Key takeaways from Healthcare Litigation, Compliance, and Investigations Forum 2025

McDermott Will & Schulte

In Depth


Three enforcement trends to watch

  1. Escalated fraud and abuse enforcement activity: US Department of Justice (DOJ) and the US Department of Health and Human Services re-launched their joint False Claims Act Working Group, signaling a heightened focus on artificial intelligence (AI)-enabled billing, Medicare Advantage risk adjustment, and kickback theories tied to digital health and pharmaceutical and medical device manufacturers, among others.
  2. State-level expansion and private equity scrutiny: States (e.g., California, Colorado, New York, and Washington) are moving aggressively with “mini-Hart-Scott-Rodino” and other transaction notice laws. They’re also heightening review of private equity ownership and Corporate Practice of Medicine compliance in physician platforms.
  3. Political and social enforcement drivers: Enforcement priorities increasingly intersect with policy issues such as diversity, equity, and inclusion; reproductive health; and gender-affirming care. Hospitals and health systems face new risks and challenges while navigating conflicting federal and state mandates.

Three action items before year-end

  1. Refresh fraud and abuse risk mapping: Coordinate with your compliance and internal audit teams to ensure relevant risk areas are included in the internal compliance work plan. Consider including compensation, marketing, and technology-use arrangements in light of DOJ’s evolving theories and data-driven analytics. Also evaluate whether particular compliance reviews should be performed under attorney-client privilege.
  2. Develop informed transactional planning: Integrate regulatory and ownership-disclosure reviews early in deals in anticipation of DOJ and state attorney-general scrutiny. Identify associated timelines early in deal processes so all stakeholders are aligned.
  3. Prepare for multi-front investigations: To best position the organization for a nimble, consistent, and coordinated response to a government investigation or other request for information, create alignment among your organization’s legal, compliance, and government-relations functions under a government investigation and communications initiative, and provide a training for personnel regarding the updated policy requirements.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Attorney Advertising.

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