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Navigating the NEXT.
Addressing Global Regulatory & Enforcement Actions
The intersection of law and politics has always had a significant impact on regulations for multinational companies. From data privacy laws to international trade to global enforcement trends, the interplay of these regional laws and regulators is a key priority for many businesses. Enforcement trends from the US Department of Justice, Securities and Exchange Commission, and Food and Drug Administration, as well as state attorneys general, international regulatory and antitrust bodies, and others, will serve as a key roadmap for companies navigating uncertain waters. These actions will likely increase as COVID-19 restrictions slowly recede.
Insights
The education industry, like many others, saw a fundamental shift in 2020 as remote learning challenged some of the long-held traditions of institutions, educators, and related companies. From federal support of reopening in-person classes to changes in college athletics to overall financial challenges, here are some of the trends we could see defining the industry for the rest of 2021.
The Commodity Futures Trading Commission (CFTC) announced last week that it has obtained another admission from a trader of violations of the Commodity Exchange Act and CFTC regulations, demonstrating its continued aggressive enforcement of its market anti-manipulation provisions.
With the recent passage of the COVID-19 stimulus package, President Joseph R. Biden, his administration, and Congress have turned their attention to long-term economic recovery, deficit reduction, and tax reform. Proposals cover a broad range of tax policy issues, from raising the corporate income tax rate to reforming the current international tax regime. This LawFlash summarizes key elements of some of the tax reform proposals that have recently emerged.
There has been an increasing focus in recent years on the intersection of ERISA’s fiduciary duties and the issues of cybersecurity and data (including participant data) protection. Beyond the potential for pecuniary and reputational harm due to a breach, this interest has been driven by an increasing number of lawsuits in which plaintiffs allege that a plan fiduciary and/or service provider breached ERISA by failing to protect against a cybersecurity attack or data breach.
Following Brexit, EU competition law continued to apply in the United Kingdom until 31 December 2020 as part of an agreed Transition Period. In this LawFlash, we summarise how the end of the Transition Period is likely to impact the enforcement of competition law in the United Kingdom going forward, the extent to which UK competition agencies and courts are free to diverge from EU principles and case law, and our initial thoughts on the future landscape of competition law in the United Kingdom.
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.
The American Rescue Plan Act of 2021 (ARPA) provides $1.9 trillion in relief funding to address the COVID-19 pandemic, support the US economy, and provide relief for impacted Americans. Signed into law by President Joseph R. Biden on March 11, 2021, ARPA includes provisions affecting healthcare providers, who remain on the frontlines of the pandemic as the new law takes effect.
Partners Carl Valenstein and Celia Soehner authored a Bloomberg Law Insight column about the need for companies to be cautious and exact when they are drafting mandatory or voluntary environmental, social, and governance (ESG) disclosures. In the piece, they outline the US Securities and Exchange Commission’s areas of focus and best practices for developing an ESG program and disclosures.
France’s highest Court (Cour de Cassation) recently ruled that an acquiring entity, in this case Iron Mountain, could be found liable for violations committed by the target, here Recall France, before the transaction. The November 25, 2020 decision, which reversed French case law, foreshadows serious concerns for future acquirers in M&A transactions.
Morgan Lewis’s 15th annual 2020 Year in Review and a Look Forward provides a comprehensive overview and analysis of key 2020 US Securities and Exchange Commission (SEC) enforcement and examination developments, notable broker-dealer cases, and anticipated enforcement priorities for 2021, including under the potential leadership of SEC chair nominee Gary Gensler.
The Financial Market Integrity Strengthening Act includes a large number of innovations aimed at strengthening confidence in the German financial market by placing more comprehensive obligations on auditors when auditing companies of public interest. In addition to optimizing balance sheet control and further regulating the auditing of financial statements, the innovations also affect corporate governance at companies.
All dual-regulated and FCA solo-regulated firms are now under the scope of the Senior Managers & Certification Regime (SMCR), with many working hard in recent months to ensure all aspects of the regime are well embedded. As part of these efforts, it is crucial that firms establish an effective framework to prevent but also detect and manage conduct breaches if they do happen, and when it is necessary, report them.
The Centers for Disease Control and Prevention (CDC) issued public health recommendations for fully vaccinated people that provide guidance on activities these individuals can engage in as well as ongoing precautions of which to be aware. These updates include directions that apply to non-healthcare settings and specifically describe activities that the CDC deems to be low or high risk for individuals who are fully vaccinated against COVID-19. Separate from the CDC guidance, various states are beginning to issue more vaccine-related guidance, including on whether employers can mandate vaccines and whether otherwise applicable quarantine requirements apply to vaccinated individuals, which is in line with prior CDC guidance.
The National Futures Association (NFA) has proposed a new rule that would require registered commodity pool operators (CPOs) that are members of the NFA (CPO Members) to report to the NFA by 5:00 pm Central Time the next business day after the occurrence of a reportable event relating to the inability of a fund operated by the CPO Member to meet a margin call or satisfy redemption requests, or relating to a commodity pool that has halted redemptions or is declared in default by a swap counterparty.
Partner Jon Roellke and associate Frank Ren authored a Practical Guidance article about the proposed Competition and Antitrust Law Enforcement Reform Act (CALERA), which, if passed, will make significant changes to US antitrust laws. The piece details key takeaways from the bill and the obstacles it faces in the Congress.
Partner Jon Roellke and associate Frank Ren authored a Practical Guidance article about the proposed Competition and Antitrust Law Enforcement Reform Act (CALERA), which, if passed, will make significant changes to US antitrust laws. The piece details key takeaways from the bill and the obstacles it faces in the Congress.
In an unexpected development, the US State Department on March 2 rescinded the “National Interest” (NIE) exception determinations relating to Presidential Proclamation 10143. Presidential Proclamation 101043, which was issued by President Joe Biden on January 25, 2021, bars the admission into the United States of persons (other than United States citizens, permanent residents, and other discrete classes of foreign nationals) who were physically present in the Schengen area, the United Kingdom, the Republic of Ireland, Brazil, and South Africa during the 14 days before their attempted entry into the country.
Laws in the United Kingdom and United States are increasingly taking a more restrictive view on the permitted scope of exclusivity and noncompete clauses.
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).
The development of connected automobiles crystallizes the tensions between intellectual property law and competition law that have existed for years, particularly in the area of standard essential patents (SEPs). These SEPs are essential to standards that set the technical specifications defining requirements for products, production processes, services, or test-methods, and which cannot be designed around. European courts, legislatures, and regulatory bodies have been engaging in an evolving debate, often centered on the issue of what constitutes a “fair, reasonable, and non-discriminatory (FRAND)” license.
Much of the attention in President Joseph Biden’s executive actions in his first 100 days has been focused on his numerous executive orders on topics ranging from climate and COVID-19 to race and gender. Although these executive orders will immediately alter certain policies, observers have overlooked one non-executive order that may have a more consequential impact during the remainder of President Biden’s term: his January 20, 2021 memorandum titled “Modernizing Regulatory Review” (MMR).
As discussed in our earlier LawFlash, the Consolidated Appropriations Act, 2021 (Act) contains certain permissible provisions plan sponsors may adopt to offer employees greater flexibility under a healthcare flexible spending account (HCFSA) and a dependent care flexible spending account (DCFSA). While this flexibility was welcome news for plan sponsors, the Act left some unanswered questions.
Morgan Lewis marks its 15th year of publishing Year in Review and a Look Forward, a comprehensive summary and analysis of the practices, developments, considerations, and enforcement actions of the SEC and FINRA, as well as a forward-looking discussion of what to expect on the enforcement front in the year ahead.
The US Department of Justice’s Criminal Division Fraud Section (DOJ) released its annual Year in Review report on February 24, covering 2020. This year’s report highlights DOJ’s sustained aggressive enforcement efforts despite the global pandemic. In 2020 we saw record-setting dollar figures, the ongoing trend of cooperation with foreign authorities, DOJ’s quick ramp-up in prosecuting Paycheck Protection Program fraud, and emphasis on corporate compliance programs—or the lack thereof—as a key factor driving some of the largest resolutions in Fraud Section history.
The US Department of Labor (DOL) announced on February 19 that the Occupational Safety and Health Administration (OSHA) will begin investigating whistleblower complaints of retaliation under the Criminal Antitrust Anti-Retaliation Act and the Anti-Money Laundering Act. Morgan Lewis previously reported on the Criminal Antitrust Anti-Retaliation Act in its December 16 and December 28 LawFlashes, and on the Anti-Money Laundering Act in its January webinar discussing key whistleblower developments in the past year.
Virginia has become the second state in the United States to pass a comprehensive data privacy law after the Virginia Consumer Data Protection Act (CDPA) passed both houses of Virginia’s state legislature in February with overwhelming bipartisan support and was promptly signed into law by Virginia Governor Ralph Northam. The CDPA has a number of key similarities to the California Consumer Privacy Act (CCPA), the California Privacy Rights Act (CPRA), which comes into effect in 2023, and the European Union’s General Data Protection Regulation (GDPR), and it follows a similar framework with proposed data privacy bills pending in other statehouses.
The Russian State Duma has approved draft changes to the Russian Code of Administrative Offences that significantly increase monetary fines for violation of the Russian privacy law.
The UK Supreme Court in the Financial Conduct Authority’s business interruption test case has overturned a decade-long standing judgment relating to causation and how the “trends” clauses should be interpreted. The decision overturning Orient-Express constitutes a massive pendulum swing from an insurer-friendly interpretation to a policyholder-favoured approach, which will have far-reaching consequences on the insurance sector generally.
Consumer Financial Protection Bureau (CFPB) Acting Director David Uejio has put a special focus on the manner in which responses are made to the CFPB’s consumer complaint system. Signaling the importance of this issue by undertaking it even before President Joe Biden’s nominee for director, Rohit Chopra, is confirmed to the position, Uejio has called out in a publicly released message to CFPB staff the possibility that some responses to complainants are incomplete—and vary by the complainant’s apparent demographic community.
The Biden administration has vowed to invoke the Defense Production Act (DPA) to increase domestic production of essential supplies needed to respond to the COVID-19 pandemic. In this Insight, we address key features of the DPA, guidance for companies that may receive a rated order, financing incentives offered by the DPA, and how we anticipate the Biden administration will use the DPA over the next year.
Shortly after the inauguration of President Joe Biden on January 20, former Consumer Financial Protection Bureau (CFPB or Bureau) Director Kathleen Kraninger submitted her resignation. Soon after that, the president announced that he had appointed David Uejio, a veteran CFPB official who most recently served as the Bureau’s chief strategy officer, to serve as acting director until the Senate confirms Rohit Chopra, his nominee for director.
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.
The DOJ and FTC have suspended early termination (i.e., early clearance) for filings made under the Hart-Scott-Rodino Act.
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.
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 German Act on the Further Development of the Restructuring and Insolvency Law (Sanierungs- und Insolvenzrechtsfortentwicklungsgesetz – SanInsFoG) took effect on January 1, 2021, transforming the European Restructuring Directive of June 20, 2019 ((EU) 2019/1023) and introducing a self-administrated restructuring option outside the standard insolvency proceeding.
The Federal Trade Commission (FTC) announced on February 1 that it will lower the Hart-Scott-Rodino Act (HSR Act) jurisdictional and filing fee thresholds. Any transaction closing on or after March 4, 2021 will be subject to the revised thresholds.
President Trump’s Executive Order Addressing the Threat from Securities Investments that Finance Communist Chinese Military Companies (EO 13959) prohibits transactions by or on behalf of US persons in publicly traded securities of Chinese companies identified by the US government as “Communist Chinese military companies.” This update discusses significant developments related to EO 13959 since our November 17 LawFlash, including OFAC actions and interpretations, and implications arising from those developments.
US President Joe Biden’s focus on Buy American Act domestic preference regulations and agency practices of implementing regulations and issuing waivers is likely to lead to an increased focus on federal government contractors’ compliance with heightened requirements.
January 28 was designated as “health day” for President Joe Biden’s early push of executive orders, with two new executive actions added to a growing list. The Executive Order on Strengthening Medicaid and the Affordable Care Act and Memorandum on Protecting Women’s Health at Home and Abroad were described by President Biden as “restorative” of policies modified by the prior administration.
Recent sanctions imposed by the European Union, United Kingdom, and the United States on Turkey and certain Turkish persons will be of interest to European and American investors in Turkey’s defense and energy sectors. The following update contains a summary of each regime.
The US Department of Commerce’s Bureau of Industry and Security (BIS) published an Interim Final Rule on January 15 to implement changes to, and impose new licensing obligations under, the Export Administration Regulations (EAR) relating to the expansion of specific end-use and end-user controls, as well as controls on specific activities of US persons (the Rule).
President Joe Biden’s first days in office have focused heavily on issues of diversity, inclusion, equity, and human rights as applied across federal agencies and programs. We anticipate that this pattern will continue and that the principles underlying his first actions will heavily influence policy, federal contracting, and eligibility to participate in federal programs, and may help businesses focus their approach to federal policymaking going forward.
President Joe Biden issued on January 25 an Executive Order on Ensuring the Future Is Made in All of America by All of America's Workers (EO). This EO leaves in place key portions of the prior administration’s July 15, 2019 EO 13881 (Maximizing Use of American-Made Goods, Products, and Materials) and related implementing regulations, orders a sweeping review of multiple domestic preference rules, including proposing standards for domestic products, and establishes a central Office of Management and Budget (OMB) authority to approve federal agency waiver requests of Made in America requirements.
Action, or in some cases inaction, by the Federal Energy Regulatory Commission (Commission or FERC) during its last open meeting before the start of the Biden administration sent a strong message to the natural gas industry that challenges to siting new natural gas infrastructure are likely to continue, possibly leading to insurmountable hurdles for certain projects over time.
Under President Joe Biden, pharmaceutical regulation may see increased FDA guidance, new strategies to speed up innovation and regulatory review, and a renewed focus on diseases with unmet needs, among other expectations.
The Internal Revenue Service (IRS) issued Notice 2021-10 on January 19, which extends relief to Qualified Opportunity Funds (QOFs) and their investors as a response to continued challenges brought on by the COVID-19 pandemic.
Considering the tight timeline for preparing responses to FDA compliance actions coupled with the agency’s expectation for timely implementation of corrective and preventive actions, the benefit of obtaining feedback through the Q-submission program (also referred to as a “pre-submission”) may be limited.
This LawFlash provides a summary of the UK Supreme Court’s final decision in the FCA Business Interruption test case. The judgment is more policyholder friendly than the High Court judgment, particularly in relation to causation and quantification, and will have a far-reaching and long-lasting impact on policy interpretation.
The Internal Revenue Service (IRS) issued Revenue Procedure 2021-12 on January 14, extending the safe harbors in Revenue Procedures 2020-26 and 2020-34 to September 30, 2021. This LawFlash discusses the portion of Revenue Procedure 2021-12 relating to Revenue Procedure 2020-26. The safe harbors were previously set to expire and would not apply to forbearances and related modifications entered into after December 31, 2020. As the coronavirus (COVID-19) emergency persists, the extension in Revenue Procedure 2021-12 provides welcome relief to the securitization industry, which faced uncertainties over the tax consequences that such an expiration could have on securitization vehicles such as real estate mortgage investment conduits (REMICs) and investment trusts.
Proposition 65 mandates that companies doing business in California provide warnings about exposures to chemicals listed as known to the state to cause cancer or reproductive toxicity. The California Office of Environmental Health Hazards Assessment seeks to eliminate the use of short-form warnings on certain products and for businesses to list at least one chemical in short-form warning language.
The California Department of Financial Protection and Innovation (DFPI) announced in its January 2021 monthly bulletin that it will begin exercising its enhanced powers under the California Consumer Financial Protection Law (CCFPL) that came into effect January 1.
The Internal Revenue Service and the US Department of the Treasury pre-released final regulations, T.D. 9945, under Section 1061 on January 7, providing guidance to the holders of certain carried interests. These rules are of particular interest to sponsors of private investment funds.
Recently proposed regulations could present significant compliance burdens for the banks and money service businesses that engage in cryptocurrency transactions with unhosted wallets or wallets held in jurisdictions specified by FinCEN. In this LawFlash, we summarize the proposed rule and provide some key takeaways and observations on what appears to be a continuation of the trend of subjecting such transactions to the equivalent requirements found in the traditional banking system.
In response to the changes in the transmission of COVID-19, both domestically and across the globe, the UK government has announced that passengers from all international destinations will now be required to present a negative COVID-19 test result before departing for England.
The European Data Protection Board (EDPB) has finally released its much anticipated guidance following the Schrems II decision in July 2020, which invalidated the "Privacy Shield" system that allowed the transfer of personal data to the United States. EDPB also released draft new Standard Contractual Clauses (SCCs) that allow for data transfers from processors who are exporters as well as new SCCs for controllers who are exporters.
Medical device companies should be prepared for an increase in FDA enforcement activity with the incoming Biden administration, in addition to changes in agency leadership and repeals of regulatory reform.
Partner Sandra Moser was quoted in an Anti-Corruption Report article about the most notable trends in anticorruption enforcement from 2020.
The US Department of Health and Human Services Office of Inspector General (OIG) recently issued important updates to its Anti-Kickback Statute (AKS) safe harbor rules that provide additional legal protections and flexibilities, in particular with regard to value-based enterprise (VBE) arrangements. While hospices have not been frequent parties to many of the burgeoning risk-based, value-based payment arrangements within the healthcare sector, with the anticipated Medicare Advantage carve-in, this will likely change and consequently hospices and their legal counsel are well advised to familiarize themselves with how hospices may benefit from the OIG’s revised AKS safe harbors.
Coinciding with the end of the UK-EU Brexit transition period, the United Kingdom has dramatically reduced the scope of DAC 6 reporting obligations in the United Kingdom.
Morgan Lewis partner Mark Krotoski was quoted in a Legaltech News article about what the privacy and cybersecurity industry will likely see in 2021.
The Criminal Antitrust Anti-Retaliation Act establishes new federal protections for whistleblowers who report violations of antitrust laws. This may impact enforcement efforts and litigation on labor mobility issues, including no-poaching and wage-fixing agreements. Companies can prepare for the new legal standards by updating or enhancing their whistleblower programs and taking a holistic view of their compliance programs to meet new US Department of Justice Antitrust Division standards.
Morgan Lewis partner Daniel Skees was quoted in a Utility Dive article about the US Federal Energy Regulatory Commission’s (FERC’s) proposed rule regarding incentives for utilities that elect to make voluntary security investments. Dan noted that FERC’s approach "could expand the scope of facilities receiving heightened cybersecurity protections" and it "allows FERC to use a carrot approach, to bring more facilities into CIP compliance."
The California attorney general released a fourth set of proposed modifications to the California Consumer Privacy Act regulations; notable regulatory changes include a new opt-out button for websites and an offline notice of the right to opt out.
As part of a modernization of the nation’s anti-money laundering regime, the Anti-Money Laundering Act of 2020 creates enhanced whistleblower rewards that are likely to lead to increased enforcement action.
Partner Matt Miner and BDO partner Paul Peterson sat down with Risk & Compliance to discuss the Foreign Corrupt Practices Act (FCPA), including recent enforcement activity and key trends on how companies should respond if they are subject to an FCPA-related investigation.
Businesses in the United Kingdom which engage contractors through intermediaries should prepare now for changes to the “IR35” rules that will take effect in April 2021.
President-elect Joseph Biden announced on December 15 that he intends to nominate former Michigan Governor Jennifer Granholm to serve as secretary of energy in his new administration. Ms. Granholm previous served as the attorney general of Michigan and as Michigan’s governor from 2003 to 2011.
The Internet of Things Cybersecurity Improvement Act of 2020 was signed into law on December 4, resulting in the first federal regulation of the Internet of Things (IoT).
From 1 January 2021 the United Kingdom will cease to follow EU rules, bringing significant changes to trademark law in the United Kingdom and European Union that are relevant to all owners of UK and EU trademarks.
The Brexit “transition period” will come to an end on 31 December 2020, and from 1 January 2021, the United Kingdom will cease to follow EU rules. This brings significant changes to design law in the United Kingdom and European Union, relevant to all owners of Registered
Morgan Lewis partner Sandra Moser spoke with the Anti-Corruption Report about Foreign Corrupt Practices Act (FCPA) enforcement efforts in 2020 and the impact of the coronavirus (COVID-19) pandemic. In the article, she discussed two of the largest settlements of the year and what they mean for an ongoing trend.
Morgan Lewis partner Baird Fogel spoke with Law360 about the US Supreme Court agreeing to review a case regarding limits on compensation and benefits for college athletes. In the article, he discussed the implications of the case, Alston v. NCAA.
The US Congress passed S.2258, the Criminal Antitrust Anti-Retaliation Act of 2019, on December 8 and presented the bill to the president on December 11 – almost a year-and-a-half after Senator Chuck Grassley (R-IA) introduced the bill in the Senate.
The Corporate Transparency Act, found within the National Defense Authorization Act, directs the Financial Crimes Enforcement Network to establish and maintain a national registry of beneficial ownership information.
A federal grand jury in Texas indicted the owner of a therapist staffing company on wage-fixing charges on December 9. Although this is the US Department of Justice’s first criminal wage-fixing prosecution, the indictment underscores that enforcement agencies remain focused on policing these types of anticompetitive agreements that restrict competition in labor markets.
Our tax team published a LawFlash on the recently released Internal Revenue Service Revenue Ruling 2020-27 and Revenue Procedure 2020-51, which provide guidance on the deductibility of certain expenses paid or incurred in a taxpayer’s business using loan proceeds from a “covered loan” provided under the CARES Act’s Paycheck Protection Program (PPP).
The US Department of Health and Human Services’ Office of Inspector General updated the warranty safe harbor to account for bundled product and service warranties to reflect realities of healthcare product sales, but rejects industry calls for broader protections.
The coronavirus (COVID-19) pandemic has made the development and use of drug and device products to diagnose, treat, or prevent COVID-19 essential.
With coronavirus (COVID-19) vaccines on the horizon amid the surging pandemic, critical extensions expand the scope of liability immunity under the PREP Act.
Members of the US Congress announced on December 2 the proposal of a new consumer protection bill to increase the oversight and regulation of existing stablecoin issuers, potential stablecoin issuers, and stablecoin-related service providers.
We invite you to join us for a webinar series where we discuss our views on the enforcement priorities expected from the incoming Biden-Harris administration.
The Internal Revenue Service recently released Revenue Ruling 2020-27 and Revenue Procedure 2020-51, which provide guidance on the deductibility of certain expenses paid or incurred in a taxpayer’s business using loan proceeds from a “covered loan” provided under the CARES Act’s Paycheck Protection Program.
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.
The Centers for Disease Control and Prevention (CDC) issued new guidance to public health agencies on December 2 to provide options to reduce the duration of quarantine periods for asymptomatic individuals who were exposed to coronavirus (COVID-19).
The NRC held a public meeting with industry on November 2 to discuss approaches for performing supplier oversight during the coronavirus (COVID-19) pandemic.
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.
The NRC held a public meeting on November 17 to review regulatory relief currently available to medical and other materials licensees, and to identify potential additional relief that the Staff is currently considering.
The EU Parliament has approved the EU Council’s position on representative actions. By doing so, it has paved the way for consumers in Europe to be able to sue companies collectively.
Powerfully illustrating the efforts of the US Department of Health and Human Services (HHS) to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) have finalized rules that will alter critical healthcare fraud and abuse regulations to remove or diminish obstacles to value-based enterprises that meaningfully embrace patient care coordination.
While workplace safety standards have been thrust into the national conversation since the coronavirus (COVID-19) pandemic began, Occupational Safety and Health Administration (OSHA) enforcement has been relatively quiet. That will likely change under a Biden administration.
Here’s what we know: After the November 3 US election, the Biden-Harris ticket has 290 electoral votes, 20 more than what is needed to win (with one state, Georgia, undecided). Senate Republicans hold a two-seat advantage (50-48) with the two Georgia seats undecided, and House Democrats maintain control with a current advantage of 221-205 (218 is needed to retain the majority) and 9 races undecided.
With only weeks until the US presidential administration changes hands, companies and consumers alike are anticipating what a Biden presidency will mean for consumer financial protection and for the Consumer Financial Protection Bureau (CFPB), the agency charged with overseeing it. Partner Robin Nunn and of counsel Eamonn Moran outline some of the changes that may lie ahead.
There was a perception in 2017 when then President-elect Trump took office that white collar enforcement actions under the US Department of Justice (DOJ) might drop dramatically. Many expected the Republican administration to effect policy changes or resourcing decisions that would keep corporations out of the spotlight when it came to major investigations and massive penalties.
A new US presidential administration brings new priorities across various areas and industries, including regulation and enforcement of activities that affect the environment. With President-Elect Joe Biden expected to assume the presidency on January 20, 2021, there are a number of considerations for companies tracking potential changes to the law governing the use of chemicals and antimicrobials.
The new Executive Order (EO or the Order) bans transactions by US persons in publicly traded securities of companies identified as “Chinese military companies,” and includes a ban on trading in derivatives of those securities and any securities designed to “provide investment exposure” to such securities, thereby capturing Exchange Traded Funds and arguably extending to funds that rely on those companies’ securities in any manner. The EO provides an 11-month wind down for divestiture of covered securities and positions.
Morgan Lewis partner Matt Miner spoke with Compliance Hots Spots for an article about the implications of the 2020 election outcomes on congressional oversight and investigations.
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.”
Morgan Lewis partner and co-leader of the firm’s privacy and cybersecurity practice Reece Hirsch spoke with Politico about potential changes the Biden administration might bring to the digital health landscape.
Morgan Lewis partner Susan Feigin Harris spoke with Fierce Healthcare about California v. Texas, a recent US Supreme Court case regarding the Affordable Care Act’s (ACA’s) individual mandate and overall constitutionality. In the article, she discussed the oral argument presented by the House.
The UK’s Competition and Markets Authority (CMA) on 6 November published draft updates to two of its merger guidance documents (CMA2 and CMA56) in preparation for the end of the Brexit Transition Period on 31 December 2020.
Morgan Lewis partner Susan Feigin Harris discussed the oral arguments in California v. Texas, which was heard by the US Supreme Court Wednesday, regarding the Affordable Care Act’s (ACA’s) individual mandate and overall constitutionality, with Fierce Healthcare.
Last week’s state attorney general races brought little change on the surface, but change in Washington significantly increases the risk of enforcement and litigation by the states. If it seems counterintuitive, it is. But this Washington changeover heightens the complexity of the relationship between Washington and state capitols.
A majority of California voters approved the California Privacy Rights Act of 2020 (CPRA) on November 3. The CPRA expands provisions of the California Consumer Privacy Act (CCPA), creates new consumer privacy rights, establishes the California Privacy Protection Agency as California’s privacy regulator, and removes the ability of businesses to fix violations before being penalized for violations. The CPRA becomes effective on January 1, 2023, with enforcement commencing on July 1, 2023. This article summarizes a few notable aspects of the CPRA and highlights practical steps that businesses should take to ensure compliance.
The Securities and Exchange Commission (SEC) on August 26 adopted amendments (Amendments) to the “accredited investor” definition , which is one of the principal tests for determining who is eligible to participate in certain private securities offerings and if an issuance of securities is exempt from registration under Regulation D of the Securities Act of 1933 (Securities Act).
As the dust settles on the 2020 presidential election, autonomous and self-driving vehicles could receive a long-awaited federal regulatory framework under President-elect Joe Biden and Vice President–elect Kamala Harris’s administration.
As the nation has turned its attention to fighting a global pandemic and the very real, human cost associated with that fight, the decade-old battle over the Affordable Care Act (ACA) is once again in the limelight. On November 10, right after the election, the US Supreme Court will hear arguments in California v. Texas, S. Ct. Nos. 19-840 & 19-1019.
Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), all pesticide products (including surface sanitizing products) must be registered with the Environmental Protection Agency (EPA) prior to sale, distribution, or use in the United States.
The shift to a remote working environment as a result of the coronavirus (COVID-19) pandemic has drawn attention to data security and business continuity risks. With increased demand for technology services comes increased scrutiny, which may include False Claims Act investigations and litigation targeting providers of hardware, software, and other technology products and services to the government.
While an SEC proposal to exempt “finders” from broker-dealer registration requirements is promising, potential hazards remain and interpretive questions may persist.
The Environmental Protection Agency will expedite review of certain types of applications for new and amended registrations of pesticide products intended for use against the coronavirus (COVID-19).
An August 31 memorandum issued by the Office of Information and Regulatory Affairs (OIRA), an arm of the Office of Management and Budget (OMB) within the Executive Branch, could dramatically change the way agencies handle civil and administrative enforcement proceedings. The memorandum directs covered agencies to provide greater due process to individuals and companies under investigation and reemphasizes the principle that the burden of proof of a violation rests solely with the government. The memorandum was issued to implement the directives contained in Section 6 of Executive Order 13924, Executive Order on Regulatory Relief to Support Economic Recovery (issued May 19, 2020). In relevant part, the executive order directed agency heads to revise agency procedures and practices in light of “the principles of fairness in administrative enforcement and adjudication.”
The Financial Crimes Enforcement Network (FinCEN) issued a final rule that requires minimum standards for anti-money laundering (AML) programs for banks lacking a federal functional regulator (the Federal Reserve Board, OCC, FDIC, OTS, NCAU, and SEC), i.e., banks and similar financial institutions that are subject only to state regulation and supervision, and certain international banking entities (collectively, “covered banking entities”).
This White Paper presents a high-level overview of the current cybersecurity legislation in force or proposed at the European Union (EU) level as well as in a selection of EU member states.
As environmental, social, and governance (ESG) considerations continue to gain traction with investors, asset managers are confronted with varying levels of regulation that they must balance with the wide array of ESG demands being made by investors. Our global investment funds team has prepared a White Paper as a regulatory framework to navigate such considerations across the United States, United Kingdom, European Union, Hong Kong, and Singapore.
In the News
In a recent Law360 article, partner Eleanor Pelta discussed the expiration of the Trump administration’s Proclamation 10052 and the benefits the expiration presents multinational companies. "
Morgan Lewis partner Eleanor Pelta was quoted in a Bloomberg Law article about the visa application backlog caused by the COVID-19 pandemic. In the piece, she discussed the economic ramifications.
Partner Christine Lombardo was quoted in the first of a two-part series by Hedge Fund Law Report, which looks at the new US Securities and Exchange Commission (SEC) Marketing Rule “through the eyes of private fund managers.” The article examines important changes that have been made to the amendments that were originally proposed.
Partner Dennis Gucciardo was quoted in a MedTech Dive article about the outlook for the US Food and Drug Administration (FDA) under the Biden administration. Dennis noted that companies can expect an increase in “for cause” FDA inspections. "Under the Trump administration, we didn't really see that kind of activity unless there was a public health threat," he said.
Partner Dennis Gucciardo spoke with BioWorld about the hurdles medtech companies will likely face while converting their emergency use authorizations (EUAs) to conventional premarket filings.
Morgan Lewis partner Christine Lombardo was quoted by Hedge Fund Law Report in an article about the US Securities and Exchange Commission’s (SEC’s) modernized marketing rule. The new single “Marketing Rule” replaces the current Cash Solicitation Rule and Advertising Rule.
Morgan Lewis partner Greg Parks spoke with Compliance Week for an article about Virginia’s Consumer Data Protection Act.
Morgan Lewis partner Matt Miner commented on the findings of the US Justice Department’s (DOJ) Criminal Fraud Section’s Year in Review in a Law360 article breaking down the DOJ analysis.
Partner Greg Parks spoke with Law360 about Virginia’s potential new consumer privacy law. In the article, he discussed the draft of the law using the term "personal data" rather than "personal information."
Morgan Lewis partner Giovanna Cinelli noted in a Global Investigations Review article that the flexibility demonstrated by the Justice Department’s National Security Division, the Commerce Departments’ Bureau of Industry and Security, and the State Department’s Directorate of Defense Controls amid the COVID-19 pandemic has allowed companies under investigation more time to respond to demands for information.
Partner Pulina Whittaker was quoted in a Law360 article about the Trade and Cooperation Agreement, which maintains an arrangement for data transfer between companies in the European Union and the United Kingdom.
Morgan Lewis partner Michele Buenafe spoke with MedCity News about proposed exemptions issued by the US Department of Health and Human Services in the final days of the Trump administration regarding machine-learning-based software.
Partner Christine Lombardo was quoted in an article by FundFire about how managers should prepare for the US Securities and Exchange Commission’s (SEC’s) modernized marketing rule. The SEC has created a new single “Marketing Rule” that replaces the current Cash Solicitation Rule and Advertising Rule.
Partners David Monteiro, Robin Nunn, and Rebecca Hillyer were quoted in a Compliance Week article about consumer protection initiatives, which are expected to be a major area of focus under the incoming Biden administration.
Morgan Lewis partners Baird Fogel and Alexander Reid and associate Elizabeth Polido authored a Law360 article about the issues regarding the compensation of college athletes, which the US Supreme Court is expected to hear in a 2021 case.
Morgan Lewis senior attorney Brooke McGlinn and associates Pejman Moshfegh and Arjun Ramadevanahalli authored a Pratt’s Energy Law Report article on the growth of microgrid installation in the energy sector.
Morgan Lewis partner Reece Hirsch spoke to Law360 about the major cybersecurity and privacy policy issues he will be tracking in 2021. In the piece, he discussed the California Consumer Privacy Act (CCPA).
Morgan Lewis partner Melissa Hill spoke with Law360 for an article about the outlook for Employee Retirement Income Security Act (ERISA) disputes in 2021.
Morgan Lewis partner Mark Krotoski was quoted in a Legaltech News article about what the privacy and cybersecurity industry will likely see in 2021.
Morgan Lewis partners Daniel Tehrani and Robin Nunn and associate Bryan Woll authored a Law360 Expert Analysis about the potential implications of the Corporate Transparency Act (CTA), found within the National Defense Authorization Act for fiscal year 2021.
Morgan Lewis partner Katie McDermott spoke with Bloomberg Law about the potential policy agenda of President-elect Joseph Biden’s pick to lead the US Department of Health and Human Services (HHS). In the article, she discussed potential coronavirus (COVID-19) related claims.
Morgan Lewis partners and co-heads of the firm’s privacy and cybersecurity practice Mark Krotoski and Reece Hirsch spoke with Law360 about the major privacy and cybersecurity developments that occurred in 2020. In the article, Reece discussed the California Consumer Privacy Act and Mark outlined the oral arguments in US Supreme Court cases that addressed robocalls.
Lawyers from our London practice have contributed to Lexology’s Getting the Deal Through (GTDT) – Distressed M&A 2021 guide. The UK chapter features insight from lawyers in our corporate, finance, tax, and antitrust practices.
A LawFlash authored by Morgan Lewis partner Duke McCall and associates Douglas Hastings and Meredith Compton was cited in an AgriPulse article about the US Environmental Protection Agency’s draft guidance regarding implementation of a US Supreme Court decision regulating pollutions in US waterways. The Lawflash details the implications of the guidance.
Morgan Lewis partner Reece Hirsch was quoted in a MedCity News article about the US Department of Health and Human Services’ proposed changes to the HIPAA privacy rule. “[The proposed change] is more flexible than the current standard,” said Reece in the article.
In this NSI Live podcast addressing the findings and recommendations of the US Congress’s US-China Economic and Security Review Commission Annual Report, partner Giovanna Cinelli, leader of Morgan Lewis’s international trade and national security practice and National Security Institute (NSI) fellow, discussed how the US-China relationship may evolve or stay the same under President-elect Joseph Biden’s administration.
Morgan Lewis’s insurance practice is profiled in a Law360 feature celebrating its recognition as a 2020 Practice Group of the Year. In the piece, practice leader Paul Zevnik noted that “the firm secured around $1 billion for its clients in 2020 and about $15 billion for its clients over the last 17 years.”
Morgan Lewis partner Mark Krotoski spoke with Law360 about a cybersecurity and privacy case before the US Supreme Court that seeks to resolve a longstanding circuit split about the circumstances under which companies, organizations, and government agencies can enforce access restrictions on information and data under the Computer Fraud and Abuse Act.
Morgan Lewis partner Mark Krotoski and associate Jonathan Justl authored a Law360 article about the oral arguments recently heard by the US Supreme Court in Van Buren v. United States, a case that is expected to clarify under what circumstances insiders "exceed authorized access" to a computer that may result in a federal crime under the Computer Fraud and Abuse Act (CFAA). In the piece, they discuss the background of the CFAA and the potential implications of the case.
Partner Jonathan Snare and associate Alana Genderson spoke with HR Magazine for an article about what employers may expect regarding enforcement by the Occupational Safety and Health Administration (OSHA) under a Biden administration.
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.
Morgan Lewis partners Sandra Moser and Kenneth Polite authored a Law360 article about what a Biden administration will likely mean for white collar enforcement actions under the US Department of Justice (DOJ).
Morgan Lewis partner Douglas Baruch was quoted in a Bloomberg Law article following the announcement that the 2018 policy on whistleblower case dismissals, known as the Granston memorandum, would continue under the incoming presidential administration.
Morgan Lewis partner Sandra Moser spoke with Law360 about a recent Organization for Economic Cooperation and Development (OECD) report on US enforcement of the Foreign Corrupt Practices Act (FCPA).
Morgan Lewis partners Giovanna Cinelli and Kenneth Nunnenkamp contributed to “The U.S. Defense Industrial Base: Can It Compete in the Next Century?”, a collaboration between NSI (National Security Institute) and Duco.
Partner John McGahren spoke with Law360 for an article about what a Biden administration may mean for environmental policy.
Morgan Lewis partners Susan Feigin Harris and David Salmons and of counsel Saghi Fattahian authored a Law360 article previewing California v. Texas
Morgan Lewis partner Reece Hirsch spoke with Bloomberg Law about California Proposition 24, which has been approved by voters in the state.
Morgan Lewis partner Jeff Boujoukos spoke with Investment News about the US Securities and Exchange Commission’s (SEC’s) enforcement report for fiscal year 2020. In the article, he discussed what the report shows lies ahead for the SEC.
Partner Reece Hirsch spoke with Law360 about California’s Proposition 24, a ballot measure that, if adopted, would build on the California Consumer Privacy Act (CCPA).
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