North America

FDA Issues Update to Guidance for Clinical Trials During the COVID-10 Pandemic

On Friday, March 27, 2020, FDA issued an update to previous guidance titled, “FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic” (the “Guidance”), adding an Appendix with ten questions and answers for specific topics based on feedback received on the initial March 18th Guidance. To supplement our prior blog post, we identify some key takeaways from the updated Guidance below:

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You Are Excused: Force Majeure and the Workplace in the COVID-19 Era

In a matter of weeks, COVID-19 has changed the workplace.  Travel restrictions, shelter-in-place orders, and mandatory closures have meant that it is far from business as usual for nearly all employers.  The unprecedented events of the last few weeks have forced many employers, facing major business disruptions or closures, to make tough decisions about hiring, layoffs, furloughs, and compensation.

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Congress Passes the CARES Act and the DOL Provides Updated FFCRA Guidance

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law by President Trump and became effective on March 27, 2020.  The unprecedented legislation, which experts estimate will inject over $2 Trillion into the U.S. economy, has many pertinent changes to existing law with significant impact for employers, employees and other workers. While the Davis Malm Employment Law Practice Group continues to analyze the CARES Act, this Alert provides a summary of relevant changes, as well as updated guidance from the Department of Labor regarding paid sick and leave under the Families First Coronavirus Response Act. Read more…

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U.S. Department of Labor Issues New Opinion Letters Clarifying Regular Rate Principles

In addition to its recent, exigent responsibility of preparing guidance on the protections and relief offered by the Families First Coronavirus Response Act, the U.S. Department of Labor’s Wage and Hour Division (“WHD”) has issued three new opinion letters addressing the excludability of certain types of payments from the regular rate of pay under the Fair Labor Standards Act (“FLSA”).  While these opinion letters do not tread new ground, they are useful reminders of important regular rate principles and merit careful review.

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NLRB Issues Guidance on When Duty to Bargain May Be Suspended During COVID-19 Pandemic

On March 27, 2020, NLRB General Counsel John Ring issued General Counsel Memorandum 20-04, entitled “Case Summaries Pertaining to the Duty to Bargain in Emergency Situations” providing employers with guidance “regarding the rights and obligations of both employers and labor organizations, particularly in light of responsive measures taken to contain the virus,” including both “measures taken out of prudence” as well as and other actions that “have been required by state, local or federal authorities.” Our Act Now Advisory reports on the General Counsel’s review of summarized in the Memorandum are those touching on the duty to bargain during public emergency situations and those touching on the duty to bargain during emergency situations particular to an individual employer. Stay tuned to this blog and Epstein Becker Green’s Coronavirus Resource Center for updates.

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Value-Based Payment Arrangements During the COVID-19 Pandemic

The ongoing pandemic caused by the novel coronavirus has upended the American health care system in many ways. One of the many effects of COVID-19 will likely be substantial disruption in value-based payment arrangements between health plans and providers. Though this is an issue that is not on the top of providers or payors minds as the health care system prepares to respond to the crisis, there are some simple steps that providers can take now to avoid issues in the future.

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Major Cities in Texas Enter “Stay at Home” Orders: Implications and Other Considerations for Employers

On March 13, 2020, Governor Greg Abbott declared a State of Disaster in Texas due to COVID-19. Subsequently, on March 19. 2020, Governor Abbott issued a Public Health Disaster Declaration, and an Executive Order, which, among other things, prohibited congregating in groups consisting of more than ten people, and closed all Texas restaurant dining rooms [1] bars, gyms and schools, effective March 20, 2020.  Governor Abbott has refrained from issuing a statewide shelter-in-place order, and has instead left the decision up to city and county leaders.  In the days that followed, and throughout this week, 16 counties, and major cities in Texas, including Austin, Dallas, El Paso, Houston, and San Antonio have issued “Stay at Home” orders, which share many similarities, with a few distinctions.  The following are summaries of the key aspects of the orders that may impact the workplace, followed by a glossary defining some of the key terms in the orders.

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Coronavirus and Cash Shortfalls – What Can You Do to Mitigate the Effects of Coronavirus on Your Organization’s Financial Health?

The coronavirus is having a direct effect – financial and otherwise – on nearly every business.  While the long-term effects of the global pandemic will be significant and far-reaching, the short-term financial consequences to businesses, due to expected cash shortfalls, could make the difference in a company’s survival.  Here are four areas that businesses should review that could impact – and potentially improve – their financial situation:

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Massachusetts Suspends State Permitting Deadlines

On March 26, 2020, Governor Baker issued Executive Order No. 17 as part of his continued response to the COVID-19 pandemic. This order suspends or tolls deadlines related to permits being sought or pending before state permit agencies that report to the Executive Office of Energy and Environmental Affairs, such as the Massachusetts Department of Environmental Protection and the Executive Office of Housing and Economic Development, which could include developments being planned under G.L. c. 40B.
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Tax Credits Offered to Employees Under the Families First Coronavirus Response Act

The Families First Coronavirus Response Act (the Act) was signed into law on March 18, The Act authorizes certain relief to businesses pertaining to the COVID-19 pandemic, including tax credits to employers to help offset the cost of wages to employees taking time off under the Emergency Paid Sick Leave Act and the Emergency Family and Medical Leave Expansion Act.
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