Date: November 8, 2021
The Centers for Medicare and Medicaid Services (CMS) published their federal vaccine mandate interim final rule with comment period (IFC) on November 4th. CMS also published an FAQ covering the most important aspects of the rule.
The interim final rule takes effect immediately. All Rural Health Clinic (RHC) staff (with some exceptions as noted below) will need to have their first shot by December 4th, 2021, and be fully vaccinated by January 4th 2022.
Failure to meet the vaccination requirements in this IFC could result in monetary penalties, denial of payment for new Medicare/Medicaid admissions, or termination of the Medicare/Medicaid provider agreement depending on the level of non-compliance.
The FAQ makes it clear that this IFC pre-empts any state law to the contrary per the Supremacy Clause in the U.S. Constitution. There are active lawsuits led by certain states against the federal government on the vaccine mandate rules. At this time, the impact (if any) that those lawsuits might have on this mandate is unclear.
This IFC changes the conditions of participation for a wide array of healthcare facilities including Rural Health Clinics permanently. Unless these regulations are changed at some point in the future, the COVID-19 vaccine requirements will remain. In other words, the mandate does not automatically go away when Public Health Emergency ends.
RHCs will need to update their policies and procedures to account for these new conditions of participation and will have until the end of phase 1 (December 4th) to update their policies and procedures accordingly. Please see the bottom of this article for the full text of the new section of the RHC regulations being added as 42 CFR 491.8(d).
Staff Subject to COVID-19 Vaccination Requirements
The IFC states that:
Each facility’s COVID-19 vaccination policies and procedures must apply to the following facility staff, regardless of clinical responsibility or patient contact and including all current staff as well as any new staff, who provide any care, treatment, or other services for the facility and/or its patients:
- facility employees;
- licensed practitioners;
- students, trainees, and volunteers;
- and individuals who provide care, treatment, or other services for the facility and/or its patients, under contract or other arrangement.
These requirements are not limited to those staff who perform their duties within a formal clinical setting, as many health care staff routinely care for patients and clients outside of such facilities, such as home health, home infusion therapy, hospice, PACE programs, and therapy staff. Further, there may be staff that primarily provide services remotely via telework that occasionally encounter fellow staff, such as in an administrative office or at an off-site staff meeting, who will themselves enter a health care facility or site of care for their job responsibilities. Thus, CMS believes it is necessary to require vaccination for all staff that interact with other staff, patients, residents, clients, or PACE program participants in any location, beyond those that physically enter facilities, clinics, homes, or other sites of care. Individuals who provide services 100 percent remotely, such as fully remote telehealth or payroll services, are not subject to the vaccination requirements of this IFC.
RHCs are expected to create policies on contracted workers as well. CMS writes:
- When determining whether to require COVID-19 vaccination of an individual who does not fall into the categories established by this IFC, facilities should consider frequency of presence, services provided, and proximity to patients and staff. For example, a plumber who makes an emergency repair in an empty restroom or service area and correctly wears a mask for the entirety of the visit may not be an appropriate candidate for mandatory vaccination. On the other hand, a crew working on a construction project whose members use shared facilities (restrooms, cafeteria, break rooms) during their breaks would be subject to these requirements due to the fact that they are using the same common areas used by staff, patients, and visitors. Again, CMS strongly encourages facilities, when the opportunity exists and resources allow, to facilitate the vaccination of all individuals who provide services infrequently and are not otherwise subject to the requirements of this IFC.
Definition of “Fully Vaccinated”
CMS defines fully vaccinated as “being 2 weeks or more since completion of a primary vaccination series.”
However, “staff who have completed the primary series for the vaccine received by the Phase 2 implementation date (January 4th, 2022) are considered to have met these requirements, even if they have not yet completed the 14-day waiting period required for full vaccination.”
Booster shots, while encouraged, are not required for staff to be considered “fully vaccinated.”
Infection Prevention and Control
CMS will require that RHCs have additional precautions for staff that are not fully vaccinated:
- CMS requires through this IFC that all applicable providers and suppliers have a process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated [presumably because of one of the exemptions listed below] for COVID-19.
Particularly of note for RHCs, CMS is adding a requirement in the conditions of participation that RHCs have “a process for ensuring that they follow nationally recognized infection prevention and control guidelines intended to mitigate the transmission and spread of COVID-19.” CMS goes on to write that:
- This process must include the implementation of additional precautions for all staff who are not fully vaccinated for COVID-19. For the providers and suppliers included in this IFC that are already subject to meeting specific infection prevention and control requirements on an ongoing basis, CMS requires that they have a process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19.
The rule does not provide any detail as to what “additional precautions” for unvaccinated (due to an exemption) staff means. For instance, would COVID testing be sufficient? What frequency would that testing need to be done? This is not addressed in the IFC and is one area that may require further clarification from CMS.
Proof of Vaccination
Examples of acceptable forms of proof of vaccination include:
- CDC COVID-19 vaccination record card (or a legible photo of the card),
- Documentation of vaccination from a health care provider or electronic health record, or
- State immunization information system record.
There are some notable exemptions to the vaccine mandate including individuals with certain allergies, recognized medical conditions, or religious beliefs, observances, or practices. Vaccination may be temporarily delayed for staff with recent COVID-19 diagnosis.
For medical exemptions, RHCs should refer to the Summary Document for Interim Clinical
Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States.
For religious exemptions the IFC refers RHCs to the Equal Employment Opportunity Commission’s Compliance Manual on Religious Discrimination.
All requests for exemptions must be documented according to federal law and each RHC’s policies and procedures.
CMS will issue interpretive guidelines which will include survey procedures for state surveyors and accreditors to ensure compliance. Surveyors will be instructed to conduct interviews with staff to verify vaccination status.
RHC Regulatory Changes:
§ 491.8 Staffing and staff responsibilities.
(d) COVID-19 vaccination of staff. The RHC/FQHC must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine.
(1) Regardless of clinical responsibility or patient contact, the policies and procedures
must apply to the following clinic or center staff, who provide any care, treatment, or other services for the clinic or center and/or its patients:
(i) RHC/FQHC employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and volunteers; and
(iv) Individuals who provide care, treatment, or other services for the clinic or center and/or its patients, under contract or by other arrangement.
(2) The policies and procedures of this section do not apply to the following clinic or
(i) Staff who exclusively provide telehealth or telemedicine services outside of the clinic or center setting and who do not have any direct contact with patients and other staff specified in paragraph (d)(1) of this section; and
(ii) Staff who provide support services for the clinic or center that are performed exclusively outside of the clinic or center setting and who do not have any direct contact with patients and other staff specified in paragraph (d)(1) of this section.
(3) The policies and procedures must include, at a minimum, the following components:
(i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the clinic or center and/or its patients;
(ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations;
(iii) A process for ensuring that the clinic or center follows nationally recognized infection prevention and control guidelines intended to mitigate the transmission and spread of COVID-19, and which must include the implementation of additional precautions for all staff who are not fully vaccinated for COVID-19;
(iv) A process for tracking and securely documenting the COVID-19 vaccination status for all staff specified in paragraph (d)(1) of this section;
(v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC;
(vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law;
(vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the facility has granted, an exemption from the staff COVID-19 vaccination requirements;
(viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains
(A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and
(B) A statement by the authenticating practitioner recommending that the staff member be exempted from the clinic’s or center’s COVID-19 vaccination requirements for staff based on the recognized clinical contraindications;
(ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and
(x) Contingency plans for staff who are not fully vaccinated for COVID-19.