Expert Analysis

• Key Takeaways As HRSA Aims To Revive 340B Rebate Pilot

  

  The U.S. Department of Health and Human Services' recent request for feedback on the 340B Rebate Model Pilot Program demonstrates that it intends to correct the model's procedural defects, which is positive news for participating manufacturers, but a setback for covered entities, say attorneys at Manatt.

• How The New Tariff Landscape May Unfold

  

  To replace tariffs formerly imposed under the International Emergency Economic Powers Act, the administration will rely on a patchwork of statutes, potentially leading to procedural challenges and a complex tariff landscape with varying levels, durations and applicability, says Joseph Grossman-Trawick at King & Spalding.

• 5 Key Issues Affecting Deal Structurings In Ship Finance

  

  Several trends are shaping the ship finance landscape, including the impact of Basel IV in Europe and the Nordic bond market, making it essential for both lenders and shipowners to utilize creative deal structuring and maintain an awareness of competitive dynamics across traditional bank and private lending, say attorneys at Holland & Knight.

• 9th Circ. Ruling Evinces Tightening Of Nonmedical Hardship

  

  The Ninth Circuit’s recent ruling in Vilchis-Gomez v. Bondi illustrates how a series of immigration decisions are transforming the extreme hardship defense to removal into a de facto medical necessity requirement, but practitioners can push back by continuing to assert long-standing precedents and building comprehensive records, says Abdoul Konare at Konare Law.

• Sentencing Amendments Could Spell Paradigm Shift

  

  Three of the U.S. Sentencing Commission’s recently proposed guideline amendments would have an immediate and dramatic impact on economic offenders, resulting in significantly fewer defendants receiving sentences of imprisonment and meaningfully addressing congressional directives, say Mark Allenbaugh at SentencingStats.com and Doug Passon at Doug Passon Law.

• Character.AI Case Highlights Agentic AI Liability Questions

  

  The recently settled litigation against Character Technologies Inc. provides an early case study for exploring salient legal issues related to agentic artificial intelligence, such as tort liability, strict liability, statutory liability and contractual liability, says Samuel Mitchells at Smith Gambrell.

• Can Trump's AI Order Override State Insurance Rules?

  

  Although a December executive order charts a course to potentially dismantle state artificial intelligence regulations applicable to virtually any industry, the effect on the insurance industry deserves special attention because under federal law, the regulation of the business of insurance is largely delegated to the states, say attorneys at Eversheds Sutherland.

• How DOL Rule Would Preserve App-Based Contractor Work

  

  The U.S. Department of Labor's proposed 2026 independent contractor rule reinforces the centrality of worker autonomy and entrepreneurial opportunity that characterize many app-based arrangements, and returns to a framework that may offer increased predictability for platforms and workers alike, say attorneys at Gibson Dunn.

• Complaint Portal Updates Prove That The CFPB Is Listening

  

  The Consumer Financial Protection Bureau's recent updates to its online complaint portal not only clarify complaint pathways and strengthen identity verification, but also signal that the bureau is more willing to consider industry perspectives on its activities and change course where warranted, say attorneys at Manatt.

• Del. Justices' Upholding Of SB 21 Gives Cos. Needed Clarity

  

  The Delaware Supreme Court's recent unanimous decision in Rutledge v. Clearway Energy — upholding 2025 corporate law amendments enacted through S.B. 21, which clarified safe harbor protections and key terms — may help stem the DExit movement, whose proponents have claimed unpredictability in Delaware courts, say attorneys at Nelson Mullins.

• Why Mukherji Won't End USCIS' EB-1A Two-Step

  

  A Nebraska federal court's recent decision in Mukherji v. Miller seemed to vindicate longstanding complaints about the U.S. Citizenship and Immigration Services' controversial two-step adjudication process, declaring the framework unlawful — but Mukherji is unlikely to be the death blow that immigration practitioners have hoped for, says Jun Li at Reid & Wise.

• Unique Issues Facing Brand-Compounder Patent Litigation

  

  Recent litigation and potential enforcement action against Hims & Hers Health raise questions about how compounders and branded pharmaceuticals companies would be positioned in patent litigation as compared to generics companies, which would require strategies different from those that would be used in traditional Hatch-Waxman Act litigation, say attorneys at Morgan Lewis.

• How Banks Can Apply FinCEN Beneficial Ownership Relief

  

  A recent Financial Crimes Enforcement Unit order limiting the circumstances under which banks should identify and verify beneficial owners may allow banks to tailor their approach to verification compliance, but only after reviewing customer due diligence policies and evaluating alignment with their risk profiles, say attorneys at Cleary.

• How CFTC Prediction Market Agenda Shifts The Playing Field

  

  Commodity Futures Trading Commission Chairman Michael Selig recently signaled that a more welcoming regulatory landscape for prediction markets like Kalshi and Polymarket is coming soon, but we can expect a hotly contested regulatory and legal environment with important implications for the platforms, state regulators and market participants, say attorneys at Sidley.

• PFAS Risks In M&A Amid Litigation, Legislative Developments

  

  Per- and polyfluoroalkyl substances have become a significant M&A concern amid new trends in settlements and state laws, and potential buyers must find ways to evaluate potential related risks, say attorneys at Debevoise.