PUBLICATIONS

On November 4, 2021, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule (the “CMS Rule”) that applies to most healthcare entities that participate in Medicare and Medicaid programs. Subject to a few exceptions, the CMS Rule requires all individuals who work for those entities to be vaccinated against COVID-19. According to CMS, its rule takes priority above other federal vaccination requirements, including those set forth in the new OSHA Emergency Temporary Standard (“ETS”). Additionally, CMS maintains that pursuant to the Supremacy Clause of the United States Constitution, its rule preempts any state or local laws.

This week, Missouri and nine other states brought a lawsuit in federal court to challenge the CMS Rule, arguing that the mandate violates the Administrative Procedures Act (APA). While the CMS Rule is being challenged, covered healthcare entities should nevertheless be prepared to comply with the Rule’s requirements by the initial deadline (December 6, 2021). To that end, this Legal Alert provides an overview of the CMS Rule and its impact on healthcare providers and their workers.

How Do I Determine Whether My Organization Must Comply with the Interim Final Rule?

The CMS Rule applies to your organization if it is one of the Medicare and Medicaid-certified provider and supplier types (referred to as “facilities”) that are regulated under the Medicare health and safety standards known as Conditions of Participation (CoPs), Conditions for Coverage (CfCs), or Requirements, and is not otherwise excluded from the Rule. The chart below summarizes the entities to which the CMS Rule applies and excludes or does not apply:

If an Entity is Covered by the CMS Interim Rule, Who Must be Vaccinated?

All personnel working at a facility that participates in Medicare and Medicaid programs as defined by the CMS Rule, including students, trainees, and volunteers, must be vaccinated. The vaccination requirements also apply to personnel working for a covered entity who perform duties offsite (i.e., home health) and to personnel that may be employed by a non-covered entity but are contracted to provide services onsite at a CMS regulated facility (i.e., a provider at a physician office who has hospital privileges). The CMS Rule’s vaccination requirement does not apply to staff who exclusively provide telehealth outside of the facility setting and other staff who work outside the facility setting and have no direct contact with patients and other staff.

What Are Covered Employers Required to Do?

All employers covered by the CMS Rule are required to develop and implement policies and procedures regarding COVID-19 vaccination. The policies and procedures must address, at a minimum, the following components:

• Ensuring that all applicable staff receive their first dose (or a single dose) prior to providing any care, treatment or services;
• Ensuring that all applicable staff are fully vaccinated by the deadlines mentioned below;
• A process for tracking vaccination status;
• Processes for tracking and documenting requests for religious exemption or medical exemption and ensuring that they are handled in accordance with the CMS Rule;
• Tracking and documentation processes for staff for whom vaccination must be temporarily delayed for medical reasons;
• Implementation of additional precautions for staff who are not fully vaccinated to mitigate transmission and spread of COVID-19; and
• Contingency plans for staff who are not fully vaccinated.

Notably, unlike the ETS, the CMS Rule does not allow masking and weekly testing as an alternative to mandating vaccinations.

Are There Any Exceptions to the Requirements?

The CMS Rule requires covered entities to allow exemptions as accommodations for workers with medical conditions for which COVID-19 vaccines are contraindicated or with sincerely held religious beliefs in conflict with vaccination. Covered entities must establish processes by which employees may request a medical or religious exemption from the vaccination mandates.

With respect to personnel seeking a medical exemption, covered entities must obtain documentation signed by a licensed practitioner that specifies the worker’s recognized clinical contraindications to each of the authorized COVID-19 vaccinations along with a statement from the practitioner recommending exemption. For workers seeking a religious exemption, covered entities must document and evaluate the requests in conformity with applicable federal law and guidance from the U.S. Equal Employment Opportunity Commission. In the absence of objective evidence to the contrary, covered entities should generally assume that requests for religious accommodation are based on sincerely held religious beliefs. However, covered entities may make reasonable requests for verification of the sincerity or religious nature of a professed belief, including seeking supporting information. Moreover, accommodation is available only if based on religious beliefs, not social, political, or economic views, or personal preferences. A covered entity need not provide an accommodation if doing so would cause an “undue hardship,” such as by impairing workplace safety.

Covered entities must take additional precautions to minimize the risk of transmission of COVID-19 by workers entitled to an exemption from the vaccination requirements, including testing, source control, and physical distancing.

When Must Employees be Fully Vaccinated to comply with the Requirements?

Covered entities must achieve the vaccination requirements in two phases. First, within 30 days of the Rule’s implementation (i.e., by December 6, 2021), all covered workers must obtain a single dose COVID-19 vaccine or the first dose of a two-dose vaccine prior to providing services for a covered entity. Second, within 60 days (i.e. by January 4, 2022), all covered workers must obtain the second dose of a two-dose vaccine.

How Does the CMS Rule Relate to Recent OSHA Regulations?

On the same day the CMS Rule was released, OSHA released the ETS containing COVID-19 vaccination and testing requirements for employers with 100 or more employees. The OSHA ETS, however, expressly excludes all employers covered by OSHA’s June 2021 ETS, which specifically addresses COVID-19 in the healthcare industry (the “OSHA Healthcare ETS”).

As discussed in our prior alert, the OSHA Healthcare ETS applies to a broad range of healthcare settings. Although it does not contain a vaccination mandate, the OSHA Healthcare ETS mandates numerous measures aimed at promoting COVID-19 vaccination and protecting against transmission and spread. These measures include (among other things) granting employees paid time off to get vaccinated and to recover from any side effects; providing additional paid time off benefits up to $1,400 per week for quarantine or isolation; providing training; implementing various facility-specific precautions such as barriers and air filtration; and recordkeeping requirements. (See OSHA’s Fact Sheet for a summary of requirements).

Employers covered by the new CMS Rule are likely also subject to the OSHA Healthcare ETS. Therefore, it is important when developing policies and procedures to ensure that they comply with both rules.

How will CMS Monitor Compliance with its Rule?

CMS will require state survey agencies to conduct onsite reviews to ensure compliance with its rule. These reviews will occur in conjunction with standard recertification surveys and with all complaint surveys. When conducting onsite reviews, surveyors will review the following:

• Documentation related to written vaccination policies and procedures, including the entity’s written process or plan for vaccinating staff, providing exemptions, and tracking vaccination status,
• The number of resident and staff COVID-19 cases over the last four weeks, and
• A list of all staff and their vaccination status.

Additionally, Accrediting Organizations will be required to update their survey processes to assess facilities they accredit for compliance with vaccination regulations.

What Best Practices Should My Organization Undertake Now to Comply with the CMS Rule?

• Identify a team of individuals that will be responsible for implementing the CMS Rule’s requirements.
• Determine the various staff members to whom the Rule does and does not apply, including evaluating any agreements with contracted staff or labor that may enter your facility and be subject to the CMS Rule even if employed by another entity.
• Prepare a written policy outlining the facility’s vaccination requirement.
• Develop forms and a compliant process to facilitate the request of medical and religious exemptions and ensure the team members fielding the requests are trained to properly evaluate the requests.
• Develop a secure process for tracking and documenting the COVID-19 vaccination status of all impacted personnel.
• Because vaccine hesitancy may lead to leave of absence requests and/or resignations, be prepared to address decreases in labor.
• Be prepared to address employee morale and public relations issues stemming from the implementation of policies relating to COVID-19 vaccines in the workplace, which can elicit strong feelings.
• If the CMS Rule does not apply to your organization, evaluate the applicability to your organization of the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors, the OSHA COVID-19 Healthcare Emergency Temporary Standard, and the ETS.

Additional Resources

• CMS’ slides and recorded Zoom call from November 5, 2021, providing an overview of the Interim Final Rule
• CMS’ Interim Final Rule FAQs

FordHarrison will be conducting a complimentary webinar, “Navigating the CMS Rule Addressing COVID-19 Vaccination Requirements for Healthcare Workers,” on November 16, 2021. For more information please click here. To register, click here. 

If you have any questions regarding this Alert or the issues discussed, please contact the authors, Julie Adams, jadams@fordharrison.com, Sami Asaad, sasaad@fordharrison.com, and Ben Fryer, bfryer@fordharrison.com, all of whom are members of FordHarrison’s Coronavirus Taskforce. Of course, you can also contact the FordHarrison attorney with whom you usually work.