COVID-19 Viewpoints

In response to the growing COVID-19 crisis, an increasing number of state and local governments will be issuing Executive Orders that mandate the closure of private businesses and require citizens to “stay home” or “shelter in place.” Several jurisdictions, including San Francisco, Los Angeles, and New York, are trying to mitigate the downstream economic impact of such Orders by limiting or banning commercial evictions during the pendency of the COVID-19 epidemic.

This alert reviews a March 20 FCC declaratory ruling clarifying that COVID-19–related texts qualify as emergency exceptions under TCPA.

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.

401(k) plans must, by law, limit the circumstances under which plan money can be withdrawn by active employees.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.

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. 

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 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.

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.

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.

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. 

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.

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:

In response to the coronavirus pandemic, Congress and President Trump have taken the following actions:

Telehealth is going to play a critical role in the delivery of care in the coming weeks and months as health care providers respond to the COVID-19 pandemic. As the CDC and other public health agencies continue to recommend social distancing and self-quarantine after exposure, telehealth is a vital tool for getting both sick and healthy individuals access to health care services they need if in-person services are not necessary. The use of telehealth services should help alleviate the ever-growing pressures on health care systems as they respond to the outbreak.  In light of these benefits, the Emergency Appropriations Bill passed by Congress last week includes provisions that allow the Secretary of Health and Human Services (HHS) to lift certain restrictions that are currently required for Medicare  reimbursement of telehealth services. 

This advisory from the Mintz Government Law Practice outlines the details of Governor Baker’s March 15, 2020 executive orders aimed at reducing exposure to COVID-19.

As part of the Commonwealth’s extensive response to the COVID-19 outbreak, Governor Charlie Baker has temporarily suspended certain requirements of the Massachusetts Open Meeting Law in hopes of reducing the public’s risk of exposure at public meetings. This alert reviews the details of the Governor’s Executive Order, which takes steps to preserve the public’s rights to participate in meetings held by public bodies.

Read about the federal government’s response to COVID-19, including $8B in emergency funding and the Families First Coronavirus Response Act pending in the House.

Ellen Janos discusses the role telemedicine is expected to play in the management of the coronavirus outbreak as well as the Emergency Appropriations Bill passed Congress which contains provisions intended to loosen the restrictions on Medicare reimbursement for telehealth services.