COVID-19 Viewpoints

This week, Governor Charlie Baker issued COVID-19 Order No. 19, “Order Regarding the Conduct of Shareholder Meetings by Public Companies.  This Order, which is effective immediately, suspends certain requirements of M.G.L. chapter 156D, section 7.08 that relate to shareholder meetings by remote means.

Governor Charlie Baker just announced he is extending his executive order that mandates the closure of non-essential businesses.

The NYDFS has announced that it has extended the deadline for compliance with certain cybersecurity requirements due to the coronavirus emergency. The announcement from the Superintendent of Financial Services of the State of New York recognizes that COVID-19 may present compliance challenges for regulated entities and covered persons in meeting reporting obligations.

Read about Massachusetts Governor Baker’s executive order that temporarily permits Mass. Public Companies to Hold Virtual-Only Shareholder Meetings.

A timely and robust response to the COVID-19 virus demands the attention and resources of, and action by, federal and state regulators, employers, and individuals alike. The stakes could not be higher. State and local “shelter-in-place” orders have effectively, if not actually, resulted in widespread job losses for at least some indeterminate period of time.

On Monday, FCC Chairman Ajit Pai circulated a plan to his fellow Commissioners detailing how the $200 million the agency will receive via the CARES Act should be deployed for a telehealth program to combat COVID-19.  The telehealth program will enable eligible healthcare providers to purchase telecommunications, broadband connectivity and information services, and devices necessary to provide telehealth services to beneficiaries.  The increased access to the tools needed to provide care via telehealth will allow COVID-19 patients to receive care and providers to give it, while reducing opportunities for further exposure.

On March 23, 2020 the SEC issued a statement warning about the risks of insider trading posed by the COVID-19 pandemic.

As a follow up to our recent blog post, FDA User Fees: Highlights from FDARA & Our Forecast for the Next Round, President Trump signed the bipartisan over-the-counter (OTC) monograph teform bill into law on March 27, 2020.  The passage of the OTC monograph reform bill is a surprise addition into the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the third COVID-19 stimulus bill enacted since the pandemic began. The reform legislation represents the first significant update to federal oversight of OTC drug products since 1972. It enables the Food and Drug Administration (FDA) to quickly respond to safety concerns and keep pace with innovation in hopes of protecting consumers from unsafe drugs and permitting manufacturers to market new products more expeditiously. 

Congress has now passed the CORONAVIRUS AID, RELIEF AND ECONOMIC SECURITY ACT OR CARES ACT – Federal government’s Phase III response to the health and economic impacts related to the COVID-19 pandemic. President Trump has pledged to sign the Act into law immediately.

On March 25, 2020, the Food and Drug Administration (FDA) issued a temporary policy relating to enforcement of regulatory requirements for face masks and respirators during the COVID-19 crisis. Since the public health emergency began, the United States has experienced a shortage of masks, respirators, and other personal protective equipment (PPE) which are critically needed for health care workers caring for COVID-19 patients in all states. FDA previously created emergency use authorizations (EUAs) for NIOSH-approved disposable respirators for use in health care settings and imported non-NIOSH-approved disposable respirators, but the temporary enforcement policy represents an attempt to open the manufacturing, importation, and distribution flood gates to make more masks and respirators available as quickly as possible.

On March 23, 2020, the New York Senate proposed legislation that would forever waive rent payment obligations and mortgage payment obligations due from certain residential tenants and small business commercial tenants for 90 days in response to the COVID-19 pandemic.

As the COVID-19 pandemic continues to spread, so too have concerns about collaboration between competitors attempting to address unmet needs due to this national emergency. Shortages of medical supplies, personal protective equipment (PPE), and health care services pose questions of whether stakeholders can join forces in order to provide these much needed services and supplies.

Yesterday, we blogged on how scammers are trying to monetize on the COVID-19 health crisis for their personal gain. Though the U.S. Food & Drug Administration (FDA) issued a consumer update yesterday saying that there is still no approved vaccine or drug to prevent or treat this disease, companies have continued to market products that claim to prevent, treat, or even cure COVID-19 in an attempt to “help” or profit from distressed, vulnerable Americans. While the FDA is working tirelessly to review possible vaccines, treatments, and cures, Americans should avoid endangering their health or lives by self-medicating. Per the FDA, self-medicating with any new product on the shelf (real or virtual) could not only lead to adverse effects but also could interfere with crucial medications. We are closely monitoring whether Congress will take specific actions on these increasingly prevalent issues in the context of the COVID-19 pandemic.

This alert reviews executive orders by New York Governor Cuomo and administrative orders by the New York State courts that have stayed residential and commercial evictions and foreclosures in New York.

As authorized by Section 1135 of the Social Security Act, the Centers for Medicare & Medicaid Services (CMS) has announced that it will extend temporary Medicare billing privileges to physicians and non-physician practitioners via telephone and that it will expedite pending enrollment applications submitted by all other providers and suppliers, including DMEPOS.  CMS made the announcement on March 13th and followed up with the publication of FAQs related to enrollment relief earlier this week.

On March 23, 2020, Governor Charlie Baker of Massachusetts issued COVID-19 Order No. 13 (the “Order”) requiring all businesses and organizations in the Commonwealth of Massachusetts that do not provide “COVID-19 Essential Services” (“Essential Services”) to close their physical workplaces and facilities to workers, customers and the public as of 12:00 noon on Tuesday, March 24, 2020 until 12:00 noon on April 7, 2020.  

Two weeks ago, on March 9, the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) sent warning letters to seven companies that allegedly made false or deceptive claims about their products’ ability to treat Coronavirus Disease 2019 (COVID-19).  The agencies warned the companies that their health claims lacked credible supporting evidence and emphasized the FDA does not recognize a vaccine, drug, or treatment for the disease.  

In the past couple of days, the Department of Health and Human Services Office of Inspector General (HHS-OIG) and the Department of Justice (DOJ) each issued warnings about fraudulent schemes relating to COVID-19. While we are all taking precautions to stay safe and #flattenthecurve -- with many under orders to shelter in place -- scammers are preying on fears and insecurities and hawking test kits and vaccines for the virus. These scams are reminders to trust our medical professionals and access them when we feel sick and to think twice when something sounds too good to be true. 

With the advent of COVID-19, countries around the world are facing a novel challenge that affects them in unprecedented ways economically, socially, and otherwise.  From a public health perspective, now perhaps more than ever before, authorities are interested in understanding more about the movement patterns of those within their borders, including where certain individuals have traveled to, who they have met with, and where they are located now.  

As part of the “New York State on PAUSE” response to the COVID-19 outbreak, on March 20, 2020 Governor Cuomo issued Executive Order No. 202.8 requiring a 100% reduction of the in-person workforce of all non-essential businesses in New York State. While the reduction of in-person workforce is broad reaching, the essential services exception serves to allow landlords to continue providing basic security, janitorial service, and other services truly needed for maintaining and operating their buildings.  Furthermore, landlords and tenants should be able to maintain the IT infrastructure needed for remote work, provided they are doing so in a manner that otherwise comports with the NY State on Pause requirements.