test positive to leave the workplace.
Require unvaccinated employees to wear masks.
Report COVID-19 related fatalities to OSHA within 24 hours.
Make certain vaccination records available upon request. Within one business day, employers must provide their vaccination policy and aggregate vaccination data to employees who make such requests.
Starting January 4, 2022, the OSHA Rule requires that employees be fully vaccinated or that any unvaccinated employees must begin weekly testing. If an employer chooses to allow a testing opt-out, the employer is not required to pay for testing and unvaccinated employees are required to wear a mask while working in addition to being tested.
However, the testing opt-out is optional under the OSHA Rule, meaning employers may choose, but are not required, to provide a testing opt-out for unvaccinated employees. If an employer decides not to provide a testing opt-out for unvaccinated employees, then all employees must be fully vaccinated by January 4, 2022.
CMS Rule compliance requirements and dates
The CMS Rule imposes similar requirements on employers as the OSHA Rule, but there are some significant differences, such as:
The CMS Rule does not allow employers to provide a testing opt-out like the OSHA Rule.
The CMS Rule does not have an employee threshold and applies to all Medicare-certified facilities regardless of the number of employees.
A “covered individual” under the CMS Rule is broader and includes: employees, staff, practitioners, students, trainees, volunteers, and even independent contractors who may use shared facilities (such as bathrooms, cafeterias and common areas) or interact with patients or employees. However, the rule does not apply to 100% remote/virtual workers.
The CMS Rule requires that employers have a plan in place by December 5, 2021, for tracking and ensuring that all employees (except those who are exempt) are vaccinated. This plan should also include procedures to mitigate the spread of COVID-19, a contingency plan to replace workers who do not comply, and an application process for exemptions.
Employees who are not exempt must receive their first dose of the vaccine by December 5, 2021, and be must fully vaccinated by January 4, 2022.
If both the OSHA Rule and the CMS Rule apply to a facility, the CMS Rule takes priority.
Employees who may be exempt from vaccination under the OSHA Rule or CMS Rule include:
Employees who are unvaccinated because of a medical contraindication (such as severe allergic reaction to a previous dose of COVID-19 vaccine)
Employees with a medical necessity that requires a delay (such as recent exposure to COVID-19, currently receiving antibodies, or immunocompromised status)
Employees entitled to reasonable accommodations under Title VII of Civil Rights Act of 1964 (CRA) or the Americans with Disabilities Act (ADA)
Additional information on employer-mandated COVID-19 vaccination and accommodations can be found here.
Step 3: Understand the penalties your organization may face for noncompliance
Noncompliance under the OSHA Rule
The standard OSHA fines for violations will apply to employers who do not comply with the OSHA Rule. However, because the OSHA Rule was issued pursuant to the “grave danger” of COVID-19, OSHA will likely consider any violation of the OSHA Rule to be at minimum a “serious” violation. Each serious violation carries a $13,653 penalty.
Intentional or repeated failures to comply with the OSHA Rule may be considered “willful” violations, which carry the higher penalty of $136,532 per violation.
Noncompliance under the CMS Rule
Penalties for violating the CMS Rule may result in civil fines, denial of payment for Medicare and Medicaid charges, or even termination of the covered facility’s Medicare or Medicaid provider agreement.
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The information provided in this resource does not constitute legal, medical or any other professional advice, nor does it establish a standard of care. This resource has been created as an aid to you in your practice. The ultimate decision on how to use the information provided rests solely with you, the PolicyOwner.