On November 5, 2021, on the same day that the Occupational Health and Safety Administration issued its COVID-19 Vaccination and Testing Emergency Temporary Standard (the “ETS”), the Centers for Medicare and Medicaid Services (“CMS”) released its Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule (the “CMS Vaccination Rule” or the “Rule”). The CMS Vaccination Rule requires certain healthcare providers to mandate vaccination against COVID-19 for all applicable staff. The Rule, which permits medical and religious exemptions only as required by law, does not require testing of unvaccinated staff.
The basic requirements of the Rule are that all staff in a covered facility receive their initial dose of a two-dose vaccine or the only dose of a single dose vaccine within 30 days of the publication of the Rule (i.e., by December 6, 2021). Within 60 days of the publication of the Rule (i.e., by January 4, 2022, covered staff must have received the second dose of a two-dose vaccine. While the Rule considers staff to be fully vaccinated fourteen days after the completion of the applicable vaccination series, the Rule does not require staff to be fully vaccinated by January 4, 2022, so long as they have completed the applicable vaccination series (i.e., two shots for Moderna or Pfizer, one shot for Johnson and Johnson). Covered providers must implement policies or procedures to ensure vaccination over these two “phases.”
Types of Facilities Covered
Not all healthcare facilities are covered by the CMS Vaccination Rule. Rather, the Rule applies only to those facilities that are regulated under Conditions of Participation, Conditions for Coverage, and Requirements for Participation, which are CMS health and safety standards. The types of facilities that fall under these standards include the following:
- 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,
- Intermediate Care Facilities for Individuals with Intellectual Disabilities,
- Rehabilitation Agencies,
- 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 Rule does not apply to the following, though other state or federal vaccine requirements could apply to such facilities:
- Religious Nonmedical Health Care Institutions,
- Organ Procurement Institutions,
- Portable X-Ray Suppliers,
- Assisted Living Facilities,
- Group Homes,
- Home and Community-based Services, or
- Schools that receive Medicaid Funding.
The general rule is that all staff working at a covered facility must be vaccinated. Staff includes employees, licensed practitioners, students, trainees, volunteers, and individuals who provide care, treatment, or other services for the facility and/or its patients under contract or other arrangements. Staff need not engage in patient contact or have clinical responsibility in order to be covered. While staff who perform their work off-site are covered, those staff who are 100% remote or who do not work in the covered facility and who have no contact with patients or other staff are not covered.
The requirements apply equally to existing and new staff.
Exemptions for Medical and Religious Reasons
Covered facilities must allow for exemptions to employees with medical contraindications. Covered facilities must also allow for exemptions to staff because of religious beliefs, observances, or practices. However, CMS makes clear that exemptions may not be granted except where legally required by the Americans with Disabilities Act or Title VII of the Civil Rights Act of 1964. CMS directs employers to deny requests that are not legally required or that are designed solely to evade vaccination. In this regard, CMS points to the EEOC’s recently updated guidance (https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws).
There is no exemption for individuals who have previously been infected or show the presence of COVID-19 antibodies in their system.
While CMS makes clear that where exemptions are granted, employers must develop a process to implement additional precautions for unvaccinated staff, but the Interim Final Rule stops short of requiring regular testing.
Which Vaccines Are Acceptable
Staff may receive a vaccine licensed or authorized by the FDA (Pfizer, Moderna, or Johnson & Johnson), or a vaccine listed by the WHO for emergency use, or who received a vaccine during participation in a clinical trial.
If staff received a vaccine that is not within the scope of the Rule, they should wait 28 days following the last dose of a non-approved vaccine to begin a series of an acceptable vaccine.
Booster Shots Not Required
While the Rule does not require boosters, even where recommended by the CDC, CMS seems to encourage booster shots where recommended. Tracking of receipt of booster shots, however, is required by the Rule, as is tracking and documenting vaccination status.
Penalties for Non-Compliance
Penalties for non-compliance differ depending on the type of facility, but can include civil money penalties, denial of payment, or termination from Medicare and Medicaid Programs. CMS states that its goal is not termination, but to bring covered facilities into compliance by offering an opportunity to make corrections.
Interaction with Other Laws
The CMS Vaccination Rule preempts any inconsistent or contradictory state laws. CMS indicates that it worked closely with OSHA and other government agencies to ensure the Rule is complementary to both the OSHA Healthcare ETS (June 21, 2021) and the more broadly applicable OSHA ETS (November 5, 2021). Employers who are covered by the CMS Vaccination Rule are directed by CMS to prioritize compliance with the Rule before looking to other federal vaccination requirements, such as the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors or the OSHA standards.
CMS has also issued FAQs on its Interim Final Rule that may be useful for covered healthcare facilities.
This is obviously a fast-moving and ever-changing situation, and we will continue to send out E-lerts on any significant developments. You may also wish to check our FAQs.
Although the Interim Final Rule is effective as of November 5, 2021, CMS will be accepting public comments ending on January 4, 2022, which it will consider in developing a Final Rule. You may submit comments during the comment period starting on November 5, 2021 here.