Morgan Lewis has long recognized the importance of employing a strategic, business-focused approach to addressing client matters. That has never been as important as right now, when companies across all industries are looking for practical guidance on ways to protect their businesses and their people. Our cross-disciplinary teams take a comprehensive approach to understanding our clients’ industry-based needs, providing a deep well of resources across broad sectors: energy, financial services, healthcare, life sciences, and retail and ecommerce.
States and localities across the country are continuing to respond as quickly and effectively as possible to the coronavirus (COVID-19) outbreak. These responses include guidance for taxpayers on numerous topics, such as providing tax relief through filing and payment deadline extensions.
A new coronavirus (COVID-19) relief bill—the Consolidated Appropriations Act, 2021, which includes the Taxpayer Certainty and Disaster Tax Relief Act of 2020 (the Act)—was signed into law on December 27. The Act not only contains tax provisions to provide direct relief to individuals, but also includes tax benefits for various industries, including the “green” energy and technology industries.
The Commodity Futures Trading Commission (CFTC) recently issued an interim report by CFTC Staff on the April 2020 price collapse of the West Texas Intermediate light sweet crude oil futures contract (WTI Futures Contract).
Partners Althea Day, Randall Tracht, and Johnathan Zimmerman authored a Pratt’s Energy Law Report article about the challenges energy companies face as they return to “normal” operations amid the coronavirus (COVID-19) pandemic.
Under the assumption that the coronavirus (COVID-19) public health emergency (PHE) will continue into 2021, the US Nuclear Regulatory Commission (NRC) Staff hosted a public meeting via teleconference on October 15 to discuss future requests for relief from regulatory requirements.
FERC has issued an order extending the blanket waivers of all requirements to hold meetings in person and/or to provide or obtain notarized documents in open-access transmission tariffs through January 29, 2021.
The CARES Act’s Paycheck Protection Program provides loans targeted to small businesses to help keep their workers employed during the coronavirus (COVID-19) pandemic, and offers loan forgiveness to borrowers maintaining a high percentage of employees on payroll. This LawFlash provides the latest developments in PPP loan availability, eligibility, and forgiveness, as well as a comprehensive overview of the PPP and related guidance.
The Department for Business, Energy & Industrial Strategy published a statement on 30 July announcing that furloughed employees will receive statutory redundancy pay based on their normal wages, rather than a reduced furlough rate.
The Federal Reserve took additional actions on April 9 to provide up to $2.3 trillion in loans to support the US economy during the coronavirus (COVID-19) pandemic. This LawFlash covers the new and expanded programs, and provides comprehensive coverage of the Coronavirus Economic Stabilization Act.
Following the declaration of a global pandemic due to the widespread transmission of the coronavirus (COVID-19), the issuance of shutdown and/or stay-at-home directives cascaded from commercial enterprises and state and local governments across the United States. During this period of extreme disruption to daily routine, the continuity and integrity of energy operations were necessary to ensure that the massive shift to home-based life could exist with minimal business disruption.
This LawFlash provides a summary on navigating the regulatory landscape in various jurisdictions throughout the Latin America region during the global coronavirus (COVID-19) crisis.
Two key amendments to the German competition law entered into effect on May 29, 2020, temporarily extending merger control review periods and temporarily suspending interest payments for antitrust fines, further to a bill adopted by the German Parliament to mitigate the consequences of the coronavirus (COVID-19) pandemic on trade.
The NRC’s Office of Enforcement (OE) recently issued Attachment 3 to Enforcement Guidance Memorandum (EGM) 20-002, providing guidance to NRC Staff to disposition violations of emergency preparedness (EP) regulations during the coronavirus (COVID-19) public health emergency (PHE). The guidance applies to entities licensed under 10 CFR Parts 30, 40, 50, 52, 70, and 72.
The Federal Energy Regulatory Commission (FERC) issued a notice on May 20 that it will convene a Commissioner-led technical conference to consider the ongoing, serious impacts that the emergency conditions caused by the coronavirus (COVID-19) pandemic are having on the energy industry. The conference will be free, open to the public, and held remotely on Wednesday and Thursday, July 8-9, 2020.
The NRC’s Office of Enforcement (OE) recently issued Attachment 2 to Enforcement Guidance Memorandum (EGM) 20-002, providing guidance to NRC inspection staff for exercising enforcement discretion for certain byproduct material licensees that suspended their use of licensed material and are maintaining the licensed material in safe storage because of the coronavirus (COVID-19) public health emergency (PHE).
The NRC Staff released specific guidance to all licensees on how to request exemptions from emergency preparedness (EP) biennial exercise requirements on May 14. The guidance supplements the NRC’s April 30 teleconference, during which it acknowledged that there may be instances in which licensees are unable to comply with certain EP requirements, including required training and drills, during the coronavirus (COVID-19) public health emergency (PHE).
The NRC Staff released specific guidance to operating and decommissioning reactor licensees on requesting exemptions from fire protection requirements during the coronavirus (COVID-19) public health emergency (PHE) on May 14. The guidance supplements the NRC’s April 29 teleconference, during which it contemplated such regulatory relief pathways. Morgan Lewis reported on the teleconference earlier this month.
The US Department of the Treasury issued a letter on May 7 stating that it plans to modify the continuity safe harbor for both the production tax credit (PTC) and the energy investment tax credit (ITC). Under the current law, taxpayers seeking to claim a PTC for electricity produced from qualifying facilities or an ITC for qualifying energy property must generally begin construction on the qualifying facility or property by specified dates.
US companies trying to close international deals or set up new branches in foreign countries are struggling to secure apostilles to certify documents due to quarantine mandates and office closures resulting from the coronavirus (COVID-19) pandemic.
In response to President Donald Trump’s declaration of a national emergency due to the coronavirus (COVID-19) pandemic, the Pipeline Hazardous Materials Safety Administration (PHMSA) issued a notice that it does not intend to take enforcement action related to certain new gas pipeline safety regulations with which gas pipeline operators must comply by July 1, 2020.
The NRC issued a draft letter to holders of licensees (other than operating power reactor licensees) to possess Category 1 or 2 quantities of radioactive material (RAM) as defined in Appendix A to 10 CFR Part 37.
Companies with substantial business interruption losses related to the coronavirus (COVID-19) pandemic must take immediate, concrete steps now to preserve their ability to pursue recoveries from insurance and/or financial relief from future governmental programs.
The NRC issued a letter to the National Organization of Test, Research, and Training Reactors on April 30 regarding the NRC’s expedited review of requests for regulatory relief from certain material control and accounting (MC&A) requirements during the coronavirus (COVID-19) public health emergency (PHE).
The NRC Staff hosted a public meeting via teleconference on April 30 to discuss regulatory relief from emergency preparedness (EP) requirements during the coronavirus (COVID-19) public health emergency (PHE).
The European Commission published its first comfort letter in nearly 20 years on April 29, in an effort to foster cooperation among businesses during the coronavirus (COVID-19) pandemic. Here is what companies should know about the specific practices permitted under the comfort letter, as well as the specific conditions and safeguards for cooperation.
The US Nuclear Regulatory Commission (NRC) Staff hosted a public meeting via teleconference on April 29 to discuss available regulatory relief pathways from fire protection requirements during the coronavirus (COVID-19) public health emergency (PHE).
Key issues that UK employers should begin considering now to minimize difficulties as they reopen or expand their operations include reintegrating staff, assessing internal policies in light of the pandemic, testing for the coronavirus (COVID-19), and more.
The US Department of the Treasury recently began accepting loan applications from qualifying Defense Industrial Base contractors, with a short deadline of May 1, 2020, to submit the application for expedited review.
The NRC issued temporary Staff guidance intended to help Staff review and process requests for regulatory relief from fuel facilities on April 21. Although intended for NRC Staff, the guidance provides insights into the process licensees should follow when submitting requests for relief and the information they should anticipate including.
The US Nuclear Regulatory Commission (NRC) issued a letter on April 27 to the Nuclear Energy Institute and the National Organization of Test, Research, and Training Reactors, and others, clarifying and expanding the guidance on respiratory protection requirements that it previously provided to stakeholders during an April 15 teleconference.
The Nuclear Regulatory Commission (NRC) Staff hosted a public meeting via teleconference on April 23 to discuss available regulatory relief pathways for materials licensees subject to 10 CFR Parts 30 and 34 during the coronavirus (COVID-19) public health emergency (PHE).
The US Nuclear Regulatory Commission (NRC) Staff hosted a public meeting via teleconference on April 22 to discuss available regulatory relief pathways for medical licensees during the coronavirus (COVID-19) public health emergency (PHE).
This is our first edition of Morgan Lewis Spark, a quarterly update highlighting new and amended Russian legislation of importance to companies operating in the Russian energy and mining sectors.
Prepackaged bankruptcies, prearranged bankruptcies, and expedited sales are available options for businesses in need of accelerated restructurings during the coronavirus (COVID-19) pandemic.
As the coronavirus (COVID-19) pandemic disrupts everyday life throughout the world, boards of directors of corporations working around the clock to understand, address, and mitigate its effects on business operations must direct attention to their fiduciary duties. Boards must act affirmatively, and with an eye on the future, to assure that duties to corporations and stockholders continue to be met.
The Internal Revenue Service (IRS) and the US Department of the Treasury released two Revenue Procedures and a new FAQ on April 21 to provide relief to US residents and alien individuals affected by travel disruptions due to the coronavirus (COVID-19) emergency.
The US Nuclear Regulatory Commission (NRC) Staff issued SECY-20-0034 on April 22, informing the NRC Commissioners of the Staff’s plan to exercise enforcement discretion for licensee noncompliance with regulatory requirements resulting from illnesses or other factors caused by the coronavirus (COVID-19) public health emergency (PHE).
New guidance from the UK Competition and Markets Authority warns that it will not relax its substantive or evidentiary standards for merger investigations during the coronavirus (COVID-19) pandemic. Statutory deadlines will not be altered, although aspects of investigations may be subject to delay, and the authority will continue to impose interim measures. The authority also set out its position on mergers involving “failing firms,” indicating some flexibility in its interpretation of the counterfactual test.
In response to coronavirus (COVID-19) pandemic, the US Securities and Exchange Commission’s Corporation Finance Division and Investment Management Division have issued guidance to assist companies in making changes to the format of its shareholder meetings, the way in which companies accept shareholder proposals, and the timing of Form 10-K corporate governance and compensation disclosures that are all adaptive to the changing times. Additionally, various states have loosened the restrictions around annual shareholder meetings. This LawFlash gives an overview of this guidance and relief.
Compensation Committees are addressing whether compensation should be adjusted to reflect the effect of the coronavirus (COVID-19) pandemic on companies’ businesses and how to correlate executive compensation with changing company priorities. Here is how compensation committees can approach this challenge in the coming months.
In connection with the current national state of emergency, Republic of Kazakhstan Prime Minister Askar Mamin signed Resolution of the Government No. 220 on Certain Issues of Entry into (Exit from) the Republic of Kazakhstan and the Stay of Immigrants in the Republic of Kazakhstan on April 17, suspending the effect of certain norms of the law providing visa-free travel regime for citizens of specific countries.
In an order issued on April 17, the Federal Energy Regulatory Commission (FERC) agreed to defer implementation of certain cybersecurity and operational reliability standards administered by the North American Electric Reliability Corporation (NERC) that had important compliance milestones later this year, including the suite of supply chain risk management standards that have been under development for several years and were set to take effect on July 1. The move by FERC is intended to provide some measure of relief from impending compliance burdens and to allow electric utilities to focus their resources on responding to the coronavirus (COVID-19) pandemic.
The US Nuclear Regulatory Commission’s (NRC’s) Office of Nuclear Materials Safety and Safeguards (NMSS) issued an internal memorandum on April 10 to its regional directors describing a process that could be used to review medical licensees’ requests for temporary exemptions from certain NRC regulations due to the coronavirus (COVID-19) pandemic. Enclosed with the memorandum is a template letter that regions can use to streamline granting temporary exemptions.
The NRC’s Office of Nuclear Reactor Regulation (NRR) now has a web portal for nuclear reactor licensees to submit coronavirus (COVID-19) related regulatory exemption requests. The web portal currently allows online submissions for Part 26 Work Hour exemption requests. Online submissions for Part 55 Operator Licenses, Part 50.55a Owner’s Activity Reports, and Part 73 Physical Protection exemptions are coming soon.
The US Department of Labor’s chief administrative law judge (ALJ) issued a supplemental administrative order on April 10, extending the suspension of in-person hearings before the Office of Administrative Law Judges (OALJ).
The US Department of Homeland Security’s Cybersecurity & Infrastructure Security Agency (CISA) issued Version 3.0 of its guidance on April 17 on identifying essential critical infrastructure workers amid the coronavirus (COVID-19) pandemic.
US Nuclear Regulatory Commission (NRC) regulations at 10 CFR 20.1703(c)(5)(iii) and 10 CFR 20.1703(c)(6) require licensees to maintain a respiratory protection program that requires (1) a periodic—often annual—determination by a physician that the user is medically fit to use respiratory protection, and (2) annual “fit testing” to ensure that the licensee’s respiratory protection seals tightly to the licensee’s face.
The Occupational Safety and Health Administration has issued a new guidance allowing field offices flexibility in handling COVID-19-related matters, including complaints. The guidance focuses on highly affected industries, such as healthcare and first responders and prioritizes inspections in areas of imminent danger of exposures and fatalities. Enforcement for other industries is likely to shift from primarily on-site inspections to informal complaints and whistleblower actions.
Morgan Lewis partner Philip Miscimarra spoke with Bloomberg Law about how businesses are responding to the coronavirus (COVID-19) pandemic.
The NRC’s Office of Enforcement (OE) recently issued Enforcement Guidance Memorandum (EGM) 20-002, providing guidance to NRC inspection staff for exercising enforcement discretion for licensees impacted by the coronavirus (COVID-19) pandemic.
Insurance regulators across the country have enacted emergency regulations, issued administrative guidance, and requested carriers to take certain actions to try to address the financial impact of the coronavirus (COVID-19) pandemic on individuals and businesses. Requirements imposed on or requested of health insurers to expand access to telehealth and eliminate or limit prior authorization or concurrent review have been widely reported, but there have been numerous other industry-wide actions. And, some state legislators have introduced bills to expand the scope of coverage to ameliorate the impact of the pandemic on insureds.
In light of the ongoing coronavirus (COVID-19) pandemic, the ICC on April 9 released a guidance highlighting a number of measures that parties, counsel, and tribunal members can take in order to avoid extensive disruption to arbitral proceedings.
This Insight authored by Morgan Lewis lawyers and published by Bloomberg Law poses 100 questions related to the COVID-19 payroll tax and fringe benefits provisions, which we have been explained in our LawFlashes.
Morgan Lewis partners Julia Frost-Davies and Andrew Budreika, of counsel Jason Alderson, and associate Benjamin Stango authored a INSOL International article about access to bankruptcy courts in light of the coronavirus (COVID-19) pandemic.
As jurisdictions contemplate lifting pandemic-related workplace restrictions, employers must start considering how best to cope with a vast array of issues, including restarting or expanding operations, reintegrating remote-working or furloughed employees, implementing new state and local orders/requirements, and protecting the safety of employees and customers. Employers who proactively plan for these challenges will be best positioned to adapt to the “new normal.”
The US Department of Labor’s Occupational Health and Safety Administration (OSHA) released a statement on April 8 reminding employers that they cannot retaliate against workers who report unsafe or unhealthy working conditions during the coronavirus (COVID-19) pandemic.
Our labor and employment colleagues have prepared a LawFlash providing our current thinking regarding key issues that employers should begin considering now to minimize difficulties as they reopen or expand current operations.
Read the practical guidance provided by our labor and employment lawyers, highlighting key considerations employers should begin analyzing regarding how to reopen or expand operations. The focus is on what can be done now with the understanding that guidance on when and how workplaces can reopen or expand will rely in large part on jurisdiction-specific local orders and guidance.
Following a recent trend, New York Governor Andrew Cuomo has issued two executive orders requiring individuals to wear face coverings when near other people. One order requires all customer/public-facing employees to wear face coverings and requires employers to provide these face coverings at no cost to employees. The other order requires all individuals in a public place to use a mask or face covering.
In connection with the current state of emergency in Kazakhstan related to the coronavirus (COVID-19) pandemic, President Kassym-Zhomart Tokaev has signed a decree on a special military call-up in the Republic of Kazakhstan.
The US Environmental Protection Agency (EPA) has released additional interim guidance for field work decisions at cleanup sites under EPA authority, emphasizing its commitment to ensuring the health and safety of the public, its staff, and others performing work at the sites. In its guidance, the EPA provides principles to consider when evaluating whether to proceed with or pause field work related to Superfund (CERCLA) cleanups, Resource Conservation and Recovery Act (RCRA) corrective actions, Toxic Substance and Control Act PCB cleanups, Oil Pollution Act spill responses, and Underground Storage Tank Program actions.
Shortly after the announcement that the 2020 Summer Olympics would be delayed until Summer 2021, the Japanese government on April 7 announced a state of emergency for Tokyo and six prefectures (Kanagawa, Saitama, Chiba, Osaka, Hyogo, and Fukuoka) in light of the coronavirus (COVID-19) pandemic. This LawFlash answers key questions about employers’ obligations to their employees during the state of emergency and provides an overview of the government subsidies currently available.
In response to the coronavirus (COVID-19) pandemic, Russia has introduced non-work days through 30 April 2020 to keep people at home. The non-work days are mandatory for all employers with limited exemptions. On 2 April, President Vladimir Putin authorized the heads of subjects of the Russian Federation (Russia’s constituencies) to provide further exemptions or stricter rules depending on the epidemiological situation in a particular territory. In this alert we address the most recent restrictions introduced by the Mayor of Moscow, including the introduction of digital passes.
As New Jersey continues to battle the spread of coronavirus (COVID-19), Governor Phil Murphy ordered essential businesses in the state to adopt several measures including mandatory face coverings at worksites, occupancy limits for stores, and frequent handwashing breaks for employees. Employers should pay close attention to these comprehensive and far-reaching—and sometimes confusing—orders that impose affirmative duties and could raise a host of reasonable-accommodations issues.
The US Department of the Treasury on April 10 released updated criteria outlining which businesses are eligible to apply for CARES Act loans out of the $17 billion allocated for businesses “critical to maintaining national security.”
The joint statement recognizes that while the COVID-19 pandemic offers businesses an opportunity for procompetitive collaboration and benefits, it also increases significant risk of anticompetitive conduct in the labor market. Here are some issues and factors that businesses should consider to mitigate antitrust risk as the Antitrust Division and Federal Trade Commission continue to consider enforcement actions for antitrust violations.
Businesses that avail themselves of financial assistance under Section 4003 or 4116 of the CARES Act must limit compensation and severance paid to certain officers and employees.
US antitrust laws already on the books facilitate rapid investment without government delay: important practical tools and rules for dealmakers and their counsel in the wake of the coronavirus (COVID-19) pandemic and the current economic challenges.
The US Department of Energy’s National Nuclear Security Administration (NNSA) recently posted guidelines on its continued operations during the coronavirus (COVID-19) pandemic. While NNSA personnel are mostly working remotely, the agency is otherwise operating business-as-usual.
The European Commission has provided antitrust guidance to companies cooperating in response to urgent coronavirus (COVID-19) related matters, particularly in the health sector for critical hospital medicines and medical equipment, and has also exceptionally issued a “comfort letter” on a cooperation project in the generic pharmaceuticals sector aimed at ensuring the supply of critical hospital medicines. Other ad hoc “comfort letters” may follow at the EU Commission’s discretion.
As the coronavirus (COVID-19) pandemic continues to impact most countries around the world, governments have introduced travel restrictions, temporarily suspended flights, imposed mandatory home isolation measures, and suspended services for some immigration procedures, as well as closed some government agencies. For employers looking to move essential employees globally, and/or repatriate them to their home countries, we’ve compiled a list of current immigration updates to consider.
The French government has been adopting a series of legal measures in response to the coronavirus (COVID-19) pandemic. The French Parliament voted on a law responding to the epidemic on 23 March (the Bill). In addition to measures relating to the holding of municipal elections and sanctions for breaches of the confinement regime which has been in force since 17 March, the government also took measures that affect French business and legal proceedings before the French courts in a variety of ways.
In response to the coronavirus (COVID-19) pandemic and the resulting economic fallout, the government of Kazakhstan has introduced several emergency measures to stabilize the country’s economy and help businesses. This LawFlash discusses some of those measures, including tax incentives and extended grace periods for loans, among others.
Employers considering layoffs in the face of the coronavirus (COVID-19) crisis have additional opportunities to support furloughed workers, aside from options offered by the CARES Act.
The US Nuclear Regulatory Commission (NRC) issued a letter on April 9 to provide guidance on reporting requirements under 10 CFR 50.55a, “Codes and Standards,” in light of the coronavirus (COVID-19) pandemic. The guidance is applicable to nuclear reactors licensed under 10 CFR Part 50.
The Japanese government declared a state of emergency with respect to seven prefectures on April 7. The government also has issued emergency policies in response to the new coronavirus (COVID-19) pandemic, including the Emergency Economic Measures for New Coronavirus Infectious Disease Control, issued that same day.
The US Nuclear Regulatory Commission (NRC) issued a letter including frequently asked questions (FAQs) on April 7 to all agreement and non-agreement states to address the NRC’s regulation of nuclear materials—and its policies and recent activities related thereto—in light of the coronavirus (COVID-19) pandemic. The NRC posted a copy of the FAQs to its password-protected Materials Security Toolbox and intends to update that site “as additional information becomes available.”
The NRC issued its final Temporary Staff Guidance (Final Guidance) on April 6 on its review procedures for coronavirus (COVID-19)-related Part 26 exemption requests. The NRC previously issued a draft of this guidance on April 1 and also discussed the draft during a teleconference with the industry on April 2, which we reported on.
In three new Unemployment Insurance Program Letters, the US Department of Labor (DOL) issued guidance to state workforce agencies to implement the unemployment provisions in the CARES Act. The guidance has several important aspects for employers.
The US Nuclear Regulatory Commission (NRC) issued a letter on April 7 to all NRC licensees authorized to possess byproduct, source, and special nuclear material – excluding operating power reactor and research test reactor licensees – outlining how those licensees might seek relief from certain regulatory requirements as a result of the coronavirus (COVID-19) pandemic.
La pandémie de coronavirus (COVID-19) en France a donné lieu à des mesures d'interdiction et de restriction des déplacements, y compris la mise en quarantaine des personnes. Ces mesures ont perturbé les chaînes d'approvisionnement et les activités de nombreuses entreprises, notamment par la fermeture d'usines et de commerces.
Texas Governor Greg Abbott issued Executive Order GA-14 on March 31, directing every person in Texas to minimize social gatherings and in-person contact with people who do not live in the same household except where necessary to provide or obtain essential services.
Federal Energy Regulatory Commission Chairman Neil Chatterjee on April 2, 2020, announced the commission’s plan to assist regulated entities in managing enforcement- and compliance- related burdens during the ongoing coronavirus (COVID-19) pandemic.
The US Nuclear Regulatory Commission (NRC) and the US Department of Homeland Security’s Federal Emergency Management Agency (FEMA) issued internal guidance on March 30 regarding potential discussions with licensees and offsite response organizations (OROs) related to the postponement and rescheduling of radiological emergency preparedness (REP) exercises due to the worsening coronavirus (COVID-19) pandemic.
As we recently reported, the US Nuclear Regulatory Commission (NRC) is prepared to grant exemptions to the work-hour controls in 10 CFR 26.205(d)(1)-(7) if the coronavirus (COVID-19) public health emergency affects a licensee’s staffing for workers who fall within the scope of Part 26.
As the coronavirus (COVID-19) pandemic continues, state government agencies are increasingly responding with closures and cancellations. In Pennsylvania, the Department of Environmental Protection recently cancelled seven highly anticipated public hearings.
As the coronavirus (COVID-19) pandemic continues to evolve, regulatory and legislative authorities are taking actions, in the form of directives and orders, that could directly impact companies’ business interruption coverage. Careful review of insurance policies and insurers’ responses in light of these actions, as well as monitoring of regulatory and legislative developments, will be critical in preserving companies’ rights to coverage for COVID-19 losses.
In response to the coronavirus (COVID-19) public health emergency, the US Nuclear Regulatory Commission (NRC) announced that it is prepared to grant upon request from individual Part 50 licensees, exemptions to the work-hour controls specified in 10 CFR 26.205(d)(1)-(7).
President Donald Trump signed the $2.2 trillion Coronavirus Aid, Relief, and Economic Security Act (CARES Act or the Act) into law on March 27. The CARES Act aims to offer economic relief to companies and their employees due to the coronavirus (COVID-19) pandemic in the United States. Although the Act does not expressly provide relief for energy companies, many of its provisions impact energy sector companies.
A week after first issuing guidance identifying the workers considered essential for critical industries in the United States during the coronavirus (COVID-19) pandemic, the US Department of Homeland Security’s Cybersecurity & Infrastructure Security Agency (CISA) on March 28, 2020, revised that guidance to capture a broader array of workers, particularly in the energy sector.
As the coronavirus (COVID-19) continues to spread around the world, this remains an unprecedented time for global industry. The same is true for outsourcing and managed services arrangements: both service providers and customers find themselves under unique pressures and in unchartered circumstances testing the parameters and strengths of their solutions and business continuity plans.
The ultimate impact of the coronavirus (COVID-19) pandemic on shareholder activism remains largely uncertain and comparisons with the surge in activism that followed the 2008 global financial crisis are tempting, but suspect as it remains questionable whether activists can still rely on the same forces that have been driving activism.
The US Department of Labor (DOL) issued additional frequently asked questions on March 27 to explain how the recently enacted Emergency Paid Sick Leave Act and the Emergency Family Medical Leave Expansion Act (Emergency FMLA) will work in various situations during the coronavirus (COVID-19) crisis.
Overwhelmingly passed by both houses of the US Congress this week and signed into law by President Donald Trump on March 27, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) provides a $2 trillion economic stimulus and contains many major tax changes to help businesses and individuals.
The US Environmental Protection Agency announced a temporary policy regarding its enforcement of certain environmental legal obligations in an effort to protect workers and the public from exposure to the coronavirus (COVID-19).
Here are some frequently asked questions to help employers understand the legal ramifications of furloughs and terminations of H-1B workers in light of the coronavirus (COVID-19) outbreak.
In response to the US president’s declaration of a national emergency due to the coronavirus (COVID-19) pandemic, on March 20 the Pipeline and Hazardous Materials Safety Administration (PHMSA) issued a notice to operators stating that, effective immediately and until further notice or modification, PHMSA does not intend to take any enforcement action with respect to operator qualification (OQ) and control room management (CRM) requirements, and will consider exercising enforcement discretion regarding certain drug testing requirements.
Over the past few days, several civic and environmental organizations have requested that federal departments and agencies pause rulemaking activities in response to the worsening coronavirus (COVID-19) pandemic.
The Families First Coronavirus Response Act imposes a mandate on all employers with fewer than 500 employees, and on all federal and state employers, to provide paid time off to employees who need leave for reasons connected to the public health emergency.
Widely expected to pass both houses of the US Congress by March 27, and to be signed into law by the president, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) lays out a $2 trillion economic stimulus, including over $300 million in emergency supplemental appropriations. This is a high-level summary of key portions of the bill.
The US Securities and Exchange Commission announced on the morning of March 25 the extension of filing periods covered by previously enacted conditional reporting relief for certain public company filing obligations, and provided current views regarding disclosure considerations and other securities law matters related to the coronavirus (COVID-19) crisis.
Over the past days and weeks, various US state and local governments have issued orders that restrict travel and certain gatherings in an effort to slow the spread of the coronavirus (COVID-19). Although those orders have largely excepted, among others, individuals who are employed by industries that provide critical infrastructure, a lack of uniformity among those ordersand their piecemeal, jurisdictional naturehas caused some confusion. Recent guidance issued from the US Department of Homeland Security aims to reduce this confusion.
California Governor Gavin Newsom has issued multiple orders affecting how and under what conditions state and local agencies may meet and discuss and/or approve of contracts for services and products during the coronavirus (COVID-19) pandemic.
The US Federal Trade Commission and the Antitrust Division of the US Department of Justice have announced that they aim to respond within one week to coronavirus (COVID-19) collaborative proposals submitted pursuant to the agencies’ respective processes.
In light of the coronavirus (COVID-19) pandemic, here are some questions for employers to consider with regard to Form I-9 compliance.
The NRC recently hosted a public meeting—exclusively via teleconference—to discuss regulatory implications of the coronavirus (COVID-19) pandemic for power reactor licensees. Of particular note, the NRC Staff is developing pandemic-related enforcement guidance. The first installment of this guidance is expected to be released early this week.
In response to the coronavirus (COVID-19), the US Department of Labor’s (DOL’s) chief administrative law judge (ALJ) issued an administrative order on March 19 clarifying the status of matters pending before the DOL’s Office of Administrative Law Judges (OALJ).
Functioning critical infrastructure is crucial during the response to the coronavirus (COVID-19) emergency for public health and safety reasons. And as noted in the Coronavirus Guidelines for America issued on March 16, US President Donald Trump has recommended that workers in critical infrastructure industries have a “special responsibility” to maintain normal work schedules. The Cybersecurity and Infrastructure Security Agency (CISA) on March 19 issued guidance on defining the Essential Critical Infrastructure Workforce. That guidance explicitly discusses workers in the nuclear and electric industries.
Functioning critical infrastructure is crucial during the response to the coronavirus (COVID-19) emergency for public health and safety reasons. And as noted in the Coronavirus Guidelines for America issued on March 16, US President Donald Trump has recommended that workers in critical infrastructure industries have a “special responsibility” to maintain normal work schedules. The Cybersecurity and Infrastructure Security Agency (CISA) on March 19 issued guidance on defining the Essential Critical Infrastructure Workforce. That guidance explicitly discusses workers in the nuclear and electric industries.
The rapidly evolving coronavirus (COVID-19) crisis has given rise to several immediate impacts to ongoing cleanups of contaminated sites under state and federal environmental laws.
Commission Chairman Neil Chatterjee held a press conference on March 19 to discuss FERC’s work during the current pandemic, provide updates regarding the coronavirus (COVID-19), and respond to questions from the media.
FERC and NERC issued a joint notice on Wednesday providing compliance flexibility on certain key reliability standard requirements during the ongoing coronavirus (COVID-19) pandemic. Although this guidance can allow utilities to avoid findings of noncompliance for certain requirements where timely compliance activities could be difficult due to personnel shortages and other limitations, this is not a blanket waiver. Instead, utilities must provide written notices of their intent to use this guidance. The content of those notices must be drafted carefully as they will be necessary to demonstrate compliance in future reviews.
FERC and NERC issued a joint notice on Wednesday providing compliance flexibility on certain key reliability standard requirements during the ongoing coronavirus (COVID-19) pandemic. Although this guidance can allow utilities to avoid findings of noncompliance for certain requirements where timely compliance activities could be difficult due to personnel shortages and other limitations, this is not a blanket waiver. Instead, utilities must provide written notices of their intent to use this guidance. The content of those notices must be drafted carefully as they will be necessary to demonstrate compliance in future reviews.
In responding to the coronavirus (COVID-19) pandemic, the mantra of “working together” is heard often. But as businesses confront sudden and extensive demand and supply disruptions—and a range of sometimes conflicting information and guidance from the public sector about the health crisis—questions inevitably arise about the extent to which the private sector can coordinate its responses consistent with the antitrust laws.
As countries grapple with the spread of the coronavirus (COVID-19) pandemic, recent international travel restrictions have been put in place around the world, including in Europe, Canada, India, and Australia. This LawFlash covers the latest travel impacts in those areas and discusses visa and other considerations for international travelers, employers, and employees.
In responding to the coronavirus (COVID-19) pandemic, the mantra of “working together” is heard often. But as businesses confront sudden and extensive demand and supply disruptions—and a range of sometimes conflicting information and guidance from the public sector about the health crisis—questions inevitably arise about the extent to which the private sector can coordinate its responses consistent with the antitrust laws.
With significant business disruptions occurring as a result of coronavirus (COVID-19), companies should consider how insurance coverage, including business interruption, supply chain, and event cancellation coverage, can help mitigate losses.
Morgan Lewis partner Jennifer Breen spoke with Law360 about the US Internal Revenue Service’s response to Coronavirus COVID-19.
Following the increased spread of COVID-19 within the United States, the North American Electric Reliability Corporation (NERC) issued a Level 2 Alert on March 10 to all users, owners, and operators of the bulk-power system, outlining a series of recommendations and requiring certain responses from each entity about their plans for continued reliable operation under pandemic circumstances.
A blog post authored by Morgan Lewis partner Michelle McCarthy and of counsel Saghi Fattahian was cited in an HR Daily Advisor article about the 2019 Novel Coronavirus (COVID-19) and HIPAA compliance.
The 2019 Novel Coronavirus (COVID-19) outbreak has led to travel bans and restrictions, the lockdown of cities, and the quarantine of individuals. These government measures have disrupted businesses and supply chains, and many companies listed on the Singapore stock exchange have announced disruptions to their operations in China, including factory and store closures.
The UK Supreme Court issued a policyholder-friendly decision earlier this year on the Financial Conduct Authority’s business interruption test case. The judgment will apply to policyholders’ claims on a case-by-case basis.
States and localities across the country are continuing to respond as quickly and effectively as possible to the coronavirus (COVID-19) outbreak. These responses include guidance for taxpayers on numerous topics, such as providing tax relief through filing and payment deadline extensions.
Following the enactment of the Economic Aid to Hard-Hit Small Businesses, Nonprofits, and Venues Act in December 2020, the Biden administration announced several changes to the Paycheck Protection Program on February 22, 2021 aimed at providing greater access to funds for underserved businesses and communities. This LawFlash discusses these recent changes, highlighting key provisions and guidance for businesses seeking to participate in the program before it officially expires on March 31, 2021 (pending any additional legislation from Congress).
As part of President Joe Biden’s efforts to address the continuing impact of the COVID-19 pandemic on American families, on February 16, the US Department of Housing and Urban Development, US Department of Veterans Affairs, and US Department of Agriculture (together, the agencies) announced a coordinated extension and expansion of forbearance and foreclosure relief programs. This announcement extends and expands the agencies’ forbearance and foreclosure relief programs through June 30, 2021. The programs were due to expire in March.
Despite a strict prohibition on gatherings of more than two persons in any public place in Hong Kong through at least February 17, there is an exemption for shareholders’ meetings of companies listed on the Stock Exchange of Hong Kong, with certain conditions.
The US Congress has passed a spending bill that includes $285 billion to extend and expand the Paycheck Protection Program, providing new first-time loans and adding second-draw loans to help support small businesses. This LawFlash discusses the new stimulus package that is part of the Consolidated Appropriations Act, highlighting key provisions and guidance for businesses seeking to participate in the revived program.
Morgan Lewis partner Jeffrey Boujoukos spoke with Law360 for an article about the likely impact of the COVID-19 pandemic and a Biden administration on the US Securities and Exchange Commission’s (SEC’s) enforcement priorities.
The shock, turmoil, uncertainty, and lack of visibility that followed the immediate onset of the coronavirus (COVID-19) pandemic in March 2020 were significant factors accounting for why shareholder activism was relatively subdued during the 2020 proxy season. However, given that activist investors have now had more than eight months to acquire their “sea legs” and recalibrate their playbook for the evolving “new normal,” it is likely that, even as the COVID-19 pandemic shows no signs of abating, activist investors will be less reluctant to wage an activism campaign in whatever “new normal” we find ourselves in during the 2021 proxy season.
Nonprofit organizations are on the front lines in the battle against the coronavirus (COVID-19), but they also number among the many victims of COVID-19’s devastating financial impact. In response, the Federal Reserve recently announced that loans would be available to nonprofit borrowers under the Main Street Lending Program, and issued a FAQ on two new facilities—the Nonprofit Organization New Loan Facility and the Nonprofit Organization Expanded Loan Facility.
Morgan Lewis partners Matthew Schernecke and Kristen Campana authored a Bloomberg Law article about the concessions lenders have made in exchange for additional credit support, capital contributed, and/or additional covenants amid the coronavirus (COVID-19) pandemic.
The US Internal Revenue Service (IRS) issued news release IR-2020-194 on August 28, approving the temporary use of digital signatures for certain IRS forms that must be filed with the IRS manually.
The Centers for Disease Control and Prevention (CDC) on September 1 issued an order under Section 361 of the Public Health Service Act to temporarily—at least through the end of 2020—halt residential rental evictions for Americans struggling to pay rent due to the coronavirus (COVID-19) pandemic.
The Financial Conduct Authority (FCA) has challenged eight insurers in a business interruption insurance test case in order to seek coverage for insureds. The UK’s financial services industry regulator is taking an adversarial stance in order to determine whether 17 different policy wordings can provide cover for businesses across the country, in the hope this will provide a level of certainty at this difficult time for businesses.
As state revenue agencies train their auditors in traditional IRC §482 transfer-pricing methodologies or outsource transfer-pricing audits to third-party specialists, a recent initiative by the Indiana Department of Revenue follows another, alternative federal transfer-pricing compliance tool: advance pricing agreements (APAs).
Morgan Lewis partner Roger Joseph spoke with Fund Directions for an article about virtual board meetings amid the coronavirus (COVID-19) pandemic.
The coronavirus (COVID-19) pandemic has caused upheaval in the global economy. This massive disruption has led to a wave of class action lawsuits relating, directly or indirectly, to COVID-19. This White Paper reviews the various categories of such class actions, the most commonly asserted theories of liability, and possible defenses to such actions, both as to the merits and against class certification.
The US Securities and Exchange Commission’s Office of Compliance Inspections and Examinations (OCIE) published a Risk Alert on August 12 highlighting compliance considerations created by the coronavirus (COVID-19) pandemic for SEC-registered investment advisers and broker-dealers (Firms). This LawFlash highlights the areas of focus in the Risk Alert and provides a checklist of considerations and actions to assist Firms in addressing COVID-19-related compliance issues.
The CARES Act’s Paycheck Protection Program provides loans targeted to small businesses to help keep their workers employed during the coronavirus (COVID-19) pandemic, and offers loan forgiveness to borrowers maintaining a high percentage of employees on payroll. This LawFlash provides the latest developments in PPP loan availability, eligibility, and forgiveness, as well as a comprehensive overview of the PPP and related guidance.
As negotiations for a further comprehensive stimulus package drag on in Congress, US President Donald Trump on August 8 signed two executive actions—a combination of a memorandum and an executive order—that purportedly extend various aid measures previously provided through the Coronavirus Aid, Relief, and Economic Security (CARES) Act, or impose additional economic relief measures for homeowners, renters, and student loan borrowers impacted by the coronavirus (COVID-19) pandemic.
The Federal Financial Institutions Examination Council (FFIEC) on behalf of its members issued a statement on August 3 setting forth prudent risk management and consumer protection principles for financial institutions as initial coronavirus (COVID-19) related loan accommodation periods end and they consider additional accommodations.
The Federal Reserve took additional actions on April 9 to provide up to $2.3 trillion in loans to support the US economy during the coronavirus (COVID-19) pandemic. This LawFlash covers the new and expanded programs, and provides comprehensive coverage of the Coronavirus Economic Stabilization Act.
Although many companies are already revisiting contractual provisions relating to nonperformance, like force majeure clauses, as the coronavirus (COVID-19) pandemic continues to wreak havoc on public health and the economy.
The Consumer Financial Protection Bureau (CFPB or Bureau) issued an interim final rule (IFR) on June 23, 2020 that temporarily permits mortgage servicers to offer to borrowers impacted by the coronavirus (COVID-19) pandemic certain loss mitigation options based on the evaluation of an incomplete loss mitigation application.
With the issuance of Notice 2020-39 (the Notice), the Internal Revenue Service (IRS) has provided relief for Qualified Opportunity Zone Funds (QOFs) and for investors in QOFs. While the relief provided in the Notice does not solve every challenge for QOFs and investors during the pandemic, investors and sponsors alike should warmly receive the specific relief.
As governments around the world work to stem the coronavirus (COVID-19) pandemic, merger control authorities in jurisdictions around the globe are adapting their operations and procedures.
This LawFlash provides a summary on navigating the regulatory landscape in various jurisdictions throughout the Latin America region during the global coronavirus (COVID-19) crisis.
The Coronavirus Aid, Relief and Economic Security (CARES) Act provides two measures of relief to taxpayers, but taxpayers amending federal income tax returns should be aware these benefits may not reach their state income tax returns.
Measures under the Targeted Economic Support Scheme include allowing UAE banks to temporarily defer loan repayments and extend existing facilities for corporate and retail clients.
Two key amendments to the German competition law entered into effect on May 29, 2020, temporarily extending merger control review periods and temporarily suspending interest payments for antitrust fines, further to a bill adopted by the German Parliament to mitigate the consequences of the coronavirus (COVID-19) pandemic on trade.
Temporary relief provided by the US Securities and Exchange Commission focuses on financial statements and timing and cancellation requirements with regard to Regulation Crowdfunding, and is expected to make it easier and faster for small businesses to complete offerings.
New guidance from the Internal Revenue Service will allows RICs and REITs to retain more capital by distributing less cash to shareholders in certain stock distributions—welcome relief during the current economic volatility resulting from the coronavirus (COVID-19) pandemic.
In a recent keynote speech, Co-Director of the US Securities and Exchange Commission’s Division of Enforcement Steven Peikin made it clear that the Division has made coronavirus (COVID-19) related enforcement matters a top priority and is dedicating significant time and resources to respond to such issues.
Federal and state regulators and Congress continue to release new guidance and requirements to assist mortgage borrowers facing economic hardships resulting from the coronavirus (COVID-19) pandemic. Due to the high volume of borrower requests, the associated burden on servicers, and the unknown duration of the COVID-19 pandemic, it is critical for servicers to be in compliance with all forbearance-related requirements and to be responsive to borrower communications and inquiries.
The widespread economic disruption precipitated by the coronavirus (COVID-19) global pandemic and oil price volatility has caused debt portfolios to come under scrutiny and fund sponsors and investors to consider opportunities in the marketplace. Many asset managers are forming funds focused on liquid credit opportunities, secondary portfolio purchases and, as with the expansion of nonbank lending after the 2008 global financial crisis, providing customized solutions to distressed and other borrowers that are either unable or unwilling to borrow from traditional banks. In addition, certain existing funds are extending their offering periods and modifying their investment strategies to capture the opportunity.
US companies trying to close international deals or set up new branches in foreign countries are struggling to secure apostilles to certify documents due to quarantine mandates and office closures resulting from the coronavirus (COVID-19) pandemic.
Evidence is growing of a hardening of French public policy regarding the need for political control of acquisitions of French companies and other foreign direct investment (FDI) transactions.
For-profit medical care providers that receive CARES Act grants to provide funds for healthcare-related expenses or lost revenues attributable to the coronavirus (COVID-19) may be taxed for those receipts. Because Congress did not otherwise exclude or address the tax treatment of these grant payments, taxability would be determined based upon applicable tax law and guidance, which require that such funds be reported as taxable income. For-profit healthcare providers that received these grants should consider this issue and its resulting tax implications.
This LawFlash discusses awarding equity grants to newly hired employees as “inducement grants” outside the shareholder approved plan and the pros and cons of making inducement grants.
Employers should be aware that remote working arrangements during the coronavirus (COVID-19) pandemic may inadvertently trigger state payroll tax registration and filing requirements for their businesses, and possibly trigger corporate income/franchise tax “nexus” with another state, subjecting the business to that state’s tax regime.
The European Commission published its first comfort letter in nearly 20 years on April 29, in an effort to foster cooperation among businesses during the coronavirus (COVID-19) pandemic. Here is what companies should know about the specific practices permitted under the comfort letter, as well as the specific conditions and safeguards for cooperation.
Key issues that UK employers should begin considering now to minimize difficulties as they reopen or expand their operations include reintegrating staff, assessing internal policies in light of the pandemic, testing for the coronavirus (COVID-19), and more.
The US Department of the Treasury recently began accepting loan applications from qualifying Defense Industrial Base contractors, with a short deadline of May 1, 2020, to submit the application for expedited review.
The Malaysia Securities Commission (SC) announced on April 28 that flexibility will be granted for businesses issuing convertible notes to venture capital (VC) and private equity (PE) firms registered with the SC.
Morgan Lewis partners Joseph Zargari and Stephen Tirrell were quoted in a FundFire article about the reemerging interest in credit-focused hedge funds in light of the coronavirus (COVID-19) pandemic. In terms of increasing interest, Joe noted, “This is really standing out.
New York’s Department of Financial Services (DFS) issued guidance on April 13 alerting regulated entities of the significant increase in cybercrime during the coronavirus (COVID-19) pandemic.
The UK government has announced two new schemes for funding to innovative companies and startups, launching in May 2020.
The coronavirus (COVID-19) pandemic has forced companies to reassess their financial projections amid the rapidly shifting landscape of the global economy. In response, there has been a rapid uptick in the number of corporations that have suspended dividend payments to preserve assets and capital. The last few weeks have seen corporations in the auto, aerospace, cruise line, entertainment, hospitality, mining, and restaurant industries, to mention a few, suspend dividends.
This article summarizes a recent webinar presented by Morgan Lewis partners Andrew Budreika and Raechel Kummer and associate Ben Stango in conjunction with the American Bakers Association.
The Internal Revenue Service (IRS) and the US Department of the Treasury released two Revenue Procedures and a new FAQ on April 21 to provide relief to US residents and alien individuals affected by travel disruptions due to the coronavirus (COVID-19) emergency.
In response to coronavirus (COVID-19) pandemic, the US Securities and Exchange Commission’s Corporation Finance Division and Investment Management Division have issued guidance to assist companies in making changes to the format of its shareholder meetings, the way in which companies accept shareholder proposals, and the timing of Form 10-K corporate governance and compensation disclosures that are all adaptive to the changing times. Additionally, various states have loosened the restrictions around annual shareholder meetings. This LawFlash gives an overview of this guidance and relief.
New guidance from the UK Competition and Markets Authority warns that it will not relax its substantive or evidentiary standards for merger investigations during the coronavirus (COVID-19) pandemic. Statutory deadlines will not be altered, although aspects of investigations may be subject to delay, and the authority will continue to impose interim measures. The authority also set out its position on mergers involving “failing firms,” indicating some flexibility in its interpretation of the counterfactual test.
The US Senate approved an additional $310 billion in funds for the Paycheck Protection Program (PPP) on April 20, and the House of Representatives is expected to approve these additional funds within days.
In light of the UK government’s lockdown measures and the COVID-19 pandemic, there are key issues English public companies should consider for their annual general meetings (AGMs) while awaiting further legislation and flexibility.
Recent announcements from the US Securities and Exchange Commission make it clear that, although it will not be business as usual, the agency will ably navigate the coronavirus (COVID-19) crisis and its work will move forward. However, over the next several months, the SEC and its staff will be confronted with choices about where and how to deploy the Commission’s limited enforcement and examination resources, and those decisions will have a profound effect on regulated entities.
Following the declaration of a state of emergency due to COVID-19, Japan’s Financial Services Agency (FSA) made recent announcements extending the filing deadline for annual securities reports and other disclosure reports, and providing guidance on annual shareholder meetings. In addition, the government announced additional areas subject to the declaration and an amended assistance plan.
As the coronavirus (COVID-19) pandemic evolves, governmental executive and legislative authorities are taking actions in the form of emergency declarations and proposed legislation that could improve a company’s ability to mitigate business income losses by maximizing its insurance recovery. Keeping an eye on these developments and documenting your losses accordingly could make all the difference.
For retailers, it is key to be prepared before, during, and after times of crisis. As retailers across the globe navigate the current coronavirus (COVID-19) crisis, they are dealing with having to close their doors if deemed nonessential, monitoring the safety and well-being of their employees, evaluating their liquidity, and preserving their cash position.
The Nasdaq Stock Market has temporarily suspended the continued listing bid price and market value of publicly held shares listing requirements for its issuers through June 30, 2020. This relief, effective immediately, provides issuers with additional time to regain compliance with the bid price and/or market value of publicly held share requirements.
The UK government today launched a new loan guarantee programme for UK businesses—the Coronavirus Large Business Interruption Loan Scheme (CLBILS)—intended to plug the gap by providing loan guarantees for medium and large businesses which were not covered by the two earlier UK loan guarantee programmes related to the coronavirus (COVID-19) pandemic.
The US Securities and Exchange Commission, the Financial Industry Regulatory Authority, and state securities regulators recognize the significant impact of the coronavirus (COVID-19) pandemic on broker-dealers, investors, and other stakeholders, and have provided important guidance and relief to broker-dealers on how to meet some of these challenges.
Insurance regulators across the country have enacted emergency regulations, issued administrative guidance, and requested carriers to take certain actions to try to address the financial impact of the coronavirus (COVID-19) pandemic on individuals and businesses. Requirements imposed on or requested of health insurers to expand access to telehealth and eliminate or limit prior authorization or concurrent review have been widely reported, but there have been numerous other industry-wide actions. And, some state legislators have introduced bills to expand the scope of coverage to ameliorate the impact of the pandemic on insureds.
Morgan Lewis partners Julia Frost-Davies and Andrew Budreika, of counsel Jason Alderson, and associate Benjamin Stango authored a INSOL International article about access to bankruptcy courts in light of the coronavirus (COVID-19) pandemic.
As jurisdictions contemplate lifting pandemic-related workplace restrictions, employers must start considering how best to cope with a vast array of issues, including restarting or expanding operations, reintegrating remote-working or furloughed employees, implementing new state and local orders/requirements, and protecting the safety of employees and customers. Employers who proactively plan for these challenges will be best positioned to adapt to the “new normal.”
The US Department of Labor’s Occupational Health and Safety Administration (OSHA) released a statement on April 8 reminding employers that they cannot retaliate against workers who report unsafe or unhealthy working conditions during the coronavirus (COVID-19) pandemic.
A recent US Securities and Exchange Commission statement stressed the importance of disclosure and highlighted its role in the national effort to foster a meaningful, responsible increase in economic activity. In light of the coronavirus (COVID-19) pandemic and its effect on national and global economies, public companies should take a careful look at the impact of these circumstances on their disclosure obligations under federal securities laws.
The Internal Revenue Service on Monday, April 13 issued welcome relief to the securitization industry, providing that certain forbearances and related modifications to mortgages will generally not cause real estate mortgage investment conduits (REMICs) and other securitization vehicles to lose their special tax status if such modifications arise from new programs/procedures created by the CARES Act or by similar programs/procedures to address the coronavirus (COVID-19) emergency.
The Internal Revenue Service has released guidance allowing partnerships subject to amended return filing restrictions enacted under the Bipartisan Budget Act of 2015 to amend 2018 and 2019 partnership returns, including in order to take advantage of retroactive relief provided under the Coronavirus Aid, Relief, and Economic Security (CARES) Act.
The joint statement recognizes that while the COVID-19 pandemic offers businesses an opportunity for procompetitive collaboration and benefits, it also increases significant risk of anticompetitive conduct in the labor market. Here are some issues and factors that businesses should consider to mitigate antitrust risk as the Antitrust Division and Federal Trade Commission continue to consider enforcement actions for antitrust violations.
For companies forced to postpone or cancel live events during the coronavirus (COVID-19) pandemic, event cancellation insurance may serve as a way to protect assets and mitigate losses.
Morgan Lewis partner William Yonge was quoted in an ACA Insight article about two new sets of “expectations” issued recently by the United Kingdom’s Financial Conduct Authority and Prudential Regulation Authority that investment advisory firms and brother-dealers are required to follow.
Businesses that avail themselves of financial assistance under Section 4003 or 4116 of the CARES Act must limit compensation and severance paid to certain officers and employees.
Morgan Lewis partner Jennifer Breen was quoted in a Tax Notes article about the CARES Act implications on restrictions in the Tax Cuts and Jobs Act.
In continued efforts to help taxpayers address the challenges brought on by the coronavirus (COVID-19) pandemic, the Internal Revenue Service announced further relief on April 9, including automatically extending deadlines for various filing and payment obligations and allowing tentative carryback refunds for net operating losses.
US antitrust laws already on the books facilitate rapid investment without government delay: important practical tools and rules for dealmakers and their counsel in the wake of the coronavirus (COVID-19) pandemic and the current economic challenges.
The European Commission has provided antitrust guidance to companies cooperating in response to urgent coronavirus (COVID-19) related matters, particularly in the health sector for critical hospital medicines and medical equipment, and has also exceptionally issued a “comfort letter” on a cooperation project in the generic pharmaceuticals sector aimed at ensuring the supply of critical hospital medicines. Other ad hoc “comfort letters” may follow at the EU Commission’s discretion.
Employers considering layoffs in the face of the coronavirus (COVID-19) crisis have additional opportunities to support furloughed workers, aside from options offered by the CARES Act.
Morgan Lewis partner Jennifer Breen spoke with Tax Notes about the US Internal Revenue Service’s decision to extend hundreds of tax deadlines to July 15.
The Japanese government declared a state of emergency with respect to seven prefectures on April 7. The government also has issued emergency policies in response to the new coronavirus (COVID-19) pandemic, including the Emergency Economic Measures for New Coronavirus Infectious Disease Control, issued that same day.
As the outbreak of the coronavirus (COVID-19) continues, the Monetary Authority of Singapore has introduced a number of initiatives to assist Singapore financial institutions in supporting their customers. This LawFlash provides an overview of the MAS relief initiatives.
This alert reviews the impact of the Government of Japan’s recent state of emergency declaration due to the coronavirus (COVID-19) global pandemic on the practices of the Kanto Local Finance Bureau, which has switched to rotating shift work resulting in the anticipation of longer filing times.
The US Securities and Exchange Commission, Financial Industry Regulatory Authority, Commodity Futures Trading Commission, and National Futures Association have each announced temporary regulatory relief for market participants whose operations may be affected by the coronavirus (COVID-19) pandemic.
To help address market participants in the face of the coronavirus (COVID-19) crisis, the Basel Committee on Banking Supervision and the International Organization of Securities Commissions have provided a one-year extension to the fifth and sixth phases of the implementation schedule of the rules requiring margin for uncleared swaps.
Morgan Lewis partner Andrew Budreika was quoted in an Advertising Specialty Institute article about the latest developments in the CARES Act’s Paycheck Protection Program (PPP).
The UK Financial Conduct Authority and Prudential Regulation Authority have published statements setting out their expectations of dual-regulated and solo-regulated firms on their senior managers and certification regime requirements in the context of the coronavirus (COVID-19). They intend to provide flexibility to firms where they can and have made specific provisions in light of COVID-19.
In three new Unemployment Insurance Program Letters, the US Department of Labor (DOL) issued guidance to state workforce agencies to implement the unemployment provisions in the CARES Act. The guidance has several important aspects for employers.
The Coronavirus Aid, Relief, and Economic Security (CARES) Act offers broad-based economic support for companies contending with the disruptions caused by the coronavirus (COVID-19) pandemic. This LawFlash provides a comprehensive overview of the aid that is available to or directly affects banks and related companies.
The Commodity Futures Trading Commission and the National Futures Association in recent weeks have issued relief in response to the challenges that many market participants face in light of the coronavirus (COVID-19) pandemic. This LawFlash covers the latest relief provided.
The European Commission has approved a £50 billion (EUR 57 billion) “umbrella” UK state aid scheme to support small and medium-sized enterprises and large corporates in the United Kingdom affected by the coronavirus (COVID-19) outbreak. The umbrella scheme was approved on April 6, 2020, under the State Aid Temporary Framework, as amended.
As the outbreak of the coronavirus (COVID-19) continues, the Hong Kong Monetary Authority has introduced a number of initiatives to further support small-medium enterprises. These initiatives include enhancements to standby liquidity facilities, including that banks may temporarily operate with a lower liquidity ratio and defer the implementation of certain aspects of Basel III.
Texas Governor Greg Abbott issued Executive Order GA-14 on March 31, directing every person in Texas to minimize social gatherings and in-person contact with people who do not live in the same household except where necessary to provide or obtain essential services.
Both borrowers and lenders need to be aware of issues arising from a new US government loan program for small businesses relative to existing capital structures, although some guidance also is not yet available. Both borrowers and lenders may also request negotiations of various terms.
The Ministry of Law of Singapore announced the introduction of a new bill on 1 April aimed at protecting individuals and businesses that are unable to fulfil their contractual obligations because of the coronavirus (COVID-19) pandemic.
Firms will need to separately engage with the US Securities and Exchange Commission on delays related to the coronavirus (COVID-19) pandemic.
The Massachusetts Office of the Attorney General issued an emergency rule on April 1 to prevent unfair and deceptive collection practices during the coronavirus (COVID-19) crisis. The rule temporarily prohibits some debt collectors from initiating or threatening collection lawsuits, acting on vehicle repossession, and taking steps toward wage garnishment – among other restrictions.
As local jurisdictions attempt to slow the spread of the coronavirus (COVID-19) and “flatten the curve,” several Northern and Central California counties have updated their existing shelter-in-place orders to impose more restrictions on employers and company operations. Employers should immediately prepare for compliance with the new protocols, some of which take effect on April 2.
The Singapore Ministry of Health (MOH) imposed tighter safe-distancing measures on 24 March to minimize further spread of the coronavirus (COVID-19). Because of the fluid and unpredictable nature of COVID-19, companies and shareholders must maintain flexibility throughout this emergency and implement alternative means to ensure compliance with MOH directives.
Foreign investment trust notifications, foreign investment corporation notifications, and Article 63 notifications required to be filed prior to making a solicitation for investments to relevant Japanese investors may be affected by the coronavirus (COVID-19) pandemic and resulting lockdowns.
The Hong Kong Securities and Futures Commission has released a number of circulars relating to COVID-19, including March 31 guidance on licensing and ongoing compliance matters. This LawFlash provides an overview of the guidance and its implications for licensed corporations.
Due to the current unstable situation in the world financial and local currency markets due to the coronavirus (COVID-19) pandemic, the National Bank of Kazakhstan has started changing currency control regulations.
Two orders from the US Securities and Exchange Commission amend previous regulatory relief for certain investment advisers and investment funds affected by the coronavirus (COVID-19), provide such investment advisers and investment funds with more time to satisfy certain filing and delivery requirements, and extend the relief from requirements to hold in-person board meetings.
In response to the coronavirus (COVID-19) pandemic, California Governor Gavin Newsom has issued two executive orders that place temporary restraints on the ability of landlords to evict residential tenants, authorize local governments to halt residential and commercial evictions, and call on banks and other financial institutions to suspend residential and commercial foreclosures and related evictions.
In response to the coronavirus (COVID-19) pandemic, New Jersey Governor Phil Murphy has announced an initiative whereby participating financial institutions will provide mortgage forbearance and financial protections for New Jersey residents facing economic hardship as a result of COVID-19.
The staff of the US Securities and Exchange Commission (SEC) has given registered open-end management companies (mutual funds) an additional tool in the wake of the coronavirus (COVID-19) crisis to combat the potentially deleterious effects of dislocations in the debt markets.
This is the first in a series of alerts from Morgan Lewis’s investment management team in Tokyo that summarize how the coronavirus (COVID-19) global pandemic impacts investment fund-related businesses in Japan. This first alert summarizes how the pandemic impacts annual business report filing requirements, particularly for financial instruments business operators and business operators conducting permitted businesses for qualified institutional investors under Article 63 of the Financial Instruments and Exchange Act.
As the effects of the coronavirus (COVID-19) pandemic hit the United States, downsizings and shutdowns are spreading indiscriminately throughout the economy.
The ultimate impact of the coronavirus (COVID-19) pandemic on shareholder activism remains largely uncertain and comparisons with the surge in activism that followed the 2008 global financial crisis are tempting, but suspect as it remains questionable whether activists can still rely on the same forces that have been driving activism.
While offering guidance on which financial services workers could be considered essential, the UK Financial Conduct Authority says that firms themselves are best placed to make those decisions.
All IRA owners have until July 15, 2020 to make IRA contributions for 2019 and pay early distribution penalties for 2019, but a few questions remain on deadlines and reporting for IRA providers.
The US Securities and Exchange Commission announced on the morning of March 25 the extension of filing periods covered by previously enacted conditional reporting relief for certain public company filing obligations, and provided current views regarding disclosure considerations and other securities law matters related to the coronavirus (COVID-19) crisis.
The US Securities and Exchange Commission is providing increased flexibility to certain open-end funds and insurance company separate accounts, plus no-action relief to money market funds and their affiliates amid the coronavirus (COVID-19) pandemic.
In response to the coronavirus (COVID-19) crisis, New York Governor Andrew Cuomo has issued two executive orders that place temporary restraints on the ability of banks, residential mortgage servicers, and landlords to exercise remedies under certain agreements, mortgages, and leases.
This LawFlash addresses the potential impact of anti-price-gouging efforts by government enforcement officials on anticipated civil litigation, particularly class actions premised on state unfair and deceptive practices acts. Many parties in the supply chain for food, emergency, and medical supplies, as well as consumer goods, are potentially subject to price-gouging investigations by government officials and each therefore face risk from consumer actions based on the same alleged underlying conduct.
In response to the coronavirus pandemic, the UK government announced “£330 billion of guarantees,” which is divided into two schemes: the Covid Corporate Financing Facility and the Coronavirus Business Interruption Loan Scheme.
California Governor Gavin Newsom has issued multiple orders affecting how and under what conditions state and local agencies may meet and discuss and/or approve of contracts for services and products during the coronavirus (COVID-19) pandemic.
The US Federal Trade Commission and the Antitrust Division of the US Department of Justice have announced that they aim to respond within one week to coronavirus (COVID-19) collaborative proposals submitted pursuant to the agencies’ respective processes.
Morgan Lewis partners Jennifer Breen and Steven Johnson’s letter to the US Internal Revenue Service (IRS) regarding the coronavirus (COVID-19) outbreak was cited in a Tax Notes article about close-of-tax year issues.
The spread of the coronavirus (COVID-19) continues to impact global financial markets and private funds. Private investment fund managers should consider—in addition to the potential economic exposure from unsteady financial markets—numerous risks to their businesses and the funds they manage from operational and other disruptions that may occur as a result of the global pandemic.
The coronavirus (COVID-19) pandemic is historic, fast-moving, and constantly evolving. While the most immediate concerns involve the public health and restoring business operations to normalcy, certain steps may be necessary in the near term to protect your insurance assets, which may help mitigate financial losses.
The Federal Housing Finance Agency (FHFA) and the US Department of Housing and Urban Development (HUD) announced on March 18 that they have directed Fannie Mae and Freddie Mac, the government sponsored enterprises (GSEs), to suspend foreclosures and evictions for at least 60 days due to the coronavirus (COVID-19) national emergency.
The day after US Secretary of the Treasury Steven Mnuchin’s announcement on March 17, the Internal Revenue Service issued helpful guidance (Notice 2020-17) on the coronavirus (COVID-19) crisis. Importantly, the IRS is deferring all federal income tax payments due April 15, 2020 for 90 days.
Many Commodity Futures Trading Commission registrants and other market participants are responding to the coronavirus (COVID-19) pandemic by implementing business continuity plans that move personnel from their “normal business sites,” which implicates CFTC regulatory requirements.
The UK Financial Conduct Authority (FCA) issued a further statement on 17 March elaborating usefully on its initial statement of 4 March (see our prior blog). Strikingly, it has abandoned the rather terse tone of the initial statement in favour of a more reassuring and understanding one, recognising the pressures exerted by the pandemic on regulated firms and consumers. Here are the key points.
Global financial markets have experienced unprecedented volatility as heightened concerns about the ongoing coronavirus (COVID-19) pandemic take hold and its impact on the global macroeconomic landscape remains unknown. From its record high, the S&P 500 has plunged as much as 30%, and companies in sectors disproportionately impacted by COVID-19–particularly those that have had to reduce or suspend operations to comply with the current social distancing guidance from the US Centers for Disease Control and Prevention–have experienced stock price declines of more than 70% from their 52-week highs.
The US Securities and Exchange Commission on March 13 announced temporary regulatory relief for registered investment advisers and exempt reporting advisers as well as for registered funds, registered unit investment trusts, and business development companies whose operations may be affected by the coronavirus (COVID-19). Most notably, the relief provides up to an additional 45 days for eligible advisers and funds to satisfy relevant filing and delivery requirements, and exempts eligible funds from in-person voting requirements.
The spread of the coronavirus (COVID-19) continues to impact global financial markets and private funds. Institutional investors, funds-of-funds, family offices, and other investors in private funds should consider the economic exposure to their private fund investments from operational disruptions that may occur as a result of the pandemic.
With significant business disruptions occurring as a result of coronavirus (COVID-19), companies should consider how insurance coverage, including business interruption, supply chain, and event cancellation coverage, can help mitigate losses.
The Russian parliament urgently passed a new law on 14 March that amends the Federal Law on Joint Stock Companies (the JSC Law) to allow shareholder meetings in 2020 to be conducted by absentee voting if the agenda includes certain items.
The staff of the Securities and Exchange Commission’s Division of Corporation Finance on March 13 issued guidance designed to assist companies in complying with federal proxy rules in light of the coronavirus (COVID-19) outbreak. The guidance clarifies flexibility under the federal proxy rules for companies wishing to effect changes to annual meetings, including moving from physical locations to virtual or hybrid meetings.
The EU watchdog, The European Securities and Markets Authority (ESMA), which coordinates securities market supervision across the 27 countries of the European Union, announced on March 11 that it was prepared to use its powers to ensure the orderly functioning of markets, financial stability, and investor protection, and issued the following recommendations to financial market participants (FMPs) in the European Union.
The Asset Management Association of China encourages new private equity funds to invest in medical enterprises related to epidemic prevention and control, and has extended certain reporting deadlines.
With the situation surrounding the 2019 Novel Coronavirus rapidly changing, key practical considerations for financial institutions regulated by the Hong Kong Securities and Futures Commission and Hong Kong Monetary Authority include business continuity planning, contract issues, and notification and filing requirements.
The Biden administration announced on January 30, 2023 that the COVID-19 Public Health Emergency (PHE) would officially end on May 11, 2023. The PHE declaration, which first was issued by the Secretary of the US Department of Health and Human Services (HHS) on January 31, 2020, and subsequently renewed several times, provided the basis for numerous flexibilities upon which the healthcare and life sciences industries have relied to furnish patient care during the pandemic. With the PHE coming to an end, organizations may need to make drastic changes as the regulatory enforcement returns to “normal.”
Key provisions that provided flexibility to long-term care providers and helped alleviate administrative burdens will expire May 11, 2023.
President Biden signed into law a House bill on April 10 that immediately ended the COVID-19 presidential declaration of national emergency established in March 2020. The COVID-19 federal public health emergency—a separate declaration by the Secretary of Health and Human Services from January 2020—remains in effect for now. However, based on comments from the Biden administration, that too is set to expire on May 11. As such, employers may wish to take stock of their COVID-19 policies and reevaluate those that touch on benefits, vaccine and testing requirements, and other safety measures.
Concurrent with the termination of the COVID-19 Public Health Emergency, various regulatory flexibilities will also come to an end, including the blanket waivers to the Stark Law and related enforcement discretion under the Federal anti-kickback statute. Accordingly, healthcare providers should promptly assess the ongoing compliance of all financial arrangements with physicians relying on these regulatory flexibilities and remediate or terminate such arrangements as appropriate.
With the COVID-19 public health emergency and the presidential declaration of national emergency intended to end on May 11 and the US government recently issuing guidance on unwinding these emergency declarations, this LawFlash breaks down the relief tied to each declaration and the next steps for plan sponsors.
Is the COVID-19 pandemic making you feel a bit like Bill Murray in Groundhog Day? Although most parts of life have returned to the "new normal," the federal government remains in a seemingly endless cycle of regulatory uncertainty.
According to a recent report from the Department of Health and Human Services, since the start of the pandemic sweeping policy changes made by the Centers for Medicare and Medicaid Services have led to a surge in virtual doctor visits.
As the availability and variety of digital health tools continue to increase, evidence is also being presented that those tools are having a meaningful impact on health outcomes. In a recent blog post, members of our technology, outsourcing, and commercial transactions team dove into the findings of two reports, Digital Health Trends 2021: Innovation, Evidence, Regulation, and Adoption, offered by the IQVIA Institute for Human Data Science; and a report from the University of Michigan’s Institute for Healthcare Policy and Innovation’s Telehealth Research Incubator.
Members of our emerging business and technology team recently hosted a webinar on seed financing structures for digital health companies. The program, led by partner Benjamin David Novak and associate Jessica Lee, discussed the market trends in digital health company financings as well as the various deal structures frequently used in seed financings.
Our healthcare team recently launched a publication series highlighting the global impact of COVID-19 on healthcare transactions. Around the globe, the healthcare industry has faced similar issues from the unprecedented pandemic, prioritizing their operational response to COVID-19. Now, as countries begin to reopen, healthcare entities may refocus on planning for long-term transformation of their business models. In this series, we will explore how the pandemic impacted healthcare transactions in specific regions and what we can expect in a post-pandemic world.
Associate Alana Genderson was quoted in a Law360 article regarding the Occupational Safety and Health Administration’s (OSHA’s) most recent COVID-19 workplace safety emergency temporary standards (ETS).
The recent rollout of various COVID-19 vaccines has raised many questions around their availability, distribution, and requirements for employers and other groups, including essential insurance, liability, and enforcement considerations. Here we provide key legal and regulatory perspectives for those organizations providing access to the vaccines and/or mandating vaccination. Highlights include the state and federal laws providing protection to organizations during an outbreak of an infectious disease and what employers contemplating the administration of a closed point-of-delivery (POD) vaccination program need to know.
Partner Sharon Masling spoke to CNBC after the US Food and Drug Administration (FDA) approved Pfizer’s COVID-19 vaccine for children ages 12–15 years.
Associate Alana Genderson spoke to K-12 Dive about the potential of US schools to require students to receive the COVID-19 vaccine before returning to campus.
Morgan Lewis associate Alanda Genderson spoke to Axios about the possibility of schools in the US requiring students to receive COVID-19 vaccines as they are approved for younger people.
Given the significant push to vaccinate the public since the start of 2021, the increasing availability of vaccines, and the need to recruit additional personnel to administer vaccinations, the secretary of the US Department of Health and Human Services (HHS) has again amended its declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to accommodate some workforce barriers that had not been previously contemplated.
States and localities across the country are continuing to respond as quickly and effectively as possible to the coronavirus (COVID-19) outbreak. These responses include guidance for taxpayers on numerous topics, such as providing tax relief through filing and payment deadline extensions.
It’s now been over a year since the COVID-19 pandemic was declared a public health emergency, ushering in monumental changes for telehealth regulation. If you’ve been following Health Law Scan, we hope our updates have provided some clarity to the everchanging regulatory healthcare framework and the legal issues that can vary across payers, across states, and even across countries.
Our immigration team has been actively publishing resources as the Biden administration continues to make changes to existing immigration framework. These topics may be of importance to Health Law Scan readers, and we encourage you to access these publications below.
In a Law360 feature, Morgan Lewis partner Dennis Gucciardo and associate Jacob Harper highlighted some of the defining moments for the healthcare and life sciences industries in the year since the US government declared the COVID-19 pandemic of sufficient severity and magnitude to warrant an emergency declaration.
The US Department of Health and Human Services Office of Inspector General (OIG), the Department of Justice (DOJ), and other federal regulators have grown increasingly concerned about the use of telehealth technologies by perpetrators of various fraud schemes. While this is in part due to the meteoric rise in use of telehealth services during the past year and the need to quickly formalize permanent policy around the technology, the federal government’s concern extends well before the COVID-19 public health emergency (PHE).
With telehealth surging around the globe due to the COVID-19 pandemic, the UK National Health Service has released guidance that provides a set of good practice principles for third-party partners to follow.
In response to delayed EU shipments of certain COVID-19 vaccines to the European Union, the European Commission (Commission) passed on 29 January 2021 Regulation 2021/111 (Export Authorization Regulation) which is in force from 30 January 2021. The Commission intends for the Export Authorization Regulation to apply until at least 31 March 2021.
The US Department of Health and Human Services (HHS) announced on Friday, January 15, 2021, one month before the former reporting deadline, that it will push back the CARES Act Provider Relief Fund (PRF) reporting timeline due to the enactment of the Coronavirus Response and Relief Supplemental Appropriations Act of 2021 (the Act).
Our finance, corporate and business transactions, litigation, and tax teams recently published a LawFlash discussing the new coronavirus (COVID-19) relief stimulus package that is part of the Consolidated Appropriations Act, 2021 (CAA), highlighting key provisions and guidance for small businesses seeking to participate in the revived Paycheck Protection Program (PPP).
With coronavirus (COVID-19) vaccines on the horizon amid the surging pandemic, critical extensions expand the scope of liability immunity under the PREP Act.
Associate Jacob Harper spoke with Modern Healthcare about the need for congressional action as the coronavirus (COVID-19) pandemic continues to increase the use of telehealth services.
A LawFlash authored by Morgan Lewis partners Sharon Perley Masling and Kathy Sanzo, and associates Alana Genderson, Christopher Jaynes, and Maria Kalousi-Tatum was quoted in an EHS Today article about the potential for employers to establish policies related to a COVID-19 vaccine.
Healthcare systems have been on the front lines of the coronavirus (COVID-19) pandemic and may have several questions about how to manage workforce challenges as we look toward the upcoming months.
The US Department of Health and Human Services (HHS) issued two welcome announcements on October 22 relating to the CARES Act Relief Fund Provider Relief Fund (PRF). First, the agency expanded the pool of eligible recipients to “include provider applicants such as residential treatment facilities, chiropractors, and eye and vision providers that have not yet received Provider Relief Fund distributions.”
The US Department of Health and Human Services (HHS) on August 19 published a sweeping announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it stated that the Food and Drug Administration (FDA) would not require premarket review of laboratory developed tests (LDTs) without notice-and-comment rulemaking.
Our global healthcare industry team continues to highlight how regions around the world have quickly adapted to providing telehealth services following the coronavirus (COVID-19) pandemic.
During the coronavirus (COVID-19) pandemic, we have seen a dramatic shift from in-person visits to telehealth services around the globe, unveiling what may be the new normal for providing healthcare services.
The CARES Act’s Paycheck Protection Program provides loans targeted to small businesses to help keep their workers employed during the coronavirus (COVID-19) pandemic, and offers loan forgiveness to borrowers maintaining a high percentage of employees on payroll. This LawFlash provides the latest developments in PPP loan availability, eligibility, and forgiveness, as well as a comprehensive overview of the PPP and related guidance.
Imagine you are the primary caretaker for your 94-year-old terminally ill mother who lives in your home while under hospice care during the coronavirus (COVID-19) pandemic.
US President Donald Trump issued an executive order on August 3 that aims to expand telehealth access to Medicare beneficiaries beyond the coronavirus (COVID-19) public health emergency (PHE) period. The executive order focuses on rural healthcare providers in particular, noting the difficulties patients in rural areas face in obtaining accessible, high-quality healthcare services over the years.
The coronavirus (COVID-19) pandemic has created unforeseen and unavoidable circumstances within the healthcare industry that may provoke further crisis for hospitals, nursing homes, physicians, and other frontline healthcare providers in the form of potential liability claims for noncompliance with COVID-19 protocols or other standards.
The Federal Reserve took additional actions on April 9 to provide up to $2.3 trillion in loans to support the US economy during the coronavirus (COVID-19) pandemic. This LawFlash covers the new and expanded programs, and provides comprehensive coverage of the Coronavirus Economic Stabilization Act.
Morgan Lewis FDA lawyers authored a LawFlash on June 29 summarizing FDA’s drug and biologic coronavirus (COVID-19) guidances to date.
Morgan Lewis FDA, litigation, and healthcare lawyers authored a LawFlash outlining key issues that companies marketing products and services for coronavirus (COVID-19) should be aware of, including healthcare, FDA, clinical laboratory, product liability, and digital and telehealth laws and regulations.
As summarized in a July 17 LawFlash, FDA has resumed inspections of regulated domestic facilities using a new risk assessment rating system that takes into account the reopening phase of the applicable state, and county level COVID-19 statistics.
The Centers for Medicare and Medicaid Services (CMS) recently announced that it intends to resume both prepayment and postpayment medical reviews conducted by the Medicare Administrative Contractors, Supplemental Medical Review Contractors, and Recovery Audit Contractors, including those under the Targeted Probe and Educate program, on August 3, 2020.
Singapore’s telehealth sector is driven by the growing telemedicine industry, which has seen an increase in digital self-help options to consult medical doctors through online web-based applications. Telehealth providers in Singapore are mainly focused on providing remote telemedicine and/or on-demand house call services.
If a proposed bill by the California Senate is passed, parties to certain post-pandemic healthcare transactions involving private equity groups, hedge funds, healthcare systems, facilities, and provider groups would need to plan for and obtain regulatory approval from the California attorney general.
Companies marketing products or services for coronavirus (COVID-19) should be aware of key areas of healthcare law and regulation, including Food and Drug Administration regulation, clinical laboratory testing oversight, product liability, and digital health/telehealth regulation.
Much to the relief of the healthcare provider community, US Department of Health and Human Services (HHS) spokesperson Michael Caputo tweeted on Monday that HHS intended to extend the public health emergency that was declared earlier this year.
The UK Competition and Markets Authority on June 19 announced that it had opened investigations against four pharmacies and convenience stores in relation to suspected breaches of antitrust rules by charging excessive and unfair prices for hand sanitiser products during the coronavirus (COVID-19) pandemic, and on June 29 published an open letter warning pharmacists against price gouging, raising the possibility of additional investigations.
To keep you abreast of these changes, our tax lawyers have produced a chart, updated regularly, detailing state and local responses to COVID-19.
Congressional stimulus packages appropriated $175 billion in relief funds under the CARES Act and the Paycheck Protection Program and Health Care Enhancement Acts for the benefit of hospitals and other healthcare providers in response to losses incurred due to the coronavirus (COVID-19) pandemic.
Morgan Lewis associate Jacob Harper was quoted in a Becker’s Hospital Review article about the impact of the COVID-19 pandemic on the telehealth industry. “With the COVID-19 pandemic, we’ve seen an overnight switch from in-person to telehealth services, and I think this is a dress rehearsal for telehealth as a mainstream modality of providing healthcare,” said Jake.
Morgan Lewis associate Jacob Harper spoke with Bloomberg Law about the increased use of telehealth services.
Morgan Lewis partner Albert Shay was quoted in a Bloomberg Law article about the whistleblower suits expected to arise as a result of the COVID-19 pandemic.
Two key amendments to the German competition law entered into effect on May 29, 2020, temporarily extending merger control review periods and temporarily suspending interest payments for antitrust fines, further to a bill adopted by the German Parliament to mitigate the consequences of the coronavirus (COVID-19) pandemic on trade.
With just days left until provider attestations are due related to acceptance of CARES Act Provider Relief Funds, the US Department of Health and Human Services (HHS) has recently been updating its FAQs, providing some additional clarity, and potentially confusion, surrounding the acceptance of Relief Funds from its initial tranche $30 billion of General Distribution payments. Attestations for the first tranche of payments on April 10 are due May 25, and HHS continues to furnish guidance regarding the details of the General Distribution Relief Fund.
The Centers for Medicare & Medicaid Services and the US Department of Health and Human Services Office of Inspector General have provided additional guidance and clarification on the application of Stark Law blanket waivers and enforcement of the Anti-Kickback Statute amid the coronavirus (COVID-19) pandemic, helping providers establish new arrangements or modify existing arrangements to accommodate unprecedented demands.
The Centers for Medicare & Medicaid Services released a second, sweeping interim final rule in response to the coronavirus (COVID-19) pandemic on April 30, 2020. Building on the agency’s unprecedented March 31, 2020 regulation, which prioritized distancing patients from their care teams in response to the public health emergency, this second round of policy changes emphasized easing COVID-19 testing restrictions and expanding health system capacity for a phased reopening of the country.
The Centers for Medicare & Medicaid Services released guidance on April 19 updating its previous recommendation to delay all elective surgeries and procedures during the coronavirus (COVID-19) pandemic. In response, state and local officials are issuing updated orders easing or removing restrictions previously placed on elective, nonurgent surgeries and procedures.
For-profit medical care providers that receive CARES Act grants to provide funds for healthcare-related expenses or lost revenues attributable to the coronavirus (COVID-19) may be taxed for those receipts. Because Congress did not otherwise exclude or address the tax treatment of these grant payments, taxability would be determined based upon applicable tax law and guidance, which require that such funds be reported as taxable income. For-profit healthcare providers that received these grants should consider this issue and its resulting tax implications.
CMS recently issued Frequently Asked Questions (FAQs) clarifying requirements and considerations for hospitals and other providers related to the Emergency Medical Treatment and Labor Act (EMTALA) during the coronavirus (COVID-19) pandemic.
CMS posted an expanded set, dated April 29, of Medicare regulatory flexibility measures for hospice organizations related to the coronavirus (COVID-19) pandemic, supplementing the previous COVID hospice flexibilities guidance from March 29.
The US Nuclear Regulatory Commission (NRC) Staff hosted a public meeting via teleconference on April 22 to discuss available regulatory relief pathways for medical licensees during the coronavirus (COVID-19) public health emergency (PHE).
As we all settle into our new sense of normalcy, Health Law Scan continues to monitor developments surrounding the coronavirus (COVID-19) pandemic. We have lawyers across the firm providing updates on a wide variety of topics to keep our clients apprised of all the developments.
Provisions in the Coronavirus Aid, Relief, and Economic Security (CARES) Act signaled that the government intends to closely monitor the more than $2 trillion in relief funds, including loans through the Paycheck Protection Program. New developments confirm that businesses seeking these loans must understand the risks before accepting and retaining the funds.
The Centers for Medicare & Medicaid Services (CMS) announced on April 26 that it will no longer be accepting new applications for the Medicare Accelerated/Advanced Payment Program (AAPP).
US President Donald Trump signed the Paycheck Protection Program and Healthcare Enhancement Act (HR 266) into law on April 24. HR 266 appropriates $483 billion in new spending, including $321 billion for the Payment Protection Program, an additional $75 billion for the Public Health and Social Services Emergency Fund, and $25 billion to support expanded testing across the United States.
Medicare providers that receive grant money under the CARES Act Relief Fund must pay close attention to the terms and conditions of the assistance and rigorously document how the funds are used to avoid potential future False Claims Act allegations.
The US Nuclear Regulatory Commission’s (NRC’s) Office of Nuclear Materials Safety and Safeguards (NMSS) issued an internal memorandum on April 10 to its regional directors describing a process that could be used to review medical licensees’ requests for temporary exemptions from certain NRC regulations due to the coronavirus (COVID-19) pandemic. Enclosed with the memorandum is a template letter that regions can use to streamline granting temporary exemptions.
The Occupational Safety and Health Administration has issued a new guidance allowing field offices flexibility in handling COVID-19-related matters, including complaints. The guidance focuses on highly affected industries, such as healthcare and first responders and prioritizes inspections in areas of imminent danger of exposures and fatalities. Enforcement for other industries is likely to shift from primarily on-site inspections to informal complaints and whistleblower actions.
As jurisdictions contemplate lifting pandemic-related workplace restrictions, employers must start considering how best to cope with a vast array of issues, including restarting or expanding operations, reintegrating remote-working or furloughed employees, implementing new state and local orders/requirements, and protecting the safety of employees and customers. Employers who proactively plan for these challenges will be best positioned to adapt to the “new normal.”
The US Department of Labor’s Occupational Health and Safety Administration (OSHA) released a statement on April 8 reminding employers that they cannot retaliate against workers who report unsafe or unhealthy working conditions during the coronavirus (COVID-19) pandemic.
Not to be confused with the $100 billion in Provider Relief Funds established as grants to healthcare providers through the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), Congress also broadened the access to the Medicare Accelerated/Advanced Payment Program (AAPP) as a tool to address financial concerns associated with reduced cash flow during the pandemic.
FEMA exercised the authority recently granted to it by Executive Orders and pursuant to the Defense Production Act to regulate and redirect respirators, surgical masks, gloves, and other personal protective equipment (PPE) designated as scarce or threatened materials that are prepared for export. FEMA and CBP will work together to identify “commercial quantities” of these items to be redirected for domestic use.
Morgan Lewis is staying informed on all of the developments surrounding the coronavirus (COVID-19) pandemic. Our healthcare team continues to follow developments, producing a number of publications and webinars to help keep our healthcare industry readers informed.
The joint statement recognizes that while the COVID-19 pandemic offers businesses an opportunity for procompetitive collaboration and benefits, it also increases significant risk of anticompetitive conduct in the labor market. Here are some issues and factors that businesses should consider to mitigate antitrust risk as the Antitrust Division and Federal Trade Commission continue to consider enforcement actions for antitrust violations.
In response to the coronavirus (COVID-19) pandemic, Russia has introduced non-work days through 30 April 2020 to keep people at home. The non-work days are mandatory for all employers with limited exemptions. On 2 April, President Vladimir Putin authorized the heads of subjects of the Russian Federation (Russia’s constituencies) to provide further exemptions or stricter rules depending on the epidemiological situation in a particular territory. In this alert we address the most recent restrictions introduced by the Mayor of Moscow, including the introduction of digital passes.
The US Department of Health and Human Services recently announced the use of blanket waivers for healthcare providers under the Stark Law, and its Office of Inspector General noted it will exercise enforcement discretion in imposing administrative sanctions related to such blanket waivers under the Anti-Kickback Statute.
Employers considering layoffs in the face of the coronavirus (COVID-19) crisis have additional opportunities to support furloughed workers, aside from options offered by the CARES Act.
Texas Governor Greg Abbott issued Executive Order GA-14 on March 31, directing every person in Texas to minimize social gatherings and in-person contact with people who do not live in the same household except where necessary to provide or obtain essential services.
On March 30, 2020, the Centers for Medicare & Medicaid Services released a stunning and far-reaching interim final rule to address the coronavirus (COVID-19) crisis. The rule is a comprehensive set of policy changes designed to—almost overnight—shift the provision of healthcare services to Medicare beneficiaries from face-to-face care to remote care through telehealth. Healthcare providers must quickly understand what the rule entails to ensure that they can continue to treat their needy patient populations while maintaining compliance with Medicare billing and benefit rules.
The Center for Medicare and Medicaid Services (CMS) released a far-reaching interim final rule (IFR) to address the coronavirus (COVID-19) pandemic on March 30. The IFR represents a comprehensive set of policy changes designed to shift the provision of Medicare services from face-to-face care to remote care through telehealth, in order to mitigate the risks of exposure to COVID-19 for patients and healthcare providers. Above all else, the IFR prioritizes physically distancing patients from their care teams and other patients.
Helping to address a critical COVID-19 need, Morgan Lewis guided Airon Corp, a privately held company specializing in high-tech pneumatic life support products, in a collaboration with GE Healthcare, one of the world’s largest healthcare companies.
The Morgan Lewis healthcare team continues to monitor the developments surrounding the coronavirus (COVID-19) pandemic. We are acutely aware of what the healthcare service provider community is currently facing and are here to help.
With each passing day, more US companies are voluntarily rising to answer the president’s call to manufacture face masks, ventilators, and other critical coronavirus (COVID-19) protective equipment, but without a government contract, they may not be exempt from patent infringement liability.
In light of the coronavirus (COVID-19) outbreak, the US Food and Drug Administration (FDA) recently issued a guidance on adverse event (AE) report for drugs, biologics, medical devices, dietary supplements, and other products during pandemics, Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic (the Guidance).
The Centers for Medicare & Medicaid Services has expanded its payment program to provide emergency funding and increased cash flow to providers and suppliers that participate in Medicare based on historical Medicare payments in response to the coronavirus (COVID-19) pandemic.
The Coronavirus Aid, Relief, and Economic Security Act establishes mechanisms for relief that healthcare providers are anxious to access. This alert outlines those mechanisms.
As we reported on Health Law Scan, the Centers for Medicare and Medicaid Services (CMS) issued an Open Payments COVID-19 Announcement on March 25, citing its plans to exercise enforcement discretion regarding the late or incomplete submission of Program Year 2019 data in some cases.
Through FDA’s Policy for Certain REMS Requirements During COVID-19 Public Health Emergency, FDA provides temporary relief from laboratory testing and imaging requirements for certain drugs and biologics subject to REMS with those specific prerequisites.
During the coronavirus (COVID-19) outbreak, FDA guidance allows healthcare providers to prescribe drugs subject to Risk Evaluation and Mitigation Strategies without conducting the required laboratory tests or imaging studies. Providers should communicate their medical judgments and the risks to their patients, and manufacturers should document and summarize steps taken to accommodate patient access to such drugs in their next REMS assessment report to FDA.
In managing the quickly evolving healthcare landscape during this current crisis, healthcare companies should be wary of fraudsters who attempt to divert critical resources.
The US Federal Trade Commission and the Antitrust Division of the US Department of Justice have announced that they aim to respond within one week to coronavirus (COVID-19) collaborative proposals submitted pursuant to the agencies’ respective processes.
The FDA issued guidance on March 20 for the manufacture of hand sanitizers by companies not previously registered to make OTC drugs.
This LawFlash covers the regulatory relief that has been granted thus far, and where government enforcement and program integrity fits against that backdrop.
Aided by ingenuity and growing regulatory flexibility, retail pharmacies across the country are finding ways to serve their customers while reducing face-to-face contact. Protocols may vary by state.
The Families First Coronavirus Response Act (Act), signed into law Wednesday, requires group health plans to provide coverage for coronavirus (COVID-19) diagnostic testing, including the cost of healthcare provider visits (as well as telehealth visits), urgent care center visits, and emergency room visits in order to receive testing. Coverage must be provided at no cost-sharing to participants.
As we noted in our previous Health Law Scan blog CMS Issues Program Instructions for Medicare Telehealth Waiver, CMS issued program instructions on March 17 to implement the Medicare telehealth waiver in response to the coronavirus (COVID-19) crisis.
In the face of the coronavirus (COVID-19) pandemic, the US president’s National Emergency Declaration, issued on March 13, set in motion several actions required of other agencies to provide the regulatory relief needed to ensure that healthcare providers have flexibility in responding quickly to the growing need in the United States.
CMS issued program instructions on March 17 (through a Fact Sheet and FAQ) to implement the Coronavirus Preparedness and Response Supplemental Appropriations Act (CPRSAA), which was enacted on March 6 in response to the coronavirus (COVID-19) crisis.
Following President Donald Trump’s national emergency declaration on March 13, the US Department of Health and Human Services has finalized licensure waivers that would permit physicians participating in Federal health care programs to receive payment for telemedicine services in states where they do not hold a license during the coronavirus (COVID-19) emergency. The waivers were published on March 15, with a retroactive effect back to March 1.
The Morgan Lewis healthcare team is keeping up to date on all of the developments surrounding coronavirus (COVID-19). We have compiled a list of our recent publications for ease of access.
The pharmaceutical and biotech industries are assessing how the coronavirus (COVID-19) pandemic may impact business operations. Presently, most countries have confirmed cases of COVID-19 and thousands of people have had confirmed diagnoses. Given the global impact of this virus, the global nature of the pharmaceutical and biotech industry, and the rapidly changing infection landscape, key operational areas will be impacted, and understanding the regulatory and legal implications of these effects and steps to mitigate them are critical.
The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade Commission to crack down on unapproved products.
In this LawFlash, Morgan Lewis healthcare industry partner Susan Feigin Harris analyzes recent CMS guidance on Emergency Medical Treatment and Labor Act (EMTALA) requirements and implications related to the coronavirus (COVID-19).
The IRS issued guidance on March 11 that clears the way for employers to offer employees covered by a high-deductible health plan (HDHP) testing and treatment for the 2019 Novel Coronavirus (COVID-19) with no deductible or at a lower deductible.
The Centers for Medicare & Medicaid Services (CMS) continues to issue frequent guidance to the healthcare industry, including guidance after receiving questions on fulfilling Emergency Medical Treatment and Labor Act screening obligations by hospitals and critical access hospitals while minimizing the risk of exposure from COVID-19 patients.
The Centers for Medicare & Medicaid Services (CMS) issued a statement on March 9 related to actions the agency is taking to protect the health and safety of patients and providers. CMS urges providers to stay abreast of CDC guidance on the 2019 Novel Coronavirus (COVID-19).
As part of emergency funding to combat the threat of the 2019 Novel Coronavirus (COVID-19), last week Congress waived many of the telehealth restrictions for Medicare services in certain situations. This monumental change could—depending on how it is implemented—radically alter how telehealth is performed in connection with the government’s most ubiquitous healthcare program.
Recent guidance from the Office for Civil Rights and the Centers for Medicare and Medicaid Services reiterates that existing privacy laws and emergency preparedness standards provide an effective framework for providers during the 2019 Novel Coronavirus outbreak.
A blog post authored by Morgan Lewis partner Michelle McCarthy and of counsel Saghi Fattahian was cited in an HR Daily Advisor article about the 2019 Novel Coronavirus (COVID-19) and HIPAA compliance.
In two draft companion guidance documents, the US Food and Drug Administration (FDA) establishes a proposed framework for transitioning medical devices currently marketed under emergency use authorization (EUA) or enforcement policy guidance to permanent marketing authorization. The draft FDA guidance documents provide manufacturers a 180-day transition period to submit a marketing application and stress that they should submit permanent marketing authorizations prior to finalization of the guidance documents.
As employers continue to deal with the ongoing impacts of the pandemic heading into 2022, partners Michael Jones and Siobhan Mee and associate Alana Genderson shared some related legal trends to watch in the new year.
The recent rollout of various COVID-19 vaccines has raised many questions around their availability, distribution, and requirements for employers and other groups, including essential insurance, liability, and enforcement considerations. Here we provide key legal and regulatory perspectives for those organizations providing access to the vaccines and/or mandating vaccination. Highlights include the state and federal laws providing protection to organizations during an outbreak of an infectious disease and what employers contemplating the administration of a closed point-of-delivery (POD) vaccination program need to know.
The Biden-Harris administration announced on May 5 its intent to support a waiver on intellectual property protections on COVID-19 vaccines. The scope of any potential waiver is subject to further negotiation at the World Trade Organization (WTO). Any decision made at the WTO level requires a consensus among all of its 164 members.
States and localities across the country are continuing to respond as quickly and effectively as possible to the coronavirus (COVID-19) outbreak. These responses include guidance for taxpayers on numerous topics, such as providing tax relief through filing and payment deadline extensions.
In a Law360 feature, Morgan Lewis partner Dennis Gucciardo and associate Jacob Harper highlighted some of the defining moments for the healthcare and life sciences industries in the year since the US government declared the COVID-19 pandemic of sufficient severity and magnitude to warrant an emergency declaration.
In one of the last proposed notices from the US Department of Health and Human Services (HHS) under the Trump administration, HHS removed the 510(k) premarket notification requirement for seven types of gloves and proposed the same for 84 other devices ranging from gowns to ventilators.
In response to delayed EU shipments of certain COVID-19 vaccines to the European Union, the European Commission (Commission) passed on 29 January 2021 Regulation 2021/111 (Export Authorization Regulation) which is in force from 30 January 2021. The Commission intends for the Export Authorization Regulation to apply until at least 31 March 2021.
January was a busy month for the US Food and Drug Administration’s precision medicine efforts, as the agency produced guidance on ASO drugs for patients with debilitating or life-threatening genetic disorders and guidance on manufacturing considerations for certain cellular and gene therapy products during the COVID-19 pandemic.
The Food and Drug Administration (FDA or the Agency) spent the remaining weeks of 2020 issuing Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home and the first OTC home sample collection kit for COVID-19 testing, as well as additional prescription at-home tests and sample collection kits.
A LawFlash authored by Morgan Lewis partners Sharon Perley Masling and Kathy Sanzo, and associates Alana Genderson, Christopher Jaynes, and Maria Kalousi-Tatum was quoted in an EHS Today article about the potential for employers to establish policies related to a COVID-19 vaccine.
MedTech Dive featured comments from Morgan Lewis partner Dennis Gucciardo in an article about the US Department of Health and Human Services directive to the US Food and Drug Administration to review requests for emergency use authorization for COVID-19 laboratory developed tests "in a timely manner.”
The coronavirus (COVID-19) pandemic continues to impact the biopharmaceutical industry. In a recent guidance, Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency (the Guidance), FDA provides manufacturers a heads up on steps they should consider when resuming normal operations.
The US Department of Health and Human Services (HHS) on August 19 published a sweeping announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it stated that the Food and Drug Administration (FDA) would not require premarket review of laboratory developed tests (LDTs) without notice-and-comment rulemaking.
Morgan Lewis partner Michael Abernathy spoke with Business Insurance for an article about the pharmaceutical industry’s efforts to produce a COVID-19 vaccine.
Morgan Lewis partner Robert Hibbert and associate Maria Kalousi-Tatum authored a Food Safety Magazine article about the US Food and Drug Administration (FDA) and the US Department of Agriculture’s memorandum of understanding (MOU) intended to prevent potential disruptions to the food supply chain resulting from the COVID-19 pandemic.
Morgan Lewis partner Dennis Gucciardo spoke with MedTech Dive for an article about the COVID-19 pandemic’s impact on the US Food and Drug Administration’s enforcement efforts. In the piece, he discussed the potential for virtual inspections.
The CARES Act’s Paycheck Protection Program provides loans targeted to small businesses to help keep their workers employed during the coronavirus (COVID-19) pandemic, and offers loan forgiveness to borrowers maintaining a high percentage of employees on payroll. This LawFlash provides the latest developments in PPP loan availability, eligibility, and forgiveness, as well as a comprehensive overview of the PPP and related guidance.
The Federal Reserve took additional actions on April 9 to provide up to $2.3 trillion in loans to support the US economy during the coronavirus (COVID-19) pandemic. This LawFlash covers the new and expanded programs, and provides comprehensive coverage of the Coronavirus Economic Stabilization Act.
With the coronavirus (COVID-19) pandemic showing no signs of abating, many digital health developers have refocused their technical expertise to develop products for use in the pandemic, including software apps for COVID-19 screening and risk assessments, digital therapeutics, and remote patient monitoring systems.
As the coronavirus (COVID-19) pandemic resurges, PREP Act liability immunity continues to be critical for manufacturers and users of COVID-19 medical products.
The US Food and Drug Administration’s recent policy, issued in part due to the coronavirus (COVID-19) pandemic, also suspends enforcement of Direct Marking requirements for certain Class I, Class II, Class III, and life-supporting/life-sustaining devices.
Kathy Sanzo spoke with MedCity News regarding the Department of Health and Human Services’ Covid-19 vaccine development program, Operation Warp Speed, which aims to develop vaccines against the SARS-CoV-2 in the space of a year rather than the multiple years normally required
The US Food and Drug Administration (FDA) announced on July 10 that it will resume domestic inspections of regulated facilities and activities using a new risk assessment rating system.
A LawFlash authored by Morgan Lewis partners Kathy Sanzo and Jacqueline Berman was cited in a BioProcess International article about guidance recently issued by the US Food and Drug Administration (FDA) for firms developing vaccines against SARS-CoV-2. As noted by the publication, the LawFlash advised developers to track FDA’s COVID-19-related actions, “as additional guidance and modifications to existing guidances are likely to be issued as reopening plans are implemented.”
Companies marketing products or services for coronavirus (COVID-19) should be aware of key areas of healthcare law and regulation, including Food and Drug Administration regulation, clinical laboratory testing oversight, product liability, and digital health/telehealth regulation.
From the beginning of the coronavirus (COVID-19) pandemic, FDA actively provided guidance to members of the drug and biologic industries, including sponsors, investigators, pharmacies, and compounders. Now, as states begin to reopen, FDA appears to be looking toward the future, specifically providing guidance on prospectively addressing the impact of COVID-19 on clinical trials and compliance with current Good Manufacturing Practices (cGMPs). Below we provide brief summaries of key points from FDA’s drug and biologic COVID-19 guidance to date.
Two key amendments to the German competition law entered into effect on May 29, 2020, temporarily extending merger control review periods and temporarily suspending interest payments for antitrust fines, further to a bill adopted by the German Parliament to mitigate the consequences of the coronavirus (COVID-19) pandemic on trade.
Morgan Lewis partner Kathy Sanzo spoke with Bloomberg Law about the efforts by drugmakers to produce a vaccine and navigate a web of US Food and Drug Administration (FDA) regulations.
Life science companies should consider offering FDA creative solutions for submissions that require pre-approval inspections.
The US Patent and Trademark Office (USPTO) on May 8 announced a new COVID-19 Prioritized Examination Pilot Program (Pilot Program), under which eligible small and micro entities will receive prioritized examination without payment of the additional fees for prioritized examination. As such, eligible small and micro entities will save $2,000 and $1,000, respectively, when making a request for prioritized examination under the new Pilot Program.
As the public health emergency caused by the coronavirus (COVID-19) continuously evolves, the US Department of Agriculture Food Safety Inspection Service (FSIS) and the Food and Drug Administration (FDA) are actively releasing new, and updating existing, policy statements and temporary guidance providing flexibility on certain regulatory requirements during the pendency of the COVID-19 pandemic.
As the public health emergency caused by the coronavirus (COVID-19) continuously evolves, the US Department of Agriculture Food Safety Inspection Service (FSIS) and the Food and Drug Administration (FDA) are actively releasing new, and updating existing, policy statements and temporary guidance providing flexibility on certain regulatory requirements during the pendency of the COVID-19 pandemic.
Underscoring the significance of utilizing intellectual property (IP) in the ongoing fight against the coronavirus (COVID-19), the US Patent and Trademark Office (USPTO) on Monday publicly unveiled a new online database that acts as a patent “marketplace” aimed at facilitating the voluntary licensing and commercialization of key technologies related to the prevention, diagnosis, and treatment of COVID-19.
The European Commission published its first comfort letter in nearly 20 years on April 29, in an effort to foster cooperation among businesses during the coronavirus (COVID-19) pandemic. Here is what companies should know about the specific practices permitted under the comfort letter, as well as the specific conditions and safeguards for cooperation.
Key issues that UK employers should begin considering now to minimize difficulties as they reopen or expand their operations include reintegrating staff, assessing internal policies in light of the pandemic, testing for the coronavirus (COVID-19), and more.
The UK government has announced two new schemes for funding to innovative companies and startups, launching in May 2020.
The Kazakhstan government has adopted a resolution that establishes the so-called “adjustment coefficient” zero to salary-related taxes and payments in an effort to stabilize the economy during the coronavirus (COVID-19) pandemic.
The Internal Revenue Service (IRS) and the US Department of the Treasury released two Revenue Procedures and a new FAQ on April 21 to provide relief to US residents and alien individuals affected by travel disruptions due to the coronavirus (COVID-19) emergency.
New guidance from the UK Competition and Markets Authority warns that it will not relax its substantive or evidentiary standards for merger investigations during the coronavirus (COVID-19) pandemic. Statutory deadlines will not be altered, although aspects of investigations may be subject to delay, and the authority will continue to impose interim measures. The authority also set out its position on mergers involving “failing firms,” indicating some flexibility in its interpretation of the counterfactual test.
The US Department of Agriculture Food Safety Inspection Service (FSIS) and US Food and Drug Administration (FDA) have released policy statements and temporary guidance providing flexibility on certain regulatory requirements during the pendency of the coronavirus (COVID-19) pandemic.
As jurisdictions contemplate lifting pandemic-related workplace restrictions, employers must start considering how best to cope with a vast array of issues, including restarting or expanding operations, reintegrating remote-working or furloughed employees, implementing new state and local orders/requirements, and protecting the safety of employees and customers. Employers who proactively plan for these challenges will be best positioned to adapt to the “new normal.”
The US Department of Labor’s Occupational Health and Safety Administration (OSHA) released a statement on April 8 reminding employers that they cannot retaliate against workers who report unsafe or unhealthy working conditions during the coronavirus (COVID-19) pandemic.
The joint statement recognizes that while the COVID-19 pandemic offers businesses an opportunity for procompetitive collaboration and benefits, it also increases significant risk of anticompetitive conduct in the labor market. Here are some issues and factors that businesses should consider to mitigate antitrust risk as the Antitrust Division and Federal Trade Commission continue to consider enforcement actions for antitrust violations.
Businesses that avail themselves of financial assistance under Section 4003 or 4116 of the CARES Act must limit compensation and severance paid to certain officers and employees.
US antitrust laws already on the books facilitate rapid investment without government delay: important practical tools and rules for dealmakers and their counsel in the wake of the coronavirus (COVID-19) pandemic and the current economic challenges.
As the federal government seeks innovative solutions from a broader group of suppliers to respond to the coronavirus (COVID-19) pandemic, new or nontraditional contractors will want to familiarize themselves with the intellectual property rights associated with different contracting vehicles and circumstances.
The European Commission has provided antitrust guidance to companies cooperating in response to urgent coronavirus (COVID-19) related matters, particularly in the health sector for critical hospital medicines and medical equipment, and has also exceptionally issued a “comfort letter” on a cooperation project in the generic pharmaceuticals sector aimed at ensuring the supply of critical hospital medicines. Other ad hoc “comfort letters” may follow at the EU Commission’s discretion.
Employers considering layoffs in the face of the coronavirus (COVID-19) crisis have additional opportunities to support furloughed workers, aside from options offered by the CARES Act.
In three new Unemployment Insurance Program Letters, the US Department of Labor (DOL) issued guidance to state workforce agencies to implement the unemployment provisions in the CARES Act. The guidance has several important aspects for employers.
Morgan Lewis partners Dennis Gucciardo, Michele Buenafe, and Jacqueline Berman authored a Bloomberg Law Insight regarding the US Food and Drug Administration’s announcement to suspend onsite routine domestic inspections in an effort to slow the spread of the coronavirus (COVID-19).
With each passing day, more US companies are voluntarily rising to answer the president’s call to manufacture face masks, ventilators, and other critical coronavirus (COVID-19) protective equipment, but without a government contract, they may not be exempt from patent infringement liability.
In light of the coronavirus (COVID-19) outbreak, the US Food and Drug Administration (FDA) recently issued a guidance on adverse event (AE) report for drugs, biologics, medical devices, dietary supplements, and other products during pandemics, Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic (the Guidance).
The $2 trillion economic stimulus package laid out in the Coronavirus Aid, Relief, and Economic Security (CARES) Act includes $11 billion in appropriations for vaccines, therapeutics, and other medical needs, and $34.9 billion supporting agriculture, rural development, the US Food and Drug Administration, and related industries. This LawFlash addresses the act’s drug, device, and food product provisions, and outlines the impact of those provisions on manufacturers and other affected parties.
In light of the hand sanitizer shortage during the coronavirus (COVID-19) pandemic, many manufacturers are seeking alternative sources of alcohol for incorporation into their hand sanitizer products.
During the coronavirus (COVID-19) outbreak, FDA guidance allows healthcare providers to prescribe drugs subject to Risk Evaluation and Mitigation Strategies without conducting the required laboratory tests or imaging studies. Providers should communicate their medical judgments and the risks to their patients, and manufacturers should document and summarize steps taken to accommodate patient access to such drugs in their next REMS assessment report to FDA.
The US Federal Trade Commission and the Antitrust Division of the US Department of Justice have announced that they aim to respond within one week to coronavirus (COVID-19) collaborative proposals submitted pursuant to the agencies’ respective processes.
Can the government compel your company to sell its products to the government, even if committed to commercial customers? In the last few days, many companies have received their first “rated order” under the Defense Product Act of 1950 (DPA), or their employees are seeing rated orders for the first time. Here is what you need to know about the DPA and rated orders.
FDA Announces Path Forward to Protect Food Supply During COVID-19 Period
In light of the hand sanitizer shortage during the coronavirus (COVID-19) emergency, many companies have been trying to find alternative sources of product, especially employers in healthcare and essential service sectors where employees are still present or interacting with consumers. In response, the US Food and Drug Administration (FDA) issued guidance on March 20 for the manufacture of hand sanitizers by companies not previously registered to make over-the-counter (OTC) drugs.
The White House is reportedly in discussions with US auto companies to aid in the COVID-19 relief effort by producing ventilators, and some US distilleries have already switched manufacturing operations to make hand sanitizer.
FDA representatives on March 18 initiated a conference call with representatives of the food industry to discuss public health and food safety issues related to the coronavirus (COVID-19) outbreak. The FDA was represented by Frank Yiannas (FDA Deputy Commissioner for Food Policy and Response), Michael Rogers (Assistant Commissioner for Human and Animal Foods), and Dr. Susan Mayne (Director of the Center for Food Safety and Applied Nutrition).
For-cause inspections will proceed if deemed “mission critical.” The US Food and Drug Administration (FDA) had previously announced on March 10 that routine foreign inspections were suspended. FDA suggests that it may attempt to conduct domestic inspections through other means.
As the coronavirus (COVID-19) pandemic continues to grow, the US Food and Drug Administration (FDA) on March 18 issued a guidance document titled FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic. The guidance provides general considerations to “assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity . . . .”
In responding to the coronavirus (COVID-19) pandemic, the mantra of “working together” is heard often. But as businesses confront sudden and extensive demand and supply disruptions—and a range of sometimes conflicting information and guidance from the public sector about the health crisis—questions inevitably arise about the extent to which the private sector can coordinate its responses consistent with the antitrust laws.
With the increasing numbers of coronavirus (COVID-19) cases and the declaration of a global pandemic by the World Health Organization, the pharmaceutical and biotech industries are assessing how this situation may impact business operations.
The pharmaceutical and biotech industries are assessing how the coronavirus (COVID-19) pandemic may impact business operations. Presently, most countries have confirmed cases of COVID-19 and thousands of people have had confirmed diagnoses. Given the global impact of this virus, the global nature of the pharmaceutical and biotech industry, and the rapidly changing infection landscape, key operational areas will be impacted, and understanding the regulatory and legal implications of these effects and steps to mitigate them are critical.
The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade Commission to crack down on unapproved products.
As employers continue to deal with the ongoing impacts of the pandemic heading into 2022, partners Michael Jones and Siobhan Mee and associate Alana Genderson shared some related legal trends to watch in the new year.
Associate Alana Genderson spoke with HR Magazine about how employers can accurately assess employee numbers in the wake of the contested Occupational Safety and Health Administration (OSHA) emergency temporary standard (ETS), which applies to companies with more than 100 employees.
Partners Daryl Landy and Jason Mills and associate Nicholas Armer co-authored an article for the Daily Journal regarding Cal/OSHA’s changing approach to the Emergency Temporary Standards (ETS) it has issued over the last year. The article highlights the inconsistency in the standards, which has created a “skeptical employer audience when it comes to future emergency standards.”<
States and localities across the country are continuing to respond as quickly and effectively as possible to the coronavirus (COVID-19) outbreak. These responses include guidance for taxpayers on numerous topics, such as providing tax relief through filing and payment deadline extensions.
Morgan Lewis partner Lee Harding and associate Will Mallin co-authored an article for Employment Law Journal about a recent High Court judgement, which held that the UK government failed to extend health and safety protections to “limb b” workers.
Morgan Lewis partner Anne Marie Estevez was quoted by Law360 in an article about the effect of COVID-19 on the retail sector, especially heading into what was traditionally a busy holiday season.
The primary focus of many retailers in the near term will likely be on staying afloat and addressing their liquidity needs, the health and safety of their employees and customers, the overall health of their businesses, and how best to pivot their business models to adapt to shifting consumer preferences and expectations in the wake of the ongoing coronavirus (COVID-19) pandemic.
Reopening procedures for retailers in Russia focus on employee scheduling, social distancing and sanitary plans, and medical screening protocols.
While retailers in China have been permitted to reopen, required steps to do so include health and sanitation measures. Some local governments are also considering extending the weekend in order to stimulate consumption and promote economic recovery.
Key questions and issues facing the UK retail sector, an industry that has been acutely impacted by the coronavirus (COVID-19) pandemic, include mitigation strategies, reopening in line with government guidance, and future expected challenges.
The CARES Act’s Paycheck Protection Program provides loans targeted to small businesses to help keep their workers employed during the coronavirus (COVID-19) pandemic, and offers loan forgiveness to borrowers maintaining a high percentage of employees on payroll. This LawFlash provides the latest developments in PPP loan availability, eligibility, and forgiveness, as well as a comprehensive overview of the PPP and related guidance.
The Federal Reserve took additional actions on April 9 to provide up to $2.3 trillion in loans to support the US economy during the coronavirus (COVID-19) pandemic. This LawFlash covers the new and expanded programs, and provides comprehensive coverage of the Coronavirus Economic Stabilization Act.
The United Kingdom is starting to see a return of the workforce for nonessential retail, which reopened on June 15. Shortly thereafter, the prime minister announced further easing of lockdown restrictions as the United Kingdom begins the third stage of its plan. From July 4, pubs, restaurants, hairdressers, hotels, and other outdoor activities are able to reopen if they comply with new guidance. From July 13, beauticians, spas, and salons are able to reopen. The UK government has also launched a new scheme, “Eat Out to Help Out,” to help the restaurant industry, giving diners 50% (up to £10) off their bill if they eat in a registered cafe or restaurant on a Monday, Tuesday, or Wednesday during August. To facilitate the reopening of these retail stores, the well-established two-meter social distancing rule will change to “one meter plus.” This Retail Did You Know? explores the issues UK nonessential retailers face from an employment perspective.
On July 1, California Governor Gavin Newsom announced closures of indoor dining and entertainment venues, as well as all bars, in 19 counties. California immediately issued Guidance describing these closures. Gov. Newsom also announced coordinated enforcement efforts, including the creation of Enforcement Strike Teams between state agencies and local counties and cities. Businesses are advised to regularly review the rules that remain in constant flux.
Morgan Lewis partners Leni Battaglia, Gregory Parks, and Melissa Rodriguez authored a Chain Store Age article about the impact of COVID-19 on luxury retail brands and best practices for reopening and continuing business. In the piece, they discuss how convincing retailers it’s safe to start shopping will be key to recovery.
The UK Competition and Markets Authority on June 19 announced that it had opened investigations against four pharmacies and convenience stores in relation to suspected breaches of antitrust rules by charging excessive and unfair prices for hand sanitiser products during the coronavirus (COVID-19) pandemic, and on June 29 published an open letter warning pharmacists against price gouging, raising the possibility of additional investigations.
As Latin America continues to manage the adverse economic effects resulting from the coronavirus (COVID-19) pandemic and prepares for what lies ahead, there are certain post-shutdown processes and regulatory requirements to keep in mind before the restart of operations in the region.
New York State has continued to issue the state’s phased, regional plan for reopening businesses following the statewide closure of all nonessential businesses due to the coronavirus (COVID-19) public health emergency, a process known as “New York Forward.”
The US Department of Labor (DOL) published a Final Rule on June 8 confirming that paying bonuses, commissions, and other incentive-based pay to salaried, nonexempt employees does not disqualify employers from using the fluctuating workweek (FWW) method of calculating overtime pursuant to the Fair Labor Standards Act (FLSA).
Additional reopening steps come several weeks after Illinois released a five-phase, regional plan for reopening businesses following the statewide closure of all nonessential businesses due to the coronavirus (COVID-19) public health emergency, a process known as Restore Illinois.
Two key amendments to the German competition law entered into effect on May 29, 2020, temporarily extending merger control review periods and temporarily suspending interest payments for antitrust fines, further to a bill adopted by the German Parliament to mitigate the consequences of the coronavirus (COVID-19) pandemic on trade.
The offeror for Moss Bros sought to rely on standard material adverse change conditions to lapse the offer, on the basis of the impact of the coronavirus (COVID-19) pandemic and related UK governmental measures on Moss Bros. The Panel Executive ruled that the impact on Moss Bros’ business was not sufficiently material to permit the lapsing of the offer.
The Food and Drug Administration (FDA) and the US Department of Agriculture (USDA) have announced a memorandum of understanding (MOU) to help prevent potential disruptions to the food supply chain, particularly fruit and vegetable processing plants, resulting from the coronavirus (COVID-19) pandemic.
As local and national governments begin easing pandemic-related restrictions on in-person activities, businesses must weigh how best to proceed with reopening, including restarting or expanding operations, reintegrating remote-working or furloughed employees, implementing new state and local orders, and protecting the safety of employees and customers. Here are a few key considerations. For more information, please see our Retail Reopens Guide.
New York State began on May 15 to implement the state’s phased, regional plan for reopening businesses following the statewide closure of all nonessential businesses due to the coronavirus (COVID-19) public health emergency, a process known as “New York Forward.” Pursuant to New York Forward, certain industries in qualifying regions of New York can begin in-person operations, provided they affirm compliance with industry-specific health and safety guidance promulgated by the state and develop and post a compliant safety plan. This LawFlash discusses the nature and scope of the New York Forward reopening process, and key provisions from health and safety guidance issued to date.
As the public health emergency caused by the coronavirus (COVID-19) continuously evolves, the US Department of Agriculture Food Safety Inspection Service (FSIS) and the Food and Drug Administration (FDA) are actively releasing new, and updating existing, policy statements and temporary guidance providing flexibility on certain regulatory requirements during the pendency of the COVID-19 pandemic.
The European Commission published its first comfort letter in nearly 20 years on April 29, in an effort to foster cooperation among businesses during the coronavirus (COVID-19) pandemic. Here is what companies should know about the specific practices permitted under the comfort letter, as well as the specific conditions and safeguards for cooperation.
Key issues that UK employers should begin considering now to minimize difficulties as they reopen or expand their operations include reintegrating staff, assessing internal policies in light of the pandemic, testing for the coronavirus (COVID-19), and more.
Prepackaged bankruptcies, prearranged bankruptcies, and expedited sales are available options for businesses in need of accelerated restructurings during the coronavirus (COVID-19) pandemic.
The Internal Revenue Service (IRS) and the US Department of the Treasury released two Revenue Procedures and a new FAQ on April 21 to provide relief to US residents and alien individuals affected by travel disruptions due to the coronavirus (COVID-19) emergency.
In response to the coronavirus (COVID-19) pandemic, US bankruptcy courts have granted extraordinary equitable relief in some cases. As government orders enforcing stay-at-home measures have forced many businesses to shutter indefinitely, bankruptcy courts have implemented procedures to allow the ongoing—albeit virtual—administration of bankruptcy cases.
Governor Charlie Baker signed emergency legislation on April 20 limiting evictions for residential and small business properties, and limiting foreclosures and requiring forbearance for residential properties. This legislation follows a number of actions by Governor Baker and the City of Boston to protect renters, homeowners, and small businesses during the coronavirus (COVID-19) pandemic.
As the coronavirus (COVID-19) pandemic evolves, governmental executive and legislative authorities are taking actions in the form of emergency declarations and proposed legislation that could improve a company’s ability to mitigate business income losses by maximizing its insurance recovery. Keeping an eye on these developments and documenting your losses accordingly could make all the difference.
For retailers, it is key to be prepared before, during, and after times of crisis. As retailers across the globe navigate the current coronavirus (COVID-19) crisis, they are dealing with having to close their doors if deemed nonessential, monitoring the safety and well-being of their employees, evaluating their liquidity, and preserving their cash position.
Following a recent trend, New York Governor Andrew Cuomo has issued two executive orders requiring individuals to wear face coverings when near other people. One order requires all customer/public-facing employees to wear face coverings and requires employers to provide these face coverings at no cost to employees. The other order requires all individuals in a public place to use a mask or face covering.
As jurisdictions contemplate lifting pandemic-related workplace restrictions, employers must start considering how best to cope with a vast array of issues, including restarting or expanding operations, reintegrating remote-working or furloughed employees, implementing new state and local orders/requirements, and protecting the safety of employees and customers. Employers who proactively plan for these challenges will be best positioned to adapt to the “new normal.”
The US Department of Labor’s Occupational Health and Safety Administration (OSHA) released a statement on April 8 reminding employers that they cannot retaliate against workers who report unsafe or unhealthy working conditions during the coronavirus (COVID-19) pandemic.
The Internal Revenue Service on Monday, April 13 issued welcome relief to the securitization industry, providing that certain forbearances and related modifications to mortgages will generally not cause real estate mortgage investment conduits (REMICs) and other securitization vehicles to lose their special tax status if such modifications arise from new programs/procedures created by the CARES Act or by similar programs/procedures to address the coronavirus (COVID-19) emergency.
For companies forced to postpone or cancel live events during the coronavirus (COVID-19) pandemic, event cancellation insurance may serve as a way to protect assets and mitigate losses.
As New Jersey continues to battle the spread of coronavirus (COVID-19), Governor Phil Murphy ordered essential businesses in the state to adopt several measures including mandatory face coverings at worksites, occupancy limits for stores, and frequent handwashing breaks for employees. Employers should pay close attention to these comprehensive and far-reaching—and sometimes confusing—orders that impose affirmative duties and could raise a host of reasonable-accommodations issues.
The joint statement recognizes that while the COVID-19 pandemic offers businesses an opportunity for procompetitive collaboration and benefits, it also increases significant risk of anticompetitive conduct in the labor market. Here are some issues and factors that businesses should consider to mitigate antitrust risk as the Antitrust Division and Federal Trade Commission continue to consider enforcement actions for antitrust violations.
US antitrust laws already on the books facilitate rapid investment without government delay: important practical tools and rules for dealmakers and their counsel in the wake of the coronavirus (COVID-19) pandemic and the current economic challenges.
The European Commission has provided antitrust guidance to companies cooperating in response to urgent coronavirus (COVID-19) related matters, particularly in the health sector for critical hospital medicines and medical equipment, and has also exceptionally issued a “comfort letter” on a cooperation project in the generic pharmaceuticals sector aimed at ensuring the supply of critical hospital medicines. Other ad hoc “comfort letters” may follow at the EU Commission’s discretion.
Employers considering layoffs in the face of the coronavirus (COVID-19) crisis have additional opportunities to support furloughed workers, aside from options offered by the CARES Act.
In three new Unemployment Insurance Program Letters, the US Department of Labor (DOL) issued guidance to state workforce agencies to implement the unemployment provisions in the CARES Act. The guidance has several important aspects for employers.
This edition of Morgan Lewis Retail Did You Know? examines how the Coronavirus Aid, Relief, and Economic Security (CARES) Act impacts companies in the retail and hospitality sector, which has been severely impacted by the coronavirus (COVID-19) pandemic due to the government-mandated shutdown of “non-essential businesses” in some states, as well as the decrease in customer traffic given the uncertain economic climate. Companies in the retail and hospitality sectors should carefully consider the eligibility requirements for CARES Act relief measures.
As local jurisdictions attempt to slow the spread of the coronavirus (COVID-19) and “flatten the curve,” several Northern and Central California counties have updated their existing shelter-in-place orders to impose more restrictions on employers and company operations. Employers should immediately prepare for compliance with the new protocols, some of which take effect on April 2.
The Los Angeles City Council held an emergency meeting on March 27 in response to the coronavirus (COVID-19) crisis and approved several ordinances, including one pertaining to sick leave and another relating to retail and delivery workers. The council tabled two controversial proposals that would subject employers to various obligations to retain and recall employees during and after the COVID-19 threat period.
In response to the coronavirus (COVID-19) pandemic, California Governor Gavin Newsom has issued two executive orders that place temporary restraints on the ability of landlords to evict residential tenants, authorize local governments to halt residential and commercial evictions, and call on banks and other financial institutions to suspend residential and commercial foreclosures and related evictions.
Aided by ingenuity and growing regulatory flexibility, retail pharmacies across the country are finding ways to serve their customers while reducing face-to-face contact. Protocols may vary by state.
This edition of Morgan Lewis Retail Did You Know? examines the impact of anti–price-gouging efforts by government enforcement officials in the time of the coronavirus (COVID-19) pandemic.
A financial crisis-era program is being resurrected to fight the liquidity crisis caused by the global coronavirus (COVID-19) pandemic through lending collateralized by new issuances of asset-backed securities.
FDA representatives on March 18 initiated a conference call with representatives of the food industry to discuss public health and food safety issues related to the coronavirus (COVID-19) outbreak. The FDA was represented by Frank Yiannas (FDA Deputy Commissioner for Food Policy and Response), Michael Rogers (Assistant Commissioner for Human and Animal Foods), and Dr. Susan Mayne (Director of the Center for Food Safety and Applied Nutrition).
New Jersey Governor Phil Murphy on March 21 signed Executive Orders 107 and 108, which took effect at 9:00 pm the same day. Executive Order 107 mandates that all residents remain home unless performing certain delineated activities; orders the closure of brick-and-mortar retail locations of all non-essential businesses; and instructs all businesses and nonprofits—even those deemed essential—to implement telework or work-from-home options for employees, to the extent practicable.
The White House is reportedly in discussions with US auto companies to aid in the COVID-19 relief effort by producing ventilators, and some US distilleries have already switched manufacturing operations to make hand sanitizer.
The UK government announced on March 19 that as part of a package of measures to allow supermarkets to work together to feed the nation during the coronavirus (COVID-19) outbreak, elements of competition law will be temporarily relaxed for the food sector. Authorities, however, stressed that they will remain vigilant against competition law infringements.
The sports industry was among the first to navigate the resumption of some sense of regular play amid the pandemic, but it was far from normal. That wasn’t necessarily a bad thing. As sports have routinely blazed a trail for others to follow, teams and franchises continued that streak, first testing and then improving on ways to protect their players and staff from COVID-19, all the while attracting new interest from investors and advancing the call for racial justice. Now as many stadiums reopen to full capacity, we take a look back at what lessons the sports industry is likely to carry forward for the rest of 2021.
States and localities across the country are continuing to respond as quickly and effectively as possible to the coronavirus (COVID-19) outbreak. These responses include guidance for taxpayers on numerous topics, such as providing tax relief through filing and payment deadline extensions.
A federal district court in California issued a series of orders to dismiss claims in a putative class action by Major League Baseball ticket purchasers against ticket sellers, sports teams, and the league.
President-elect Joseph Biden has indicated that he will make significant changes to the policies and practices of the prior administration that will impact the public and employers, including in the sports industry.
The CARES Act’s Paycheck Protection Program provides loans targeted to small businesses to help keep their workers employed during the coronavirus (COVID-19) pandemic, and offers loan forgiveness to borrowers maintaining a high percentage of employees on payroll. This LawFlash provides the latest developments in PPP loan availability, eligibility, and forgiveness, as well as a comprehensive overview of the PPP and related guidance.
The coronavirus (COVID-19) pandemic brought much of the world’s professional sport to a standstill during the first half of 2020. Set against the background of widespread border closures, there has been significant uncertainty with respect to the lawful movement of people. Here, we look at the options available for people working across the breadth of the sports sector who wish to visit or move to the United Kingdom.
The Federal Reserve took additional actions on April 9 to provide up to $2.3 trillion in loans to support the US economy during the coronavirus (COVID-19) pandemic. This LawFlash covers the new and expanded programs, and provides comprehensive coverage of the Coronavirus Economic Stabilization Act.
Morgan Lewis partner Louise Skinner and associate Elizabeth Polido authored a Bloomberg Law article about the best practices to protect the health and safety of players, staff, and fans as sports restart around the world amid the COVID-19 pandemic.
Two key amendments to the German competition law entered into effect on May 29, 2020, temporarily extending merger control review periods and temporarily suspending interest payments for antitrust fines, further to a bill adopted by the German Parliament to mitigate the consequences of the coronavirus (COVID-19) pandemic on trade.
Investors pursing global investment opportunities across the sports industry should be aware of the key considerations likely to apply to the M&A process amid the coronavirus (COVID-19) pandemic.
Investors pursing global investment opportunities across the sports industry should be aware of the key considerations likely to apply to the M&A process amid the coronavirus (COVID-19) pandemic.
The European Commission published its first comfort letter in nearly 20 years on April 29, in an effort to foster cooperation among businesses during the coronavirus (COVID-19) pandemic. Here is what companies should know about the specific practices permitted under the comfort letter, as well as the specific conditions and safeguards for cooperation.
Key issues that UK employers should begin considering now to minimize difficulties as they reopen or expand their operations include reintegrating staff, assessing internal policies in light of the pandemic, testing for the coronavirus (COVID-19), and more.
The Internal Revenue Service (IRS) and the US Department of the Treasury released two Revenue Procedures and a new FAQ on April 21 to provide relief to US residents and alien individuals affected by travel disruptions due to the coronavirus (COVID-19) emergency.
The impact of the coronavirus (COVID-19) pandemic on the global sports industry and its affiliated sectors is substantial and unprecedented. Constructive stakeholder engagement at all levels is crucial to ensuring business continuity. Organizations should be cognizant that decisions made now will attract post-crisis scrutiny, and start planning for post-pandemic recovery and growth.
By the second week of March, the National Basketball Association, National Hockey League, Major League Soccer, and Major League Baseball had suspended games due to the coronavirus (COVID-19) pandemic. The good news for those missing the rush from watching a competitive game is that not all sports are suffering from the same challenges. Esports, the now mainstream billion-dollar industry, is on its way to being the most resilient sport during these devastating times.
As jurisdictions contemplate lifting pandemic-related workplace restrictions, employers must start considering how best to cope with a vast array of issues, including restarting or expanding operations, reintegrating remote-working or furloughed employees, implementing new state and local orders/requirements, and protecting the safety of employees and customers. Employers who proactively plan for these challenges will be best positioned to adapt to the “new normal.”
The US Department of Labor’s Occupational Health and Safety Administration (OSHA) released a statement on April 8 reminding employers that they cannot retaliate against workers who report unsafe or unhealthy working conditions during the coronavirus (COVID-19) pandemic.
For companies forced to postpone or cancel live events during the coronavirus (COVID-19) pandemic, event cancellation insurance may serve as a way to protect assets and mitigate losses.
Businesses that avail themselves of financial assistance under Section 4003 or 4116 of the CARES Act must limit compensation and severance paid to certain officers and employees.
Loans for US small businesses to keep employees on payroll during business slowdowns resulting from the coronavirus (COVID-19) pandemic became available April 3 under the Paycheck Protection Program. Loan forgiveness may be available if businesses meet certain requirements.
Employers considering layoffs in the face of the coronavirus (COVID-19) crisis have additional opportunities to support furloughed workers, aside from options offered by the CARES Act.
The threat of coronavirus (COVID-19) has caused a sudden, unprecedented disruption to many areas of our lives. The decision to suspend the English Premier League (PL) is far from the most important or immediate concern, but it does factor as one of the many social, cultural, and financial fallouts of the crisis. We explore some of the legal issues arising out of the current suspension of the 2019/20 season and the legal challenges the PL and its key stakeholders will be considering in relation to the prospect of a total cancellation.
The European Commission has approved a £50 billion (EUR 57 billion) “umbrella” UK state aid scheme to support small and medium-sized enterprises and large corporates in the United Kingdom affected by the coronavirus (COVID-19) outbreak. The umbrella scheme was approved on April 6, 2020, under the State Aid Temporary Framework, as amended.
HM Revenue & Customs has made available further details to the UK government’s 20 March announcement on a series of initiatives, including a valued added tax deferral, to support British businesses in the face of the coronavirus (COVID-19) pandemic.
Given the number of employees and independent contractors working remotely, it is a good time for companies to reassess their trade secret policies and remind all personnel of their obligations to maintain and protect the confidentiality of company information.
As the coronavirus (COVID-19) pandemic continues to evolve, regulatory and legislative authorities are taking actions, in the form of directives and orders, that could directly impact companies’ business interruption coverage. Careful review of insurance policies and insurers’ responses in light of these actions, as well as monitoring of regulatory and legislative developments, will be critical in preserving companies’ rights to coverage for COVID-19 losses.
As the effects of the coronavirus (COVID-19) pandemic hit the United States, downsizings and shutdowns are spreading indiscriminately throughout the economy.
Tenants and landlords should consider whether certain provisions such as force majeure, frustration of purpose, and/or impracticability of performance can protect them under current leases—and whether to include such provisions in future leases—as a result of the current coronavirus (COVID-19) pandemic.