The Centers for Medicare & Medicaid Services has issued an interim final rule requiring that all staff working in Medicare- or Medicaid-certified facilities be vaccinated against COVID-19. The rule took effect on Friday and amends specific sections in the Code of Federal Regulations pertaining to the facilities identified below.
Which facilities are subject to the CMS Rule?
The Rule applies to the following facilities if they are certified by Medicare or Medicaid:
- Ambulatory Surgical Centers
- Psychiatric residential treatment facilities
- Program of All-Inclusive Care for the Elderly
- Hospitals (acute care hospitals, psychiatric hospitals, long term care hospitals, children’s hospitals, swing bed facilities, transplant centers, cancer hospitals, and rehabilitation hospitals)
- Long Term Care Facilities, including nursing facilities and skilled nursing facilities
- Intermediate Care Facilities for Individuals with Intellectual Disabilities
- Home Health Agencies
- Comprehensive Outpatient Rehabilitation Facilities
- Critical Access Hospitals
- Clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services
- Community Mental Health Centers
- Home Infusion Therapy suppliers
- Rural Health Clinics and Federally Qualified Health Centers
- End-Stage Renal Disease Facilities
- Organ Procurement Organizations (only if staff provide organ transplant services directly to hospital and transplant center patients)
Who is included in the term “staff?”
The Rule broadly defines “staff” to include employees, licensed practitioners, students, trainees, volunteers, and individuals who provide care, treatment, or other services for the facility or its patients under contract or by other arrangement “regardless of clinical responsibility and patient contact.” In context, this means the vaccination mandate applies to the following:
- Staff who physically enter a facility
- Staff routinely providing patient care or performing duties within a facility or site of care
- Staff who routinely provide care for patient and clients at outside facilities (e.g., home health, home infusion therapy, hospice care, or therapy)
- Staff who encounter other staff in an administrative office or at an off-site staff meeting who themselves enter a facility or site of care for their job responsibilities
- Staff who interact with other staff, patients, residents, clients, or PACE program participants in any location beyond those that physically enter facilities or other sites of patient care
- Any new staff
- Staff primarily working in a remote setting, but who occasionally encounter fellow staff who themselves enter a facility or site of patient care
- Staff who enter a facility or site of care for their job responsibilities
- Administrative staff
- Facility leadership
- Fiduciary board members
- Food services staff
- Sanitation staff
For purposes of the COVID-19 vaccine mandate, “Individuals under contract or arrangement” are also considered “staff” (e.g., hospice and dialysis staff, physical therapists, occupational therapists, mental health professionals, social workers, and portable x-ray suppliers). But the Rule does not require mandatory vaccination for staff who work 100 percent remotely (e.g., staff who perform telehealth or remote payroll services off site or from home), “one off” vendors, volunteers, or professionals who provide ad hoc non-health-care services (e.g., annual elevator inspections), or individuals performing services exclusively off-site.
Notably, facilities may still be required to impose vaccination requirements on individuals who do not fall into any of the categories set forth by the Rule. For example, a plumber who makes an emergency repair in an empty restroom or service area and correctly wears the appropriate personal protective equipment for the entirety of the visit would not be an appropriate candidate for mandatory vaccination. On the other hand, an individual who is part of a construction crew whose members use shared common space (e.g., restrooms, cafeteria, or break rooms) with staff, patients or visitors within the facilities would be subject to the vaccination requirement.
To assess whether it needs to require a particular individual to be vaccinated, the facility needs to consider the individual’s (1) frequency of presence, (2) services provided, and (3) proximity to patients and staff.
What are the facilities required to do?
Generally, the Rule requires the facilities identified above to do the following in a two-stage rollout:
- Phase One, ending on December 5:
- Ensure all staff receive at minimum a single-dose COVID-19 vaccine or the first dose of a multi-dose COVID-19 vaccine before providing any patient care, treatment or other services.
- Implement policies and procedures 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.
- Requesting a medical or religious exemption from the vaccination mandate.
- Ensuring all documentation submitted in support of staff’s request for medical exemption contains the requisite information and details for consideration (described below).
- Ensuring the tracking and secure documentation of the vaccination status of staff who have received approval to temporarily delay vaccination due to clinical precautions and considerations (for example, because of an acute illness).
- A contingency plan for emergency situations.
- Phase Two ending on January 4, 2022:
- Ensure all staff (unless exempted) are fully vaccinated.
- The Rule recommends but does not require boosters.
When are staff considered “fully vaccinated”?
Generally, full vaccination means 14 days after the only dose of a single-dose COVID-19 vaccine (Johnson & Johnson) or the second dose of the two-dose COVID-19 vaccine (Pfizer or Moderna). However, for purposes of the deadline to complete Phase Two, staff are considered “vaccinated” once they receive the only dose of a single-dose COVID-19 vaccine or the second dose of the two-dose COVID-19 vaccine.
What records should covered facilities collect and maintain?
If they have not already done so, facilities must develop and implement policies or procedures to track and securely document the
- COVID-19 vaccination status of all staff (including any booster doses).
- Information provided by staff who have requested and who have been granted an exemption from the vaccine mandate.
The Centers for Disease Control and Prevention has created a staff vaccination tracking tool. Staff must present proof of vaccination in the form of a CDC COVID-19 vaccination record card (or a legible photo of the card), documentation from a health care provider or electronic health record, or a state immunization information system record. Facilities must keep vaccine documentation confidential and should not store the information in an employee’s personnel file. Instead, proof of vaccination should be stored with immunization records, health information files, medical records files, or in another relevant location.
Are there exemptions?
Yes. Staff may apply for an exemption from the vaccination mandate based on a “sincerely held religious belief, practice, or observance,” certain allergies, or a recognized medical condition. In the case of requests for religious exemption, facilities may ask staff about their objections to the COVID-19 vaccination requirement; how compliance with the mandate would substantially burden religious exercise or conflict with sincerely held religious beliefs, practices, or observances; and about any additional information that would help the facility assess the request (for example, how long the staff member has held the claimed religious belief). The Rule offers an example of a Religious Exemption Form for facilities to use.
For medical exemptions, staff must provide documentation signed and dated by a licensed practitioner acting within their respective scope of practice, which includes the following information:
- Which authorized COVID-19 vaccine is clinically contraindicated;
- The recognized reasons for the contraindications; and
- The authenticating licensed practitioner’s statement recommending exemption based on the recognized clinical contradictions.
Staff may also seek a delay in receiving the vaccination through the facility’s general accommodation process. The Rule does not provide any explicit examples of the types of circumstances that warrant an accommodation. However, upcoming surgery, a recent positive COVID-19 test, or pregnancy may justify a vaccination delay. When granting an indefinite or temporary accommodation, facilities must ensure minimal risk of transmission of COVID-19 to at-risk individuals in keeping with the obligation to protect the health and safety of patients.
What’s the compliance deadline?
The Rule is being implemented in two phases, described above. Phase One requires the development and implementation of nearly all the provisions of the Rule with the exception of full vaccination. Unless exempted or accommodated, all staff must have received a single-dose vaccine or the initial dose of a two-dose vaccine before they may treat, care for, or provide services to any patient. The deadline for compliance with Phase One is December 5, 2021. Phase Two requires that all staff be fully vaccinated. The deadline for compliance with Phase Two is January 4, 2022.
How will the Rule be enforced?
The CMS plans to issue interpretive guidelines as to how the Rule will be enforced. In the meantime, CMS has provided the following examples:
- Reviewing entity records of staff vaccinations.
- Conducting interviews of staff to verify vaccination status.
- Review of policies and procedures.
If a facility is found to be noncompliant, the CMS may impose civil monetary penalties, deny payment for new admissions, or even terminate the facilities’ Medicare/Medicaid provider agreement depending on the severity of noncompliance.
Can the CMS really impose a vaccine mandate?
Yes. The CMS has made the implementation of a mandatory COVID-19 vaccination policy a condition of participation for the facilities identified above in order to participate in the Medicare and Medicaid programs.
What if state or local law contradict the Rule?
The Rule is considered a nationwide regulation that preempts any inconsistent state or local laws in relation to Medicare or Medicaid certified facilities, including attempts to broaden the types of exemptions available to the vaccine mandate.
What should covered facilities do between now and the effective dates?
The Rule appears on its face to provide a great deal of information for facilities to digest in a short time. But fortunately, much has probably been implemented already, given prior federal, state, and local requirements and guidelines surrounding the COVID-19 vaccine and other vaccines. Nevertheless, we recommend that facilities do the following:
- Calendar the Phase One and Phase Two deadlines, as well as the deadline to comment on the Rule if desired. (The formal comment period ends on January 4, 2022.)
- Determine whether you need to develop new or update existing policies and procedures to comply with the Rule. In doing so, remember that the Rule trumps any conflicting state and local laws. It is also wise to review rules from complementary federal authorities (for example, the Equal Employment Opportunity Commission and the Occupational Safety and Health Administration) to ensure that you do not fun afoul of other federal requirements.
- Consider offering COVID-19 vaccinations to staff on-site for convenience.
- Create a process for identifying other individuals who may need to receive the vaccination based on the (1) frequency of their presence, (2) services provided, and (3) proximity to patients and staff.
- Ensure that your exemption and reasonable accommodation policies and procedures are implemented in a fair and consistent manner, given the increase in lawsuits against health care facilities based on denials. And, when granting an exemption or accommodation, you will still need to ensure minimal risk of transmission of COVID-19 to at-risk individuals in keeping with your obligation to protect the health and safety of patients. For example, you could implement a weekly testing requirement for those who are unvaccinated (a requirement in the simultaneously released OSHA Emergency Temporary Standard that applies to most employers with 100 or more employees).
This is only a general overview of the Rule, and there may be more nuanced requirements for certain types of facilities.