Biden Administration

The 117th Congress kicked off its First Session with, among other initiatives, oversight hearings on the SolarWinds cyber hack.  On February 23, the Senate Intelligence Committee held a hearing on the high profile, far-reaching breach; followed by a joint hearing on February 26 in the House of Representatives held by the Oversight and Reform and Homeland Security Committees.  At both hearings, Sudhakar Ramakrishna, President and CEO of SolarWinds, Kevin Mandia, CEO of FireEye, and Brad Smith, President and Chief Legal Officer of Microsoft, testified.  In addition, George Kurtz, the President and CEO of Crowdstrike, testified at the Senate Intelligence hearing, while Kevin Thompson, the former CEO of SolarWinds, testified in front of the joint House hearing.  Together, the hearings represent what will likely be the first of several congressional forays into the SolarWinds hack, including possible legislative initiatives to address future possible incidents and supply chain security.

Read about President Joe Biden’s termination of the U.S. entry ban on new immigrants, or “green card” holders, implemented by the Trump administration in April 2020.

As COVID-19 vaccines become more available, employment-based programs requiring or incentivizing employee vaccination will become more commonplace. In a previous post, we covered recent employer guidance from the CDC, with a particular focus on mandatory workplace testing programs. This post examines how an employer might design a voluntary workplace vaccination program using incentives to encourage participation, and how to avoid potential pitfalls in doing so.

Despite the threat of COVID-19 paralyzing much of the country in 2020, government health care fraud enforcement continued even though the Department of Justice (DOJ) had the added burden of pursuing COVID-19 related fraud. Mintz’s Health Care Enforcement Defense team has reviewed the key policy issues, statistics, settlements, and court decisions from 2020, and in this report we reflect on those developments and also predict the trends in health care enforcement in 2021 and beyond.

In this fireside discussion, Mintz attorney Joanne Hawana and Aaron Josephson and Anthony DeMaio from ML Strategies explored policy activities that will likely have the greatest impact on stakeholders in 2021, and how the new Administration may impact the FDA in the year ahead and beyond.

Despite the threat of COVID-19 paralyzing much of the country in 2020, government health care fraud enforcement continued even though the Department of Justice (DOJ) had the added burden of pursuing COVID-19 related fraud. Mintz’s Health Care Enforcement Defense team has reviewed the key policy issues, statistics, settlements, and court decisions from 2020, and in this report we reflect on those developments and also predict the trends in health care enforcement in 2021 and beyond.

Last week, the Senate Committee on Health, Education, Labor, and Pensions voted 18-4 to advance Boston Mayor Marty Walsh’s nomination for labor secretary. The bipartisan approval signals a non-controversial confirmation vote of the full Senate. When that occurs, Secretary-designate Walsh will take over a department that is front and center in the nascent Biden administration. Executing White House priorities including the federal response to the COVID-19 pandemic, addressing the climate crisis, and reversing certain Trump era actions, will soon be Walsh’s responsibility. His experience in Massachusetts politics gives a sense of how Walsh will approach his new post.

With Democratic majorities in the U.S. House and U.S. Senate, Congress and President Biden’s new administration are working to quickly advance proposals to provide for economic relief as the nation continues to reel from the now nearly one-year pandemic. One area of emerging bipartisan focus is a long-sought measure to address the nation’s crumbling and outdated infrastructure, which could be paired with a required surface transportation reauthorization bill.

Although the Biden-Harris Administration that assumed control of the Executive Branch on January 20, 2021 immediately ordered a regulatory freeze of new or pending rules while the new administration gets its bearings (as reported by our colleagues in this post), several important changes to the laws enforced by the Food and Drug Administration (FDA) were recently enacted by Congress. As legislative actions, those changes are of course unaffected by President Biden’s regulatory freeze and so we thought worth a summary to ensure our readers are up to speed on the large amount of activity that occurred in the final weeks of the 116th Congress and the Trump Administration.

In the waning days of the Trump administration, the Office for Civil Rights (“OCR”) announced a number of new initiatives, including proposed HIPAA amendments, discussed here, and a very recent COVID-19 related Notice of Enforcement Discretion. Under the Notice of Enforcement Discretion, published on January 19, 2021, OCR announced that it would not impose penalties for non-compliance with HIPAA on covered entities making good faith use of online or web-based applications for COVID-19 vaccination scheduling. With the swearing in of President Biden, these and other regulatory initiatives, including all regulations that have been sent to the Office of the Federal Register, but not yet published, are to be withdrawn until a department or agency head appointed by President Biden reviews and approves the rule.

The U.S. Department of Health and Human’s Services (HHS) Health Resources and Services Administration’s (HRSA) long-awaited administrative dispute resolution (ADR) final rule went into effect last week, on January 13, 2021. The ADR regulations, which have lingered in HHS since 2010, arrive amid increasing tensions and a flood of 340B-related litigation between covered entities, manufacturers, and HHS.

After what felt like one of the longest election seasons in history, Washington is preparing to welcome the incoming administration of President-elect Joe Biden and Vice President-elect Kamala Harris. Meanwhile, Capitol Hill adjusts to a dramatic shift in power as Democrats achieved an election night stunner by winning both Senate run-off elections in Georgia on January 5, sending Rev. Raphael Warnock and Jon Ossoff to Washington and giving Democrats a 50-seat majority with the new incoming vice president casting any tie votes. In the House of Representatives, Republicans narrowed the Democrats’ majority in November but are still in the minority and Rep. Nancy Pelosi (D-CA) has been reelected to serve as Speaker of the House.

As 2021 begins and intellectual property (IP) strategies are being developed for the new year, it is a good time to reflect on what IP issues were prominent in 2020.  According to many readers, hot topics included Chinese foreign filing licenses, patenting involving either artificial intelligence (AI) or COVID-19, inter partes review, and attorney fee awards.

Read the transcript of CompensationStandard.com’s November 2020 webcast titled, “Pay Equity: What Compensation Committees Need to Know” in which Anne L. Bruno was among the experts to discuss pay equity, shareholder expectations, disclosure trends, board oversight, and more.

Recently enacted H.R. 133, the Consolidated Appropriations Act, 2021 (“the Act”), is a massive, 5,593-page piece of legislation that includes appropriations for the U.S. government for the upcoming fiscal year and funding for coronavirus emergency response and relief, among many other things.

Please join Mintz’s Employment, Labor & Benefits and Health Law attorneys and noted immunologist Dr. Darryl Carter for a webinar to discuss key takeaways from the EEOC’s recently updated vaccination guidance and other COVID-19–related workplace question.

The new 1,246-page Trade and Cooperation Agreement (TCA) between the United Kingdom and the European Union has ended the suspense over what restrictions will apply to the transfer of personal data between the EU and the UK now that the Brexit transition period has run its course.   As expected, the UK has chosen to allow UK personal data to be transferred to the EU freely on the basis that the EU’s GDPR provides adequate protection for the transferred data.  But the EU has not yet agreed that EU personal data can be transferred freely to the UK.