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DOJ Proposes Restrictions on Transactions Involving Bulk Sensitive Data, Including Health Data

On October 29, 2024, the US Department of Justice (DOJ) issued a proposed rule to implement US President Joe Biden’s Executive Order (EO) 14117. This order aims to prevent countries of concern from accessing Americans’ sensitive personal data and US-government-related data. The proposal specifically includes health data as a category of sensitive personal data that could be exploited. Health insurers, service providers to health plans, and healthcare providers should review this proposed rule closely.

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New Proposed Rules Aim to Enhance Healthcare Accessibility for People With Disabilities

The US Department of Health and Human Services and the US Department of Justice recently published new proposed rules that update and create various requirements under Section 504 of the Rehabilitation Act of 1973 and Title II of the Americans with Disabilities Act of 1990. What are some of the biggest changes?

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DOJ Announces Major Changes to Corporate Compliance Program Evaluation Criteria, Including Compensation and Personal Messaging Applications

During speeches on March 2 and 3, 2023, at the American Bar Association National Institute on White Collar Crime, Deputy Attorney General Lisa Monaco, Assistant Attorney General for the Criminal Division Kenneth A. Polite, Jr. and other US government officials announced significant changes to the US Department of Justice’s Evaluation of Corporate Compliance Programs and continued to emphasize the importance of effective and robust compliance policies. These changes come on the heels of DOJ’s recent announcement of a single corporate voluntary self-disclosure policy for every US Attorneys’ Office nationwide, and are simply the latest evidence of the Biden Justice Department’s substantial focus on corporate criminal enforcement.

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Doctor-Patient Relationships and Medical Marijuana: Where Are We Now?

Recently, President Joe Biden signed the Medical Marijuana and Cannabidiol Research Expansion Act, which provides a mechanism for industry and academia to access and research cannabis (including marijuana and other cannabis-derived products) without violating the Controlled Substances Act. This legislation creates a pathway for researchers to register with the US Department of Justice to legally conduct scientific research on such products subject to certain requirements. It also creates a system to allow drug manufacturers to legally produce products approved by the US Food and Drug Administration that contain cannabidiol or marijuana for commercial sale. The legislation also includes a doctor-patient relationship provision that permits state-licensed physicians to discuss the “currently known potential harms and benefits of marijuana and its derivatives, including cannabidiol, which may be derived from marijuana or other cannabis products such as hemp, as a treatment,” which may be of significant interest for healthcare providers.

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Conversations on Healthcare Governance

In this three-part podcast series focusing on healthcare governance, McDermott Partner Michael Peregrine joins the American Health Law Association to discuss a range of governance issues, including the following:

  • The nature and scope of the fiduciary responsibilities facing board members within nonprofit health systems;
  • Standards of conduct, expectations and the line between governance and management;
  • The board’s role in tackling the pressing challenges facing nonprofit health systems, including environment, social and governance issues;
  • How to handle issues related to charitable status, cybersecurity and the US Department of Justice’s recent pronouncements on corporate compliance;
  • How legal counsel can advise their clients who are board members of nonprofit health systems; and
  • How chief legal officers can effectively share information with the board, approaches to board education and training, and the role of board assessments.

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Insights and Challenges for the Executive Compensation Committee

The board’s executive compensation committee is the focus point for many of the extraordinary financial, economic and operating challenges currently facing healthcare organizations. Executive compensation increases are impacted by both an inflationary economy and significant revenue downturn. In addition, the US Department of Justice has identified executive compensation as an important conduit through by which corporate compliance incentives and deterrence can be implemented. Furthermore, executive recruitment and retention amidst the “Great Resignation” remains a key compensation concern.

These and similar issues have become important agenda items for the board’s executive compensation Committee. Michael Peregrine is joined by industry experts Tim Cotter and Ralph DeJong for the first in a two-part conversation about the impact of the developments on the compensation committee, including:

  • Key topics for briefing the board’s compensation committee.
  • Increasing communication between the compensation committee and the C-Suite.
  • Addressing pressures felt by executive committee members.
  • Insights from the Sullivan Cotter compensation data survey.
  • Projections for the impact of inflation on next year’s salary increases.
  • Expectations for future CEO salary increases and organization departures.
  • The segmenting approach to leadership plans.
  • Coordination with the Audit & Compliance Committee on compensation incentives

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US Supreme Court to Hear Whistleblower’s False Claims Act Suit

The US Supreme Court will hear a whistleblower’s False Claims Act suit that the US Department of Justice (DOJ) had previously moved to throw out. In this Law360 article, McDermott Partner Tony Maida offers perspective about the DOJ’s 2018 Granston memo.

“It does not make sense for the government to need to justify its decision to dismiss a case brought on its behalf,” Maida said. “Reducing the ability of DOJ to dismiss cases would erase some of those positive results of the Granston memo.”

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Healthcare Enforcement in the Post-Pandemic Era

As the world emerges from the COVID-19 pandemic, healthcare fraud enforcement remains a top priority for the US Department of Justice (DOJ) and other government agencies with enforcement authority. In this Westlaw Today article, McDermott Partners Laura McLane, Tony Maida and Dana M. McSherry describe some of the areas that have assumed particularly high enforcement priority, including private equity, telehealth and pandemic relief funds.

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HHS Finalizes Anti-Discrimination Revisions to ACA Section 1557

On June 12, 2020, the Office for Civil Rights (OCR) of the US Department of Health and Human Services (HHS) finalized a rule under Section 1557 of the Patient Protection and Affordable Care Act (the 2020 Final Rule) that rescinds certain protections afforded to LGBTQ individuals and persons with limited English proficiency. At the same time, the 2020 Final Rule removes burdensome disclosure requirements that may be a welcome relief for entities covered by Section 1557. On June 15, 2020, the Supreme Court of the United States ruled that workplace discrimination based on gender identity and sexual orientation is forbidden under Title VII of the Civil Rights Act of 1964. Although Title VII is not included in the precedential civil rights laws that gave rise to Section 1557, we nevertheless anticipate that the Supreme Court’s holding will lead to legal challenges in a number of areas, including healthcare and health insurance, religious exemptions and the 2020 Final Rule from HHS OCR.

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