Florida Legislation and the CMS COVID-19 Requirements

Employers in the United States have undoubtedly been following developments regarding the various federal vaccine mandates and the state’s response to them. Since President Biden signed the three executive orders on the OSHA emergency standard for employers with 100 or more employees, the federal contractor mandate, and the CMS mandate for health care providers accepting Medicare and Medicaid funds (collectively, the “Federal Vaccine Mandates”), Nelson Mullins attorneys assisted and advised clients in a variety of industries and sectors on compliance and implementation issues.

Last week, the state of Florida passed legislation that goes against federal vaccine mandates[1] and filed a lawsuit specifically challenging the CMS mandate for health care providers accepting Medicare and Medicaid funds.[2] Below, we explore issues relevant to Florida healthcare providers as they evaluate their obligations under the federal CMS rule and under new Florida law.

  1. What is the CMS rule?

Centers for Medicare & Medicaid Services (CMS), a division of the Department of Health and Human Services, has released the Omnibus COVID-19 Health Care Staff Vaccination Requirements that most Medicare and Medicaid-certified providers and suppliers must meet in order to participate. participate in the Medicare and Medicaid programs (the “CMS Rule”). This emergency ordinance is effective from November 5, 2021 and will affect approximately 17 million employees in approximately 76,000 healthcare facilities across the country.

  • Covered Entities: The CMS rule requires employees who work at the following Medicare and Medicaid certified providers and suppliers (“Covered Entities”) to be vaccinated against COVID-19: Ambulatory Surgery Centers; Community Mental Health Centers; Extensive outpatient rehabilitation facilities; Critical Access Hospitals; Facilities for end-stage renal disease; home care institutions; home infusion therapy providers; hospice; hospitals; Intermediate care facilities for persons with intellectual disabilities; clinics; Rehabilitation Agencies; and public health agencies such as providers of outpatient physical therapy and speech 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.

  • Not Covered Entities: The CMS rule does not apply to medical practices; Assisted living facilities; Religious Non-Medical Care Institutions (RNHCIs); Organ Purchasing Organizations (OPOs); portable x-ray providers; and Medicaid home care services, such as Home and Community-based Services (HCBS), as 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 Temporary Emergency Standard for Healthcare Employers, if applicable.

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

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

  • Exemptions: The CMS rule allows exemptions for personnel with recognized medical conditions for which vaccines are contraindicated (as a reasonable adjustment under the Americans with Disabilities Act (ADA)) or genuine religious beliefs, customs, or practices (established under Title VII of the Civil Rights Act of 1964).

  • Sanctions: The ultimate goal of CMS is to bring healthcare institutions in line with the CMS rule. As such, the CMS rule uses different enforcement methods and sanctions. For nursing homes, home care facilities, and hospices (as of 2022), enforcement will include civil fines, denial of payment, and even termination of the Medicare and Medicaid programs. The remedy for non-compliance by hospitals and certain other acute and ongoing health care providers is termination of the Medicare and Medicaid programs. Termination generally does not occur until a facility has been given an opportunity to make corrections and comply with regulations.

  1. What Does Florida’s New Law Say?

On Monday, November 15, 2021, the Florida legislature convened a special legislative session focused on vaccine mandates. On Thursday, November 18, 2021, the legislature passed legislation prohibiting private employers in Florida from imposing COVID-19 vaccination mandates on an employee without providing certain individual waivers that allow an employee to opt out of vaccination requirements. This legislation came into effect immediately.

  • Rule: Private employers are banned from COVID-19 vaccine mandates.

  • Exemptions: If a Florida employer establishes a policy that requires employees to be vaccinated against COVID-19, that policy must include certain exemptions. Employees can choose from a variety of exemptions, including but not limited to health or religious considerations; pregnancy or expected 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. In addition, employees who voluntarily opt for periodic testing or agree to wear PPE in the workplace may be exempt 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 inspections and PPE exemptions for employees.

  • Sanctions: Employers who violate these workers’ health protections will be fined. Small businesses (99 employees or less) will be fined $10,000 per violation. Mid-sized and large companies (100 employees or more) face a $50,000 fine per violation.[4]

  1. What does the lawsuit in Florida say?

There are widespread lawsuits across the country challenging federal vaccine mandates. To add 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 to challenge the CMS rule.[5] and seeking a temporary restraining order, interim and permanent injunctions, and declaratory relief (Case No. 3:21-cv-02722-MCR-HTC). The Florida lawsuit challenges the CMS rule on the following grounds: (a) CMS does not have the power and authority to issue an industry-wide vaccination mandate; (b) CMS has failed to comply with its legal obligation to consult appropriate governmental authorities in developing the mandate in violation of 42 USC § 1395; (c) CMS did not participate in the notification and comment process set out in the Administrative Procedure Act (“APA”), and had no good reason to do so; (d) CMS acted arbitrarily and erratically in issuing the authorization; and (e) the CMS rule violates the spending clause of the US Constitution. See Complaint at ¶¶ 9-13. These arguments are similar to arguments filed in pending lawsuits across the country. At the same time, the State of Florida filed a Motion for Preliminary Injunction, which was rejected by the District Court on Saturday, November 20, 2021.

Nelson Mullins will continue to monitor the Florida lawsuit and will provide updates on any injunctions issued that affect the enforcement of the CMS rule.

  1. What Should Florida Healthcare Providers Do Now?

This situation is rapidly evolving and Florida health care providers are facing challenges as Florida law violates the CMS rule. The CMS rule only provides exemptions from the vaccination requirement for employees with medical conditions under the ADA or genuine religious beliefs under Title VII. However, Florida law allows for much broader exemptions that are arguably inconsistent with the CMS rule, as does an employee’s agreement to undergo periodic testing and an employee’s agreement to use personal protective equipment in the workplace, a option that is specifically addressed and rejected by the CMS rule.

While there are many unknowns at this point, the CMS rule offers some guidance. Pending legal challenges from the state or legal bans 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 laws to the contrary, consistent with the U.S. Constitution’s supremacy clause. See US Const. art. VI 2.

The recent rejection of Florida’s request for a provisional provision 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 the above state fines. However, there are greater risks associated with non-compliance with the CMS rule, including termination of the Medicare and Medicaid programs. Therefore, Florida healthcare providers must comply with all CMS regulations so that they cannot guarantee interruption of payments, fines, or termination of the CMS programs.

FOOTNOTES

[1] HB 1-B, 2d Spec. session. (Fl. 2021).

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

[3] The CDC addressed pregnancy-related concerns around 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 on November 22, 2021). However, the Florida Department of Health has expanded the exemptions based on pregnancy and “expected pregnancy” in its recently published exemption forms that go well beyond federal guidelines for both medical and religious exemptions. See Florida Department of Health COVID-19 Vaccination Waiver Forms | Florida Department of Health (floridahealth.gov).

[4] Accordingly, Florida law provides broader exemptions than the CMS rule. In addition, while less relevant to Florida health care providers, the legislation states:

  • Government agencies should not require COVID-19 vaccinations from anyone, including employees.

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

  • School districts may not have face mask policies.

  • School districts are not allowed to quarantine healthy students.

  • Students and parents can sue school districts for the violation and recover costs and attorneys’ fees.

[5] The defendants named in the lawsuit 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.

Copyright © 2021 Nelson Mullins Riley & Scarborough LLPNational Law Review, Volume XI, Number 328

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