COVID-19 Viewpoints

In recognition of the widespread disruptions the COVID-19 crisis is posing to planned and ongoing clinical trials at sites throughout the United States (and global clinical sites), the Food and Drug Administration (FDA) issued on Wednesday, March 18 a guidance describing potential considerations for adjusting trial processes and, potentially, protocols and statistical analysis plans to mitigate any difficulties meeting trial objectives due to interference from the virus and related social and governmental restrictions. The document, titled FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, describes various potential complications, such as subjects being unable to travel to the trial site, loss of access to investigational product, or the need to screen subjects for COVID-19, as well as general recommendations for addressing them.

Late Thursday evening California Governor Gavin Newsom issued Executive Order N-33-20 (the “Order”), which directs all California residents to stay home in light of the developing COVID-19 public health crisis. The Order states that except as necessary to continue the operations of businesses in the 16 “Critical Infrastructure” industries, all residents should leave their residence only as necessary for food or medical needs.

We provide the following information to assist our clients to keep track of some of the most salient Coronavirus-related immigration changes and developments:

In the midst of the upheaval caused by social distancing and related efforts to minimize and contain COVID-19-related risks, we have been monitoring steps taken by the Department of Justice (DOJ), the U.S. Attorneys’ Offices (USAOs), and federal courts to adapt to these circumstances.  Any steps taken are sure to affect ongoing government investigations and related proceedings and how we, as defense counsel, approach them. 

401(k) plans must, by law, limit the circumstances under which plan money can be withdrawn by active employees. However, 401(k) plans can (and most do) allow in-service withdrawals in the event of an employee’s financial hardship. The COVID-19 pandemic is guaranteed to have financial repercussions for many 401(k) participants, and hardship distributions may provide a financial bridge to better times. The post summarizes the hardship distribution rules to help 401(k) plan sponsors prepare for an uptick in requests. It should be noted that the hardship distribution rules changed in 2018 and 2019, so employers are advised to confirm that they are familiar with the most current rules.

The Department of Health and Human Services (HHS) has taken many actions to loosen or waive requirements on the provision of health care during the current coronavirus pandemic, as we discussed yesterday and Tuesday. In addition to HHS’s waiver of certain HIPAA requirements, HHS’s Office for Civil Rights (OCR) recently announced that it will not be imposing penalties for providers who use communication devices or other technologies that do not meet HIPAA’s requirements in order to treat patients via telehealth.

The response to the coronavirus situation is fluid and fast-moving – particularly by Congress’ standards.  In response to the coronavirus pandemic, three phases of legislation have been considered in Congress: Coronavirus Supplemental Appropriations Act (signed into law March 6th); Families First Coronavirus Response Act (signed into law March 18th); and a large ($1 trillion+) economic recovery package (currently being drafted). This post provides details about these legislative efforts and other recent actions by the White House to address the coronavirus pandemic.

This alert outlines the conditions set forth in the DSIO and DMO’s no-action letters providing temporary relief to market participants facing COVID-19–related challenges.

New York Governor Andrew Cuomo has issued an expansive executive order, which mandates that, beginning Friday, March 20, 2020, at 8:00 PM, all “non-essential” businesses and non-profits entities in New York State must reduce their in-office workforce by at least 75%, and where possible, utilize telecommuting arrangements.

The Baker Administration, along with prioritizing the medial professionals on the front lines of the fight against the novel coronavirus (“COVID-19”), have taken significant steps to relieve pressures on small businesses negatively impacted by the virus.  Most notably, opportunities through the Small Business Administration’s (“SBA”) Economic Injury Disaster Loan program and other tax relief for small businesses including those in the restaurant and hospitality sectors.

President Trump signed the Families First Coronavirus Response Act into law late Wednesday night.  We summarize the enacted version below (which replaces our analysis of an earlier version the House passed, which it since amended).  The law goes into effect into effect April 2, 2020 and will remain in place until the end of the year. 

As part of the continuing effort to respond to the COVID-19 pandemic, Governor Newsom has issued an Executive Order temporarily modifying the California WARN Act requirements for employers engaging in mass layoffs.

Amidst the novel coronavirus (COVID-19) outbreak, the Secretary of the U.S. Department of Health and Human Services (HHS), Alex M. Azar, took steps on March 15, 2020, to waive sanctions and penalties related to certain provisions of the HIPAA Privacy Rule (the “Waiver”). However, the HIPAA Privacy Rule is not suspended, and the Waiver only applies: (1) in the emergency area identified in the public health emergency declaration; (2) to hospitals that have instituted a disaster protocol; and (3) for up to 72 hours from the time the hospital implements its disaster protocol. To demonstrate how the Privacy Rule and Waiver provisions work in real life, let’s look at an example: A patient at a hospital reports contact with a confirmed COVID-19 diagnosis. How can this information be shared?

The Financial Industry Regulatory Authority (FINRA), the independent nongovernmental organization that writes and enforces the rules governing U.S. registered brokers and broker-dealers, has issued guidance to its member firms regarding pandemic-related planning. 

As we write this update on the actions of the Food and Drug Administration (FDA), more state and local governments (along with private businesses and employers) are taking sweeping actions to protect the public from the continued spread of COVID-19. The federal response to what is now a pandemic of COVID-19 started off slowly, but we are now seeing frequent and promising announcements from FDA and other agencies within the Department of Health and Human Services.

We published our first installment highlighting FDA’s role in this public health emergency on March 4, 2020 (see our prior post here). In the two weeks that have elapsed since then, FDA has taken several actions related to COVID-19 testing and other important public health protections which are explained below. One of the most striking things about the list of actions included in this post may be how diverse and broad FDA’s authorities are and what a substantial role the agency plays in protecting Americans from a variety of different types of harm.

In response to COVID-19, Massachusetts has directed health insurance carriers to, among other things, relax cost-sharing and enhance telemedicine services. These directives are part of the Commonwealth’s package of efforts to encourage early detection and treatment of COVID-19, and to slow the transmission of COVID-19. Massachusetts carriers have answered the call by enhancing benefits and services, in some cases beyond what the new directives require. Employers can play a key role by informing employees of these new benefits and encouraging employees to use the benefits.

On Wednesday, key Members of the House of Representatives sent a letter to the Chairman of the Federal Trade Commission (FTC), urging the Commission “to take immediate action to protect consumers from price gouging during this [COVID-19] declared public emergency.”  The letter was sent to FTC Chairman Joseph Simons from the chairs of the committees and subcommittees with jurisdiction over the FTC:

Below is an update on legislative efforts by Congress and the White House to address the coronavirus pandemic, prepared by our D.C. colleagues at ML Strategies, who are closely following these fluid and fast-moving developments. Efforts to provide a supply of low cost working capital to the many businesses and entities experiencing operational and/or cash flow disruption may be of particular interest to our bondholder clients.

This alert from the Mintz Financial Services Practice reviews the recent relief and guidance provided for NFA and FINRA member firms related to challenges posed by the COVID-19 pandemic.

This alert reviews worksite and Notice requirements for foreign workers and how employers can ensure compliance as employees work remotely during the coronavirus pandemic.