On the same day that OSHA issued its Emergency Temporary Standard mandating vaccination for private employers with more than 100 employees (discussed here), the Centers for Medicare and Medicaid Services (CMS), Department of Health and Human Services, issued its Interim Rule requiring most Medicare- and Medicaid-certified providers and suppliers to establish COVID-19 vaccination requirements.
Who Does the Rule Apply to?
- Facilities Covered: The CMS Rule applies to four categories of providers and suppliers: (1) residential congregate care facilities (i.e., skilled nursing facilities, intermediate care facilities for individuals with disabilities, psychiatric residential treatment facilities); (2) acute care settings (i.e., hospitals, ambulatory care centers); (3) outpatient clinical care and services (i.e., ESRD facilities, community mental health facilities); and (4) home-based care.
- Facilities Not Covered: Physician offices and other health care entities not regulated by CMS. However, those employers might still be covered by other federal rules, such as the OSHA mandate, or by state or local mandates.
- Persons Covered: The vaccination requirement applies to all staff that interacts with other staff, patients, residents, clients, or program participants in any location, including locations where there is no patient care. It does not apply to individuals who provide services 100% remotely, such as telehealth or payroll services.
This is the first time that CMS has issued a vaccine mandate and it recognized that in the rule but says that the “fast-moving nature of the COVID-19 pandemic and its ongoing threat to the health and safety of individuals receiving health care services in Medicare and Medicaid-certified providers and suppliers, our intervention is warranted.” The rule also states that this nationwide regulation is intended to pre-empt inconsistent state or local laws.
What is Required?
- Employers must develop and implement policies and procedures to ensure that their staff are vaccinated for COVID-19 and have a contingency plan for any staff that are not fully vaccinated according to the rule.
- Employers must track and securely document the vaccination status of each staff member. Vaccination exemption requests and outcomes must also be documented. This is an ongoing process as new staff are onboarded.
- Employers must implement a process by which staff may request an exemption from COVID-19 vaccination requirements based on applicable federal law and for evaluating such requests, decisions made and any accommodations that are provided. CMS states that this rule preempts the applicability of any state or local law that may seek to provide broader exemptions than those provided by the ADA and Title VII (such as exemptions based on an employee’s non-religious beliefs). Requests for medical exemptions must be signed by a licensed practitioner (not the employee seeking the exemption) and must confirm “recognized clinical contraindications to the COVID-19 vaccines.” All medical records, including vaccine documentation, must be kept confidential and stored separately from an employer’s personnel files, in compliance with the ADA. The rule also states that exemptions or accommodations granted to employees “must ensure that they minimize the risk of transmission of COVID-19 to at risk individuals”
When is the Rule Effective?
This rule takes effect immediately upon publication, scheduled for November 5, 2021. There are two phases to the implementation of the rule. Phase one includes implementing appropriate policies and procedures and all staff receiving at least the initial dose of the two dose vaccine. That phase must be completed by December 5, 2021. Phase two, which must be completed by January 4, 2022, requires all employees to be either fully vaccinated or have received both doses of the two-dose vaccine and be in the 14-day waiting period to be considered fully vaccinated.
Enforcement
The CMS is the federal agency responsible for establishing health and safety regulations for Medicare- and Medicaid-certified providers and suppliers. CMS states that it will issue interpretive guidelines, which include survey procedures, and will advise and train State surveyors on how to assess compliance with the new requirements. Surveyors may be permitted to review an entity’s records of staff vaccinations and conduct interviews of staff to verify their vaccination status. The CMS also states that it will provide guidance on how surveyors should cite providers and suppliers when noncompliance is identified, and that noncompliant entities may be subject to enforcement remedies imposed by CMS (for example, civil money penalties, denial of payment for new admissions, or termination of the Medicare/Medicaid provider agreement).
Comment: This CMS rule applies to an estimated 17 million workers at approximately 760,000 health care facilities. Unlike the OSHA ETS, the CMS rule for health care facilities does not have a testing option—all employees who are covered by the rule must be vaccinated for COVID-19. The only exemptions that can be granted are based on disability (under the Americans with Disabilities Act) and sincerely held religious belief (under Title VII). CMS has also set forth specific requirements for consideration of exemption requests and placed limits on accommodations that can be granted. Employers covered by this rule must prepare policies and procedures for implementing the mandate and addressing exemption requests. They must also maintain documentation of vaccine status and exemption requests and decisions.
Weber Gallagher’s Employment Group previously provided guidance on disability and religious accommodations.
On November 11, 2021, our Employment Law partners conducted a webinar to discuss both the OSHA ETS and CMS vaccine requirements. You can view the webinar here.