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Mintz Direct

March 1, 2021 | Blog

On our new Mintz Direct page, Mintz thought leaders across industries and practice areas offer timely insights on developments that impact our clients and communities. Visit the Mintz Direct page to hear what our experienced attorneys and professionals are saying about what’s happening now.
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Health Care Enforcement Year in Review & 2021 Outlook

February 18, 2021 | | By Eoin Beirne, Brian Dunphy, Karen Lovitch, Kevin McGinty, Samantha Kingsbury, Keshav Ahuja, Grady Campion, Jane Haviland, Caitie Hill, Rebecca Zeidel

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.
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As Walsh Awaits Confirmation Vote, DOL Priorities Take Shape

February 16, 2021 | Blog | By Anthony DeMaio, R. Neal Martin

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.
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Transportation & Infrastructure: What to Expect from the Biden Administration & 117th Congress

February 4, 2021 | Blog | By Christian Tamotsu Fjeld, R. Neal Martin, Anthony DeMaio

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.
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Recent Amendments to the FDA Laws Attempt to Clarify and Improve Existing Systems

January 28, 2021 | Blog | By Joanne Hawana, Elizabeth Conti

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.
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Travel Alert – Update on U.S. Travel Bans

January 28, 2021 | Alert | By Maryanne Kline, Danielle Porter

This alert advises caution regarding international travel and covers the CDC’s January 26, 2021 order on COVID-19 testing, current travel bans and their exemptions and waivers, visa processing, and additional notes on entry into the US.
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Energy & Sustainability Washington Updates – February 2021

January 27, 2021 | Article | By R. Neal Martin

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HIPAA Amendments and Other Trump Regulatory Actions on Hold

January 21, 2021 | Blog | By Dianne Bourque, Cassandra Paolillo

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.
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340B Administrative Dispute Resolution Goes Live Amid a Flurry of 340B Litigation

January 18, 2021 | Blog | By Daryl Berke, Ellyn Sternfield

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.
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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.
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Year in Review: The Most Popular IP Posts of 2020

January 14, 2021 | Blog | By Christina Sperry

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.
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Action Items on Technology and Communication Policies in front of the Senate Commerce Committee

January 14, 2021 | Blog | By Christian Tamotsu Fjeld, Christopher Harvie

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WEBINAR REMINDER: Mandatory or Voluntary Workplace Vaccination — Guidance for Employers

January 13, 2021 | Blog | By Geri Haight, Jennifer Rubin, Joanne Hawana

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.
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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.  
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IRS Issues Final Regulations on Taxation of Carried Interest Under Section 1061

January 13, 2021 | Alert | By Abraham (Avi) Reshtick, David Salamon

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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.
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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.
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Last week, the Department of Justice (“DOJ”) announced the criminal indictment of Surgical Care Affiliates LLC (“SCA”), an Alabama- and Illinois-based company, which owned and operated outpatient medical centers around the U.S., for its alleged agreements with competitors not to solicit senior-level employees. DOJ has been suggesting since 2006 that it would use the criminal provisions of the antitrust laws against into employee allocation agreements—commonly called no-poach agreements, and DOJ has now followed through on its warnings.
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How Companies Can Prepare for SEC Proxy Advisor Reform

January 12, 2021 | Advisory | By Anne Bruno

This advisory discusses the SEC’s final rules — effective November 2, 2020 — governing voting advice provided by proxy advisory firms such as Institutional Shareholders Service (ISS) and Glass Lewis.
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The Trademark Modernization Act Establishes New Trademark Cancellation Procedures

January 12, 2021 | Blog | By Michael Graif, Williams Dixon

On December 27, 2020, the Trademark Modernization Act of 2020 (“the Act”) became law as part of the Consolidated Appropriations Act, 2021. 
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