Employers throughout the United States have no doubt been following the developments related to the various federal vaccine mandates and state responses to the same.  Since President Biden signed the three Executive Orders on the OSHA Emergency Temporary Standard for Employers with 100 or more employees, the Federal Contractor Mandate, and the CMS Mandate for healthcare providers who accept Medicare and Medicaid funds (collectively, the “Federal Vaccine Mandates”), Nelson Mullins attorneys have been assisting and advising clients in various industries and sectors on issues related to compliance and implementation. 

Last week, the State of Florida passed legislation opposing the Federal Vaccine Mandates^[1] and filed a lawsuit specifically challenging the CMS Mandate for healthcare providers who accept Medicare and Medicaid funds.^[2]  Below, we explore issues relevant to Florida Healthcare Providers in evaluating their obligations under the federal CMS Rule and under Florida’s new legislation. 

1. What is the CMS Rule?

Centers for Medicare & Medicaid Services (CMS), a division of the Department of Health and Human Services, published its Omnibus COVID-19 Health Care Staff Vaccination requirements that most Medicare- and Medicaid-certified providers and suppliers must meet to participate the Medicare and Medicaid programs (the “CMS Rule”).  This emergency regulation is effective as of November 5, 2021 and will cover approximately 17 million workers at about 76,000 healthcare facilities across the country. 

• Covered Entities:  The CMS Rule requires staff members working at the following Medicare and Medicaid-certified provider and supplier types (“Covered Entities”) to be vaccinated against COVID-19: Ambulatory Surgery Centers; Community Mental Health Centers; Comprehensive Outpatient Rehabilitation Facilities; Critical Access Hospitals; End-Stage Renal Disease Facilities; Home Health Agencies; Home Infusion Therapy Suppliers; Hospices; Hospitals; Intermediate Care Facilities for Individuals with Intellectual Disabilities; Clinics; Rehabilitation Agencies; and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services, Psychiatric Residential Treatment Facilities (PRTFs) Programs for All-Inclusive Care for the Elderly Organizations (PACE), Rural Health Clinics/Federally Qualified Health Centers, and Long Term Care facilities.

• Entities Not Covered:  The CMS Rule does not apply to Physician Offices; Assisted Living Facilities; Religious Nonmedical Health Care Institutions (RNHCIs); Organ Procurement Organizations (OPOs); Portable X-Ray Suppliers; and Medicaid home care services, such as Home and Community-based Services (HCBS) since these providers receive Medicaid funding but are not regulated as certified facilities.  However, all Healthcare Providers must continue to comply with OSHA’s June 21, 2021 Emergency Temporary Standard for Healthcare Employers, if applicable. 

• Requirements:  Covered Entities must develop policies and procedures to ensure that (a) by December 6, 2021, all staff have received the first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine before providing any care, treatment, or other services for the facility and/or its patients (Phase 1); and (b) by January 4, 2022, all non-exempt staff are “fully vaccinated” (Phase 2).  The CMS Rule does not include a testing requirement/alternative for unvaccinated staff. 

• Exception:  The CMS Rule states that individuals who provide services 100% remotely and who do not have any direct contact with patients and other staff (such as fully remote telehealth or payroll services) are not subject to the vaccination requirements.  

• Exemptions:  The CMS Rule allows exemptions for staff with recognized medical conditions for which vaccines are contraindicated (as a reasonable accommodation under the Americans with Disabilities Act (ADA)) or sincerely held religious beliefs, observances, or practices (established under Title VII of the Civil Rights Act of 1964).

• Penalties:  CMS’s ultimate goal is to bring health care facilities into compliance with the CMS Rule.  As such, the CMS Rule employs a variety of enforcement methods and penalties.  For nursing homes, home health agencies, and hospice (beginning in 2022), enforcement includes civil monetary penalties, denial of payment, and even termination from the Medicare and Medicaid program.  The remedy for non-compliance among hospitals and certain other acute and continuing care providers is termination from the Medicare and Medicaid program.  Termination would generally occur only after providing a facility with an opportunity to make corrections and come into compliance.

2. What does Florida’s new legislation say?

On Monday, November 15, 2021, the Florida Legislature convened a Special Legislative Session focusing on vaccine mandates.  On Thursday, November 18, 2021, the legislature passed legislation prohibiting private employers in Florida from imposing COVID-19 vaccination mandates for any employee without providing certain individual exemptions that allow an employee to opt out of vaccination requirements.  This legislation went into effect immediately. 

• Rule:  Private Employer COVID-19 vaccine mandates are prohibited.

• Exemptions:  If an employer in Florida institutes a policy requiring employees to be vaccinated against COVID-19, that policy must include certain exemptions.  Employees can choose from numerous exemptions, including but not limited to, health or religious concerns; pregnancy or anticipated future pregnancy^[3]; and past recovery from COVID-19 (otherwise known as “natural immunity”).  Note:  “natural immunity” was considered and rejected in the CMS Rule.  Further, employees who voluntarily choose to engage in periodic testing or who agree to wear PPE in the workplace may be exempted from a COVID-19 vaccination requirement.  Note:  testing and PPE options were considered and rejected in the CMS Rule.  Employers must cover the costs of testing and PPE exemptions for employees.

• Penalties:  Employers who violate these employee health protections will be fined.  Small businesses (99 employees or less) will face a fine of $10,000 per violation.  Medium and big businesses (100 employees or more) will face a fine of $50,000 per violation.^[4]

3. What does the Florida lawsuit say? 

There is widespread litigation throughout the country challenging the federal vaccine mandates.  Adding to that list, on Wednesday, November 17, 2021, the State of Florida filed suit in the United States District Court for the Northern District of Florida challenging the CMS Rule^[5] and seeking a temporary restraining order, preliminary and permanent injunctive relief, and declaratory relief (Case No. 3:21-cv-02722-MCR-HTC).  The Florida lawsuit challenges the CMS Rule on the following bases: (a) CMS lacks the power and authority to issue an industry-wide vaccination mandate; (b) CMS failed to fulfill its statutory duty to consult with appropriate state agencies in developing the mandate in violation of 42 U.S.C. § 1395; (c) CMS did not engage in the notice and comment process set out in the Administrative Procedure Act (“APA”), and lacked good cause to do so; (d) CMS acted arbitrarily and capriciously in issuing the mandate; and (e) the CMS Rule violates the Spending Clause of the United States Constitution.  See Complaint at ¶¶ 9-13.  These arguments are similar to arguments lodged in pending lawsuits across the country.  The State of Florida simultaneously filed a Motion for Preliminary Injunction, which was denied by the District Court on Saturday, November 20, 2021.    

Nelson Mullins is continuing to monitor the Florida lawsuit and will provide updates regarding any court orders that are issued which affect the enforcement of the CMS Rule.   

4. What should Florida Healthcare Providers do now?

This situation is rapidly evolving, and healthcare providers in Florida face challenges because Florida’s legislation conflicts with the CMS Rule.  The CMS Rule only provides exemptions from the vaccination requirement for employees with medical conditions under the ADA or sincerely held religious beliefs under Title VII.   However, Florida’s legislation allows far broader exemptions arguably at odds with the CMS Rule, as well as an employee’s agreement to submit to periodic testing and an employee’s agreement to use PPE in the workplace, an option specifically addressed and rejected by the CMS Rule. 

Although there are many unknowns at this time, the CMS Rule provides some guidance.  In anticipation of state legal challenges or legislative prohibitions on vaccine mandates, CMS expects a Covered Facility to follow the requirements of the CMS Rule.  The CMS Rule specifically states that it pre-empts any state law to the contrary, pursuant to the Supremacy Clause of the U.S. Constitution.  See U.S. Const. art. VI § 2. 

The recent denial of Florida’s request for preliminary injunction on the CMS Rule provides some indication that Florida Providers can and should follow the CMS Rule – for now.  However, if Florida Providers were to implement the CMS Rule, that provider could be subject to state fines mentioned above.  However, there are greater risks associated with failing to comply with the CMS Rule, including termination from the Medicare and Medicaid program.  Therefore, Florida Healthcare Providers need to comply with all CMS Rules so that they can ensure no interruption of payments, penalties, or termination from the CMS programs. 

FOOTNOTES

^[1] H.B. 1-B, 2d Spec. Sess. (Fla. 2021). 

^[2] State of Florida v. Department of Health and Human Services, et al., CASE NO. 3:21cv2722-MCR-HTC (N.D. Fla.).

^[3] The CDC addressed pregnancy -related concerns surrounding the COVID-19 vaccines in Guidance:  COVID-19 Vaccines While Pregnant or Breastfeeding, available at https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregnancy.html (last visited Nov. 22, 2021).  The Florida Department of Health, however, expanded exemptions based on pregnancy and “anticipated pregnancy” in its recently published exemption forms which extend well beyond the federal guidance on both medical and religious exemptions.  See Florida Department of Health COVID-19 Vaccination Exemption Forms | Florida Department of Health (floridahealth.gov). 

^[4] Accordingly, Florida’s legislation provides broader exemptions than the CMS Rule.  In addition, although less relevant to Florida healthcare providers, the legislation states:

• Government entities may not require COVID-19 vaccinations of anyone, including employees.

• Educational institutions may not require students to be COVID-19 vaccinated.

• School districts may not have school face mask policies.

• School districts may not quarantine healthy students.

• Students and parents may sue violating school districts and recover costs and attorney’s fees.

^[5] The defendants named in the suit are the Department of Health and Human Services; Xavier Becerra, in his official capacity as Secretary of the Department of Health and Human Services; the United States of America; Chiquita Brooks-Lasure, in her official capacity as Administrator of the Centers for Medicare and Medicaid; and the Centers for Medicare and Medicaid.