There is no doubt that employers across the United States have been paying attention to developments related to various federal vaccine regulations and state responses to them. Since President Biden signed three administrative orders regarding OSHA emergency interim standards, federal contractor authorization, and CMS authorization for employers with 100 or more employees, applicable to healthcare providers receiving medical insurance and Medicaid funds (Collectively referred to as the "Federal Vaccine Authorization"), Nelson Mullins lawyers have been providing assistance and advice to clients in various industries and sectors on issues related to compliance and implementation.
Last week, the state of Florida passed legislation against federal vaccine authorization[1] and filed a lawsuit specifically to challenge the CMS authorization of health care providers receiving Medicare and Medicaid funds. [2] Below, we will discuss issues related to Florida healthcare providers to assess their obligations under the federal CMS rules and the new Florida legislation.
The Center for Medicare and Medicaid Services (CMS), a department of the Ministry of Health and Human Services, has issued its comprehensive COVID-19 vaccination requirements for health care workers, and most providers and vendors certified by Medicare and Medicaid must meet These requirements are required to participate in the Medicare and Medicaid program ("CMS Rules"). This emergency regulation will take effect on November 5, 2021, and will cover approximately 17 million employees in approximately 76,000 medical institutions across the country.
Covered entities: CMS rules require workers who work at the following Medicare and Medicaid-certified providers and vendor types ("covered entities") to be vaccinated against COVID-19: outpatient surgery centers; community mental health centers; comprehensive outpatient rehabilitation facilities; emergency departments Hospitals; end-stage renal disease facilities; home health institutions; home infusion therapy providers; shelters; hospitals; intermediate care facilities for people with intellectual disabilities; clinics; rehabilitation institutions; and public health institutions as providers of outpatient physical therapy and speech pathology services, The Psychiatric Residential Treatment Facility (PRTF) program, rural health clinics/federal qualified health centers, and long-term care facilities for the comprehensive care (PACE) organization for senior citizens.
Entities not covered: CMS rules do not apply to physician offices; assisted living facilities; religious non-medical care institutions (RNHCI); organ procurement organizations (OPO); portable X-ray providers; and Medicaid home care services, such as homes and communities Services (HCBS), because these providers receive Medicaid funds but are not regulated as a certification body. However, all healthcare providers must continue to comply with OSHA's June 21, 2021, Emergency Interim Standards for Healthcare Employers (if applicable).
Requirements: Covered entities must have policies and procedures in place to ensure that (a) by December 6, 2021, all employees have been vaccinated with two doses of COVID-19 vaccine or a single dose of COVID-19 vaccine for the facility and/ Treatment or other services provided by or its patients (Phase 1); (b) By January 4, 2022, all non-exempt employees will be "fully vaccinated" (Phase 2). The CMS rules do not include testing requirements/alternatives for unvaccinated employees.
Exception: CMS rules stipulate that 100% of individuals who provide services remotely and do not have any direct contact with patients and other staff (such as complete telemedicine or payroll services) are not subject to vaccination requirements.
Exemptions: CMS rules allow employees with recognized medical conditions to be exempted from vaccinations (as a reasonable accommodation under the Americans with Disabilities Act (ADA)) or for holding religious beliefs, rituals, or practices in good faith (in accordance with Articles of the Americans with Disabilities Act). VII established). The Civil Rights Act of 1964).
Penalties: The ultimate goal of CMS is to make healthcare facilities comply with CMS rules. Therefore, the CMS rules adopt a variety of enforcement methods and penalties. For nursing homes, family health care institutions, and hospice care institutions (starting in 2022), enforcement includes civil fines, denial of payments, and even termination of medical insurance and Medicaid programs. The remedy for non-compliance between hospitals and certain other emergency and continuing care providers is to terminate Medicare and Medicaid. Termination usually only occurs after the facility is provided with an opportunity for correction and compliance.
On Monday, November 15, 2021, the Florida Legislature convened a special legislative session to focus on vaccine authorization issues. On Thursday, November 18, 2021, the legislature passed legislation prohibiting private employers in Florida from imposing COVID-19 vaccination on any employee without providing certain personal exemptions and allowing employees to opt out of vaccination requirements. This legislation takes effect immediately.
Rule: Private employers are prohibited from compulsory use of the COVID-19 vaccine.
Exemptions: If an employer in Florida has a policy that requires employees to be vaccinated against COVID-19, the policy must include certain exemptions. Employees can choose from many exemptions, including but not limited to health or religious issues; pregnancy or anticipated future pregnancy[3]; and past recovery from COVID-19 (also known as "natural immunity"). Note: "Natural immunity" is considered and rejected in the CMS rules. In addition, employees who voluntarily choose to undergo periodic testing or agree to wear PPE in the workplace can be exempt from the COVID-19 vaccination requirement. Note: The test and PPE options are considered and rejected in the CMS rules. The employer must pay the employee's test and PPE waiver fees.
Penalties: Employers who violate these employee health protection measures will be fined. Small businesses (99 employees or less) face a fine of $10,000 for each violation. Large and medium-sized companies (100 employees or more) face a fine of US$50,000 for each violation. [4]
There are extensive lawsuits across the country challenging the federal vaccine regulations. In addition, the State of Florida filed a lawsuit in the U.S. District Court for the Northern District of Florida on Wednesday, November 17, 2021, challenging the CMS rules[5] and seeking temporary restraining orders, preliminary and permanent injunctive relief, and declaratory relief (Case No. 3:21 -cv-02722-MCR-HTC). The Florida lawsuit challenged the CMS rules on the following grounds: (a) CMS lacked the power and authority to issue industry-wide vaccination authorizations; (b) CMS violated 42 USC § 1395 and failed to perform its consultation with appropriate state agencies when establishing authorizations (C) CMS did not participate in the notification and comment procedures stipulated in the Administrative Procedure Act ("APA") and lacked sufficient reasons for doing so; (d) CMS was arbitrary and erratic in issuing authorization; ( e) The CMS rules violate the spending provisions of the U.S. Constitution. See the complaint at ¶¶ 9-13. These arguments are similar to those raised in pending lawsuits across the country. Florida also filed a preliminary injunction motion, which was rejected by the District Court on Saturday, November 20, 2021.
Nelson Mullins will continue to follow the Florida litigation and will provide updated information on any court orders issued that affect the enforcement of the CMS rules.
This situation is developing rapidly, and health care providers in Florida are facing challenges because Florida’s legislation conflicts with CMS rules. The CMS rules are only exempted from the vaccination requirements for employees who are in good faith with religious beliefs under the medical conditions specified by the ADA or specified in Chapter 7. However, Florida legislation allows for broader exemptions, which may be inconsistent with CMS rules, and employees agree to undergo periodic testing and employees agree to use PPE in the workplace, which is an option specifically addressed and rejected by CMS rules.
Although there are still many unknowns at this time, the CMS rules provide some guidance. In view of state legal challenges or legislation prohibiting mandatory vaccine requirements, CMS expects covered facilities to comply with the requirements of the CMS rules. The CMS rules clearly state that according to the supremacy clause of the U.S. Constitution, it takes precedence over any opposite state law. See the U.S. Constitution. Art. VI § 2.
The recent rejection of Florida's preliminary injunction request for CMS rules shows that Florida suppliers can and should comply with CMS rules-for now. However, if a Florida provider is to implement the CMS rules, the provider may be fined by the above-mentioned state. However, non-compliance with the CMS rules will bring greater risks, including termination of medical insurance and Medicaid programs. Therefore, Florida health care providers need to comply with all CMS rules so that they can ensure that payments, fines, or termination of the CMS plan are not interrupted.
[1] HB 1-B, 2d specification. Seth. (Florida 2021).
[2] Florida v. Department of Health and Human Services et al., case number. 3:21cv2722-MCR-HTC (ND in Florida).
[3] The CDC has addressed pregnancy-related issues related to the COVID-19 vaccine in the guide: COVID-19 vaccine during pregnancy or breastfeeding is available at https://www.cdc.gov/coronavirus/2019-ncov/ vaccines/recommendations/ Get .html (last accessed on November 22, 2021). However, the Florida Department of Health has expanded its exemptions based on pregnancy and "expected pregnancy" in its recently released exemption form, far beyond federal guidance on medical and religious exemptions. See the Florida Department of Health COVID-19 Vaccination Waiver Form | Florida Department of Health (floridahealth.gov).
[4] Therefore, Florida legislation provides broader exemptions than CMS rules. In addition, despite its low relevance to Florida health care providers, the legislation provides:
Government entities may not require anyone (including employees) to be vaccinated against COVID-19.
Educational institutions may not require students to be vaccinated against COVID-19.
The school district may not have a school mask policy.
School districts may not isolate healthy students.
Students and parents can sue for violations of school district regulations and recover costs and attorney fees.
[5] The defendants named in the lawsuit are the Department of Health and Human Services; Xavier Becerra, in the official capacity of Minister of Health and Human Services; United States of America; Chiquita Brooks-Lasure, in the official capacity of the administrator of the Center for Medicare and Medicaid; And the Medical Insurance and Medicaid Center.
Kristin has worked in Florida for more than 20 years, focusing on employment litigation, compliance and commercial litigation. She serves as legal counsel to a wide range of public and private clients in federal and state courts, administrative agencies and alternative dispute resolution forums.
Kristin represents local, national and international companies, management and individuals in employment-related matters, including discrimination and harassment, and claims involving age, disability, race...
Elizabeth advises various entities on regulatory and compliance matters related to the consumer finance industry, including state and federal consumer protection laws, supervision and licensing, anti-money laundering and bank secrecy law compliance, and traditional and non-traditional loans. She assists customers throughout the entire life cycle of product development as they strive to provide new and innovative products and services through traditional and online channels. Elizabeth often works with banks, mortgage companies, consumer lenders, payment companies,...
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