COVID-19 Viewpoints

On December 22, 2021, FDA took another step in rolling back enforcement policies implemented in response to the COVID-19 pandemic by publishing guidance documents describing the regulatory requirements for devices that were authorized under the emergency use authorization process and those under temporary FDA policies implementing specific enforcement discretion during the pandemic once the Public Health Emergency for COVID-19 ends. The Transition Plan Guidances will help device manufacturers prepare for the end of the PHE and continue to commercialize devices necessary for the long-term response to COVID-19.

New York City has released its anticipated vaccine order for private businesses alongside a workplace vaccine requirement webpage containing interpretative guidance and other helpful links. The new vaccine order generally requires employers to obtain proof of a worker’s vaccination before allowing them entry into the workplace. As we previously reported, Mayor Bill de Blasio described this mandate as a “preemptive strike” made in an effort to confront looming challenges posed by the Omicron variant and the holiday season. We summarize relevant portions from the order and interpretative guidance below, and note that NYC employers will need to take several affirmative actions to come into compliance in the next couple of weeks.

Over the course of 2020, the Food and Drug Administration (FDA) released numerous guidance documents covering diverse areas and aimed at increasing the availability of various medical products to prevent, treat, and diagnose COVID-19. Some of our prior blog posts on those pandemic response activities implemented by FDA can be found here and here. In all of those actions, FDA made clear that the agency’s enforcement discretion policy was temporary, or that an emergency use authorization (EUA) was being granted pursuant to statutory criteria that include a requirement that there be “no adequate, approved, and available alternative to the product,” which by definition renders the EUA temporary, as well. Accordingly, several EUAs granted to diagnostic tests, therapeutic products, and medical devices have been revoked based on a determination that all of the criteria necessary to support emergency authorization under the statute can no longer be met. And although the public health emergency is not over even as 2021 comes to a close, FDA has kept its promise to continually reassess circumstances and needs on the ground in the United States and to modify policies and emergency authorizations as necessary.

The EEOC has updated its technical guidance and answers to add six religious accommodation-based questions and answers in a new Section L (Vaccinations – Title VII and Religious Objections to COVID-19 Vaccine Mandates).  The updated guidance does not necessarily break new ground in this area; instead, it mostly reinforces several preexisting concepts, including (i) how employers should analyze the religious nature and sincerity of an employee’s belief; (ii) what might constitute “undue hardship”; and (iii) the need for employers to analyze each accommodation request on a case-by-case basis.  We break down the updated guidance further below. 

The New York State Commissioner of Health has designated COVID-19 as a “highly contagious communicable disease that presents a serious risk of harm to the public health.” This means that the HERO Act’s many requirements are no longer theoretical: Almost all private New York employers must now activate their HERO Act-compliant workplace exposure prevention plans and take numerous implementation steps required by the recently enacted law. Per the Commissioner’s designation notice, the “activation” designation will remain in effect until at least September 30, 2021, at which point the Commissioner will review the level of transmission of COVID-19 in New York State and determine whether to continue this designation.

The New York State Department of Labor (NYSDOL) has released its HERO Act minimum standards and template policies related to airborne infectious disease prevention. Employers now have 30 days after the standards’ publication – until August 5, 2021 – to either: (1) adopt one of the model standard exposure prevention plans applicable to their industry, or (2) develop and establish an alternative prevention plan that meets or exceeds the minimum standards.

In this video, Mintz Employment Member, Jen Rubin, discusses a few important issues employers need to know with respect to vaccination programs.

Now that widespread vaccination appears to be slowing the pandemic, and in light of the CDC’s guidance regarding measures fully vaccinated individuals can take, returning to the office has become a priority for employers across the nation. In this video, Mintz Employment Member, Jen Rubin, discusses some concepts employers should consider as they plan to return employees to the office. 

It’s been a long road to recovery for employers since New York first issued its NY Forward reopening requirements for offices and other similar environments back in May 2020.  Today, as New York reached a key vaccination metric – 70% of adults have now received at least one vaccine shot – Governor Cuomo announced that New York businesses will no longer be required to abide by the current industry-specific guidelines in order to reopen.  Accordingly, the current NY Forward guidelines on capacity restrictions, social distancing, cleaning and disinfection, health screenings, contact tracing, and other virus-related restrictions are now lifted in most commercial settings. 

It’s been a busy month (year?) for New York employers – one that has brought several important updates with respect to employers’ reopening plans. On the heels of the State’s May 19th adoption of the recent CDC guidance outlining increased privileges for fully vaccinated individuals, New York State updated its NY Forward COVID-19 reopening guidance on June 8, 2021, including its guidance geared toward office environments. As a reminder, New York businesses opting to reopen during the COVID-19 pandemic must do so consistent with the State’s industry-specific reopening guidelines, found here; affirm their compliance with same prior to reestablishing in-person operations; and implement a written safety plan governing its workplace safety protocols.

The New York State Legislature recently passed the Health and Essential Rights Act (the “HERO Act”), which has been delivered to Governor Cuomo for his signature. The legislation seeks to address continued COVID-19 safety concerns in the workplace and is designed to codify, supplement, and replace numerous executive actions that have been issued throughout the pandemic. The HERO Act would also pass into law significant new health and safety obligations for New York employers, including the formation of joint labor-management workplace safety committees to help ensure worker safety. Employers should prepare now to come into compliance with the new law, which we summarize below.

On May 13, 2021, the Centers for Disease Control and Prevention (the “CDC”) published guidance indicating that fully vaccinated individuals do not need to wear a mask or physically distance in certain indoor and outdoor environments, except where otherwise required by federal, state, local, tribal, or territorial laws, rules, and regulations, including local business and workplace guidance. The guidance does not apply to healthcare settings and certain other environments.

The CDC has issued new guidance focused on ensuring employees’ informed consent for COVID-19 testing in the workplace. This builds on earlier guidance the CDC issued regarding workplace testing programs last fall. Because the CDC notes that employers should not conduct testing without an employee’s informed consent, employers should be prepared to answer employee questions and concerns by utilizing the recommend framework discussed 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.

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.

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.

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.