Which Local Health Department Employees Must Be Vaccinated under the New CMS Rule?

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Diane Juffras

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Local government employers must now comply with three separate vaccine mandates from the federal government:

  • one that requires employees of certain Medicare-certified healthcare organizations to receive a first dose by December 4, 2021 and a second dose by January 6, 2022 (the CMS Rule);
  • one that requires employees of federal contractors to be vaccinated by January 4, 2022 (the Federal Contractor Mandate); and
  • one that will require local governments to test all employees who are not vaccinated on a weekly basis beginning on January 4, 2022 and possibly later (“the new OSHA ETS”).

This blog post discusses only the first one—the CMS Rule.  The CMS Rule will apply to some local health departments and human services agencies.  But it will not apply to employees of emergency medical services, even if those services are reimbursed by Medicare and Medicaid.

Future blog posts will address the other two—the Federal Contractor Mandate and the new OSHA ETS. They have later effective dates than the CMS Rule. But if you are a local health department or a county human services agency, read on to learn more about CMS Rule.  

BACKGROUND

On September 9, 2021, President Biden announced a new COVID-19 Action Plan. As part of that plan, he directed the Centers for Medicare and Medicaid (CMS) to develop a regulation requiring vaccination of “workers in most health care settings that receive Medicare or Medicaid reimbursement.” The CMS Rule was issued on November 5.  You can see it here: Interim Final Rule Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination. Under it, employees must receive their first dose of a COVID-19 vaccine that requires a 2-dose series by December 6, 2021 and their second dose by January 4, 2022. If the employee receives a vaccine that requires a single dose, the single dose must be completed by January 4, 2022. The CMS Rule does not provide for a testing alternative to vaccination, but, as with other vaccine mandates, employees who require medical exemptions under the Americans with Disabilities Act (ADA) or religious exemptions under Title VII of the Civil Right Act of 1964 (Title VII) must be accommodated.

WHICH LOCAL GOVERNMENT HEALTHCARE PROVIDERS ARE COVERED?

The announcement of the COVID-19 Action Plan suggested that the CMS Rule would cover a broad swath of healthcare providers who are reimbursed by Medicare and/or Medicaid, but the actual rule is more limited in scope. The CMS Rule covers Medicare- and Medicaid-certified providers offering any of 15 specified services.  In North Carolina, many counties offer none of the 15 services, and are not subject to the vaccine requirement of the CMS Rule.  But other counties offer some of the 15, almost always through the local health department or human services agency.  Of the 15, here are the five that some North Carolina counties may provide:

  • home health agencies,
  • hospice,
  • infusion services,
  • clinics, rehabilitation agencies, and public health agencies providing outpatient physical therapy and speech-language pathology services, and
  • Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs).

Other health department clinical services, including traditional primary care clinics, immunization clinics, maternal health services, the Women, Infants and Children (WIC) program, sexually transmitted disease clinics, breast and cervical cancer screening, and family planning clinics, are not covered by the CMS Rule and its vaccine mandate.

A local health  department that provides any of the listed services—home health services, hospice care, infusions or outpatient physical and speech therapy—is covered. Some provide all those services. Others provide one or two. Some contract these services out, in which case the health department must ensure that the contracting agency is in compliance with the CMS Rule. Let’s consider some hypotheticals. Imagine that Paradise County, North Carolina provides home health services, physical and speech therapy and infusion services through its home health agency, Paradise County Home Care. Brooke County provides skilled nursing and home health aide services through the Ivy Brooke Home Health Agency. These two health department agencies and any of the practitioners and outside organizations with which it contracts for services would be covered. Among covered services, Phillips County only offers hospice care. It does so through a hospice department within its health department, so the hospice department is covered. Some North Carolina counties do not provide any of the covered services directly and instead certify to the Department of Health and Human Services that home health services are otherwise available within their jurisdiction. These county health and human services departments will not be covered by the CMS Rule at all.

All staff members of rural health clinics and federally qualified health centers are covered by the CMS Rule. Some local health departments qualify as Federally Qualified Health Centers and, as such, the entirety of their operations are subject to the CMS Rule. Most rural health centers, however, are private, nonprofit organizations.

What Does the CMS Rule Require?

The CMS Rule requires covered providers to ensure that all staff members are fully vaccinated against COVID-19 unless exempt. Fully vaccinated means that it has been two or more weeks since the staff member completed a primary vaccination series. A primary vaccination series is both doses of the Pfizer or Moderna vaccines or a single dose of the Johnson & Johnson vaccine. The term fully vaccinated does not at this time include third or booster shots or additional shots for immunocompromised people. There is no testing alternative to vaccination in the CMS Rule.

The CMS rule uses the term “staff” rather than the term “employees” because the vaccine mandate applies more broadly than to those who are on a provider’s payroll. Staff members who must be vaccinated include not only employees of the local health department, but also licensed practitioners who work at the department, students, trainees and volunteers, as well as all staff members of organizations with which the local health department contracts to provides care, treatment or any other service for the organization and its patients (a number of counties contract with private organizations to provide home health or rehabilitation services).

The only staff who are excluded from the vaccine mandate are those who provide telehealth services from an off-site setting and those who provide support services and work outside of the organization’s physical setting and who do not have direct contact with patients or other staff members.

Must All Staff Members of Local Health Departments Providing Covered Services Be Vaccinated?

A local health department may have organized its home health, physical and speech therapy, infusion and/or hospice services under the rubric of a single, distinct “agency” (or division) within the health department.  In that case, it appears that the vaccine mandate would be limited to employees of that agency/division. Other health department employees would not be covered. But where services covered by the CMS Rule are not carved out, it may be that the entire health department is covered. Consider a multi-county health district, which is a federally qualified health center with respect to two of the three counties which it serves. Whether all or only some staff of the health district must be vaccinated will depend on the overlap of organization and staff between the two FQHC counties on one hand and third county on the other. The organization and the services provided by each North Carolina local health department are unique so there is no bright line rule to follow.

Who is Exempt from the Vaccination Requirement?

As with other vaccination mandates, the Americans with Disabilities Act requires local health departments subject to the CMS Rule to accommodate employees for whom vaccination is medically contraindicated by exempting them from the requirement. An ADA accommodation will generally be limited to employees with a documented allergy to polyethylene glycol (PEG) or polysorbate 80. For more on medical contraindications, see here and here.  Similarly, Title VII of the Civil Rights Act of 1964 requires employers to accommodate employees whose sincerely held religious beliefs preclude vaccination. For more on religious objections to vaccination, see here. These are the only recognized exemptions from all vaccination mandates. All other employees, practitioners, students, trainees and volunteers must be vaccinated. This includes the employees, practitioners, students, trainees and volunteers of any agency with whom the local health department contracts to provide services covered by the CMS Rule.

How Soon Must Employees Be Vaccinated?

Employees receiving either the two-dose Pfizer or two-dose Moderna vaccine must have received the first dose by December 6, 2021 and the second dose by January 4, 2022. Employees receiving the single dose Johnson & Johnson vaccine must have received the shot by January 4, 2022. Staff who have received their shots by this time will be considered to have met the deadline even though they will not be “fully vaccinated” until two weeks after receiving the last dose in the series.

What Else Does the CMS Rule Require Covered Providers to Do?

Under the CMS covered providers must have, at a minimum:

  • a process that will ensure that no staff member provides care, treatment or other services to a patient without having had at least one dose of a vaccine;
  • a process for tracking and documenting the vaccination status of all staff members, including those who cannot be vaccinated and that ensures that all staff members have received a full dose of vaccine by January 4, 2022;
  • a process for tracing and documenting any booster doses that staff members have received;
  • a process by which staff members can request medical or religious accommodations under the ADA and Title VII and that tracks and documents information provided by those seeking medical or religious accommodations;
  • a process for ensuring that all documentation supporting a request for a medical accommodation under the ADA confirms recognized clinical contraindications to COVID-19 vaccination and is signed and date by licensed practitioner. The documentation must specify which vaccines the staff member should not take and the reasons why each vaccine is contraindicated. It must contain an explicit statement by the licensed practitioner stating that they recommend that the staff member be exempted from the vaccine requirement based on the contraindications recognized by the CDC;
  • a process for tracking and documenting the vaccination status of staff for whom the Centers for Disease Control recommends vaccination must be temporarily delayed because of acute illness due to COVID-19 or receipt of monoclonal antibodies or convalescent plasma for the treatment of COVID-19;
  • a process that sets out additional precautions against transmission of COVID-19 for those staff members who are not yet or cannot be vaccinated and contingency plans for those who are not fully vaccinated.

ENFORCEMENT OF THE CMS RULE

CMS will use its established state surveyors for enforcement.  If a covered health department or other provider does not comply with the rule’s requirements, it will be cited by a surveyor as being non-compliant and have an opportunity to return to compliance before additional actions occur. CMS’s stated goal is to bring healthcare providers into compliance, but it warns that it will not hesitate to use its full enforcement authority if necessary.

CONCLUSION

Local health departments and human services agencies must first determine whether they are covered by the CMS Rule at all.  If so, are they covered for all employees or just some?. The rule is very specific about the documentation required for a medical exemption under the Americans with Disabilities Act, so local health departments that will have separate divisions or agencies with staff members covered by the rule may want to consider adopting the same documentation requirement for employees not covered by the CMS rule but who are or will be subject to the Federal Contractor Mandate, the new OSHA ETS or a local vaccine mandate. Remember that while staff members do not have to complete the primary vaccination series until January 4, 2022, the CMS Rule itself is effective now. That means that developing the processes it calls for must be a first order of business for those organizations with staff members who are covered by it.

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