As featured in #WorkforceWednesdayThe Centers for Medicare & Medicaid Services (CMS) issued an interim final rule outlining vaccine requirements for staff at Medicare- and Medicaid-certified providers and suppliers.

Attorney Frank Morris discusses the next steps for health care providers. In addition, covered employers should continue to monitor the recent litigation filed in the Eastern District of Missouri and the Western District of Louisiana seeking to permanently enjoin the CMS interim final rule.

See below for the video and podcast links. Visit https://www.ebglaw.com/insights/cms-vaccine-rule-for-health-care-workers/

Video: YouTubeVimeo.

Podcast: Apple PodcastsGoogle PodcastsOvercastSpotifyStitcher.

Our colleagues Adam C. Abrahms and Juan Larios of Epstein Becker Green recently published an Act Now Advisory that will be of interest to our readers: “California’s New COVID-19 Vaccine (Non)Mandate and Testing Requirements.”

The following is an excerpt:

On July 26, 2021, the California Department of Public Health (“CDPH”) issued a State Public Health Officer Order (“Order”) seeking to address the increase California is experiencing in positive COVID-19 cases. With infections of the COVID-19 Delta variant rising, Governor Gavin Newsom and State Public Health Officer Tomás Aragón issued the Order as an effort to reduce COVID-19 infections in California. However, contrary to some press reports, the Order is not really a vaccine mandate in any way, shape, or form. As this Advisory describes in detail, in addition to a separate order for employees of the state, the Order applies to certain categories of health care and high-risk facilities, requires verification of workers’ vaccination status and compliance with masking guidelines, and imposes requirements for testing unvaccinated and incompletely vaccinated workers.

Click here to read the full piece.

Our colleague Nathaniel M. Glasser and Jennifer Barna of Epstein Becker Green have co-authored an article in Bloomberg Law that will be of interest to our readers: “COVID-19 Vaccines and Workplace Challenges.”

The following is an excerpt:

As COVID-19 vaccines become widely available, employers will face a critical set of challenges, ranging from whether they can—or will want to—mandate all or some employees get vaccinated, to what liability may attach to mandating vaccination, and even whether the Occupational Safety and Health Administration (OSHA) could require a vaccine program.

While uncommon, mandatory vaccination policies are not new. For example, many health-care employers have implemented mandatory flu vaccination programs to protect staff and patients. The size and scope of the current pandemic, coupled with the desire to swiftly return employees to the physical workplace, however, means that more employers across various industries will likely consider mandating that their employees receive a COVID-19 vaccine once one becomes available.

Employers need to stay ahead of workplace COVID-19 vaccine issues with awareness and planning, so they can adapt their policies to meet the moment. Following are several of the most common questions employers should be prepared to answer in considering COVID-19 vaccination programs.

Click here to download the full version in PDF format.

In the midst of one of the worst flu seasons to date, many hospitals and other health care organizations enforced mandatory flu vaccine policies for their employees to boost vaccination rates. However, recent litigation and governmental actions should serve as a reminder that health care entities should carefully consider safeguards whenever implementing mandatory vaccine policies and to not categorically deny all requests for religious exemptions based on anti-vaccination beliefs.

In January, the Department of Health and Human Services (HHS) announced the formation of a new Conscience and Religious Freedom Division in the HHS Office for Civil Rights (OCR) and released a proposed rule to provide protections for health care workers who refuse to participate in services that run counter to their religious beliefs or moral conviction. Recent legal challenges to mandatory vaccination policies in the health care context have also gained media attention.

Earlier this month, the United States Department of Justice (DOJ) accused a county-owned skilled nursing facility (SNF) in Wisconsin of violating a certified nursing assistant’s religious rights when it required her to be vaccinated or be terminated if she refused.  Although the certified nursing assistant believed that the Bible prohibited her from receiving the vaccine, the SNF refused to grant her an exemption from its vaccination policy because she was unable to produce a written statement from the clergy leader supporting her request, as the SNF’s exemption policy required. The DOJ complaint asserts that the SNF’s vaccination policy denies religious accommodations to employees who do not belong to churches with clergy leaders and that the SNF unlawfully denied the employee a reasonable accommodation for her religious beliefs when it refused her request for an exemption.

However, not all requests for accommodation must be honored.  In Fallon v. Mercy Catholic Medical Center, an employee sued his hospital employer for wrongful termination alleging religious discrimination and a failure to accommodate in violation of Title VII of the Civil Rights Act of 1964 when the hospital terminated him for refusing to get his annual flu shot. The Third Circuit Court of Appeals sided with the hospital and held that the employee’s “sincerely held beliefs” were not religious but based on health concerns, and therefore, the hospital did not violate Title VII.

In another recent development, a Massachusetts state Superior Court dismissed a lawsuit filed by the Massachusetts Nurses Association against Brigham and Women’s Hospital for lack of standing when the union challenged the hospital’s flu vaccination policy. The dismissal occurred a few months after the court denied the union’s request for an injunction.  Thus, a plaintiff’s standing to challenge mandatory vaccination policies will be scrutinized.

Key Takeaways

Despite the actions of DOJ and HHS, health care employers are well within their rights to implement a mandatory flu vaccination policy, especially considering the potential implications to patient safety. Employers need to be prepared to handle requests for reasonable accommodations made by employees who have sincerely held religious beliefs against flu vaccination.  When presented with such a request for accommodation, employers should engage in the interactive process with the employee as outlined in this recent blog post.

To lessen the risk of infringing on worker’s rights, many health care entities are employing non-mandatory tools and policies to boost employee vaccine participation through positive enforcement rather than with the threat of being fired. For example, health care entities can ensure that employees are educated and reminded about the benefits of being vaccinated, provide free and convenient access to vaccines, and issue small incentives and rewards to employees who are vaccinated.

Whenever implementing a mandatory vaccination policy, employers should be prepared for a challenge. Essentia Health required its employees to receive the flu vaccination and sustained a public legal challenge from three hospital unions.  Essentia prevailed, discharging 50 workers who refused to be vaccinated.

Lastly, health care entities should review applicable state-worker vaccination laws to ensure they are in compliance with such laws when deciding upon vaccination policies.

The United States is in the midst of an unusually lethal flu season, and health experts agree that despite inconsistencies in their effectiveness, flu shots are among the best ways to fight the spread of the flu. A recent holding from the Third Circuit Court of Appeals provides some good news for health care employers who require that their patient-facing employees receive flu shots, making it more difficult for employees to claim a religious exemption.

Courts have held that health care employers may require their patient-facing employees to be vaccinated against a number of diseases, including the flu.  Whether employers can mandate vaccinations for all employees has been a closer question.  A key issue faced by employers is determining whether an employee’s anti-vaccination beliefs qualify for a religious exemption.

In Fallon v. Mercy Catholic Medical Center, the Third Circuit considered the religious exemption, clarifying what may qualify as such. Paul Fallon, a psychiatric crisis intake employee of Mercy Catholic Medical Center (“Mercy”), refused to get his required annual flu shot. Fallon had successfully asserted a religious exemption for several years before Mercy changed its policy to require that employees seeking such exemptions provide a note from a clergy member. Fallon, who does not belong to a religious organization, did not provide the clergy note, instead outlining his “sincerely held beliefs” opposing the vaccine in a 22-page essay. Mercy determined that Fallon’s beliefs, however sincere, were not religious. It did not grant the exemption, and subsequently fired Fallon when he continued to refuse vaccination. Fallon sued Mercy for wrongful termination alleging religious discrimination and a failure to accommodate in violation of Title VII of the Civil Rights Act of 1964.

The District Court sided with Mercy, and the Third Circuit affirmed the decision. The court relied on the three-part modern definition of religion, as adopted in Africa v. Commonwealth of Pennsylvania, 662 F.2d 1025, 1032 (3d Cir. 1981): a religion (1) addresses fundamental and ultimate questions having to do with deep and imponderable matters; (2) is comprehensive in nature, consisting of a belief system as opposed to an isolated teaching; and (3) is often recognized by the presence of certain formal and external signs.  The court concluded that Fallon’s belief that “the flu vaccine may do more harm than good” amounted to nothing more than a concern about the health effects of the vaccine and demonstrated his disbelief of the scientifically accepted view that it is harmless to most people.  Therefore, Fallon could not meet either of the first two prongs of the Africa test.  In addition, Fallon was unable to meet the third pong because he could not demonstrate that his beliefs manifested in “formal and external signs,” such as services or the existence of clergy.    Accordingly, the court concluded that Fallon’s “beliefs do not occupy a place in his life similar to that occupied by a more traditional faith,” meaning that “[h]is objection to vaccination is . . . not religious and not protected by Title VII.”

While the court’s decision provides guidance for employers responding to anti-vaccination beliefs, the court recognized that anti-vaccination beliefs can be part of “a broader religious faith.”  Thus, employers should be mindful not to categorically deny all requests for religious exemptions based on anti-vaccination beliefs.

Employers also should follow the recent developments within the Department of Health and Human Services (HHS), which recently established a new Conscience and Religious Freedom Division in the Office for Civil Rights (OCR) and released a proposed rule that would provide protections for health care workers who refuse to participate in services that run counter to their religious beliefs or moral convictions.   In an HHS press release on January 19, 2018, Acting HHS Secretary Eric D. Hargan said that the creation of the Division constitutes “a rollback of policies that had prevented many Americans from practicing their profession and following their conscience at the same time,” adding that “Americans of faith should feel at home in our health system, not discriminated against.”  These developments, and the public comments by HHS officials, may signal a move to prevent employers from enforcing mandatory flu vaccination policies.

As we previously reported, the Centers for Medicare and Medicaid Services’ (CMS) interim final rule (“the Rule”) requiring full COVID-19 vaccination for staff and others at Medicare- and Medicaid-certified providers and suppliers (i.e., the “vaccine mandate”) has been challenged in the U.S. District Courts for the Eastern District of Missouri (“the Missouri Court”) and the Western District of Louisiana, Monroe Division (“the Louisiana Court”).  As of the date of this writing, both Courts have granted preliminary injunctions placing the Rule on hold.

On November 29, 2021, the Missouri Court granted a preliminary injunction of the Rule, which applies to the coalition of ten states [1] that filed the challenge there. The following day, the Louisiana Court entered a similar injunction, which applies to the remaining forty states.

Continue Reading Courts Grant Preliminary Injunctions Placing CMS Interim Final Rule on Hold

[UPDATE, Nov. 30, 2021: The District Court for the Eastern District of Missouri grants injunction for the ten plaintiff states listed in the First Complaint.]

As we previously reported, effective November 5, 2021, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule (the Rule) requiring full COVID-19 vaccination for staff and others at Medicare- and Medicaid-certified providers and suppliers as a Condition of Participation by January 4, 2022.

On November 10, 2021, a coalition of ten states lodged a complaint in the U.S. District Court for the Eastern District of Missouri (the “First Complaint”), which is subject to appeals in the U.S. Court of Appeals for the Eighth Circuit, seeking to set aside the Rule. On November 17, 2021, the U.S. District Court for the Eastern District of Missouri granted Plaintiff’s Motion to Expedite Briefing — requiring Defendant to file their response to the Plaintiffs’ Motion for Preliminary Injunction by November 22, 2021; and Plaintiffs to file their reply by November 23, 2021.

On November 15, 2021, a coalition of twelve different states filed a similar complaint (the “Second Complaint”) but, perhaps strategically, filed it with the United States District Court for the Western District of Louisiana, Monroe Division.  An appeal of the Louisiana District Court’s decision would go to the U.S. Court of Appeals for the Fifth Circuit, which recently stayed the OSHA vaccination Emergency Temporary Standard (ETS), reported here.

The Complaints

The First Complaint was filed by the States of Missouri, Nebraska, Arkansas, Kansas, Iowa, Wyoming, Alaska, South Dakota, North Dakota, and New Hampshire.  The Second Complaint was lodged by the States of Louisiana, Montana, Arizona, Alabama, Georgia, Idaho, Indiana Mississippi, Oklahoma, South Carolina, Utah, and West Virginia.  In total, twenty-two states joined one or the other of the complaints.

Both complaints make similar arguments.  To summarize, the States’ Attorneys General argue that CMS’s statutory authority does not authorize it to impose a vaccine mandate.  They also attack the implementation of the Rule, which was not subject to a notice and comment period as provided by the Administrative Procedure Act.  This period, usually sixty days, generally allows for interested parties to participate in the rulemaking process by submitting written data, views, or arguments before a rule is promulgated.  They further argue that the Rule is arbitrary and capricious because CMS failed to consider relevant factors in implementing the Rule, such as staff shortages, particularly in rural hospitals, alternatives to mandates (e.g., testing), and weighing an individual’s right to refuse medical treatment and failure to consult with the States under the Social Security Act where a rule would impact rural hospitals, among other contentions.

The States also make general arguments with respect to the Federal Government’s power.  First, the States’ Attorneys General argue that the Rule improperly allows for the Federal Government to have authority over states and their citizens, including Medicare state surveyors who review compliance by certified providers.  They also contend that the Rule violates Congress’s Spending Power in that Plaintiffs’ receipt of federal funds is conditioned on compliance with the Rule.

The States seek to set the Rule aside and request permanent injunctions to stop the imposition of the Rule’s vaccine requirements.

What Employers Subject to the Rule Should Do Now

Unless or until there is a stay of the Rule, covered facilities should consider moving forward with preparing the policies and procedures to comply with the Rule, including collecting vaccination information and providing a documented exemption application process based on federal law requirements (i.e., medical and religious accommodations under the Americans with Disabilities Act and Title VII of the Civil Rights Act of 1964). Employers with union represented employees should also consider discussing with the pertinent unions any potential impact the Rule may have on their represented employees.

Taking these steps, as discussed in more detail in our previously reported Insight (the first link above), will help ensure timely compliance in the event that no stay is issued.

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*Kamil Gajda, a Law Clerk – Admission Pending (not admitted to the practice of law) in the firm’s New York office, contributed to the preparation of this post.

On August 26, 2021, the Public Health and Health Planning Council approved an emergency regulation requiring health care personnel to be fully vaccinated against COVID-19. The emergency regulation is effective immediately and will remain in effect for 90 days, subject to review and renewal.

The emergency regulation supersedes the Section 16 Order issued by the New York Department of Health (“DOH”) on August 18, 2021, which mandated the vaccine for personnel at general hospitals and nursing homes.

The emergency regulation expands the mandate to cover personnel at entities beyond general hospitals and nursing homes to also include diagnostic and treatment centers, public health centers, rehabilitation centers, birth centers, adult care facilities, certified home health agencies, hospices, long-term home health care programs, AIDS home care programs, licensed home care service agencies and limited licensed home care service agencies (collectively “Covered Entities”). Under the regulation, covered personnel is defined as: “all persons employed or affiliated with a covered entity, whether paid or unpaid, including but not limited to employees, members of the medical and nursing staff, contract staff, students, and volunteers, who engage in activities such that if they were infected with COVID-19, they could potentially expose other covered personnel, patients or residents to the disease.

Covered Entities must continuously require personnel to be fully vaccinated against COVID-19. Hospitals and nursing homes must require their current personnel to receive the first dose of the vaccine by September 27, 2021. “Fully vaccinated” for the purpose of this regulation shall be determined by the Department in accordance with applicable federal guidelines and recommendations. All other health care facilities must require their current personnel to receive the first dose of the vaccine by vaccinated by October 7, 2021. Proof of vaccination must be provided and include the manufacturer, lot number(s), date(s) of vaccination, and vaccinator or vaccine clinic site.

Notably, the emergency regulation eliminated the exemption due to a sincerely held religious belief that was included in the proposed emergency regulation and in the Section 16 Order. The emergency regulation provides for a medical exemption so long as it is supported by a certification issued by a licensed physician or certified nurse practitioner opining that the vaccine mandate would be detrimental to the individual’s health based on a pre-existing condition. Covered Entities are required to document the any medical exemptions, including the nature and duration of the medical exemption, and reasonable accommodations provided, in an individual’s medical file, maintained separately from the general personnel file, and ensure that such documentation is immediately available upon request by DOH.

In addition, the emergency regulation requires Covered Entities to develop and implement a policy and procedure to ensure covered personnel are vaccinated for COVID-19 and ensure that such policy and procedure is available to the DOH on request. The emergency regulation also requires Covered Entities, upon the DOH’s request, to report the number and percentage of total covered personnel; the number and percentage that have been vaccinated against COVID-19; and those who have been granted a medical exemption, along with any reasonable accommodation.

Finally, the emergency regulation provides that “[t]he Department may require all personnel, whether vaccinated or unvaccinated, to wear an appropriate face covering for the setting in which such personnel are working in a covered entity. Covered entities shall supply face coverings required by this section at no cost to personnel.”

Our colleague Denise Dadika and Alexandria Adkins of Epstein Becker Green have a new post on the Workforce Bulletin blog that will be of interest to our readers: “New Jersey Mandates COVID-19 Vaccination or Weekly Testing for Workers in Health Care and Congregate Settings.”

The following is an excerpt:

On August 6, 2021, New Jersey Governor Philip Murphy signed Executive Order 252 (“Order 252”) requiring health care and high-risk congregate settings to maintain a policy requiring workers to either provide adequate proof of vaccination or submit to weekly COVID-19 testing. Although Governor Murphy declared an end to the state’s Public Health Emergency in June, he retained the authority to issue orders related to vaccine distribution, administration, and management as well as COVID-19 testing and data collection. Following the CDC’s vaccine guidance, Order 252 recognizes the “importance of heightened mitigation protocols in certain congregate and health care settings,” and it takes additional steps to address the significant risk of spread and the vulnerability of the populations served in those settings.

Click here to read the full post on the Workforce Bulletin blog. 

On June 12, 2021, a federal District Court in Texas soundly rejected an attempt by Houston medical workers to challenge the legality of their employer’s decision to require that all employees receive a COVID-19 vaccine. In the lawsuit, Bridges, et al. v. Houston Methodist Hospital et al., 117 hospital workers sued for an injunction to block the hospital’s mandatory vaccination policy as well as the termination of any employee unwilling to comply with the employer’s mandate that all employees be vaccinated against COVID-19. More specifically, the employees asserted that the vaccine mandate would result in wrongful termination in violation of the public policy of the state of Texas and federal law.

In an enlightened decision, Judge Hughes rejected the employees’ wrongful termination claim, as Texas law “only protects employees from being terminated for refusing to commit an act carrying criminal penalties to the worker,” and getting a COVID-19 vaccination is not an illegal act. The court found that Texas does not recognize a wrongful termination claim predicated on a violation of public policy and, even “if it did, [the hospital’s] injection requirement is consistent with public policy,” citing a 1905 U.S. Supreme Court decision that ruled that compulsory vaccination was not a violation of due process. The court further explained that the Equal Employment Opportunity Commission’s recently updated guidance provides persuasive advice that employers may require employees to be vaccinated against COVID-19, subject to reasonable accommodation requirements.

In addition, the court rejected the plaintiffs’ federal claim that the vaccine mandate violated federal law because it is not fully approved by the Food and Drug Administration, explaining that the Food, Drug, and Cosmetic Act does not confer a private right to sue an employer. It also dismissed plaintiffs’ argument that the vaccine mandate violated federal law that protects the rights of human subjects. In doing so, the court explained that the plaintiffs misrepresented the facts because the employees are not participants in a human trial, but are merely subject to a vaccine requirement. The judge further explained that the lawsuit’s reliance on the Nuremberg Code was misplaced because the Code does not apply to private employers, writing that it was “reprehensible” for the plaintiffs to equate a COVID-19 vaccine requirement to medical experimentation in Nazi concentration camps.

Finally, the court explained that the vaccine mandate is part of the bargain of at-will employment and does not constitute coercion, since the hospital is simply “trying to do their business of saving lives without giving [employees] the COVID-19 virus. It is a choice made to keep staff, patients and their families safer.” Employees “can freely choose to accept or refuse a COVID-19 vaccine; however, if [they] refuse, [they] will simply need to work somewhere else…Every employment includes limits on the worker’s behavior in exchange for his remuneration. This is all part of the bargain.”