Expert Analysis

• CMS Healthcare Enforcement Initiatives May Cause Disruption

  

  The Centers for Medicare & Medicaid Services' recently announced enforcement actions against healthcare fraud mark a significant escalation, and CMS' prior approach in the hospice sector suggests that even compliant providers and suppliers should brace for impact, say attorneys at Morgan Lewis.

• The Benefits Of Choosing A Niche Practice In The AI Age

  

  As artificial intelligence becomes increasingly accessible, lawyers with a niche practice may stand out as clients seek specialized judgment that automation cannot replicate, but it is important to choose a niche that is durable, engaging and a good personal fit, says Daniel Borneman at Lowenstein Sandler.

• How PBMs Can Adapt To Plan Sponsors' Disclosure Demands

  

  As federal reforms, growing state regulation and litigation threats push plan sponsors to expect visibility into revenue streams, pharmacy benefit managers should leverage transparency strategically, including by simplifying how they get paid, offering clients audit-ready data and co-designing contracts that are easy for fiduciaries to explain and defend, says Kristie Blase at Frazer + Blase.

• What New Animal Welfare Enforcement Push Means For Cos.

  

  The Trump administration's recently announced multiagency focus on violations of the Animal Welfare Act and related laws will likely lead to broader enforcement actions across industries, heightened scrutiny of compliance standards and a need for businesses to adopt effective risk management practices, says Shennie Patel at Crowell & Moring.

• How To Engage With Gov't's Direct-To-Consumer Drug Policy

  

  The U.S. Department of Health and Human Services' recent request for industry input on manufacturers' direct-to-consumer drug sales reflects the government's caution in this arena, and allows stakeholders a rare opportunity to help shape policy, says Mary Kohler at Kohler Health Law.

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  Podcasting Makes Me A Better Lawyer

  

  Podcasting has changed how I ask questions and connect with people, sharpening my ability to listen without interrupting or prejudging, and bringing me closer to what law is meant to be: a human profession grounded in understanding, judgment and trust, says Donna DiMaggio Berger at Becker.

• Patent Eligibility Bulletin: Steps To Consider As USPTO Shifts

  

  Recent memoranda from the U.S. Patent and Trademark Office, along with some of the first patents issued under Director John Squires, indicate a recalibration of the subject matter eligibility landscape, signaling a renewed emphasis on concrete technological improvements and a potentially pro-AI stance, say attorneys at Banner Witcoff.

• Tax Court Ruling Signals Cross-Border Loan Scrutiny

  

  The U.S. Tax Court’s recent decision in Aventis v. Commissioner compounds ongoing regulatory focus on debt originations and should prompt practitioners to assess their existing cross-border lending structures for potential exposure to U.S. federal income tax, say attorneys at Eversheds.

• Lessons From Justices' Split On Major Questions Doctrine

  

  The justices' varied opinions in Learning Resources v. Trump, which held the International Emergency Economy Powers Act did not confer the power to impose tariffs, offer a meaningful window into the U.S. Supreme Court's perspective on the major questions doctrine that will likely shape lower courts' approach to executive action challenges, say attorneys at Venable.

• Drug Wholesaler's DPA Shows Imperfect Efforts Still Count

  

  Atlantic Biologicals’ recent deferred prosecution agreement with federal prosecutors for allegedly distributing controlled substances to pill mill pharmacies demonstrates that even subpar cooperation, when combined with genuine remediation and strategic advocacy, can yield outcomes that protect a company's long-term interests, says Jonathan Porter at Husch Blackwell.

• 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.

• When MDLs Drag, State Courts Can Speed Mass Tort Results

  

  Understanding the structural dynamics that can delay resolution in multidistrict litigation is essential to understanding why a state court strategy is sometimes not merely attractive, but necessary for plaintiffs seeking timely and just outcomes, say attorneys at DiCello Levitt.

• Leveraging MDLs And State Courts In Mass Tort Strategy

  

  Multidistrict litigation's quiet drift from a pretrial coordination device to a de facto national court for mass torts poses a strategic question for plaintiffs counsel — whether an MDL will yield timely trials, meaningful accountability and fair value for clients, or whether a state court strategy will be more effective, say attorneys at DiCello Levitt.

• 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.

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  Volunteering With Scouts Makes Me A Better Lawyer

  

  Serving as an assistant scoutmaster for my son’s troop reaffirmed several skills and principles crucial to lawyering — from the importance of disconnecting to the value of morality, says Michael Warren at McManis Faulkner.