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.

• How Cos. Should Prepare For NY RAISE Act Compliance

  

  With the New York Responsible AI Safety and Education Act taking effect March 19, state regulators will expect subject artificial intelligence governance policies to understand whether appropriate safeguards and protocols are in place to prevent or mitigate discriminatory or adverse outcomes by frontier models, says Michael Paulino at Gordon Rees.

• What We Know About DOJ's New FCA Enforcement Priorities

  

  Recent remarks from the leader of the Justice Department’s commercial litigation branch provide key insights on how False Claims Act cases — especially healthcare fraud, trade fraud, antidiscrimination and cybersecurity claims — will be evaluated, prioritized and pursued as heightened enforcement becomes the new normal, say attorneys at Latham.

• 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.

• 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.

• Opinion

  It's Time To Clarify California's Elder Abuse Act

  

  As California's elderly population soars, the Golden State's high court and Legislature must provide needed clarification about the scope of the Elder Abuse Act, to resolve the inconsistencies and ambiguities that have impeded the law's ability to remedy elder abuse, neglect and abandonment, say attorneys at Horvitz & Levy.

• Series

  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.

• When Fraud Involvement Disqualifies FCA Whistleblowers

  

  A Massachusetts federal court's recent dismissal of a False Claims Act relator in U.S. ex rel. Perry v. First Psychiatric Planners provides instructive insight into when whistleblowers may be denied their share of settlement proceeds, even if their involvement in the underlying fraud is a step removed, say attorneys at Holland & Knight.

• Job Shift Accommodation Ruling Clarifies 'Essential Function'

  

  In Siebrecht v. Mercy Health-Iowa, the Eighth Circuit's recent denial of a disabled worker's shift exemption request shows that the essential function of a job can encompass more than core job requirements and include things like scheduling flexibility, says Kim Kirn at Miles Mediation & Arbitration.

• Opinion

  Fed. Circ. Must Bury Design Patent Doctrinal Zombies

  

  After recently finding noninfringement in Range of Motion Products v. Armaid, the Federal Circuit must rehear the case to confront two troublesome doctrines of design patent law claim construction — feature filtration and claim verbalization — that have lingered for decades and intensified in recent years, say attorneys at McAndrews Held.

• H-1B Registration Tips For New Wage-Weighted Selection

  

  Practitioners participating in this year’s H-1B visa registration, currently underway, must understand that under the new wage-weighted selection process that replaced the random lottery, the crucial first step is choosing the correct standard occupational classification, says Jimmy Lai at Lai & Turner.

• 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.