COVID-19 Viewpoints

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.

With the presidential transition underway, we now look forward to what the Biden administration will seek to accomplish, particularly in the realm of health care policy.

On November 18, 2020, The U.S. Department of Homeland Security (DHS) and U.S. Immigration and Customs Enforcement (ICE) announced they would again extend flexibility relating to in-person Form I-9 compliance.

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.

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.

Read about the SEC’s amendment to its capital raising rules for Regulation Crowdfunding to promote capital formation and expand investment opportunities.

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.

Earlier this month, the National Academies Committee on Equitable Allocation of Vaccine for the Novel Coronavirus released its Final Framework to guide US distribution and administration of a COVID-19 vaccine, once available. The nuts and bolts of the Final Framework remain largely the same as the Draft Framework we covered previously in our Bioethics Blog Series. After a quick review of the Allocation Phases here, we explore a few areas in the Final Framework the Committee expanded on and responded to stakeholder comments.

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.

The U.S. Food and Drug Administration (FDA) recently announced what appears to be the first public warning made by the agency to a company promoting an approved prescription drug product for the unapproved use of treating COVID-19 symptoms. Although the regulatory action was announced in the FDA’s daily pandemic update on October 2, 2020, the warning letter issued by the Office of Prescription Drug Promotion (OPDP) is dated September 22, 2020. From our perspective, this public FDA action is notable for two distinct policy reasons.

As predicted, the Department of Justice (DOJ) and other enforcement agencies have acted quickly to bring substantial criminal enforcement actions for fraud against the Paycheck Protection Program (PPP). Acting Assistant Attorney General (AAG) Brian Rabbitt announced recently that the DOJ’s Criminal Division reached the important milestone that day of criminally charging more than 50 individuals for alleged fraud committed to obtain PPP funds.

Updated: The EEOC has provided employers with supplemental guidance on navigating the COVID-19 outbreak, addressing issues such as COVID-related harassment and screening employees who are reporting to work. The EEOC reminded employers that while the anti-discrimination laws, including the ADA and the Rehabilitation Act, continue to apply during the COVID-19 pandemic, these laws do not interfere with, or prevent employers from following, the guidelines and suggestions issued by the CDC or state and local public health authorities regarding COVID-19.

References to Operation Warp Speed (OWS) have been present throughout our coverage of the ethical questions related to the development and distribution of a COVID-19 vaccine. In fact, OWS is part of a broader public-private effort to accelerate COVID-19 countermeasures, such as the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. OWS has ambitious goals. It intends to deliver 300 million doses of a safe and effective vaccine for COVID-19 by January 19, 2021. Here, we provide a brief overview of OWS, its current progress, and relevant ethical considerations.

The Department of Labor has again updated its guidance regarding the Families First Coronavirus Response Act ("FFCRA"). 
Below we summarize the DOL’s interpretative guidance, and note in bold where the DOL has either reaffirmed or changed its guidance in light of the federal court decision.  As a reminder, the law expires on December 31, 2020. 

After exploring some of the ethical questions involved in allocating and distributing a potential COVID-19 vaccine and the basic tenets of bioethics, we continue by delving into the ethical issues relating to the vaccine development process, including clinical trials. As a first step, we provide a very brief introduction on how vaccines are developed and tested prior to approval and release.

On September 15, 2020 the U.S. Department of Homeland Security (DHS) will publish an announcement that it will terminate arrival restrictions applicable to certain international flights starting on September 14, 2020.

As we noted in our previous post, the Johns Hopkins University Center for Health Security (Center) has been hard at work studying and providing thought leadership regarding the COVID-19 pandemic from a variety of angles. The Center, in conjunction with Texas State University and the Working Group on Readying Populations for COVID-19 Vaccine, recently released a report exploring the public’s role in COVID-19 vaccination (Report). The Report provides recommendations to U.S. policymakers, practitioners, and other stakeholders about how to advance public understanding of, access to, and acceptance of vaccines that protect against COVID-19.