COVID-19 Viewpoints

It is, somewhat amazingly, the beginning of January again. During this time of year we typically publish a series of blog posts that recap the most interesting Food and Drug Administration (FDA) activities over the prior 12 months and consider what the agency is likely to focus on going forward. This year, however, we’re taking a different approach and will be providing more of a birds-eye view of our favorite federal agency as it stands as of the end of 2021. Because there is just too much going on at the administrative, enforcement, and legislative levels to get into the details of everything in one fell swoop. So make sure you’re signed up for Mintz Health Law Viewpoints to receive updates throughout the year on issues as they develop.

The New York State Department of Labor has issued proposed regulations interpreting and further defining the contours of the HERO Act’s joint labor-management workplace safety committees.  We summarize the proposed regulations below. 

Mayor-elect Eric Adams has announced that he plans to keep New York City’s vaccine mandate in place once he takes office.

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.

The EEOC has updated guidance clarifying when COVID-19 may comprise a disability under the ADA. In a new Section N of its COVID-19 guidance entitled “COVID-19 and the Definition of ‘Disability’ Under the ADA, Rehabilitation Act, and other EEO Laws,” the EEOC focuses on when COVID-19 is, or is not, a disability, and the resulting impact on an employer’s obligation(s) under the law. Importantly, the guidance clarifies that depending on the circumstances, COVID-19 can meet the ADA’s three-part definition of “disability” (i.e., “actual disability”, “record of disability” or being “regarded as an individual with a disability”) and provide protections to applicants and employees. However, not every individual with COVID-19 will qualify as disabled. Employers must assess on a case-by-case basis to determine if the requisite standards are met. The guidance provides multiple examples of actual disabilities and regarded as disabilities to further assist employers in their assessments.

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.

Citing the presence of the Omicron variant in California and the heightened transmission risks surrounding the holiday season, the California Department of Public Health has instituted an indoor masking mandate for public settings effective December 15, 2021 and continuing through January 15, 2022.

This alert covers the Biden administration’s ban on travel to the US for individuals who have been present in a number of countries in southern Africa within the past 14 days.

For over a year now, there has been speculation about how the Biden Administration would handle the chronically vexing regulatory issues associated with laboratory-developed tests (LDTs). On November 15, 2021 we finally got our answer when the August 2020 policy put in place by the Trump Administration was officially withdrawn. The Food and Drug Administration (FDA) also released corresponding updates to various guidelines related to the testing response to the ongoing public health emergency. Before summarizing all of these critically important developments, we’ll provide some quick history of what has been going on with LDTs since the pandemic began.

A three-judge panel on the Fifth Circuit Court of Appeals has now permanently blocked OSHA from implementing and enforcing its vaccine rule, which impacts employers nationwide. This is not the end of the judicial review road for the vaccine rule. Challenges to the rule were filed in multiple federal circuit courts across the country. Regardless of the outcome, the Supreme Court will likely have the final word.

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.

A Federal appeals court has temporarily blocked OSHA’s vaccine rule. Citing to potential “grave statutory and constitutional issues” with the rule, the 5th Circuit promised an expedited judicial review of whether to block it permanently. We expect that even after the 5th Circuit rules, the Supreme Court will be asked to weigh in. We also, of course, will be closely monitoring this legal development, which impacts employers nationwide. Although the future of the OSHA vaccine rule is unknown at this time, employers should continue to take steps to come into compliance given the short compliance window provided by OSHA if the rule is upheld.

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. 

Read about the October 25, 2021 Presidential Proclamation confirming that it will end all COVID-19 travel bans on Monday, November 8 and how this policy change will impact nonimmigrant travelers to the U.S.

The Mintz Immigration Practice focused on the evolving immigration landscape and the anticipated changes to US immigration policies as of October 2021 in this 30-minute session.

The New York State Department of Health Commissioner has extended the designation of COVID-19 as a “highly contagious communicable disease that presents a serious risk of harm to the public health in New York State” until October 31, 2021.

The Biden Administration, via its Safer Federal Workforce Task Force (the “Task Force”), has now provided the guidance with which federal contractor and subcontractors must comply in connection with their contracts and contract-like instruments with the Federal government.

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.

In a previous post, we reported on an announcement by Delta Airlines that it would impose a premium surcharge on employees covered under its group health plan who failed to get vaccinated for COVID-19.

As we’ve previously covered, the COVID-19 pandemic has brought about a major increase in the prevalence of telehealth services, due in large part to regulatory flexibilities at the federal and state levels. Beginning in March 2020, state Medicaid programs across the country loosened requirements for coverage of telehealth services provided to Medicaid beneficiaries, reducing barriers by allowing audio-only services and covering a broader scope of services delivered via telehealth. The increase in telehealth has resulted in improved access to behavioral health services in particular, but according to an OIG report issued earlier this week, state Medicaid programs will need to increase their oversight of these services if the telehealth flexibilities become permanent.