Vaccination Mandates Emerge Amid a Weary Population

Omnibus COVID-19 healthcare staff vaccination mandates—what does it mean for you?

Physician practices and facilities have been doing everything they can to get staff and providers vaccinated for COVID-19, in fear of losing their provider status with Medicare and their funds being interrupted. But which entities really must abide by these requirements, under the Centers for Medicare & Medicaid Services (CMS) Conditions of Participation (CoP)? Hospitals? Physician offices? Skilled nursing facilities (SNFs)? Home health agencies? Assisted living facilities?

First, let me make a clarification on the vaccine “mandates,” about which many remain unaware. There are two mandates in particular that are currently polarizing the nation.

The recent Omnibus white paper that came out was issued by CMS (Medicare) only, from the IFR (interim final rule), and it applies to federal entities defined as a “CMS regulated health entity,” not tied to size. Such entities do not have employee numbers.

The staff vaccination requirements of the Omnibus Act apply to Medicare- and Medicaid-certified provider and supplier types regulated under the Medicare health and safety standards known as the CoP, Conditions for Coverage (CfC), or other requirements. Facilities are required to have a process or policy in place ensuring that all applicable staff are vaccinated against COVID-19.

The federal ETS, the emergency temporary standards, are for business with over 100 employees; this is being administrated by the Occupational Safety and Health Administration (OSHA). This “vaccine mandate” was issued by the Biden Administration, and again, it is tied to employers with over 100 employees. But if you actually read the text, it is hard to call it a “mandate,” since while the headlines may say vaccines are the only option to keep employment, the plain text reflects mandated vaccines OR weekly testing and mask-wearing for the unvaccinated. There is a current temporary stay to the OSHA mandate, issued on Nov. 6 by the 5^th Circuit Court of Appeals, to determine if these regulations are constitutionally legal.

Now, circling back to the healthcare industry and the Omnibus COVID-19 regulations, during the CMS stakeholder call of Nov. 10, over 10,000 of us were asking questions and listening to feedback about the rules. During that time, the following issues were also discussed, and stated in several key takeaways by Dr. Lee Fleisher, MD, CMO, and director of the CMS Center for Clinical Standards and Quality.

CMS also addressed many of the repeated questions on how this mandate will be managed or policed by the surveyors tasked with enforcing CMS health and safety regulations.

Some of those key takeaways included the following:

1. 1. CMS will issue additional guidance for federal, state, and CMS-contracted surveyors. The guidance will be comparable to regulation expectations for staff in healthcare facilities that participate in the Medicare and Medicaid programs.
   2. Staff who have COVID-19 antibodies are not exempt from CMS requirements. In explaining the reasoning behind the decision, the agency cited available evidence from the CDC (Centers for Disease Control and Prevention) and others, indicating that the vaccines offer better protection than natural immunity.
   3. The Equal Employment Opportunity Commission’s (EEOC’s) websitehas additional information about situations that may warrant accommodations for an unvaccinated staff member with an exemption. Physical distancing and testing are among examples of possible accommodations. Unvaccinated workers could also be assigned to non-patient care areas with low risk, when possible.
   4. Healthcare facilities covered under the CMS rule must have a process or plan in place that permits workers to request a medical or religious exemption. For medical exemptions, facilities must ensure that documentation is signed and dated by a licensed practitioner. For religious exemptions, facilities must ensure that the exemption requests are documented and evaluated based on applicable federal law.
   5. CMS does not have different requirements for current and new eligible staff members. Workers at all healthcare facilities included in the regulation must be fully vaccinated by Jan. 4, 2022. There is also no minimum number of employees. This is for all CMS regulated facility employees.
   6. The CMS vaccination rule applies to pharmacies that go on-site to covered facilities. The requirement includes those who provide care, treatment, or other services for the facility and/or its patients via contract or through other arrangements.
   7. Staff who work in assisted living facilities are required to be vaccinated if they also work in a nursing home. Assisted living facilities are not regulated by Medicare CoP and are not included in the CMS rule. However, the CMS rule requires staff who provide care, treatment, or other services for a nursing home and/or its residents to be vaccinated.
   8. Emergency services workers are not directly subject to the CMS rule. The rule could apply to some EMS providers, though, because of their professional relationship with a CMS-regulated healthcare entity. For instance, if a hospital has a contract with EMS providers, the vaccination rule would include those staff.
   9. While the CMS requirement includes ambulatory surgery centers (ASCs), it does not include physician offices. However, if a physician provides care on-site at an ASC, the physician will have to be vaccinated.

Regulated healthcare facilities that do not fully vaccinate all eligible staff members by Jan. 4, 2022, may face fines or termination of their Medicare or Medicaid contract, CMS said during a Nov. 4 briefing on the new regulations, and again on the Nov. 10 call. By Dec. 6, facilities must have plans in place on their compliance protocols.

While “termination is the ultimate last resort,” CMS will use “full enforcement authority to protect patients,” Fleisher said during the briefing. 

Along with enforcement protocols, CMS also shared more details on the Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule, including to what types of healthcare workers the standards apply, and how it interacts with other federal vaccination rules.  

Which healthcare facilities does the rule apply to? It applies to about 76,000 healthcare providers and suppliers regulated by CMS’s CoP . CMS estimates that the regulations will cover 17 million healthcare workers. 

Requirements apply to facilities regulated under the Medicare CoP, including the following:

• Ambulatory Surgery Centers;
• Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services;
• Community Mental Health Centers;
• Comprehensive Outpatient Rehabilitation Facilities;
• Critical Access Hospitals (CAHs);
• End-Stage Renal Disease Facilities;
• Home Health Agencies (HHAs);
• Home Infusion Therapy Suppliers;
• Hospices;
• Hospitals;
• Intermediate Care Facilities for Individuals with Intellectual
• Disabilities;
• Long-Term Care Facilities;
• Programs for All-Inclusive Care for the Elderly Organizations (PACE);
• Psychiatric Residential Treatment Facilities; and
• Rural Health Clinics/Federally Qualified Health Centers (FQHCs).

The regulations do not apply to the following:

• Physician offices;
• Religious nonmedical healthcare institutions;
• Organ procurement organizations;
• Portable X-ray suppliers; 
• Assisted living facilities;
• Group homes; and
• Home and community-based services.

The vaccination requirements apply to all current and new eligible staff members, including facility employees, licensed practitioners, students, trainees, volunteers, and contracted staff.

Staff members who provide duties off-site, such as home health or home infusion therapy staff, and individuals who enter a CMS-regulated facility, such as a physician with privileges at a hospital, must also be vaccinated.

The regulation does not apply to full-time telehealth workers or remote payroll services employees. But if the employee interacts at all with staff or patients in-person at a CMS regulated facility, they need to be vaccinated.

How does CMS define fully vaccinated?

CMS considers staff members fully vaccinated if it has been at least two weeks since they’ve received two doses of Pfizer’s or Moderna’s vaccine, or one dose of Johnson & Johnson’s vaccine. 

Staff members who have completed their vaccination series by the Jan. 4 deadline will be considered fully vaccinated, even if they have not yet completed the 14-day waiting period. 

The regulation does not apply to booster doses. 

How do exemptions work?

CMS requires healthcare facilities to offer religious and medical exemptions for staff, in accordance with federal law. 

Exempt staff should be provided with appropriate accommodations, such as an option for COVID-19 testing, physical distancing, or placement in nonpatient care areas. Facilities have the authority to determine the best type of accommodation to ensure that they minimize the risk of transmission to at-risk individuals. 

The regulation does not include exemptions for staff who have COVID-19 antibodies from a previous COVID-19 infection.

How will CMS ensure compliance?

CMS will work with state survey agencies to conduct on-site compliance reviews for the requirements via recertification surveys or compliance surveys.

Accrediting organizations such as the Joint Commission will also assess facilities’ compliance.

Facilities found out of compliance with the regulation will be cited and have an opportunity to comply. If hospitals still fail to comply, ​​CMS may use enforcement remedies, including civil monetary penalties, denial of payment, and/or termination from the Medicare and Medicaid programs, as a final measure. 

“​​CMS’s goal is to bring healthcare facilities into compliance,” the agency said. “Termination would generally occur only after providing a facility with an opportunity to make corrections and come into compliance.” 

As of this writing, a coalition of 10 states sued the federal government on Nov. 10 in an attempt to halt the federal mandate that healthcare workers at facilities participating in Medicare and Medicaid programs get COVID-19 vaccinations.

The 10 states, led by Missouri, are challenging the authority of CMS to implement the mandate. They also argue that rolling out the requirements could worsen healthcare staffing shortages across the country, especially in rural areas.

Stay tuned for our update on this topic. We will continue to encourage CMS regulated facilities to act, as this mandate goes into effect.

Programming Note: Listen to more about the COVID-19 vaccine mandates during today’s live edition of Talk Ten Tuesdays, 10 Eastern.