On November 30, 2021 just after the Eastern District of Missouri issued a preliminary injunction against vaccine mandates in 10 states (read on for details), U.S. District Judge Terry A. Doughty wrote the opinion in the Federal Court of Louisiana blocking enforcement of the vaccine mandate for health-care workers nationwide. Here is a link to the opinion.
The U.S. District Court for the Eastern District of Missouri on Monday, November 29, 2021, issued a preliminary injunction against the Biden administration’s COVID-19 vaccine mandate, blocking the requirement for health care workers in 10 states.
Nursing homes in Missouri, Nebraska, Arkansas, Kansas, Iowa, Wyoming, Alaska, South Dakota, North Dakota and New Hampshire are governed by this injunction. It is expected the injunction will be appealed.
U.S. District Court Judge Matthew Schelp said the mandate is agency overreach when he issued the injunction; Congressional authorization and a closer look at the economic and political significance of the mandate is needed, according to Judge Schelp. He also called for a comment period before implementation. Below is reference to Judge M. Casey Rodgers’ opinion in Florida who said she would not temporarily pause the mandate while the case was being litigated.
An overview of the mandate and recommendations for best practices follows.
Overview
Centers for Medicare & Medicaid Services (CMS) issued an interim final rule (the “CMS Rule”) on November 5, 2021, requiring COVID-19 vaccinations for workers in most health care settings, including hospitals and health systems, that are certified to participate in the Medicare and Medicaid programs. The CMS Rule took effect on November 5 and provides that all covered workers must receive their first vaccine dose by December 6, 2021, and be fully vaccinated by January 4, 2022. Solving the challenges regarding workforce issues facing the long-term care industry with recruiting and retaining staff is made even more complicated by the CMS Rule. A multi-state lawsuit challenging the CMS Rule is pending, however, they have been no suspension of the CMS Rule.
The Occupational Safety and Health Administration’s (OSHA) COVID-19 Emergency Temporary Standards on Health Care Employment and Vaccinations and Testing for Large Employers (ETS) has been suspending pending litigation but this suspension does not affect compliance with the CMS Rule.
This new bulletin will first review the pending lawsuit challenges and then discuss immediate actions to be taken by long-term care providers to comply with the CMS Rule. While “Preemption and Primacy” are beyond the scope of this month’s article, please NOTE that the CMS Rule preempts any authority that is contrary to the federal requirement. The CMS Rule also takes primacy over the OSHA ETS (currently suspended).
The Complaints Challenging the CMS Rule
The multi-state litigation challenging the CMS Rule make similar claims:
The vaccine mandates exceed CMS’s statutory rule-making authority;
The vaccine mandate violates Due Process;
The vaccine mandate is arbitrary and capricious.
The complaints seek injunctive and declaratory relief setting aside the CMS Rule. We’ll keep you updated on developments through this publication and other communications.
In Florida, Judge M. Casey Rodgers said she would not temporarily pause the mandate while the case was being litigated.
Florida officials asked a U.S. District Court for the Northern District of Florida judge to prevent CMS from enforcing the mandate, following the state’s lawsuit filed against the agency mandate on November 17. Rodgers said the state would not be irreparably injured if the mandate wasn’t suspended before December 6.
The CMS Rule and Immediate Action Plans
Long-term care facilities are “Covered Entities” under the CMS Rule as certified Medicare and Medicaid providers. Your communities are already subject to the Medicare Conditions of Participation (CoPs).
Who has to be vaccinated? The CMS Rule breaks down the staff of health care facilities into the following four categories:
Employees
Licensed practitioners
Students, trainees, and volunteers
Individuals who provide care, treatment, or other services for the health care facility and/or its patients, under contract or by another arrangement.
Anyone who falls within the above four categories has to be vaccinated unless the individual is eligible for an exemption. Specifically, individuals who perform their duties at any site of care or who have the potential to have contact with anyone at the site of care, including staff or patients, must be fully vaccinated. Even those contracted staff (e.g., administrative staff, facility leadership, housekeeping and food services) who are present at the site of care less frequently than once per week have to be vaccinated.
Individuals who provide services remotely and who do not have any direct contact with patients and other staff, such as fully remote telehealth or payroll services, do not have to be vaccinated (exempted).
Also excluded from the scope of eligible staff are those who infrequently provide ad hoc non-healthcare services (such as annual elevator inspection), or services that are performed exclusively off-site, not at or adjacent to any site of patient care (such as accounting services). Facilities may choose to extend vaccination requirements to them if feasible.
Vaccine Requirement – Action Plans
The CMS Rule requires covered facilities to implement policies and procedures to ensure that staff who are not granted an exemption are fully vaccinated in two phases:
Phase 1: By December 6, 2021, covered staff must have received their first dose of a two-shot series or a single dose of a one-shot vaccine. Covered staff must complete this step before they can provide any care, treatment, or other services for the facility and/or its patients on or after December 6.
Phase 2: By January 4, 2022, covered staff must have received the second shot of a two-shot series.
Although CMS defines “fully vaccinated” to mean two weeks or more after an individual completes a primary vaccination series for COVID-19, staff who complete their primary vaccination series by the Phase 2 date will be considered fully vaccinated even if they have yet to complete the two-week waiting period. In addition to the three vaccines currently approved in the U.S. (Pfizer, Moderna, and Johnson & Johnson), staff who received other COVID-19 vaccines listed by the World Health Organization for emergency use will also be deemed fully vaccinated. The vaccination requirement applies only to the primary series and does not include booster shots, but covered facilities must have a process to track and document boosters recommended by the CDC in addition to tracking and documenting primary doses.
Your organization must develop policies to comply with CMS’s vaccine mandate, with only limited time available to comply with the December 6 Phase 1 deadline for covered staff. As part of this process, facilities must take measures to determine and record current vaccination levels among staff and notify unvaccinated staff of the December 6 deadline.
Finally, health care entities that have 100 or more employees and do not participate in the Medicare and Medicaid programs or qualify as facilities under the CMS Rule are still covered by the OSHA ETS and should be mindful of its requirements even though the ETS is suspended.
Contingency Planning
Providers must make contingency plans in consideration of staff that is not fully vaccinated to ensure that they will soon be vaccinated and will not provide care, treatment, or other services for the provider or its patients until such time as such staff have completed the primary vaccination series for COVID-19 and are considered fully vaccinated, or, at a minimum, have received a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID19 vaccine. This planning should also address the safe provision of services by individuals who have requested an exemption from vaccination while their request is being considered and by those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations.
Contingency planning may extend beyond the specific requirements of the CMS Rule to address topics such as staffing agencies that can supply vaccinated staff if some of the facility’s staff are unable to work. Contingency plans might also address special precautions to be taken when, for example, there is a regional or local emergency declaration, such as for a hurricane or flooding, which necessitates the temporary utilization of unvaccinated staff, in order to assure the safety of patients.
CMS FAQ
CMS also provided answers to certain frequently asked questions (CMS Q&A), which can be found here.
Enforcement
The CMS Q&A indicates that state survey agencies will assess facilities for compliance with the CMS Rule during annual recertification surveys and complaint surveys. If a facility is deemed to be noncompliant with the CMS Rule, CMS has a number of enforcement tools at its disposal. For long-term care facilities, CMS can enforce civil monetary penalties, deny payments, and, as a last resort, terminate providers from the Medicare and Medicaid program. CMS has expressed its intent to work with noncompliant health care facilities to bring them into compliance.
CMS Vaccine Mandate Guidance
At a stakeholder meeting on Tuesday, November 23, 2021, CMS stated that it is working on developing vaccine mandate guidance for surveyors. While the guidance is forthcoming, CMS is placing responsibility on state agencies to conduct safe surveys.
This meeting also clarified issues presented in the November 12, 2021 CMS Memo “Changes to COVID-19 Survey Activities and Increased Oversight in Nursing Homes” and the November 12, 2021 Memo lifting all restrictions for visitation in nursing homes.
CMS clarified during the call that nursing homes cannot require visitors to be vaccinated or take a test in order to visit loved ones at a facility. Per CMS, “A facility can ask a visitor if they are vaccinated — the visitor does not have to answer. If they don’t answer or if they replied ‘no,’ then the facility and the visitor should follow CDC guidance for unvaccinated individuals,” a CMS spokesperson said. “You can also offer to test a visitor but you cannot make it a condition of visitation. You can encourage visitors to get tested prior to coming but again it cannot be a condition for visitation.”
By contrast, CMS reiterated its vendor vaccine requirements. The general rule being, if an individual provides care, treatment or other services for the nursing home under contract or by another arrangement, that individual needs to be vaccinated.
Surveyors do not need to be vaccinated and concerns were also voiced about CMS directing these same surveyors to soon penalize providers with less than perfect staff vaccination rates but not requiring vaccination.
Policy Assistance and Support
If you need help designing a vaccine policy or would like more information, an in-service or other support related to the CMS Rule, please contact me at rebeccca@adelmanfirm.com
We can assist in addressing the CMS requirements that policies include the following processes:
Ensuring that staff are fully vaccinated against COVID-19
Ensuring that staff have received at least one dose of COVID-19 vaccine prior to providing care
Requesting exemptions from COVID-19 vaccination because of certain medical conditions or sincerely held religious beliefs, practices, or observances
Tracking and securely documenting exemption requests and outcomes
Tracking and securely documenting the vaccination status of all staff
Tracking and securely documenting staff booster shots
Tracking and securely documenting the status of any temporary delays to vaccination and the plan to complete vaccination
Ensuring medical exemption requests meet documentation requirements
Additional precautions for those who are not fully vaccinated
Contingency plans for staff who are not fully vaccinated, including updating applicable emergency plans.
Multiple processes may be covered in a single policy. We can assist with cross-checking existing policies to ensure consistency with new requirements. Updates to existing policies include updating policies around educating staff on COVID-19 vaccination include the requirement for vaccination while potentially cross-referencing to the policy on requesting exemptions to COVID-19 vaccination.
The legal challenges to these mandates will continue in the state and federal courts yet you will need to address the mandates with urgency.
