Policy & Compliance

Expert Analysis

• Healthcare Orgs Should Prep For Greater Grant Oversight

  

  The U.S. Department of Health and Human Services' new Audit Enforcement and Risk Oversight initiative, and a proposed overhaul of the governmentwide framework for grants management, signal an aggressive and data-driven approach to federal grant enforcement, and could significantly expand the pathways leading to enforcement actions and private litigation, say attorneys at Norton Rose.

• 3rd Circ. Decision Sheds Light On BIPA Bank Exemption

  

  The Third Circuit's recent decision in McGoveran v. Amazon illuminates how courts are extending the Illinois Biometric Information Privacy Act's financial institution carveout beyond banks and insurers to technology vendors and other businesses handling biometric data, a defendant-friendly shift that still casts uncertainty around BIPA's enforcement, say attorneys at Dorsey & Whitney.

• Data Reveals Pivot In Feds' Financial Fraud Priorities

  

  Recent Justice Department data shows fraud prosecutions fell to their lowest rate in a decade in 2025, illustrating a move away from traditional financial cases and toward a targeted mix of healthcare, government program, consumer and sanctions matters, say Paul Hinton and Adrienna Huffman at The Brattle Group.

• New Timeline For Benefits Cases May Increase FCA Litigation

  

  Recent reforms designed to speed enforcers’ intervention decisions in False Claims Act suits involving state-administered benefits will likely encourage more qui tam relators to litigate cases without the government’s imprimatur, and increase defendants’ discovery burdens, defense costs and business disruptions, say attorneys at Morgan Lewis.

• FTC's Clinical Trial Requirement Threatens Food Claim Rules

  

  The Federal Trade Commission's general requirement for randomized controlled trials for most health-benefit claims, recently embraced by the National Advertising Review Board, lacks legal basis and endangers the existing statutory framework Congress created for marketing food and dietary supplements versus drugs, say attorneys at Keller & Heckman.

• HHS Enforcement Restructuring Signals Compliance Risks

  

  The U.S. Department of Health and Human Services' recent restructuring of its Office for Civil Rights suggests that, while Health Insurance Portability and Accountability Act enforcement remains central, its priorities have expanded to encompass civil rights, conscience and religious freedom, and data and cybersecurity issues, say attorneys at King & Spalding.

• AG Watch: Oregon's Strategic Civil Enforcement Approach

  

  Oregon Attorney General Dan Rayfield’s recent antitrust litigation activity and proposed staffing increase are the latest in a series of structural and policy changes that signal that the state Department of Justice is taking a more aggressive approach to civil enforcement, says Keturah Taylor at Cozen O'Connor.

• A Decade Later, Escobar Is Still Shaping FCA Cases

  

  The U.S. Supreme Court's decision 10 years ago in Universal Health Services v. U.S. ex rel. Escobar changed the way in which lower courts evaluate False Claims Act cases — and the ruling remains vital in nearly every FCA case filed today, say attorneys at Bradley Arant.

• How FCA, FCPA Risks Are Shifting As Feds Pull Back

  

  As the federal government continues its retreat from white collar enforcement, companies should expect False Claims Act risk to grow through private whistleblower suits and Foreign Corrupt Practices Act scrutiny to shift toward foreign prosecutors, requiring more adaptability as accountability becomes less centralized, says Temidayo Aganga-Williams at Selendy Gay.

• Trump Admin's Agency Records Purge Tests Judicial Notice

  

  While courts commonly take judicial notice of data in government websites and reports, the Trump administration's recent modification or wholesale deletion of these sources means that litigants must look elsewhere to support trial admission of this information, says Jon Gryskiewicz at Lewis Baach.

• West Coast Health Cos. Must Brace For Federal Enforcement

  

  In light of the U.S. Department of Justice's newly established West Coast strike force targeting healthcare fraud across Northern California, Arizona and Nevada, health organizations will need to prioritize knowledge, vigilance and operational discipline to reduce exposure from potentially parallel criminal and civil investigations, says Michael Beckwith at Dickinson Wright.

• High Court's Hikma Decision Reshapes 'Skinny Label' Suits

  

  The U.S. Supreme Court's decision in Hikma v. Amarin marks a significant victory for generic drug manufacturers, but rather than putting an end to so-called skinny label inducement claims, it narrows and refocuses them, say attorneys at Sterne Kessler.

• Turning To The Courts When PBM Reform Falls Short

  

  The effectiveness of state laws intended to regulate pharmacy benefit managers remains uncertain, but litigation — utilizing tried-and-true theories like breach of contract and fair dealing — offers another mechanism through which stakeholders may seek relief from PBMs, say attorneys at Reed Smith.