Dorsey Health Law

In July 2020, the Minnesota Supreme Court in Popovich v. Allina Health, 946 N.W.2d 885 (Minn. 2020), departed from 30 years of precedent regarding vicarious liability for hospitals. Before Popovich, a hospital could not be held vicariously liable for the negligence of independent contractors. After Popovich, a hospital can be held liable under a theory of apparent authority for the professional negligence of independent contractors in the hospital’s emergency room if: (1) the hospital held itself out as the provider of the services in question; and (2) the patient looked to the hospital for care and relied on the hospital to select the individuals that provided services. Although Popovich involved emergency care, the decision was expected to have wide-ranging impacts on healthcare providers. Among other things, Popovich was expected to impact professional service agreements between hospitals and independent physician groups. It was expected to impact contract provisions related to liability insurance and indemnification. It was expected to impact the manner in which certain services were marketed to the public. Many of these expectations have come to fruition. And there can be no dispute that Popovich’s application of apparent authority principles to healthcare providers has allowed some claims to proceed that, previously, would have been dismissed early in litigation or not brought at all. But interestingly, in the four years since the Minnesota Supreme Court issued its decision, the handful of Minnesota courts tasked with applying Popovich have dismissed the vicarious liability claims before them because the reliance element had not been satisfied. For example, in Rock v. Abdullah, 2022 Minn. App. Unpub. LEXIS 457 (Minn. Ct. App. July 18, 2022), the Minnesota Court of Appeals determined that a hospital could not be held vicariously liable for the alleged negligence of a non-employee physician with surgical privileges there. The court’s decision was based on the second element of Popovich: reliance. Because plaintiff did not rely on the hospital to select the physician that performed the plastic surgery, but instead made that selection herself and in advance of surgery, the hospital was not liable under a theory of apparent authority. In so holding, the Rock v. Abdullah court recognized that reliance is a context-specific standard. In Popovich, the care at issue took place in the emergency room, a situation in which most people do not select the medical professionals that treat them. By contrast, in Rock v. Abdullah, plaintiff had several visits with the physician before the treatment at issue. The mere fact that the physician may have been “affiliated” in some manner with the hospital did not satisfy the reliance standard. As another example, the Minnesota Court of Appeals, in Lund v. Calhoun Orange, Inc., 2023 Minn. App. Unpub. LEXIS 933 (Minn. Ct. App. Dec. 4, 2023), considered whether Ultimate Fitness could be held vicariously liable for the emergency medical care provided by one of its subsidiary fitness studios. The court framed the sole question before it as “whether knowledge alone satisfies the reliance prong” of Popovich. The court reviewed pre-Popovich case law, including precedent from over a century ago, and concluded that knowledge alone did not satisfy the reliance standard: “Each [pre-Popovich] case defined knowledge as a prerequisite to reliance rather than defining the terms as interchangeable. The district court correctly determined that ‘apparent authority reliance requires more than simply whether or not plaintiff was aware of the representations of authority by the principal.’” Because there was no evidence that plaintiff relied on Ultimate Fitness’s representations of authority when choosing the specific fitness studio at issue, the court affirmed dismissal of the apparent authority claim. As a final example, in Doe v. Meany, 2023 Minn. Dist. LEXIS 5370 (Minn. Dist. Ct. May 31, 2023), the Hennepin County District Court granted summary judgment to defendant on plaintiff’s vicarious liability claim. Plaintiff sued defendant (a psychiatry practice) under a theory of apparent authority for the misconduct of an independent contractor who practiced at defendant’s business. The court dismissed the case on reliance grounds. Plaintiff had identified no facts indicating that she relied on defendant to provide the independent contractor as her psychiatrist. Instead, plaintiff herself conducted a Google search, identified the psychiatrist, and scheduled an appointment directly with him. In those circumstances, plaintiff’s purported knowledge of an affiliation between defendant and the independent contractor was insufficient to satisfy the reliance standard from Popovich. As shown by these examples, Popovich has expanded the types of vicarious liability claims that may survive early dispositive motion practice. However, when these claims reach the summary judgment stage of litigation, and when evidence is required to demonstrate reliance, post-Popovich courts have expressed a willingness to hold plaintiffs to their burden. There must be specific evidence showing that plaintiff relied on the healthcare provider to select the independent contractor that ultimately provided the services in question. Absent such evidence, Minnesota courts have granted summary judgment and affirmed those decisions on appeal. To reduce the risk of apparent authority liability, healthcare providers should carefully consider their professional service agreements with independent contractor physicians, including indemnification obligations, insurance coverage, and scheduling practices. The reliance element from Popovich is more likely to be satisfied if providers are matching patients with physicians—a common occurrence in emergency care situations—as opposed to patients driving that process.

The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Dorsey’s William Miller and Joshua Hughes for the following publication: On January 10, 2024, the Iowa Court of Appeals filed its opinion in Hampe v. Charles Gabus Motors, Inc., et al., which involved a former employee who was terminated for refusing to submit to a random workplace drug test. While the court of appeals’ ruling does not impose any new requirements on employers, the ruling provides clarity on an employer’s obligations when complying with Iowa Code 730.5, Iowa’s private sector drug testing law. Read more here.

On March 17, 2022, Iowa Governor Kim Reynolds signed House File 2521, “Relating to Health Care Employment Agencies, and Providing Penalties” into law.  We previously discussed the new law on a June 10, 2022 blog post.  At that time, a looming question was how Iowa’s administrative agencies would draft rules to clarify and implement the law.  On November 30, 2022, the Iowa Department of Inspections and Appeals (DIA) submitted the final administrative rules to implement House File 2521 to final publication. By way of brief background, administrative rules are the regulations that help to implement laws passed by the Iowa Legislature.  After a bill is signed by the Governor, state agencies may propose rules to implement the statute the agencies are tasked with enforcing.  Rules are first drafted within an agency, then reviewed by the agency head, and then published in the Iowa Administrative Bulletin.  At that time, the public is allowed to comment on the proposed rules for a certain period of time.  After the public comment period, the agency head adopts the rules (with additions as appropriate) and sends them for final publication.  Even after final publication, the rules are subject to legislative review by the Administrative Rules Review Committee (ARRC).  That committee can object to rules and delay effective dates. So, what do the final rules for House File 2521 say?    First, the rules clarify the definition of a “health care employment agency” for the purpose of this law.  House File 2521 broadly defined “health care employment agency” to mean “an agency that contracts with a health care entity in this state to provide agency workers for temporary, temporary-to-hire, direct hire, or other contract or employee placements.” The rules expressly provide that “a recruitment firm that contracts with a health care entity to identify and screen potential candidates for hire and does not provide agency workers for temporary, temporary-to-hire, direct hire, or other contract employee placements” are not covered by the statute. The rules also carve out an exception for “physical therapists licensed under Iowa Code chapter 148A, occupational therapists licensed under chapter 148B, or speech pathologists or audiologists licensed under Iowa Code chapter 154F,” meaning those professions are not considered “health care employment agencies” under this law.  Under these rules, it’s status quo for those professions: employers may still include certain covenants not to compete, finder’s fees, and other contract provisions that the law otherwise prohibits. Second, the rules also confirm the language of House File 2521 in defining “direct services” to exclude the practice of “medicine and surgery or osteopathic medicine and surgery by an individual licensed under Iowa Code chapter 148 or 148C or the practice of nursing by an advanced registered nurse practitioner or an advanced practice registered nurse licensee under Iowa Code chapter 152 or 152E.”  Again, for these positions, the pre-House File 2521 status quo appears to be the law going forward. Finally, the rules provide some exceptions to the general prohibition against non-competes and other contract provisions in healthcare employment agency contracts.  Specifically, these contracts can contain non-competes and finder’s fees when: (1) the health care worker has been sponsored by or is otherwise assisted in obtaining work authorization in the United States by the employment agency, (2) the contract contains an initial term of “no less than 24 months and has a total duration, including any renewals or extensions, of no longer than 36 months,” and (3) the contract requires the agency worker to work at a single health care entity for the duration of the contract. At first glance, the rules appear to narrow the scope of the statute considerably.  It remains to be seen how the ARRC will respond (e.g. whether the rules change the House File too significantly).  The next meeting of the ARRC on December 12, 2022 may provide some insight into what concerns, if any, legislators have with the final rule.  As always, we will be closely monitoring the upcoming 2023 session of the Iowa General Assembly for further action on health care staffing issues.

For the last few months, we have been fielding calls from clients in the healthcare industry asking about things such as whether they still needed to screen patients upon entry to facilities, whether employees must still wear masks at all times, and whether they still had to treat vaccinated employees differently from unvaccinated employees.  We saw an uptick in these calls following the CDC’s August 11, 2022, updated masking guidance for the general public (“the Updated Guidance”). The CDC’s masking guidance in non-healthcare settings The CDC’s Updated Guidance for anyone not in a healthcare setting bases masking recommendations not on vaccination status, but on COVID-19 Community Levels.  Those levels measure “the impact of COVID-19 in terms of hospitalizations and healthcare system strain, while accounting for transmission in the community.”   Notably, the Updated Guidance explicitly stated that it did not apply in healthcare settings.  The Updated Guidance used Community Levels to make masking and testing recommendations without regard to vaccination status. The CDC’s prior guidance in healthcare settings Unlike the Updated Guidance, employers in healthcare were required to utilize source control based instead on COVID-19 Community Transmission, which differs from the Community Level measurement as it “refers to measures of the presence and spread of SARS-COV-2.”  In addition, the CDC guidelines for source control in health care settings differentiated between those who were and were not “up to date” with their COVID-19 vaccinations, defining “up to date” as having all recommended boosters.  This resulted in many frustrated and confused healthcare employers. The CDC’s updated guidance for healthcare settings On September 23, 2022, the CDC issued long-awaited updated infection prevention and control recommendations for healthcare settings (“the Healthcare Update”).  The Healthcare Update applies to “all U.S. settings where healthcare is delivered, including nursing homes and home health.” While healthcare employers must still utilize COVID-19 Community Transmission metrics to determine source control, the CDC’s recommendations for healthcare settings no longer use COVID-19 vaccination status in source control guidance.  The CDC provided the following summary of the Healthcare Update: Updated to note that vaccination status is no longer used to inform source control, screening testing, or post-exposure recommendations Updated circumstances when use of source control is recommended Updated circumstances when universal use of personal protective equipment should be considered Updated recommendations for testing frequency to detect potential for variants with shorter incubation periods and to address the risk for false negative antigen tests in people without symptoms Clarified that screening testing of asymptomatic healthcare personnel, including those in nursing homes, is at the discretion of the healthcare facility Updated to note that, in general, asymptomatic patients no longer require empiric use of Transmission-Based Precautions following close contact with someone with SARS-CoV-2 infection Archived the Interim Infection Prevention and Control Recommendations to Prevent SARS-CoV-2 Spread in Nursing Homes and special considerations for nursing homes not otherwise covered in Sections 1 and 2 were added to Section 3: Setting-specific considerations Updated screening testing recommendations for nursing home admissions Clarified the types of long-term care settings for whom the healthcare infection prevention and control recommendations apply What are the key differences for employers? As evidenced by the above list, the CDC made quite a few changes in the Healthcare Update.  Because our calls from clients have been primarily focused on masking and screening, we will focus on what is different with regard to those two topics.  Healthcare employers, particularly those in specific settings referenced by the Healthcare Update (Dialysis Facilities, Emergency Medical Services, Dental Facilities, Nursing Homes, and Assisted Living, Group Homes, and Other Residential Care Settings), should review the new guidance carefully and consult a healthcare attorney with questions.  With regard to what is commonly referred to as “surveillance testing,” the CDC does not recommended that testing decisions be based on vaccination status or Community Transmission levels. Screening and masking changes are highlighted below: Topic Prior Recommendations Healthcare Update Recommendations Screening for COVID-19 Encourage everyone to remain up-to-date with all recommended COVID-19 vaccine doses   Post visual alerts in entrances and high-traffic areas outlining current infection prevention and control practices and recommendations   Establish a process that should be followed by anyone entering the facility that either: (1) has a positive viral test for SARS-CoV-2, (2) has symptoms of COVID-19, or (3) has had close contact with someone infected by COVID-19 or for healthcare personnel with a higher-risk exposure    Suggested options for could include (but were not limited to): individual screening on arrival at the facility; or implementing an electronic monitoring system in which individuals can self-report any of the above before entering the facility Removes suggestion that healthcare facilities utilize individual screening on arrival at the facility or electronic monitoring systems Source Control (i.e., masking) Masking exceptions for employees up-to-date with all recommended COVID-19 vaccine doses, particularly in non-patient facing scenarios, provided Community Transmission was low to moderate  Healthcare employers may choose not to require universal source control when COVID-19 Community Transmission levels are not high, regardless of whether employees are up-to-date with all recommended COVID-19 vaccine doses, even when patient-facing   Source control still recommended for employees who have symptoms of COVID-19, have tested positive for COVID-19, been exposed to the virus, are treating COVID-19 patients, are performing certain procedures, etc.   Source control for everyone recommended when Community Transmission levels are high Obviously, employees in healthcare settings can choose to continue wearing masks even if it is not required by their employer or recommended by the CDC, and healthcare employers should not discourage such voluntary usage. Don’t forget about the CMS vaccine mandate Even though the Healthcare Update may be currently driving the news and front of mind, healthcare employers must not forget that CMS’s November 4, 2021, Interim Final Rule (“CMS Mandate”) requiring staff at certain Medicare or Medicaid providers and suppliers to be fully vaccinated against COVID-19 (unless they qualify for a medical or religious exemption) is still in effect.  The Healthcare Update slightly affects the CMS Mandate, particularly with regard to mitigation strategies for employees who are not “fully vaccinated” (which the CMS Mandate does not define to include boosters). There appears to be some tension between the Healthcare Update and the CMS Mandate.  For example, under the CMS Mandate, if an employee is not fully vaccinated because of a medical or religious exemption, employers are required to implement additional precautions to mitigate the transmission and spread of COVID-19.  One obvious precaution to mitigate transmission is to require source control for those unvaccinated employees, something the CDC says is no longer required in areas where Community Transmission levels are not high.  Because the CMS Mandate is in fact still in effect, and because surveyors are still surveying facilities for compliance with the CMS Mandate, our best advice is that facilities subject to the CMS Mandate be able to demonstrate some kind of additional precautions for unvaccinated staff (as defined by the CMS Mandate), even if the additional precautions do not include universal source control. What healthcare employers should do now Pay close attention to SARS-CoV-2 Community Transmission levels in your county of operation and make source control decisions accordingly. Ensure you have some form of additional precautions to mitigate the transmission and spread of COVID-19 for unvaccinated staff in order to demonstrate compliance with the CMS Mandate (if not required masking or other source control). If in-person or electronic screening is eliminated, ensure there are processes for infection prevention and control in place and that all who enter the facility are aware of those processes. Finally, encourage everyone to remain up-to-date with all recommended COVID-19 vaccine doses, including boosters.  

The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Dorsey’s Alex Hontos, Katie Ervin Carlson, and Jillian Kornblatt for the following publication: Lately, litigation news related to public and private workplace COVID-19 vaccine mandates has quieted.  That changed last Friday, when the Eleventh Circuit Court of Appeals narrowed a nationwide injunction against the Biden Administration’s federal contractor vaccination mandate (the “GovCon Vax Mandate”).  Because the Court concluded that the GovCon Vax Mandate was likely an unlawful exercise of authority, it kept in place a lower court preliminary injunction against enforcement of the mandate.  But, the decision reversed the lower court’s nationwide injunction, substantially narrowing the injunction’s affect.  That means federal contractors that were not parties to the Eleventh Circuit litigation are potentially subject to the GovCon Vax Mandate.  For those contractors, the focus now turns back to the federal government—and whether the Biden Administration will start to enforce the mandate piecemeal.  The Safer Federal Workforce Task Force issued the GovCon Vax Mandate.  As of this eUpdate, the Task Force’s website still indicates that, in light of various court orders and preliminary injunctions, the Government will take no action to enforce the GovCon Vax Mandate.  Whether that will change in light of the Eleventh Circuit’s decision remains unknown, creating significant operational uncertainty for organizations with federal contracts or subcontracts. Read more here.

On March 17, 2022, Iowa Governor Kim Reynolds signed into law House File 2521, “Relating to Health Care Employment Agencies, and Providing Penalties,” which will have its home in Chapter 135Q of the Iowa Code.  In general, the law does three things.  One, it requires health care employment agencies to annually register with the state Department of Inspections and Appeals (DIA) and pay a $500 registration fee.  Two, it details recordkeeping and other requirements related to agency employees, and prohibits the inclusion of certain terms in contracts with health care entities.  Three, it imposes penalties for non-compliance. The law broadly defines a “health care employment agency” as “an agency that contracts with a health care entity in this state to provide agency workers for temporary, temporary-to-hire, direct hire, or other contract or employee placements.”  Similarly, a “health care entity” is defined as “a licensed or certified facility, organization, or agency operated to provide services and supports to meet the health or personal care needs of consumers.” Under the new law, health care employment agencies must do the following: Register each location of the health care employment agency on an annual basis with DIA, and pay a $500 registration fee; Ensure that agency workers comply with all applicable requirements relating to the health requirements and qualifications of personnel in health care entity settings (i.e. licensing, certification, training, and health requirements and continuing education standards), and document that agency workers meet these requirements; Maintain records for each agency worker and report, file, or otherwise provide any required documentation to external parties or regulators which would otherwise be the responsibility of the health care entity if the agency worker worked directly for the health care entity; Maintain professional and general liability insurance coverage with minimum per occurrence coverage of $1 million and aggregate coverage of $3 million to insure against loss, damage, or expense incident to a claim arising out of death or injury as the result of negligence or malpractice by health care employment agency or agency worker; and Submit quarterly financial reports to DIA regarding amounts charged to health care entities. As previously discussed, the CMS Interim Final Rule requiring staff vaccination against COVID-19 extends to agency employees not directly employed by Medicare or Medicaid providers and suppliers (“Covered Healthcare Employers”).  House File 2521 appears to codify such a vaccination requirement in mandating that health care employment agencies ensure that agency workers comply with all applicable requirements relating to the health requirements of personnel in health care entity and documenting that compliance. Also under the new law, health care employment agencies are prohibited from placing any restrictions on “employment opportunities of an agency worker by including a non-compete clause in any contract with an agency worker or health care entity.”  In addition, contracts between agencies and health care entities may not “require payment of liquidated damages, employment fees, or other compensation if the agency worker is subsequently hired as a permanent employee of the health care entity.”  In other words, health care employment agencies may not require their employees to sign non-compete agreements as a condition of employment, and health care employment agencies may not require health care entities to pay any kind of “finder’s fee” for directly hiring an agency employee.  Any contracts that violate new Iowa Code Chapter 135Q are unenforceable. Several questions remained immediately after Governor Reynolds signed House File 2521, particularly regarding its scope of coverage.  On May 24, 2022, the Iowa legislature attempted to address one of those questions in House File 2589 by clarifying that Iowa Code Chapter 135Q applies retroactively to any contracts entered into on or after January 1, 2019.  While Governor Reynolds is yet to sign House File 2589, her signature is expected. From a legal standpoint, we likely have not heard the last of Iowa Code Chapter 135Q and House File 2589.  The DIA is tasked with implementing administrative rules to carry out the new law, and those rules may provide further clarification regarding scope of coverage, grace periods for penalties, and other clarifications. For now, Iowa Code Chapter 135Q becomes effective July 1, 2022.  At that point, any contracts between health care employment agencies and health care entities, entered into on or after January 1, 2019, that contain any of the prohibited provisions described above, are unenforceable.  From a practical standpoint, that means health care entities should renegotiate their contracts with health care employment agencies.  We recommend that in addition to ensuring compliance with Iowa Code Chapter 135Q, health care entities should ensure that the re-negotiated contracts include language requiring agency compliance with the CMS Interim Final Rule requiring staff vaccination against COVID-19.

The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Dorsey’s Stephen Lucke, Melinda Maher, Katie Ervin Carlson and Flossie Neale for the following article: Although large employers are no longer subject to OSHA’s vaccine-or-test mandate, some may choose to require testing on their own. There are a number of factors employers must consider in determining whether to voluntarily implement a vaccine-or-test policy for employees. One significant factor for self-funded employers is who pays for testing under such policies. In this article, published earlier this month by Bloomberg Law, we summarize current laws and regulations governing payment of both “over the counter” and traditional Covid-19 tests. Among other things, employers who wish to cover such should consider compliance issues, and self-funded employers should consider how testing costs may affect their health care spend. Read More >

Health care employers are not alone in feeling overwhelmed by the constantly changing legal status of the various federal vaccine mandates.  On Thursday afternoon, the Supreme Court made its rulings on two preliminary challenges to workplace mandates related to the COVID-19 pandemic: the Occupational Safety and Health Administration (OSHA)’s Emergency Temporary Standard (ETS) for large employers (100+ employees), and the Centers for Medicare and Medicaid Services (CMS) vaccine mandate for health care employers.  This article focuses on the current status of CMS’s Interim Final Rule (IFR), issued on November 4, 2021.  The IFR detailed staff vaccination requirements as a condition of receipt of Medicare or Medicaid funds.  CMS estimated that there would be more than 180 million staff, patients, and residents employed or treated at facilities covered by the rule. Legal Challenges to CMS’s Vaccine Mandate On November 29, 2021, a federal court in Missouri stayed the CMS vaccine mandate in Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming.  On December 15, 2021, a federal court in Louisiana stayed the CMS rule for fourteen additional states: Louisiana, Montana, Arizona, Alabama, Georgia, Idaho, Indiana, Mississippi, Oklahoma, South Carolina, Utah, West Virginia, Kentucky and Ohio.  Therefore, at that time, the CMS rule was on hold in the 25 (referred to in this article as the “injunction states”) and enforceable in the rest of the country (referred to in this article as the “non-injunction states”).  A few days later, though, CMS indicated that it would temporarily halt enforcement nationwide. The next day, the federal government filed a Petition asking the Supreme Court to lift the CMS IFR stay in the 25 injunction states.  The Supreme Court heard oral arguments on that Petition, as well as whether the OSHA ETS nationwide stay, on January 7, 2022. The Supreme Court’s Ruling On January 13, 2021, the Supreme Court overturned the stay of the CMS vaccine mandate in the injunction states in a 5-4 decision. In the ruling, a majority of Supreme Court justices held that CMS’s IFR “fits neatly within the language of the statute” that authorizes the Secretary of Health and Human Services to impose conditions on the receipt of Medicare and Medicaid funding that are “necessary in the interest of the health and safety of individuals who are furnished services.”  This includes other vaccination requirements, such as hepatitis B, influenza, and measles, mumps, and rubella. The court focused on the fact that those seeking health care services at this time are likely more susceptible to contracting the COVID-19 virus, and stated: [E]nsuring that providers take steps to avoid transmitting a dangerous virus to their patients is consistent with the fundamental principle of the medical profession: first, do no harm. It would be the “very opposite of efficient and effective administration for a facility that is supposed to make people well to make them sick with COVID–19.” For their part, the dissenting justices were concerned with a federal agency forcing health care workers to choose between getting a vaccine that they have thus far failed to receive and remaining employed.  In addition, the dissent disapproved of CMS’s decision to issue the vaccine mandate prior to receiving and addressing public comments. Finally, the dissent took issue with the federal government getting involved in an issue (vaccine mandates) typically reserved for states.  According to the dissent, “[i]f Congress had wanted to grant CMS authority to impose a nationwide vaccine mandate, and consequently alter the state-federal balance, it would have said so clearly.  It did not.”  Somewhat in response to that argument, the majority cautioned that while federal agencies’ ability to exercise their powers is not limitless, “such unprecedented circumstances provide no grounds for limiting the exercise of authorities that the agency has long been recognized to have.” With the majority of the Supreme Court voting to lift the stay, the CMS IFR is back on. CMS Guidance Regarding its Vaccine Mandate Prior to the ruling (on December 28, 2021), CMS issued QSO-22-07-ALL, Guidance for the Interim Final Rule.  That guidance essentially rescinded CMS’s temporary halt on nationwide enforcement of the IFR and established compliance deadlines and additional guidance for covered facilities operating in the non-injunction states.  The Guidance included provide-specific instructions for each type of facility covered by the CMS IFR (for example, Long Term Care and Skilled Nursing Facilities, Ambulatory Surgical Centers, Hospitals, Community Mental Health Centers, and Outpatient Physical Therapy. The Supreme Court’s ruling did not change the requirements of the CMS IFR.  In essence, covered facilities must: Implement a process or plan to vaccinate all eligible staff by the compliance deadline (which is different for the injunction and non-injunction states). The CMS IFR is not a “vaccinate-or-test” mandate like the OSHA ETS.  Rather, under the IFR, vaccination is the only option unless staff qualify for a medical or religious exemption. Implement a process or plan to consider requests medical and religious exemptions. Implement a process or plan to track and document staff vaccines and exemptions so each facility can produce the documentation during a survey. Our prior blog post, available here, provides additional detail on the IFR’s requirements as well as practical recommendations for compliance and next steps. In response to the Supreme Court’s ruling, on January 14, 2022 CMS issued additional guidance, QSO-22-09-ALL for the IFR, applying to all but one of the injunction states (Texas was exempted from the new guidance due to ongoing separate challenges, and CMS instructed state surveyors in the guidance to not undertake any efforts to enforce the IFR at this time).  That new CMS guidance contains the same provider-specific instructions as the previous guidance, except that there are new compliance deadlines for the injunction states. Under QSO-22-07-ALL and QSO-22-09-ALL: Penalties for non-compliance in nursing homes, home health agencies, and hospice include civil monetary penalties, denial of payments, and as a final measure, termination of participation in Medicare and Medicaid programs. Penalties for non-compliance for hospitals and other acute and continuing care providers is termination of participation in Medicare and Medicaid programs. However, “CMS’s primary goal is to bring health care facilities into compliance.” Termination from the Medicare and Medicaid programs will generally only occur after CMS gives a facility an opportunity to come into compliance. Absent approved medical or religious exemptions, CMS will consider facilities non-compliant if facility staff (as defined by the IFR) vaccination rates are under 100%. To provide covered facilities an opportunity to reach that 100% vaccination rate, CMS has adopted a phase-in period: Facilities are considered compliant with CMS’s IFR if, 30 days after the applicable QSO: 1) the facility has policies and procedures developed to ensure all facility staff are vaccinated for COVID-19, and 2) 100% of staff have at least dose of a COVID-19 vaccine (unless exempted) or 80% of staff have at least one dose of a COVID-19 vaccine and the facility has a plan to achieve 100% vaccination within 60 days. For the non-injunction states, the 30-day deadline is January 27, 2022.  For the injunction states, the 30-day deadline is February 13, 2022. Facilities are considered non-compliant with CMS’s IFR if, 60 days after the applicable QSO, less than 100% of all non-exempted staff have at least one dose of a one-dose COVID-19 vaccine or two doses of a two-dose series. In that case, the facility will receive a notice of non-compliance, except that facilities with a vaccination rate (less exemptions) above 90% with a plan to reach 100% (less exemptions) within 30 days will not be subject to additional enforcement action.  For the non-injunction states, the 60-day deadline is February 28, 2022.  For the injunction states, the 60-day deadline is March 15, 2022. Facilities are considered non-compliant with CMS’s IFR if, 90 days after the applicable QSO (and anytime thereafter), less than 100% of all non-exempted staff have received at least one dose of a one-dose COVID-19 vaccine or two doses of a two-dose series.  These facilities may be subject to enforcement action.  For the non-injunction states, the 90-day deadline is March 28, 2022.  For the injunction states, the 90-day deadline is April 14, 2022. It is important to note that the Supreme Court did not rule on the merits (legality) of the CMS IFR.  Last week’s ruling is limited to whether the CMS IFR should be enjoined prior to a ruling on the merits.  The merits question is still yet to be resolved and when federal courts make those decisions, they will almost certainly make their way back to the Supreme Court for a final decision.  Given the language and reasoning of the Supreme Court’s injunction decision, it appears there is a high likelihood that a majority of Supreme Court justices would uphold CMS’s vaccine mandate on the merits. The bottom line is that the CMS IFR is now in effect throughout the country, except in Texas, and despite CMS’s message that it will provide entities with some leeway as described above, covered entities should immediately take steps to become compliant.  Dorsey’s health care and labor & employment attorneys are available to assist any health care provider with questions about implementation of CMS’ vaccine mandate.

On November 29, 2021, a federal court in Missouri enjoined the Centers for Medicare and Medicaid Services’ (CMS) vaccine mandate in the following states: Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming.  Those ten states filed a lawsuit on November 10, 2021, challenging the vaccine mandate and requesting a preliminary injunction.  The new CMS vaccine mandate which we wrote about here requires covered staff to receive their first COVID-19 vaccine dose by December 5, 2021 and be fully vaccinated by January 4, 2022.  In granting the preliminary injunction, the district court specifically ordered: Defendants are preliminarily enjoined from the implementation and enforcement of 86 Fed. Reg. 61,555 (Nov. 5, 2021), the Interim Final Rule with Comment Period entitled “Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination,” against any and all Medicare- and Medicaid-certified providers and suppliers within the States of Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming pending a trial on the merits of this action or until further order of this Court. Defendants shall immediately cease all implementation or enforcement of the Interim Final Rule with Comment Period as to any Medicare- and Medicaid certified providers and suppliers within the States of Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming. What this means is that as of November 29, 2021, the December 5, 2021, and January 4, 2022 deadlines are on hold for employers covered by the CMS mandate in Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming.  Any vaccine mandates enforced by covered employers in those states will be considered voluntary and subject to any state laws regarding vaccine mandates.  Of the ten states, only Arkansas, Iowa, and Kansas have laws regulating COVID-19 vaccine mandates for private employers: Arkansas – On October 13, 2021, Arkansas’ Governor allowed several vaccine-related bills to become law without his signature. The bills require employers to allow employees to obtain a waiver from a COVID-19 vaccine mandate if the employee produces a negative COVID-19 test once a week or provides proof of COVID-19 antibodies once every six months. Iowa – On October 29, 2021, Iowa’s Governor signed a law requiring employers to grant exemptions from vaccine mandates beyond those required by federal law. Specifically, in addition to waivers for sincerely held religious beliefs, Iowa employers that voluntarily implement vaccine mandates must grant a waiver if an employee submits a statement that receiving the vaccine would be injurious to the health and well-being of the employee or an individual residing with the employee.  In addition, Iowa employees discharged for not complying with an employer’s vaccine mandate are eligible for unemployment benefits under the new law. Kansas – On November 22, 2021, the Governor of Kansas signed a law with medical waiver requirements similar to Iowa’s law. On religious waivers, Kansas’ law goes beyond what is required by federal law, mandating that employers grant requests for religious exemptions “without inquiring into the sincerity of the request.” The law also outlines a complaint and investigation procedure for alleged violations and provides for monetary penalties that increase depending on the size of the employer. In addition, like the Iowa law, Kansas employees discharged for not complying with an employer’s vaccine mandate are eligible for unemployment benefits. The Biden Administration will almost certainly appeal the preliminary injunction.  The Eighth Circuit Court of Appeals would consider the appeal and could overturn the injunction and reinstate the mandate.  Given the timeline, we expect that new compliance deadlines would be established in the event the preliminary injunction is overturned. What should employers do? Covered employers in the ten states at issue who do not wish to proceed with a voluntary vaccine mandate may pause their current efforts to comply with the CMS vaccine mandate, but should at a minimum proceed with preparing a policy, religious and medical exemption forms, and an exemption review process so that employers are ready to proceed within any established deadlines if the preliminary injunction is lifted and the mandate is reinstated.  This is the same recommendation we have given to large employers covered by the Occupational Safety and Health Administration’s COVID-19 Vaccination and Testing Emergency Temporary Standard (OSHA ETS), which was stayed by the Fifth Circuit Court of Appeals on November 12, 2021.[1] Employers looking for consistency when it comes to COVID-19 vaccine mandates will not find it in today’s ruling and healthcare employers can once again add themselves to the list of employers who operate in multiple states and must undertake the task of wading through the various federal mandates and their legal statuses.  It is both possible and probable that multi-state healthcare employers will be required to comply with CMS’s federal vaccine mandate in one state while operating in another state wherein, at least for now, CMS’s federal vaccine mandate no longer exists. Dorsey’s employment and health care attorneys will continue to monitor the developments in this matter and will update our blog with changes.   [1] On November 23, 2021, the Biden Administration asked the Sixth Circuit Court of Appeals to reinstate the OSHA ETS vaccine mandate, following a lottery that assigned to that Circuit multiple challenges to the vaccine mandate.

**Note that a federal court has issued a temporary injunction stopping the CMS COVID-19 vaccine mandate in certain states.  Please read our blog post here for the latest information on this injunction. Last week, the Centers for Medicare and Medicaid Services (CMS) and the Occupational Safety and Health Administration (OSHA) published their much-anticipated rules mandating COVID-19 vaccinations.  This article focuses on the new CMS rules, and you can read about Dorsey’s analysis of the new OHSA Emergency Temporary Standard (ETS) here. Please note that if the CMS COVID-19 vaccine mandate applies to your facility, you must comply with the CMS COVID-19 vaccine mandate instead of with the new OSHA ETS. However, the above link to our article on the new OSHA ETS provides useful guidance on topics which apply generally to employers such as how to handle vaccine exemption requests. On November 4, 2021, the Centers for Medicare & Medicaid Services (CMS) issued its interim final rule (IFR) with comment period regarding staff vaccination requirements as a condition of receipt of Medicare or Medicaid funds.  CMS estimates that there will be more than 180 million staff, patients, and residents employed or treated at facilities covered by the rule, making the impact colossal.  The IFR is an emergency regulation, meaning that it takes effect on the date it is published in the federal register, November 5, 2021, and prior to the comment period.  Stakeholders will have 60 days, until January 4, 2022, to submit formal comments.  At that point, CMS will consider the comments in any future rulemaking it undertakes.  CMS also issued a press release and published FAQs to assist health care facilities in the understanding of these new regulations. The IFR applies to the following Medicare/Medicaid certified providers and suppliers: Ambulatory Surgical Centers (ASCs) Hospices Psychiatric residential treatment facilities (PRTFs) Programs of All-Inclusive Care for the Elderly (PACE) Hospitals (acute care hospitals, psychiatric hospitals, hospital swing beds, long term Care hospitals, children’s hospitals, transplant centers, cancer hospitals, and rehabilitation hospitals/inpatient rehabilitation facilities) Long Term Care (LTC) Facilities, including Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs), generally referred to as nursing homes Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID) Home Health Agencies (HHAs) Comprehensive Outpatient Rehabilitation Facilities (CORFs) Critical Access Hospitals (CAHs) Clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services Community Mental Health Centers (CMHCs) Home Infusion Therapy (HIT) suppliers Rural Health Clinics (RHCs)/Federally Qualified Health Centers (FQHCs) End-Stage Renal Disease (ESRD) Facilities[1] Indian Health Service (IHS) Facilities   A. What Must Covered Facilities Do? Under the IFR, the above-described “covered facilities” must develop, by December 5, 2021, a plan and procedure for requiring the COVID-19 vaccine for covered staff (as defined below),[2] collecting and storing vaccination data, considering medical and religious exemptions for covered staff, and contingency planning for unvaccinated staff.  Individuals are on a deadline to be fully vaccinated against COVID-19, with accommodations considered as required by law (discussed below). Unless exempted, staff must have their first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine by December 5, 2021. Staff must complete the vaccination series, and be “fully vaccinated”, by January 4, 2022. Fully vaccinated is defined as two or more weeks after the completion of a vaccination series; staff members will be considered compliant even if not fully vaccinated by January 4 as long as they have completed the vaccination series by then.[3]   A previous COVID-19 infection will not be considered a substitute for proof of vaccination.  Staff hired after December 5, 2021 must receive their first vaccine dose prior to providing any care, treatment, or other services. The IFR defines the term “staff” to include “facility employees; licensed practitioners; students, trainees, and volunteers; and individuals who provide care, treatment, or other services for the facility and/or its patients, under contract or other arrangement.”[4]  The fact that care may not be provided in a formal clinical setting does not relieve staff from the mandate.  How frequently a person physically enters a covered healthcare setting is also irrelevant. Only those staff who perform 100% of their work remotely (i.e. telehealth or payroll) are fully exempt from the vaccine mandate. This means that even staff who “occasionally encounter fellow staff, such as in an administrative office or at an off-site staff meeting, who will themselves enter a health care facility or site of care for their job responsibilities,” also must be vaccinated under the IFR. The IFR lists the following as acceptable proof of vaccination: CDC COVID-19 vaccination record card (or a legible photo of the card), documentation of vaccination from a health care provider or electronic health record, or a state immunization information system record.  Covered facilities must keep the proof of vaccination confidential, i.e. with a facilities immunization record, health information files, or other relevant confidential documents.    Facilities may choose how to collect and store this information. B. Exemptions from COVID-19 Vaccination Requirements and Conflicts with State Laws Title VII of the Civil Rights Act of 1964 (Title VII) and the Americans with Disabilities Act (ADA) allow for religious and medical exemptions, respectively, to the COVID-19 vaccine.  The IFR specifically directs healthcare entities to provide exemptions from the COVID-19 vaccine consistent with federal law, but medical exemptions appear narrow, including certain allergies and recognized medical conditions that make the COVID-19 vaccine contraindicated.  The IFR specifically directs facilities to the CDC’s Summary Document for Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States. Medical exemption request must be supported by documentation that is: Signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws. Such documentation must contain all information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and a statement by the authenticating practitioner recommending that the staff member be exempted from the facility’s COVID-19 vaccination requirements based on the recognized clinical contraindications. But, what happens when there are conflicts with state laws on exemptions?  New state laws signed by the governors of Texas and Iowa, for example, provide employees with exemptions beyond those required by these federal laws.  For example, employers in Texas must allow exemptions from the COVID-19 vaccine based on an employee’s “reason of personal conscience.”  This Texas law expands the application of religious exemptions beyond a “sincerely held religious belief, practice or observance” which is the standard for a waiver under Federal law.  In Iowa, employers must allow exemptions from the COVID-19 vaccine based on an employee’s statement that receiving the vaccine “would be injurious to the health and well-being of the employee or an individual residing with the employee.”  The Iowa law not only expands the medical exemption beyond the ADA, but also removes the requirement that a medical exemption be supported by a licensed practitioner. Anticipating such conflicts, the IFR explicitly states: We understand that some states and localities have established laws that would seem to prevent Medicare- and Medicaid-certified providers and suppliers from complying with the requirements of this IFC.  We intend, consistent with the Supremacy Clause of the United States Constitution, that this nationwide regulation preempts inconsistent State and local laws as applied to Medicare- and Medicaid-certified providers and suppliers. . . . As is relevant here, this IFC preempts the applicability of any State or local law providing for exemptions to the extent such law provides broader exemptions than provided for by Federal law and are inconsistent with this IFC. (Emphasis added) The FAQs issued by CMS underscore this position, stating that no exemptions should be granted if not legally required under the ADA or Title VII, nor should an exemption be granted to someone “who requests an exemption solely to evade vaccination.”[5] In response to the federal government’s simultaneous release of the equally long-awaited Emergency Temporary Standard (ETS) from OSHA, Iowa Governor Kim Reynolds announced plans to challenge the ETS in court.  She made no similar plans regarding the IFR.  In addition, Arkansas, Alaska, Missouri, Iowa, Montana, Nebraska, New Hampshire, North Dakota, South Dakota and Wyoming joined in a federal lawsuit filed last week in Missouri challenging the government’s vaccination requirements for federal contractors and subcontractors.  The OSHA ETS was promptly stayed in court, and as of the publication of this article, we are awaiting a decision about whether the ETS will be permitted to proceed. Healthcare employers are encouraged by CMS to follow the guidance released by the Equal Employment Opportunity Commission (EEOC) related to medical and religious exemptions for employees.  Employers should develop a process for fairly reviewing medical and religious exemptions on an individualized basis that shows thoughtful consideration and analysis of each request.  If employers grant exemptions, they must take steps to minimize the risk of COVID-19 transmission.  Such steps could include additional or enhanced personal protective gear, separation barriers, elimination or substitution of less critical job duties, temporary modification of work schedules, or moving the location of where one performs work. C. How the Federal Rules Interact: Conflicts Between Federal Laws In addition to potential conflicts between state laws and the federal rules, healthcare facilities may also have questions about which of the federal rules reign supreme.  The IFR’s FAQs address this as well: If a Medicare- or Medicaid-certified provider or supplier falls under the requirements of CMS’s IFR, the IFR must be followed. If facilities participate in and are certified under the Medicare and Medicaid programs and are regulated by the CMS health and safety standards known as the Conditions of Participation (CoPs), Conditions for Coverage (CfCs), and Requirements for Participation (RoPs), then they, too, are expected to abide by the requirements established in CMS’s IFR. Importantly, the IFR takes priority over other federal vaccination requirements (i.e. the Executive Order for federal contractors and subcontractors, and the OSHA ETS for employers with 100+ employees). The Executive Order for federal contractors and subcontractors may apply to staff who are not subject to the vaccination requirements outlined in the IFR. If a facility is subject to both the Executive Order and the new OSHA ETS for large employers, the facility should follow the Executive Order for federal contractors and subcontractors. The OSHA ETS for employers with 100+ employees applies to employers that are not subject to the CMS IFR or the Federal Contractor and Subcontractor Executive Order. Additionally, employers subject to the OSHA COVID-19 Healthcare ETS need not also comply with the new OSHA ETS for large employers. The bottom line is that the federal government does not intend for an employer or covered facility to assure compliance with more than one federal rule.  If there is some question about with rule applies to a particular entity, entities should comply with the strictest federal rule applicable to the entity. Vaccine mandate laws, interpretations and challenges are rapidly developing across the U.S.  If you have any questions about vaccine mandates, please contact your regular Dorsey attorney or any of the authors of this article. [1] The IFR does not apply to other healthcare entities not regulated by CMS (i.e. physician offices, Assisted Living Facilities, Group Homes, home and community-based services, or schools), but those entities could be subject to other federal vaccine requirements.  In addition, Religious Nonmedical Health Care Institutions (RNHCIs), Organ Procurement Organizations (OPOs), and Portable X-Ray Suppliers are not covered by the IFR even though those entities are regulated by CMS.  However, it is important to note that staff of these entities may be indirectly included in CMS’ vaccine requirements through their service arrangements with hospitals, long term care facilities, and other providers and suppliers who are covered under the IFR.  Further, it is possible that staff may be required by other federal or state laws to obtain a COVID-19 vaccination. [2] Covered individuals will be referred to throughout this post as “staff,” because coverage of the rule extends beyond those individuals who are employed by covered facilities, but also includes medical staff, contractors and volunteers, as discussed herein. [3] The IFR references booster vaccines but does not require them. [4] CMS considered limiting vaccine requirements to full-time employees.  Ultimately, CMS concluded that including a broader group of those required to be vaccinated would be manageable without creating major issues for compliance, enforcement, and record-keeping. [5] The FAQs also add that the IFR preempts any contrary state laws pursuant to the Supremacy Clause of the United States Constitution.  

The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Dorsey’s Katie Ervin Carlson and Aaron Goldstein for the following e-newsletter update: On October 25, 2021, the Equal Employment Opportunity Commission (“EEOC”) released additional guidance for employers navigating their way through employee requests for religious exemptions from COVID-19 vaccine mandates.  The update supplements guidance initially released by the EEOC in May, and attempts to address some of the situations employers have faced as workplace COVID-19 vaccine mandates grow in popularity and as the Occupational Safety and Health Administration (”OSHA”) and the Centers for Medicare & Medicaid Services (“CMS”) prepare to issue federal mandates in addition to those already in place for federal contractors. You can read the rest of the article, by clicking here.

The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Dorsey’s Ryan Mick, Katie Ervin Carlson and Andrew James for the following e-newsletter update: On September 30, 2021, the Federal Acquisition Regulation (“FAR”) Council issued a memorandum requiring that most federal contractors and subcontractors include a clause in future contracts and subcontracts that require employees to be vaccinated.  This directive follows President Biden’s September 9 announcement, as well as the Safer Federal Workforce Task Force Guidance (the “Guidance”) issued on September 24. Read more here.

On May 28, 2021, a group of Houston Methodist Hospital employees filed a lawsuit challenging the hospital’s COVID-19 vaccine mandate for employees.  The lawsuit, filed by 117 employees, was the first to challenge a health care employer’s COVID-19 vaccine mandate.  The employees’ grievances included that the vaccine is unsafe and that employers may not treat an employee like “a human guinea pig.”  At that time, all three COVID-19 vaccines were still being administered under the Food and Drug Administration “FDA”)’s Emergency Use Authorization (“EUA”). On June 12, 2021, a federal district judge dismissed the lawsuit.  The judge cited several reasons in dismissing the suit, including the Equal Employment Opportunity Commission (“EEOC”)’s guidance that, with medical and religious exemptions, employers can require employees to get the COVID-19 vaccine.  In response to the claim that the hospital was violating employees’ human rights by requiring the COVID-19 vaccine, the judge stated: The hospital’s employees are not participants in a human trial.  They are licensed doctors, nurses, medical technicians, and staff members.  The hospital has not applied to test the COVID-19 vaccines on its employees, it has not been approved by an institutional review board, and it has not been certified to proceed with clinical trials. As to the employees’ argument that they were being coerced into getting the vaccine or risk termination, the judge held: If a worker refuses an assignment, changed office, earlier start time, or other directive, he may be properly fired.  Every employment includes limits on the worker’s behavior in exchange for his remuneration.  That is all part of the bargain. The idea that employers routinely set workplace rules by which employees can either choose to abide or find other employment was central to a recent decision by a court in the Eastern District of Kentucky on September 24, 2021.  That case, Beckerich, et. al. v. St. Elizabeth Medical Center, et. al., was filed on September 3, 2021, by 40 hospital employees challenging the hospital system’s COVID-19 vaccine mandate.  The employees argued several violations, including that the mandate constituted fraud on behalf of the hospital, the United States Government, the Biden Administration, and the media.  One difference between the Houston Methodist and the St. Elizabeth case is that on August 23, 2021, the FDA gave full approval to the Pfizer-BioNTech COVID-19 Vaccine.  That full approval likely ended the likelihood that any employees going forward will be able to seriously argue that requiring the vaccine was tantamount to human experimentation. In denying the employees’ request for a temporary injunction (which would have halted the hospital’s mandate from going forward until the case could be fully decided on the merits), the court rejected the employees’ attempt to make constitutional claims on the basis that the hospital, by receiving federal funds, is essentially a governmental actor.  To that argument the court stated, “[p]rivate hospitals, no matter how much federal funding they may receive, are generally not state actors for purposes of constitutional questions.” The court also examined how the “greater good” should be analyzed in the context of legal challenges to COVID-19 vaccine mandates, asking, “[i]s the ‘greater good’ made up of many different individual liberties, is it a singular collective liberty, or is it both?”  The court then looked to a United States Supreme Court case from 1905 upholding Massachusetts’ small pox vaccine mandate.  We previously discussed that case in an update outlining President Biden’s COVID-19 Action Plan. Like the court in Houston Methodist, the judge in St. Elizabeth noted that employers make rules all the time, and employees have a choice whether to follow those rules or find work elsewhere: “To work at St. Elizabeth, Plaintiffs agree to wear a certain uniform, to arrive at work at a certain time, to leave work at a certain time, to park their vehicle in a certain spot, to sit at a certain desk and to work on certain tasks.  They also agree to receive an influenza vaccine, which Defendants have required of their employees for the past five years. These are all conditions of employment, and ‘“every employment includes limits on the worker’s behavior in exchange for his remuneration.’ . . . If an employee believes his or her individual liberties are more important than legally permissible conditions on his or her employment, that employee can and should choose to exercise another individual liberty, no less significant – the right to seek other employment.” While these cases involve challenges to voluntary COVID-19 vaccine mandates, the legal reasoning utilized by the courts might prove to be a roadmap for challenges to the vaccine mandates that are part of President Biden’s COVID-19 Action Plan.  That includes an expansion of a previously announced but not yet released requirement that health care employers (previously just long term care providers) require the COVID-19 vaccination as a condition of receipt of Medicare and Medicaid funds.

On September 9, 2021, the Biden Administration announced its new COVID-19 Action Plan (the “Action Plan”), which outlines a six-pronged approach to combat the pandemic.  The wide-ranging Action Plan lays out plans to vaccinate the unvaccinated, further protect the vaccinated, keep schools safely open, increase testing and masking, protect the economic recovery, and improve care for those with COVID-19.  Three components of the Action Plan’s “vaccinate the unvaccinated” prong impose new requirements for employers.  Those components are: Require all employers with 100 or more employees to ensure their workers are vaccinated or tested weekly and to provide paid time off for employees to get vaccinated; Require COVID-19 vaccination for all federal workers and all employees of federal contractors and subcontractors; and Require COVID-19 vaccination for health care workers at Medicare and Medicaid participating hospitals and other health care settings. On the same day he issued the Action Plan, President Biden issued two executive orders requiring vaccination for all federal employees and directing the Safer Federal Workforce Task Force to issue COVID-19 safety-related guidance.  President Biden also instructed the Occupational Safety and Health Administration (“OSHA”) to issue an Emergency Temporary Standard (“ETS”) to implement the Action Plan’s employer obligations. A BRIEF HISTORY OF GOVERNMENT VACCINATION MANDATES, OSHA ETS AUTHORITY, AND EXISTING OSHA COVID-19 RULES In 1905, the United States Supreme Court upheld Massachusetts’s compulsory small pox vaccination law in a case challenging the constitutionality of the state’s vaccination mandate.  The decision did not address the constitutionality of a federal vaccination mandate or, if permissible, whether such a mandate may be issued by President without legislative action.  The decision did, however, provide analysis of the government’s ability to enact laws intending to protect the health and welfare of citizens during an outbreak or pandemic that will likely be relied on in any upcoming challenges to the Action Plan.  In response to claims that notions of liberty preclude government vaccine mandates, the Court stated: The liberty secured by the Constitution of the United States does not import an absolute right in each person to be at all times, and in all circumstances, wholly freed from restraint, nor is it an element in such liberty that one person, or a minority of persons residing in any community and enjoying the benefits of its local government, should have power to dominate the majority when supported in their action by the authority of the State. OSHA has authority to issue an ETS when “employees are exposed to grave danger from exposure to substances or agents determined to be toxic or physically harmful or from new hazards” and when such emergency standard is “necessary to protect employees from such danger.”  OSHA’s ETS authority allows it to forego its normal what rulemaking process.  An ETS can remain in place for up to six months, at which time OSHA must replace it with a permanent standard adopted through the normal rule making process.  The last ETS OSHA issued before its June 2021 ETS for the prevention of COVID-19 in healthcare employment was a 1983 rule addressing workplace asbestos exposure that the Fifth Circuit Court of Appeals (covering Louisiana, Mississippi, and Texas) struck down months later in part on the grounds that OSHA did not provide sufficient support for its claim that 80 workers would die from asbestos exposure in the 6 months the ETS would cover. On June 10, 2021, OSHA issued the first nationwide workplace-safety rule in an ETS for health care employers in response to the COVID-19 pandemic, and it was codified in the Federal Register on June 21, 2021.  The motivation behind OSHA’s June 2021 ETS addressing COVID-19 protections for health care workers was OSHA’s determination that a “grave danger” to employee health existed related to the virus.   OSHA’s August update states “OSHA has determined that CDC’s guidance on health care settings has not changed and that the requirements of the health care ETS released on June 10, 2021, remain necessary to address the grave danger of COVID-19 in health care.”  OHSA indicates it will monitor and assess monthly the need for any updates or changes to the health care ETS. The Biden Action Plan in many ways follows OSHA’s August 13, 2021 advisory guidance aimed at mitigating and preventing the spread of COVID-19 in the workplace, but also imposes new legal obligations regarding COVID safety in the workplace. WHAT DOES THE BIDEN ACTION PLAN REQUIRE? A.   Employers with 100+ Employees. Vaccination or Weekly Testing Requirement OSHA is developing a rule that will require all employers with 100 or more employees to ensure their workforce is fully vaccinated or require any workers who remain unvaccinated to produce a negative test result on at least a weekly basis before coming to work.  OSHA will issue an ETS to implement the requirement.  This requirement is expected to affect over 80 million workers in private sector businesses with 100 or more employees. Several questions remain regarding exactly how OSHA will implement the COVID-19 Action Plan for private employers, including how OSHA will determine whether an employer has more 100 or more employees for purposes of the ETS, who will pay for the weekly testing, the deadline for meeting the ETS standards, and how OSHA will apply penalties for non-compliance.  While there is little doubt that the ETS will contain exceptions for employees who are unable to be vaccinated due to a disability or sincerely held religious belief, as is protected under federal and state laws, it will remain to be seen whether states which have enacted laws prohibiting employers from mandating vaccinations for employees will bring legal challenges to the ETS and the Action Plan more broadly. It is widely anticipated they will. Paid Leave for Vaccination. OSHA’s ETS will also require employers with more than 100 employees to provide paid time off for vaccination and, if needed, post-vaccination recovery.[1] B.   The Federal Government, Federal Contractors, and Federal Subcontractors. President Biden issued an Executive Order requiring all federal agencies to require COVID-19 vaccination for all of their employees, with exceptions only as required by law (e.g. religious and medical reasons).  The Order directs The Safer Federal Workforce Task Force to issue compliance guidance by September 16, 2021. The President signed a second Executive Order that applies to organizations that contract with the federal government and subcontractors to those contracts.  While the Executive Order itself does not contain a vaccine mandate, President Biden’s Plan indicates that the requirement that all federal employees receive the COVID-19 vaccine will “be extended to employees of contractors that do business with the federal government.” As to the contracts themselves, the Executive Order applies to any: (1) new contract, (2) new contract-like instrument, (3) new solicitation for a contract or contract-like instrument, (4) extension or renewal of an existing contract or contract-like instrument, or (5) exercise of an option on an existing contract or contract-like instrument.  The Executive Order covers these contracts or contract-like instruments that are for services, construction, or a leasehold interest in real property; for services covered by the Service Contract Act; for concessions; or in connection with federal property or lands and related to offering services for Federal employees, their dependents, or the general public. The Executive Order requires agencies to take steps to include by October 8, 2021 required language for all contracts and contract-like instruments entered into or otherwise meeting the criteria above on or after October 15, 2021. Extensions and options are used by the federal government pursuant to the Federal Acquisition Regulation, which permits solicitations and contracts to include an option clause that allows the government “to require continued performance of any services within the limits and at the rates specified in the contract.”  An option provision can be exercised more than once, but the total time of extension cannot exceed six months. The Executive Order governing federal contractors and subcontractors does not apply to: (1) grants, (2) contracts, contract-like instruments, or agreements with Indian Tribes under Public Law 96-638, (3) contract or contract-like instruments with value equal to or less than the simplified acquisition threshold as defined by the Federal Acquisition Regulation, (4) employees who perform work outside of the United States, or (5) subcontracts solely for the provision of products. In defining “contract-like instruments,” the Executive Order refers to the Department of Labor’s proposed rule, “Increasing the Minimum Wage for Federal Contractors,” 86 Fed. Reg. 38816, 38887 (July 22, 2021). The Executive Order requires executive departments and agencies to ensure that contracts and contract-like instruments include a clause that contractors and subcontractors must incorporate into lower-tier subcontracts.  The clause will mandate compliance with “all guidance for contractor or subcontractor workplace locations published by the Safer Federal Workforce Task Force” and will apply to any locations in which an individual works in connection with a federal contract or contract-like instrument.  The Task Force is to issue such guidance no later than September 24, 2021.  Thus, the Executive Order does not require contractors and subcontractors to create vaccination mandate language.  Rather, their responsibility will be to include required language in contracts and develop workplace plans that ensure compliance it. For contracts not covered by the Executive Order, the President has “strongly encouraged” contractors and subcontractors to follow any safety protocols developed by the Safer Federal Workforce Task Force. C.  Medicare and Medicaid Participating Hospitals and Other Health Care Settings. Prior to the Action Plan’s launch, organizations that advocate for long-term-care facilities urged the Administration to mandate the COVID-19 vaccine throughout the health care industry, citing concerns over existing staffing shortages that facilities feared would worsen if long-term-care workers who wished to decline the vaccine had the option to work in other health care facilities.  In response, on August 18, 2021, President Biden announced plans to require long-term-care facilities to have “fully vaccinated” workforces as a condition of receiving Medicare or Medicaid funding.  Details of those requirements are yet to be released, but in the Action Plan, he expanded that mandate to all healthcare workers at Medicare and Medicaid-participating healthcare organizations, including, but not limited to, hospitals, dialysis facilities, ambulatory surgical settings, and home-health agencies. While OSHA’s June 2021 ETS was broadly aimed at protecting health care workers amid the COVID-19 pandemic, it stopped short of requiring vaccines. President Biden’s COVID-19 Action Plan goes further by requiring vaccinations for many employees in the healthcare industry. D.   All Employers For months, the Equal Employment Opportunity Commission (“EEOC”) has opined that all employers under its jurisdiction may elect to mandate COVID-19 vaccination for their employees. As we have previously discussed, employers that mandate the vaccine must make exceptions for medical and religious reasons or risk violating state and federal anti-discrimination laws. Small employers who hope to avoid vaccine mandates may also incentivize employee vaccination.  The EEOC’s guidance explains that employers that administer vaccines may incentivize vaccination, as long as the incentives are non-coercive. PRACTICAL STEPS FOR EMPLOYERS Employers with 100 or more employees should begin considering and developing a vaccination policy that will comply with the Action Plan. All employers mandating vaccines should consider the potential for exemptions for reasonable accommodations for religious belief and disabilities, pursuant to Title VII of the Civil Rights Act of 1964 (“Title VII”) and the Americans with Disabilities Act (“ADA”), as well as applicable state law. Employers should confirm whether they are a federal contractor or subcontractor. Federal contractor status is present if an organization has a contract with the federal government.  Federal subcontractor status can be determined through a letter from a government contractor stating your organization is a subcontractor necessary for the performance of a government contract or undertaking a federal contractor’s obligation under its contract. Other ways to assess federal-contractor/subcontractor status include a search on the Federal Procurement Data System or USA spending either by searching for the organization name or Dun & Bradstreet number. Employers with under 100 employees, and those without existing federal contracts not subject to the Executive Order, should consider whether to adopt vaccine mandates or incentives as outlined by the EEOC. Employers should anticipate changes to new requirements due to COVID-19 itself (Delta, Mu, and other variants) and how to respond to such changes. [1] President Biden’s COVID-19 Action Plan states that private employers with “100 or more” employees must require vaccination, but that private employers with “more than 100” employees must provide paid vaccination leave.  While this may be an unintentional typo, we recommend employers presume that if they are required to mandate the vaccine, they are also required to provide paid vaccination leave.

As we have previously written, the landscape for employers in the time of COVID-19, particularly health care employers and long term care facilities, is ever-changing and quickly moving.  In the last year, health care employers have had to navigate state laws, Centers for Disease Control and Prevention (“CDC”) and Centers for Medicare & Medicaid Services (“CMS”) guidance, EEOC guidelines, as well as compliance with a complex Emergency Temporary Standard (“ETS”) issued by the Occupational Safety and Health Administration (“OSHA”). In the midst of all that, health care providers have grappled with whether to implement policies requiring COVID-19 vaccinations for employees absent a religious or medical exemption.  In Iowa, Unity Point Health, Sanford Health, MercyOne, Genesis Health System, and Trinity Health will require employees to be vaccinated for COVID-19 in the next few weeks and months.  This includes long term care facilities administered by those entities. In a somewhat unexpected twist, the Biden Administration announced today that CMS and the CDC are “developing an emergency regulation requiring staff vaccinations within the nation’s more than 15,000 Medicare and Medicaid-participating nursing homes.”  According to the announcement, a rule is expected in the coming weeks.   The Administration’s order will surely generate multiple lawsuits challenging the legality of the mandate.  We estimate that those lawsuits will likely not be successful, in part based how quickly similar lawsuits against hospital employers have been dismissed by courts across the country.  For example, this summer a court swiftly dismissed a lawsuit filed by employees of Houston Methodist hospital challenging the hospital’s COVID-19 vaccine mandate. Last week, in addition to the OSHA ETS for healthcare employers published on June 21, 2021, OHSA issued new recommendations for all employers with a specific focus on protecting unvaccinated workers.  To combat the continued spread of COVID-19, OSHA recommends that employers do the following: Assist employees in getting vaccinated for COVID-19, including paid time off to get and recover from vaccines. Some employers can receive tax benefits for voluntarily paying employees under these and other circumstances. Remove employees with known or suspected COVID-19 exposure from the workplace for either 14 days or until the employee receives a negative test result. Make sure that unvaccinated and high risk employees physically distance from others, limit the number of unvaccinated and high risk employees at one place at any given time, allowing remote working for unvaccinated and high risk employees, and installing transparent barriers when physical distancing is not feasible. Require employees to wear masks indoors (unless other PPE is otherwise required for the job), and provide face coverings to employees who do not have their own. Educate employees on workplace COVID-19 policies and procedures, including providing materials in multiple languages as needed. Suggest that unvaccinated customers, vendors, visitors, or other guests wear a mask. Maintain properly working ventilation systems. Follow CDC guidelines regarding cleaning and disinfection. Record and report workplace infections and deaths related to COVID-19. Implement policies and procedures to ensure that employees who raise concerns about COVID-19 in the workplace are not subject to retaliation. Follow any other applicable mandatory OSHA standards. In sum, OSHA recommends that, for the most part, all employers follow the requirements set forth for healthcare providers in the ETS. We want to help all employers keep their employees safe and protected from COVID-19, and we want to help you do your part to prevent the spread of the virus.  If you have any questions about what you are required by law to do in your workplace, or what is not required but recommended, please contact a qualified employment and healthcare attorney.  

On June 10, 2021, Dorsey’s Labor & Employment attorneys outlined an Emergency Temporary Standard (“ETS”) issued by OSHA.  At the time, the ETS was not an official regulation because it had not yet been published in the Federal Register.  On June 21, 2021, the ETS was published and, for covered healthcare employers, the compliance clock started ticking. As a refresher, the ETS applies to “all settings where any employee provides healthcare services or healthcare support services.”  1910.502(a)(1).  Broadly, the following activities are exempted from coverage: the provision of first aid by an employee who is not a licensed health care provider; the dispensing of prescriptions by pharmacists in retail settings; non-hospital ambulatory care settings where all non-employees are screened prior to entry and people with suspected or confirmed COVID–19 are not permitted to enter those settings; well-defined hospital ambulatory care settings where all employees are fully vaccinated and all non-employees are screened prior to entry and people with suspected or confirmed COVID–19 are not permitted to enter those settings; home health care settings where all employees are fully vaccinated and all non-employees are screened prior to entry and people with suspected or confirmed COVID–19 are not present; health care support services not performed in a health care setting (e.g., off-site laundry, off-site medical billing); or telehealth services performed outside of a setting where direct patient care occurs. In addition, for covered employers, ETS requirements regarding masking, physical barriers, and physical distancing do not apply to fully vaccinated employees in well-defined areas where there is no reasonable expectation that any person with suspected or confirmed COVID–19 will be present.  1910.502(a)(2)(i)-1910.502(a)(4). As to employee vaccinations, the ETS specifically contemplates that there may be medical conditions, disabilities, or religious reasons employees cannot be vaccinated.   Employers are reminded in the ETS guidance that they should make exceptions where appropriate.  We discussed EEOC guidance regarding employee vaccinations in a previous blogpost. Except for requirements regarding physical barriers, ventilation, and training, employers must comply with the ETS mandates by July 6, 2021.  Employers must become compliant with the physical barrier, ventilation, and training requirements by July 21, 2021. When OSHA first issued the ETS, little direction was available directly from OSHA in terms of how employers could comply with the ETS’s many mandates.  Since publication of the ETS in the Federal Register, OHSA has fortified existing resources and added new ones.  Employers should visit OSHA's ETS website for Fact Sheets, FAQs, Notification Removal and Return to Work Flow Charts for both Employers and Employees, Employee Training Presentations, and more. Further, it is important to understand how the new OSHA regulations interact with already existing guidance on similar COVID-19 related topics for health care providers which have been published by other federal and state agencies, such as the Centers for Medicare and Medicaid Services and the Centers for Disease Control and Prevention.  In most cases, the various guidance and regulations do not conflict, but a careful review of all related laws and agency guidance is prudent, in order to fully understand the rules that apply in a given situation, especially when there is a conflict. A qualified employment lawyer can assist employers with matters such as developing their COVID-19 Plan, planning the Workplace Hazard assessment, and conducting training; all things which are required by the ETS.  Please contact the author of this blog post or your regular Dorsey & Whitney labor and employment attorney with further questions about how to come into compliance with the new OSHA guidance by the July 6 and July 21 deadlines.

The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Dorsey’s Rebecca Bernhard, Aaron Goldstein and Alyson Dieckman for the following e-newsletter update: OSHA Issues COVID-19 Workplace Safety Rule for Healthcare Employers On June 10, 2021, the Occupational Safety and Health Administration (“OSHA”) released the first nationwide workplace safety rule in response to the COVID-19 pandemic.  OSHA’s guidance is only binding on healthcare employers.  OSHA reported that it will issue supplemental voluntary guidance for other industries. (Read more here.)

One of the last pieces of legislation the Iowa legislature sent to Governor Kim Reynolds’ desk for guaranteed signature was a bill banning vaccine passports in Iowa.  House File 889 contains several prohibitions regarding inquiries into a person’s COVID-19 vaccine status.  For entities that contract with the state government or otherwise receive state funding, the law contains financial consequences for a violation (but is silent as to penalties for others).  While the law contains clear proscriptions, it also has notable explicit and implicit exclusions. Healthcare providers, and nursing home facilities specifically, have additional considerations under recently released CMS, CDC and OSHA guidance.  All employers have considerations under state and federal anti-discrimination laws and updated EEOC technical assistance. Iowa Law Iowa’s law prohibits the designation of COVID-19 vaccine status on state or political subdivision-issued identification cards.  That means there will be no COVID-19 notations on Iowa drivers’ licenses anytime soon.  The law also forbids businesses or governmental entities from requiring customers, patrons, clients, patients, or other persons invited onto the premises (“invitees”) to show proof of a COVID-19 vaccine. However, the law does not list employees in the category of people who are protected from having to show proof of a COVID-19 vaccine.  Therefore, under Iowa law, employers can legally require employees to show proof of a COVID-19 vaccine as a condition of employment. Further, the law explicitly excludes healthcare facilities from the definition of a business or a governmental entity.  Healthcare facilities include hospitals and other licensed inpatient centers, ambulatory surgical or treatment centers, skilled nursing centers and nursing facilities, residential treatment centers, diagnostic, laboratory and imaging centers, rehabilitation and other therapeutic health settings, and intermediate care facilities for people with mental illness or intellectual disabilities. CDC, CMS and OSHA Guidance On April 27, 2021, the Centers for Disease Control and Prevention (CDC) published updated health care infection prevention and control recommendations following the wide availability of COVID-19 vaccination, available here.  The CDC guidance includes updated COVID-19 testing recommendations, updated visitation guidance for health care facilities, and additional guidance for communal activities and dining in healthcare settings. Shortly thereafter, on May 11, 2021, CMS published updated guidance for long term care (LTC) facilities, called an interim final rule.  That rule, available here, focuses on COVID-19 vaccination education, consent, and refusal, as well as the procedures LTC facilities must follow in offering vaccinations to employees and residents.  It also includes recordkeeping requirements.  The guidance is silent regarding whether LTC facilities can require employee or resident vaccinations, instead simply stating, “[f]acilities should follow state law and facility policies with respect to staff refusal of vaccination.” In Iowa, that means long term care facilities could choose to require all staff and residents to be vaccinated. On June 10, 2021, OSHA published the first guidance for employers governing workplace safety rules related to COVID-19, which applies only to employment settings where employees provide healthcare services or healthcare support services in a healthcare setting.  The new OSHA rules are entitled, the “COVID-19 Healthcare Emergency Temporary Standard”, and they are available here.  FAQs regarding the new regulations were published by OSHA and are available here.  The scope of this article does not cover the new OSHA COVID-19 Healthcare Emergency Temporary Standard because Dorsey attorneys published a separate article on this new guidance including practical tips for its implementation, which is available here. EEOC Guidance Health care facilities adopting COVID-19 vaccination requirements should be mindful of state and federal anti-discrimination laws such as the Iowa Civil Rights Act (ICRA) and the Americans with Disabilities Act (ADA).  Both the ICRA and the ADA prohibit employers and places of public accommodation from discriminating against people on the basis of their religion or disability, among other things.  Public accommodations include, but are not limited to places that offer services, facilities, or goods for a fee or charge.  To name a few, a person’s health condition could prohibit them from getting a COVID-19 vaccine, a person’s religion might prohibit vaccinations, a person may be reluctant to get the vaccine while pregnant, and data has shown that minority communities disparately have lower vaccination rates.  Health care facilities mandating vaccines could run into legal issues if they are unwilling to make exceptions in certain circumstances. Additionally, on May 28, 2021, the EEOC updated its technical guidance regarding whether employers can provide COVID-19 vaccine incentives for employees in a technical assistance Q&A, available here.  The EEOC guidance echoes the considerations above, noting that employers must take care not to run afoul of state and federal employment laws when making decisions about vaccine requirements.  The guidance also states the vaccine incentives cannot be coercive, and that employers must keep vaccine information confidential. Practical Tips and Take Aways In light of the ever-changing status of employment and health laws and guidance related to COVID-19, healthcare facilities drafting or updating policies related to COVID-19 mitigation should consult with their employment and health care counsel to make sure the policies are consistent with Iowa’s vaccine passport law, state and federal employment laws and technical assistance, and any recent CDC and CMS publications. That said, the following tips may help to guide health care facilities’ development of employment-related COVID-19 policies and procedures: Healthcare employers, particularly LTC facilities, considering mandating the COVID-19 vaccine for employees should also think about the impact such a mandate might have on the available workforce. With data suggesting that only about half (or less) of Iowa’s LTC facility employees are fully vaccinated, employers might see crippling staff shortages if they start making the COVID-19 vaccination a condition of new or continued employment. Healthcare employers seeking to increase their workforce’s COVID-19 vaccination rates could come up with ways to fairly incentivize employees, consistent with the recent EEOC technical assistance. Regardless of the type of vaccine, if employers choose to require vaccinations as a condition of employment, they should remember to keep all vaccination information confidential pursuant to the ADA. If employers believe that a lack of convenient access is a contributing factor to low employee COVID-19 vaccine rates, employers could consider holding vaccine clinics consistent with the CMS guidance described and linked above. Employers who do choose to hold vaccine clinics or otherwise make the COVID-19 vaccine available to employees at work should be cognizant of their workforce and adjust accordingly. For example, employers should think about whether informational materials should be offered in languages other than English and whether some of the people administering vaccines should be bilingual. Healthcare employers which are covered under the new OSHA COVID-19 Healthcare Emergency Temporary Standard referenced above (generally, those with 10 or more employees) should ensure that the company’s written COVID-19 plan incorporates all of the elements required under the new COVID-19 Healthcare Emergency Temporary Standard, including providing reasonable time off and paid leave for vaccinations and vaccine side effects for employees. For more information on the new OSHA standards, see a separate post by our Dorsey colleagues, available here. Prior to taking any adverse action against an employee related to that person’s COVID-19 vaccination status, or any other conduct pertaining to COVID-19, employers should seek guidance from a knowledgeable employment law attorney. As described in an earlier blog post, COVID-19 related lawsuits against employers are on the rise (including in Iowa), and employers need to be proactive in ensuring their decisions are consistent with the ever-changing legal landscape on these issues.

Despite widespread vaccine availability and the corresponding optimism about returning to “normal,” the coronavirus pandemic continues to spawn hundreds of employment and health-related lawsuits.  Many of these lawsuits have been aimed at employers in the healthcare sector and relate to workplace safety, retaliation, and wrongful termination or wrongful denial of leave.  In fact, since our last update on this topic (available here), the healthcare sector has increased its relative share of coronavirus lawsuits compared to other industries.  In December 2020, approximately 20 percent of lawsuits alleging labor and employment violations related to coronavirus arose from the healthcare industry; today, that number is approximately 25 percent. The total number of coronavirus lawsuits has also increased dramatically.  At the end of 2020, 1,235 total lawsuits had been filed against employers related to the coronavirus.  Today, that number has more than doubled; there have been 2,560 lawsuits, including 200 class actions.  States with the most filings include California (666), New Jersey (293), Florida (198), New York (184) and Ohio (156). Whether brought in California, Iowa, or elsewhere, coronavirus lawsuits most commonly assert that employers violated federal and state mandates, guidelines, and regulations regarding employee safety.  One such federal mandate was the Families First Coronavirus Response Act (FFCRA), passed by Congress in March 2020 (and, with certain exceptions, expired in December 2020).  While operative, the FFCRA required employers with fewer than 500 workers to provide employees with a certain amount of compensated time off for various reasons linked to COVID-19, including if employees become ill.  Importantly, however, the FFCRA provided that certain employees—i.e., “health care providers and emergency responders”—may be excluded from entitlement to both emergency family leave and emergency paid sick leave.  In addition to FFCRA cases, employees have also filed lawsuits alleging that their employers violated the federal WARN Act (or similar state laws), which in certain circumstances requires that employers with 100 or more employees provide at least 60 days’ notice before conducting a mass layoff. Even though there are fewer lawsuits involving COVID-19 related issues in states like Iowa, the recently filed Iowa cases are representative of the types of cases occurring across the country.  In one case, an employee of a hospital asserts that she was terminated after she raised concerns about the lack of available personal protective equipment and about staff failing to wear masks correctly.  She also claims that she raised concerns about an social event where staff were attending without masks and without adhering to social distancing guidelines.  Another case involves claims by a food manufacturer’s nurse supervisor asserting her employer’s lack of preparedness for COVID-19 and her resulting firing after she raised safety concerns. Although other employment-related cases in Iowa have been filed against employers outside the health care industry, similar cases could be filed against those in the health care industry in the future.  These cases include allegations that employers denied leaves of absence for an individual with high risk conditions and failure to implement proper screening, social distancing and other protective measures, which in one case resulted in deaths from COVID-19.  On the flip side, Iowa has also seen recent litigation filed with an individual asserting a civil rights violation for requiring students to wear a mask to school. A recent development that may impact future coronavirus litigation is the updated federal guidance on mask mandates.  On May 13, 2021, the U.S. Centers for Disease Control and Prevention (“CDC”) revised its guidance to reflect that “fully vaccinated” individuals no longer need to wear masks, whether indoors or outdoors, except in limited circumstances.  And while there is a caveat for “local business and workplace guidance,” OSHA is advising employers to follow CDC guidelines for fully-vaccinated employees.  Accordingly, employers across the nation now face the practical challenge of maintaining a safe and compliant workplace in an increasingly open environment, while at the same time minimizing their risk for legal liability. While many states have enacted legislation that limits the liability of healthcare providers for actions or omissions during the pandemic, most of the legislation leaves openings for plaintiff’s lawyers to argue that their clients’ claims are not prohibited, especially with respect to employment-related claims.  For example, Iowa enacted the “COVID-19 Response and Back-to-Business Limited Liability Act”.  Under the Iowa Act, providers cannot be held civilly liable for various actions, which include, but are not limited to screening, assessing, diagnosing, caring for or treating individuals with COVID-19. The Act also provides protection for acts or omissions relating to non-COVID-19 patients, if those acts or omissions result from supporting the state’s response to COVID-19. This may include acts such as providing treatment outside the premises of a health care facility or using equipment and supplies outside their normal use.  As seen by the lawsuits described above, the Iowa Act does not prevent the filing of employment-related claims and notably, liability can still be established even in non-employment related contexts if the provider acted recklessly or engaged in willful misconduct. Navigating the highly dynamic landscape of federal, state, and local coronavirus rules and policies presents numerous challenges for employers.  But healthcare providers can still employ a number of proactive steps to reduce their potential exposure. Providers should understand their obligations under relevant federal and state law and provide employees protected leave as appropriate. When in doubt, we recommend that employers err on the side of granting the requested leave. Providers should revise company policies as necessary to incorporate the new regulations that apply to COVID-19 exposure and sick leave. To the extent feasible, providers should consider offering teleworking opportunities for eligible employees. Providers should implement a system for recording employees’ requests for leave and the reasons supporting those requests, i.e., an employee’s symptoms and the date for a test or doctor’s appointment. However, providers should not require employees to provide further documentation, such as certification that the employee sought a diagnosis or treatment from a healthcare provider. Providers should be mindful of the risks of taking personnel actions that could lead to discrimination or retaliation lawsuits by workers who requested or took applicable leave. As always, providers should properly document their termination decisions. Providers should carefully consider whether and how they will ask employees to provide proof of vaccination, and they must be aware of relevant legal considerations if making those inquires. Several jurisdictions have implemented laws banning employers from requiring so-called “vaccine passports” or other methods of requiring individuals to provide proof of vaccination to gain access, entry, or service. Providers may initially want to strongly encourage employees to get vaccinated—with the caveat that it may be mandatory in the future—and only require vaccination in the future if absolutely necessary.

In a growing wave of class action lawsuits, plaintiffs are targeting employers who have allegedly failed to provide proper notice of health care coverage under the Consolidated Omnibus Budget Reconciliation Act of 1985 (“COBRA”).  The wave prompted at least six new lawsuits in 2019 alone, and some have already netted seven-figure settlements.  To avoid this litigation trend, employers should take a hard look at their COBRA notices to ensure they comply with governing regulations. COBRA requires employers who sponsor group health plans to allow plan participants to continue coverage at their own cost when a “qualifying event” occurs that would otherwise terminate coverage.  29 U.S.C. § 1161(a).  The most common “qualifying event” is termination of employment, but there are several others, including the death or divorce of a covered employee.  Under COBRA, plan administrators must provide an individual with notice of the right to continued COBRA coverage (a) when the individual first joins the plan and (b) when a qualifying event occurs.  29 U.S.C. § 1166(a). That COBRA notice must explain the right to continue coverage “in a matter calculated to be understood by the average plan participant.”  29 C.F.R. § 2590.606-4(b)(4).  Federal regulations specify 14 items that the notice should include—for example, an explanation of how to enroll in COBRA.  29 C.F.R. § 2590.606-4(b)(4)(i)-(xiv).  In addition, the Department of Labor (“DOL”) has published a model COBRA notice.  Use of the DOL model notice “is not mandatory.”  29 C.F.R. § 2590.606-4(g).  But according to DOL official publications, use of the model notice represents “good faith compliance with COBRA’s general notice content requirements.” The recent wave of class action lawsuits challenges whether employers’ COBRA notices were sufficient.  While the precise allegations differ, the plaintiffs generally allege that the notice they received did not include all the information set forth in the regulations or in the DOL’s model notice, and that the average plan participant could not understand the notice. Failure to comply with COBRA’s notice requirements can be costly, especially in the context of a class action.  COBRA provides a statutory penalty up to $110 per day per person for failure to provide the required notices.  29 U.S.C. § 1132(c)(1).  The penalty adds up quickly.  Take, for example, a class of 100 employee who lost their coverage one year ago and received a deficient COBRA notice.  The penalty for the employer could be several million dollars, before accounting for an award of legal fees and costs (which COBRA allows). Thus far, employers have been unsuccessful in defeating these COBRA notice lawsuits at the pleading stage.  Some employers have argued that the plaintiff lacked constitutional standing to sue because the alleged defects in the notice—often seemingly innocuous—did not cause any concrete injury.  Other employers have argued they were in substantial compliance with the DOL regulations.  To date, however, those arguments have not convinced courts to dismiss complaints at the pleading stage.  A few of the lawsuits have already settled for seven- and six-figure numbers.  The rest are proceeding forward. There are steps employers can take now to minimize the risk of being swept into this COBRA notice litigation.  To begin, employers should check whether their COBRA notices contain the 14 items suggested by the regulations.  See 29 C.F.R. § 2590.606-4(b)(4) (i)-(xiv).  Employers should also draft their notices in as simple, straightforward language as possible.  In addition, employers should seriously consider using the DOL’s model notice to gain the protection of “good faith compliance.”  Even when using the model notice, it may be appropriate to supplement with additional, plan-specific information. Regardless of whether your COBRA notices could use minor or major changes, now is the time to make those changes.  Doing so could save you from a class action complaint.