COVID-19 Viewpoints

This alert reviews a CDC order, effective Jan. 26, to require all international air passengers destined for the U.S. to obtain a negative COVID-19 test and other U.S. travel bans.

Watch this webinar in which Mintz’s Employment, Labor & Benefits and Health Law attorneys and noted immunologist Dr. Darryl Carter discussed key takeaways from the EEOC’s recently updated vaccination guidance and other COVID-19–related workplace questions.

Please join Mintz’s Employment, Labor & Benefits and Health Law attorneys and noted immunologist Dr. Darryl Carter for a webinar to discuss key takeaways from the EEOC’s recently updated vaccination guidance and other COVID-19–related workplace question.

Mounting anxiety over how to control the spread of infectious disease outbreaks encourages public and political discourse of bioethics.

The new COVID-19 stimulus package is now law. As discussed herein, it provides some employers an incentive to extend COVID-19 related FFCRA leave benefits through Q1 2021.

In addition to the incredible work of agency scientists and reviewers to get the first COVID-19 vaccines authorized for emergency use in December (as we covered in Part 2 of our year-end post), the Food and Drug Administration (FDA) has continued to make substantial progress on its non-COVID priorities as well, which we cover in this part 3 of our year-end post.

Following up on our colleagues’ post earlier this month covering the Food and Drug Administration’s 2020 device law and policy activities, this post will explore prescription drug and biologic law and policy developments over the past year. We’ll also begin looking forward into 2021 and the agency’s transition to an incoming Biden Administration.

The EEOC has updated its guidance regarding mandatory vaccination in the workplace and has outlined the permissible scope of a mandatory vaccination program. While the guidance has neither the force nor application of a statute or regulation, it provides a compelling structure for a legally compliant mandatory workplace vaccination program.

What a year for the Food and Drug Administration! FDA, an agency with regulatory oversight of 20-25% of products on which consumers spend, including food and medicines, but which typically stays out of the limelight, was thrust into the public eye amidst the COVID-19 pandemic. This was the year many Americans became familiar with lesser-known and niche policies like those governing emergency use authorizations (EUAs) and with the role of FDA in regulating laboratory developed tests (LDTs). The agency also took some flak for seeming to bow to political pressure in authorizing hydroxychloroquine for emergency use as a potential COVID-19 treatment, then rescinding the authorization, as well as for its less-than-accurate pronouncements of positive data concerning convalescent plasma treatment. These were reminders that the agency Americans trust to protect the public does get things wrong sometimes and is susceptible in some ways to political pressure, and that effectively ensuring the public health requires a balance between safety and effectiveness and patient access to medical products. As we look ahead, we eagerly anticipate how FDA will protect and promote public health in a Biden administration. In this post we’ll explore the FDA’s device law and policy activities from 2020.

Mintz Member Jennifer B. Rubin authored an article published by Law360 that examined legal challenges employers face as they contemplate the impact of the coronavirus vaccine on the workforce, and how mandatory vaccination programs may create a workforce of immuno-haves, or those who have received the vaccination, and potentially expose employers to employment and consumer claims.

California employers are now subject to three new COVID-19 related reporting obligations when there is a COVID-19 positive employee or employees in their workplaces, including: reporting to their (1) workers’ compensation carrier, (2) employees and other workers, and (3) local public health authority. We address each obligation below.

In the inaugural episode of Mintz’s Health Law Diagnosed, Dianne Bourque (Member, Mintz Health Law Practice) discusses why HIPAA is so engrained in our collective consciousness, how it was already equipped to handle public health emergencies, and the important changes made over the last several months to address the COVID-19 outbreak.

Governor Cuomo has announced new guidelines allowing travelers to New York to sidestep the State’s mandatory 14-day quarantine period by obtaining a series of negative COVID-19 diagnostic test results before and after arriving in New York. Previously, the State mandated a 14-day quarantine for travelers from an evolving list of “high-risk” states that had a high rate of COVID-19 positive testing per capita. Now, the new framework applies to travelers from all states in the U.S. except those that are contiguous with New York (Connecticut, Massachusetts, New Jersey, Pennsylvania, and Vermont), which are already exempt from the 14-day quarantine requirement.

The new protocol became effective Wednesday, November 4, 2020.

As the COVID-19 pandemic and related restrictions continue, many who have endured long separations from home and family are eager to travel as the holidays approach. Everyone considering holiday travel is urged to carefully consider the risks and be fully aware of how ongoing conditions may impact travel.

Back in the early days of the COVID-19 pandemic, we published a post outlining the different kinds of diagnostic tests that were being marketed and the different roles of the two main federal regulators that oversee the quality of different subsets of tests. Since then, there have been some important policy developments affecting diagnostic and antibody testing. There also has been significant growth in the number of tests authorized by the Food and Drug Administration for point-of-care uses in various patient settings such as clinics, emergency departments, and physician offices. Read on for an update about these developments.

The New York Department of Taxation and Finance has finally provided guidance regarding telecommuting tax liability for nonresident employees working outside of New York because of the COVID-19 pandemic. In short: employees telecommuting because of COVID-19 will generally still be required to pay New York taxes on income they earn.

Earlier this month, the FDA’s Center for Biologics Evaluation and Research issued its highly anticipated guidance outlining the agency’s current thinking on granting emergency use authorization (EUA) to investigational vaccines for COVID-19. This guidance was the subject of intense political debate among the White House, FDA, and other public health officials given the urgent need for a safe and effective vaccine.

As the COVID-19 pandemic continues to upend our daily lives, the promise of a vaccine offers hope that life may, in the not-too-distant future, return to some version of normalcy. The path to getting a safe, accessible vaccine to market, however, presents a variety of its own challenges. As we’ve been exploring in our Bioethics in a Pandemic blog series, the pandemic has presented a host of bioethics issues pertinent to the vaccine development and distribution process. Mintz's Bridgette Keller recently shared her insights into how bioethics can (and should!) influence research and development at the M2D2 Challenge Awards. A video of her presentation is now available to view online.

Months into the COVID-19 pandemic, many employer telecommuting arrangements remain in place, with several large corporations opting to extend these arrangements well into 2021. The benefits of such arrangements have been clear for many employers during the pandemic, including that they permit continued productivity while keeping employees safe. However, the longer that employees remain out of the office, the more telecommuting-related issues arise, including with respect to taxation of employee income and leave requirements, which we discuss below.