On November 5, 2021, CMS published a new Interim Final Rule revising the requirements of participation for Medicare and Medicaid certified providers and suppliers to include a COVID-19 vaccination requirement for provider and supplier staff. CMS has issued this change based on its finding that the rapidly evolving public health emergency and current instability within the health care system requires immediate action to protect the health and safety of residents, clients, patients, and staff.
Providers subject to this change have less than a month to ensure initial compliance with these requirements and must act swiftly to develop policies and procedures to enforce the vaccination requirement and ensure full employee compliance by January 4, 2022.
Who Qualifies as a Certified Provider or Supplier under this Rule?
The new rule includes a list specifying Medicare and Medicaid Certified providers and suppliers subject to the rule. These identified entities must ensure that all staff are vaccinated pursuant to the requirements within this article. These providers and suppliers include:
The rule applies to all staff working at a facility that participates in Medicare and Medicaid programs, regardless of clinical responsibility or patient contact, and includes all current staff as well as any new staff. The vaccination requirement applies equally to facility employees, licensed practitioners, students, trainees, and volunteers, as well as individuals who provide care, treatment, or other services for the facility and/or its patients under contract or other arrangement. It also applies to any staff who routinely provide care to patients and clients outside of the facility’s formal setting, such as homes, clinics, other sites of care, administrative offices, etc. This includes physicians with admitting privileges at a hospital. However, employees who provide 100 percent remote services are not subject to the vaccination requirements.
The rule does not apply to other health care entities, like physician offices, assisted living facilities, or group homes that are not regulated by CMS. However, these and other entities may be subject to other state or federal vaccination requirements, like those issued by OSHA. Specifically, OSHA’s emergency standard applies to all employers with 100 or more employees and requires covered employers to develop, implement, and enforce a mandatory COVID-19 vaccination policy. Unlike CMS’ new rule, OSHA’s standard allows employers to provide an option to employees to undergo weekly COVID-19 testing and wear a mask in the workplace in lieu of vaccination.
What Constitutes “Fully Vaccinated” and When Must Employees be Vaccinated?
The rule requires that facilities establish policies and procedures that ensure that all staff receive the first of a two-dose COVID-19 vaccine (Pfizer or Moderna) or a one-dose COVID-19 vaccine (Johnson & Johnson) by December 5, 2021, or 30 days after the rule goes into effect. Pfizer, Moderna, and Johnson & Johnson are the only approved vaccines under this rule. Employees who have received a non-approved vaccine must obtain one of the approved vaccines in order to comply with this rule.
All staff must be “fully vaccinated” – i.e., received both doses of Pfizer or Moderna or one dose of Johnson & Johnson – by January 4, 2022. Importantly, to be considered fully vaccinated, an employee must receive the same shot for both doses in the two-dose series. For example, an employee would not be considered fully vaccinated if their first dose was Moderna and the second dose was Pfizer. This consistency requirement only applies to the two-dose series and does not prohibit the mix-and-match approach allowed for COVID-19 vaccine boosters.
Employees are considered fully vaccinated two weeks after the completion of the two-dose series of Pfizer or Moderna or the one dose of Johnson & Johnson. COVID-19 vaccine boosters are not required at this time under the CMS rule for employees to be considered fully vaccinated.
What are the Certified Providers and Suppliers’ Requirements under this Rule?
CMS’ rule requires the identified providers and suppliers to develop and implement policies and procedures to ensure all staff are fully vaccinated for COVID-19 as defined above. These policies and procedures should explain the rationale for the policy, identify the deadlines and requirements for reaching fully vaccinated status, and indicate the procedures for reporting vaccination or requesting a valid exemption as detailed below. Penalties for failing to comply with the policy should also be addressed.
Covered providers and suppliers must track and securely document the vaccination status of each staff member. These records must be kept confidential and stored separately from an employee’s personnel file in order to comply with the Americans with Disabilities Act and the Rehabilitation Act. Employers must request proof of vaccination from the covered employees and retain this information in the separate file. Examples of acceptable proof of vaccination include: a CDC COVID-19 vaccination record card or legible copy or photo; documentation of vaccination from a health care provider; a state immunization information system record; or, if vaccinated outside of the United States, a reasonable equivalent to these examples.
Can Employees be Exempt from the Policy?
Facilities must provide accommodations for employees who request and receive exemptions from the vaccination requirement because of disability, medical condition, or sincerely-held religious belief, practice, or observance. Requests for exemptions must be based on applicable federal law, such as the Americans with Disabilities Act, the Genetic Information Nondiscrimination Act, or Title VII of the Civil Rights Act of 1964. These requests must be documented and evaluated in accordance with applicable law and the facility’s policies and procedures.
Flexibility by employers is important in determining if an accommodation is possible. For those requesting an accommodation, reasonable accommodations may include continued wearing of face masks, working at a social distance from others, working a modified shift, periodic testing for COVID-19, telework, or a reassignment.
The EEOC recently issued updated information regarding whether an employer must honor a request for accommodation due to a sincerely held religious belief, practice, or observance. Specifically, Title VII does not protect social, political, or economic views, or personal preferences of employees. Further, employers that demonstrate that an accommodation would pose an “undue hardship” are not required to accommodate an employee’s request for a religious accommodation.
Employers should assume that a request for religious accommodation is based on a sincerely held religious belief; however, if an employer has an objective basis for questioning either the religious nature or the sincerity of a particular belief, the employer is justified in making a limited factual inquiry and seeking additional supporting information.
Employers should include the process for requesting such accommodation and indicate a contact individual in their vaccination policies and procedures. Employers may request documentation to support a request for an exemption from the policy for either medical or religious reasons. Exemptions should not be provided to any staff for whom it is not legally required or to those who request an exemption solely to evade vaccination, nor are employees who have previously had COVID-19 exempt from the vaccination requirements.
CMS has provided a short time frame for participating providers and suppliers to ensure that all employees are vaccinated pursuant to this new rule. Facilities who are covered under the new rule should begin implementing policies and procedures and making employees aware of the new requirement for mandatory vaccination. Any requests for exemption and reasonable accommodations should result in a discussion with the employee, but accommodations are not required if they would pose an undue hardship on the employer.
CMS will enforce the new rule using state survey agencies conducting onsite compliance reviews, either through standard recertification surveys or through complaint surveys. Surveyors will have to specifically review the facility’s COVID-19 vaccination policies and procedures and a list of all staff and their vaccination status. The goal is to bring health care facilities into compliance, but CMS will consider termination if a facility fails to make corrections after receiving the opportunity to do so. Facilities subject to this rule would be wise to take immediate steps to ensure compliance with this rule, especially in light of likely employee requests for exemption and accommodations and the time required to review and act on such requests.
If you or your practice have any questions about this proposed rule or would like assistance submitting a comment, please contact Peter Mellette, Harrison Gibbs, or Elizabeth Dahl Coleman at Mellette PC.
This client alert is for general educational purposes only. It is not intended to provide legal advice specific to any situation you may have and does not cover all the provisions of the proposed rule. Individuals desiring legal advice should consult legal counsel for up-to-date and fact-specific advice.