Category: Health Care Law

Oregon Health Authority Adopts COVID-19 Vaccination and Masking Rules in Healthcare and K-12 Education

On January 31, 2022, the Oregon Health Authority (OHA) published permanent rules relating to COVID-19 vaccination and masking requirements in healthcare settings, just a few days after issuing similar rules for K-12 schools. The permanent rules replaced temporary rules that expire after 180 days.

The permanent rules for both healthcare and K-12 settings will “remain in effect unless the State Public Health Director or State Public Health Officer issues an order stating that the requirements . . . are no longer necessary to control COVID-19.” Under both rules, the factors that may lead to a loosening of restrictions or rescission of the permanent rules include the following:

  • “The degree of COVID-19 transmission”

  • “COVID-19 related hospitalizations and deaths”

  • “Disparate COVID-19 related health impacts on communities of color and tribal communities”

  • “Guidance from the U.S. Centers for Disease Control and Prevention”

  • “Proportion of the population partially or fully vaccinated”

The statewide temporary indoor mask mandate is set to expire on February 8, 2022. OHA is still reviewing public comments on a proposed permanent indoor mask mandate and expects to publish a permanent rule in the coming weeks. Healthcare and K-12 employers may want to revisit their COVID-19 policies and workplace practices to consider whether they are complying

© 2022, Ogletree, Deakins, Nash, Smoak & Stewart, P.C., All Rights Reserved.
For similar articles on public health, visit the NLR Health Care Law section.

SCOTUS’s HOUSE CALL on Healthcare Industry: The Economic Impact of Mandatory Vaccination

The Supreme Court of the United States in a per curiam opinion on Jan. 13 ruled that the Secretary of HHS (United States Department of Health and Human Services) did not exceed his statutory authority in requiring that, in order to remain eligible for Medicare and Medicaid reimbursement, all healthcare providers except for physician offices not regulated by CMS (Centers for Medicare & Medicaid Services), organ procurement organizations, portable X-Ray suppliers and certain healthcare professionals solely engaged in fully remote telehealth, must insure that their employees be vaccinated against Covid-19. The Court in a 5-4 decision maintained that the Secretary had adequately examined alternatives to mandatory vaccination even though the Final Interim Rule went into effect immediately with no sunset provision nor any revisions or assessment of public comment which is usually required under 5 U.S.C. Sections 553(b), 553(c). Interestingly, the Court, both in its decision and its dissent, failed to consider the scientific data on natural immunity, the incident of Covid infection and recovery among healthcare workers, or the significant easing of both hospitalizations and mortality data from the most recent Covid mutation, which is now considered the dominant strain of infection, Omicron.[1] Of even greater concern coming from its decision is a possible grave consequence (unintended or not) of having nearly 3 million healthcare workers fired between the end of January and end of March 2022.

The decision will spur many healthcare providers to either consider downsizing its healthcare platform (eliminating elective surgeries, closing maternity wards, diverting critical patients to other facilities, moving patients into home care more rapidly, etc.) or seeking protection under the bankruptcy code to obtain some breathing room. According to the American Hospital Association (“AHA”), post-pandemic, and even before the Mandate decision, the collective turnover across ICU’s, nursing units and emergency departments has risen from 18% to 30%.[2] There is no doubt that when a nurse leaves a healthcare organization, the vacancy affects the cost of operation many more times the amount of salary paid to the nurse. According to Nursing Solutions, Inc., the average period of time it takes to fill a nursing position is 85 days — and more than three months for a specialized nursing position. While a replacement nurse is located, the healthcare organization must rely on “travelers” and direct care staffing agencies charging super competitive rates. Just in the last year the use of costly employment agencies to cover gaps in staffing is up by 250% over the last year, according to the Florida Health Care Association, Oct. 25, 2021. A turnover of a single nurse whose salary ranges from $28,800 to $51,700 can translate to an average of $3.6-$6.5 million cost to the healthcare organization, given such factors as the cost of reduced productivity of an employee in the weeks leading up to their departure, time between the departure and employee’s replacement, paid overtime to cover the replacement, hi-cost outside staffing agency fees, advertising for open positions, conducting background checks and credential verifications, training onboard new employees and climbing the learning curve on the new clinical culture.[3]

None of the above costs take into account additional expense burdens for healthcare organizations coming from the mounting labor shortage at the nursing assistant and home health aides level, which are considering leaving the healthcare setting in droves and making more money and less aggravation in the retail field. Bloomberg reports that there will be a shortfall of 3.2 million lower-wage workers among all the healthcare organizations by 2026.[4] What is the economic effect of the mandate on healthcare organizations? Well, it’s obvious that by early Spring of this year, there will be fewer healthcare workers and the costs of providing healthcare will go up in spite of an injection of an additional $10 billion of Phase 4 Provider Relief Funds under the CARES ACT. Will the economic stress create more interest in turning to bankruptcy alternatives to allow these organizations time to adjust to the new normal? Even before the mandate was issued, the AHA projected that hospitals would lose over $54 billion dollars in net income during 2021. That loss comes after accounting for the infusion of $176 billion in CARES ACT funding, which didn’t directly address the current dilemma of loss of manpower. It would be likely that the losses for 2022 will be even more dramatic. Additionally, what is not taken into account in these figures is the deepening insolvency affecting the Long Term Care Industry, where 86% of nursing homes and 77% of assisted living facilities have indicated that their workforce situation has gotten worse over the last three months.[5]

Certainly, the upcoming additional economic stress among heath care organizations from potential depletion of manpower will present several challenges within a bankruptcy setting. For one, practitioners will need to navigate how best to utilize post-petition cash between important manpower related objectives such as retention bonuses, paid time off, overtime payments, staffing agencies’ fees, recruiting, advertising, credentialling, and new employee policies, and equally demanding needs such as rent and other critical healthcare vendors. Particular attention will be given to carefully tailored DIP financing to insure the viability of the organization while in bankruptcy and through its exit. While private equity has taken larger and larger roles in healthcare, and its desire to utilize roll-ups and consolidations, specialists in healthcare financial advising will have to be employed to assist the economic constituencies in understanding the mechanism for exiting the bankruptcy, given the balancing act between workforce equilibrium and quality of continued care. Ultimately, more healthcare organizations will require strong healthcare insolvency professional guidance to find an appropriate refuge and fresh start in the trying months to come.

FOOTNOTES

[1]  Of note concerning the timing of its decision and its rationale based on the science, one of the Justices in oral argument believed that in January 2022, there were over 100,000 children in the US currently in the ICUs when the actual total was far less.  Additionally, though the Wall Street Journal reported on January 26, 2022 that the Centers for Disease Control and Prevention (“CDC”) stated that Covid-19 deaths in the U.S. topped 2,100 a day, the highest in nearly a year, the article quotes Robert Anderson, chief of mortality statistics, who says, “You can have a disease that is for any particular person less deadly than another, like Omicron, but if it is more infectious and reaches more people, then you’re more likely to have a lot of deaths.”  As this article is going to print, see, also, Dr. Martin Makary, “The High Cost of Disparaging Natural Immunity to Covid,” Wall Street Journal, Jan. 26, 2022, concluding that “the superiority of natural immunity over vaccinated immunity is clear”.

[2]  Dave Muoio, Pandemic-Era overtime, agency staffing costs U.S. hospitals an extra $24B per year, Fierce Healthcare, Oct. 8, 2021.

[3] See 2021 NSI National Health Care Retention & RN Staffing Report, published by NSI Nursing Solutions, Inc., March 2021.

[4]  Lauren Coleman Lochner, US Hospitals Pushed to Financial Ruin as Nurses Quit During Pandemic, Bloomberg, Dec. 21, 2021.

[5] See FTI Healthcare Industry Sector Outlook, FTI Consulting, December 2021.

This article was written by Frank P. Terzo of Nelson Mullins law firm. For more information about vaccine mandates, please click here.

New Tools in the Fight Against Counterfeit Pharmaceuticals

The explosive growth of internet pharmacies and direct-to-consumer shipment of pharmaceuticals has provided increased access to, and reduced the cost of, important medications. Unfortunately, these same forces have increased the risks that counterfeit medicines will make their way to consumers, endangering patient safety and affecting manufacturers’ reputation in the public eye.

While the Food and Drug Administration attempts to police such misconduct through enforcement of the Food, Drug, and Cosmetics Act (FDCA), the resources devoted to enforcement are simply no match for the size and scope of the counterfeiting threat. Fortunately, pharmaceutical manufacturers are not without recourse, as several well-established tools may be used in the right circumstances to stop counterfeiters from profiting from the sale of knock-offs.

Experienced litigators can use the Lanham Act and the Racketeer Influenced Corrupt Organizations (RICO) Act to stop unscrupulous individuals and organizations from deceiving customers with counterfeit versions of trademarked drugs. Until recently, these legal weapons – including search warrants, seizures, forfeitures, and significant penalties – were typically wielded only by the government and only in criminal prosecutions.

As one recent case demonstrates, however, many of the tools that law enforcement has used for years to combat counterfeiters are also available to pharmaceutical manufacturers. In Gilead Sciences, Inc. v. Safe Chain Solutions, LLC, et al., the manufacturer of several trademarked HIV medications filed a civil complaint, under seal, alleging violations of the Lanham Act and RICO against scores of individuals and companies that were allegedly selling counterfeit versions of these drugs to patients across the country.

By deploying private investigators and techniques typically used by law enforcement, Gilead was able to gather a substantial amount of evidence before even filing the case. The company then used this evidence to secure ex parte seizure warrants and asset freezes, allowing it to locate and seize thousands of counterfeit pills and packaging before they could be shipped to unsuspecting consumers. Through the seizure of the financial proceeds of the alleged counterfeiting, Gilead prevented the dissipation of assets. If the company can successfully prove its RICO case, it stands to recover treble damages and attorneys’ fees as well.

Manufacturers of trademarked pharmaceuticals may consider using these and other tools to tackle the threat posed by counterfeiters. By drawing upon the experience and skills of trained litigators – particularly counsel who previously deployed these tools on behalf of the government while serving as federal prosecutors – companies can proactively protect their intellectual property and the consumers who depend on their products.

Article By Eric J. Beste, Anthony J. Burba and Heather F. Delgado of Barnes & Thornburg LLP

For more health law legal news, click here to visit the National Law Review.

© 2022 BARNES & THORNBURG LLP

Phantom Participants with Real-World Ramifications: Clinical Drug Trial Data Falsification

As if medical-related disinformation was not pernicious enough, unscrupulous actors seek to enrich themselves from falsifying clinical drug trial data. A Florida-based clinical research firm project manager was sentenced to 30 months in prison because of his involvement in a conspiracy to falsify clinical drug trial data. Previously, the primary investigator, clinic owner, and another senior employee at Miami-based Tellus Clinical Research were charged with various counts of mail and wire fraud, money laundering, as well as making false statements to Food and Drug Administration (FDA) inspectors. A researcher or other employee of the medical clinic could have reported this conspiracy to the government and shared in 15-25% of the government’s recovery.

Pharmaceutical companies sponsor clinical research trials to gather data on the safety and efficacy of the drugs they manufacture. Prior to commencing research trials, pharmaceutical companies or “sponsors” must submit to the FDA their “study protocol,” which identifies who can participate, drug dosages and timing, and how the study’s performance will be measured. Sponsors engage contract research organizations (CROs) to perform the clinical trials, and the CRO must ensure compliance with the study protocol and FDA regulations. In this case, a clinical research firm contracted with pharmaceutical manufacturers to conduct trials related to an opioid dependency treatment, an irritable bowel syndrome drug, and diabetic nephropathy or kidney disease medication. The sponsors would reimburse the CRO a set amount per study participant and for some fees and Tellus would pay participants in accordance with the study protocol.

How the research firm gamed the system involved the eligibility requirements for the studies: each of these clinical trials required patients to meet certain requirements for participation. Instead of honestly recruiting patients with the diagnoses needed to participate in the program, the defendants enrolled people without applicable diagnoses and falsely claimed that study participants completed all the requirements in the study protocol, to garner more payments from the clinical trial sponsors. Several of the defendants enrolled friends and family members to bump up the research firm’s participation numbers, and other research firm employees went so far as to misappropriate personal information from third parties without their knowledge or consent. The co-conspirators also falsified clinical notes and medical records of these unwitting participants, claiming to have performed medical exams, drawn blood for testing, and made payments to participants. This elaborate conspiracy served to wrongfully enrich the research firm owner and senior management at the expense of pharmaceutical companies and ultimately patients.

Clinical research fraud is harmful to consumers. As the Assistant Commissioner for the FDA Office of Criminal Investigations (OCI) stated, “Compromised clinical trial data could impact the agency’s decisions about the safety and effectiveness of the drug under review.” Consumers could end up with unsafe medications due to fraudsters’ schemes.

A whistleblower could have reported this fraud to the FDA and ensured only drugs which perform well in clinical trials on real human beings make it to market. The Department of Justice needs whistleblowers to report fraud involving clinical drug trials.

© 2022 by Tycko & Zavareei LLP
For more content about the FDA and drug trials, visit the NLR Biotech, Food & Drug section.

U.S. Supreme Court Lifts Preliminary Injunctions on Healthcare Worker Vaccine Mandate

On January 13, 2022, the United States Supreme Court upheld the Centers for Medicare & Medicaid Services (“CMS”) Interim Final Rule (the “Rule”) in a 5-4 decision, staying the preliminary injunctions issued for 24 states by the District Courts for the Eastern District of Missouri and the Western District of Louisiana.  Therefore, the CMS vaccine mandate is in full effect for all states except Texas, which was not part of the cases before the Court.  The Rule requires nearly all workers at Medicare- and Medicaid-certified facilities—whether medical personnel, volunteers, janitorial staff, or even contractors who service the facilities—to be fully vaccinated against COVID-19 unless they qualify for a medical or religious exemption.

The Court based its holding on two main points.  First, the Court held that Congress clearly authorized CMS to put conditions on funding it provides to the Medicare and Medicaid certified facilities.  The Court opined that perhaps CMS’s “most basic” function is to ensure that regulated facilities protect the health and safety of their patients, noting that Medicare and Medicaid patients are often some of the most vulnerable to infection and death from COVID-19.  Because CMS determined that a vaccine mandate is necessary to protect patient health and safety, the Court held the mandate “fits neatly within the language of the [authorizing] statute.”  The Court acknowledged that CMS has never required vaccinations in the past, but attributed this in part to the fact that states typically already require necessary vaccinations like hepatitis B, influenza, and measles for healthcare workers.

Second, the Court held that the mandate is not arbitrary and capricious, and cautioned the district courts that their role is merely to make sure an agency acts within the “zone of reasonableness.”  The Court found the administrative record sufficient to explain CMS’s rationale for the mandate and also accepted that getting the vaccine mandate in place ahead of winter and flu season satisfied the “good cause” standard for skipping the notice and comment period.

Healthcare employers subject to the Rule should immediately start implementing vaccine requirements if they have not already.  It is anticipated that in all states but Texas, CMS will likely begin enforcement of the vaccine mandate in approximately 30 days.  On December 28, 2021, CMS released guidance to state surveyors with enforcement standards to use starting 30 days from the memo, though at the time the memo only applied to the 25 states that were not enjoined.  Healthcare employers should also keep in mind that this is not the end of the road: the Court’s holding only means that the CMS vaccine mandate is in force while the 5th and 8th Circuits complete their review of the underlying state challenges to the mandate.  While the Supreme Court’s opinion sends a strong message that lower courts should uphold the mandate, there is no guarantee they will do so.

The legal landscape continues to evolve quickly and there is a lack of clear-cut authority or bright line rules on implementation.  This article is not intended to be an unequivocal, one-size-fits-all guidance, but instead represents our interpretation of where applicable law currently and generally stands.  This article does not address the potential impacts of the numerous other local, state and federal orders that have been issued in response to the COVID-19 pandemic, including, without limitation, potential liability should an employee become ill, requirements regarding family leave, sick pay and other issues.

Article By Keeley A. McCarty and Ashley T. Hirano of Sheppard, Mullin, Richter & Hampton LLP

For more health law legal news, click here to visit the National Law Review.

Copyright © 2022, Sheppard Mullin Richter & Hampton LLP.

7 Tips to Avoid Employer Mandate Assessments and Penalties under the Affordable Care Act

As we discussed in a prior article, it is now more important than ever for employers to ensure they fully and accurately complete IRS Forms 1094-C and 1095-C — forms required to be filed and/or furnished to employees under the Affordable Care Act. A failure to do so can lead to eye-popping proposed employer shared responsibility payment (ESRP) assessments, as well as information reporting penalties.

To avoid such costly mistakes, employers should keep the following seven tips in mind when completing or reviewing Forms 1094-C and 1095-C:

Form 1094-C

  1. Be very sure that the “Yes” box is checked on Line 23, column (a) to state that minimum essential coverage was offered for all 12 months.

This is far and away the single most important data entry on both forms. The box should always be checked for an employer who provides minimum essential health coverage to all full-time employees in accordance with the Affordable Care Act (ACA). Failing to check this box may result in an automatic ESRP assessment of up to $2,700 per full-time employee for 2021. The amount is adjusted annually.

  1. Know when to check the box on Line 22 for “Qualifying Offer Method.”

If an employer is eligible to use the Qualifying Offer Method, it should check this box only if it is reporting offers of coverage on Forms 1095-C using code 1A.

Form 1095-C

  1. Conduct a coding audit and know where to prioritize.

Each of the below tips and other points of review for Forms 1095-C should be addressed prior to the furnishing and filing of the forms. Only by reviewing and understanding the codes can an employer have confidence that it will avoid an ESRP assessment or accuracy-related information return penalties. Of course, depending on the number of employees, reviewing the coding for all employees may be impracticable. Thus, employers should prioritize the following situations for review:

  • Forms for employees who were hired, terminated, or who experienced a change in status during the year;
  • Forms where code 1H is reported; and
  • Forms for employees who are more likely to be eligible for the premium tax credit (e.g., employees earning less than $51,040 in 2021).
  1. Review for “red flag” coding combinations on lines 14 and 16.

The following code combinations are triggers for an ESRP assessment and should never be used by an employer who provides minimum essential health coverage to all full-time employees: 1H/__, 1H/2C, 1H/2F, 1H/2G, and 1H/2H. All of these code combinations report that no offer of coverage was provided but fail to state a valid reason for why an ESRP should not apply. Where no offer of coverage is made, only one of the following code combinations should be used: 1H/2A, 1H/2B or 1H/2D.

  1. Review for incomplete coding on lines 14 and 16.

For employers who are not using the Qualifying Offer Method, both code series (series 1 and series 2) on lines 14 and 16 should always be completed for all months on the Forms 1095-C of all full-time employees. However, if an employer is using the Qualifying Offer Method, then it will be acceptable in many instances to use only code 1A and to leave the series 2 code blank.

  1. Make sure the safe harbor code reported on line 16 actually applies.

In more recent years, the IRS has begun scrutinizing the series 2 safe harbor codes reported by employers on line 16. For example, the IRS will automatically reject an employer’s use of code 2G, the federal poverty line safe harbor, if the monthly employee required contribution reported on the Form 1095-C exceeds $104.53 for a month in 2021.

  1. Ensure the waiting period is coded correctly on lines 14 and 16.

If an employee is in a waiting period on any day of a month, the month should be coded as 1H/2D to signify that the employee is in a limited non-assessment period. This code can only be used for up to four consecutive months for each period of employment. If an employee was terminated and rehired in the same year, the employer should determine whether the waiting period and code 1H/2D can be applied again under the rules for determining periods of employment.

© 2022 Bradley Arant Boult Cummings LLP

OSHA’s COVID-19 Vaccine, Testing Mandates Back On – Effective Jan. 10, 2022

On December 17, the U.S. Court of Appeals for the Sixth Circuit lifted the stay of OSHA’s Emergency Temporary Standard (ETS) that had been imposed by the Fifth Circuit, putting the ETS’ employer vaccination and testing requirements for COVID-19 back into effect. Following the decision, OSHA announced a Jan. 10, 2022, effective date, but added it will not cite employers for noncompliance with the testing requirements prior to Feb. 9, 2022.

Accordingly, employers can consider these dates as the new compliance deadlines: Jan. 10 for all ETS requirements except testing and Feb. 9 for testing requirements. Notably, OSHA will require employers to demonstrate good faith efforts to come into compliance. So employers covered by the ETS should begin taking steps to demonstrate compliance and documenting all such efforts.

Right now, employers should conduct vaccination inquiries, create a roster of employee vaccination status, and decide whether to require vaccinations for all employees or allow weekly testing as an alternative.

Employers should also consider reviewing options from payroll providers or HRIS software for the confidential storage and retrieval of vaccination and test information. Unionized employers need to consider their bargaining obligations over the discretionary aspects of the ETS, as well as over the effects of its nondiscretionary requirements.

This court decision adds another twist in the winding litigation challenging President Biden’s federal vaccine mandates. Following the Dec. 17 decision, the parties challenging the ETS immediately filed emergency applications with the U.S. Supreme Court to reimpose the stay. Justice Brett Kavanaugh will review and make a decision on the applications, as he is the justice assigned to hear such petitions arising from the Sixth Circuit. Justice Kavanaugh will have the option to grant the applications and stay the ETS pending review by the full Supreme Court, refer them to the full court for a decision, or take no action pending review.

It is possible the Supreme Court will weigh in on the emergency applications quickly, so employers can expect updates in the coming days and weeks.

© 2021 BARNES & THORNBURG LLP
For more about OSHA Mandates, visit the NLR Coronavirus News section.

Study Demonstrates Earlier Physician Retirement Overall and Increased Pay Equity Concerns for Female Doctors During the Pandemic

This month, Doximity issued its Fifth Annual 2021 Physician Compensation Report. With the continued strain of the pandemic spanning 2021, the self-reported physician data reflected widespread burnout and early retirement, especially by female physicians. With respect to physician compensation, Doximity findings demonstrated:

  • While average doctor pay increased 3.8 percent between 2020 and 2021, there was a decline of real income compared to 2020 given the CPI 6.2% rate of inflation in 2021.
  • The top five metro areas with the highest physician pay were Charlotte, NC; St. Louis, MO; Buffalo, NY; Jacksonville, Florida; and, Orlando, Florida.
  • The top five metro areas with the lowest physician pay were Baltimore, MD; Providence, RI; San Antonio, TX; Washington, D.C.; and Boston, MA.
  • A widening gender pay gap of 28.2% this year, with female physicians making $122,000 less than male physicians in 2021.
  • Based on 2014-2019 data, Doximity estimates that over the course of a career, female physicians will earn over $2 million less than male physicians.

Specialties with the largest pay equity gaps between men and women are oral & maxillofacial surgery; allergy and immunology; ENT; pediatric nephrology; and thoracic surgery. Significantly, there is no one medical specialty where women earned the same or more than men in 2021. All specialties had a pay gap over 10%, except Pediatric Rheumatology (which had a gap of 7.9%). To compound matters, a recent Jama Network Open research letter found that physician residents who were mothers – compared to physician residents who were fathers – were more likely to be responsible for childcare or schooling (24.6% v. .8%), household tasks (31.4% v. 7.2%), to work primarily from home (40.9% to 22%), and to reduce their work hours (19.4% to 9.4%). The study reflected the significant concern that these “short-term adjustments can have serious long-term repercussions as they may lead to lower earnings and negatively impact advancement.”

Doximity’s research also revealed that due to the pandemic, over 1% of physicians retired before expected, which is feared to strain an already tight labor market. The report also highlighted studies suggesting about half of doctors are considering an employment change due to the “COVID-related overwork.” The overwork also had a disproportionate impact on women physicians, with 25% of them reporting they are “considering early retirement” due to increased work during the pandemic.

This research reflects the importance of a physician/employer in any setting reflecting on the impact of the pandemic on its healthcare team. Moreover, the research shows continued pay equity deficits between female and male physicians, which may be exacerbated by the pandemic. Internal reflection on current pay practices to identify the factors contributing to it are critical to maintain top talent, improve morale amidst very difficult times and avoid wage and hour litigation.

Article By Dorothy Parson McDermott of Jackson Lewis P.C.

For more healthcare and health law legal news, click here to visit the National Law Review.

Jackson Lewis P.C. © 2021

US to Expand Vaccination Requirement for Foreign National Travelers to Include All Land Border Crossers from Canada and Mexico in January

Starting Jan. 22, 2022, the Biden administration will require foreign national travelers engaged in essential travel to be fully vaccinated when crossing U.S. land borders or ferry terminals. Essential travel includes travel for work or study in the United States, emergency response, and public health. The new rules apply to foreign nationals; U.S. citizens and permanent residents may still enter the United States regardless of their vaccination status but are subject to additional testing requirements.

The new rules for essential travelers are in line with those that took effect Nov. 8, 2021, when the Biden administration lifted travel restrictions to allow fully vaccinated travelers engaged in non-essential (leisure) travel to enter the United States.

While much cross-border traffic was shut down in the early days of the COVID-19 pandemic, essential travelers have been able to travel unimpeded via land borders or ferry terminals. Starting Jan. 22, 2022, however, all foreign national travelers crossing U.S. land borders or ferry terminals – traveling for essential and non-essential reasons – must be fully vaccinated for COVID-19 and provide related proof of vaccination. Any exceptions to the vaccination requirement available to travelers at U.S. land borders are expected to be limited, just as exceptions currently available for air travel have been limited. See CDC guidance for details.

©2021 Greenberg Traurig, LLP. All rights reserved.
For more on vaccine requirements, visit the NLR Coronavirus News section.

Given Deadlines Set by Sixth Circuit, ETS Likely Stayed Until At Least December 10, 2021

Earlier this month, the Occupational Safety and Health Administration (“OSHA”) issued its “COVID-19 Vaccination and Testing; Emergency Temporary Standard” (the “ETS”) requiring employers of 100 or more employees to implement policies requiring employee vaccination or enhanced safety measures for unvaccinated employees (including wearing face coverings and weekly COVID-19 testing). Our alert on the ETS is here. The ETS was subject to over 30 petitions for review in the federal circuit courts and was quickly stayed by the United States Court of Appeals for the Fifth Circuit.

Although the petitions for review were consolidated before the United States Court of Appeals for the Sixth Circuit, the Fifth Circuit’s stay remains in place. While OSHA has publically stated that it will comply with the stay, its position has been – and continues to be – that employers should prepare to comply with the ETS and that OSHA will succeed in litigation challenging the ETS. Yesterday, OSHA filed an emergency motion to immediately lift the stay.

With the stay in place, covered employers have been in the difficult position of trying to determine how much preparation to do to comply with the ETS’s requirements, many of which are scheduled to be effective on December 6, 2021. The question has been whether the stay will continue beyond the initial deadlines and, if not, whether deadlines will be extended to account for the period during which the ETS was stayed.

The deadlines set out in the Sixth Circuit’s Scheduling Order, which is available here, provide some insight into the timing of the requirements of the ETS.  The Scheduling Order sets the following briefing deadlines:

  • Tuesday, November 30, 2021 – motions to join OSHA’s emergency motion or to modify, revoke, or extend the stay.
  • Tuesday, December 7, 2021 – responses to motions regarding the stay.
  • Friday, December 10, 2021 – replies to responsive motions.

Given these deadlines, it is likely that the ETS will continue to be stayed until at least December 10th (past the December 6, 2021 deadline) while the Sixth Circuit considers briefing.  However, it is possible that, before December 10th, the Sixth Circuit lifts the stay. If the stay is lifted, the ETS requirements could become effective on the date of the court’s order or on a later date set by the Sixth Circuit.

While the briefing schedule does not provide definitive answers to employers on the potential deadlines for ETS compliance, it suggests that the ETS’s December 6, 2021, deadlines may be extended for at least a few days while the Sixth Circuit considers briefing.

© 2021 Bracewell LLP
For more on OSHA COVID-19 updates, visit the NLR Coronavirus News section.