Policy & Compliance

Expert Analysis

• A Look At Middlemen Fees In 340B Drug Discount Program

  

  A U.S. Senate committee's recent hearing on the Section 340B drug discount program, along with statistical analysis of payment amounts, contribute to a growing consensus that middlemen fees are too high, say William Sarraille at the University of Maryland, and Shanyue Zeng and Rory Martin at IQVIA.

• Nursing Home Abuse Cases Face 3 Barriers That Need Reform

  

  Recent headlines reveal persistent gaps in oversight and protection for vulnerable residents in long-term care, but prosecution of these cases is often stymied by numerous challenges that will require a comprehensive overhaul of regulatory, legal and financial structures to address, says Veronica Finkelstein at Wilmington University.

• Mulling Differing Circuit Rulings On Gender-Affirming Care

  

  Despite the Eleventh Circuit's recent holding in Lange v. Houston County that a health plan's exclusion for gender-affirming surgery did not violate Title VII, employers should be mindful of other court decisions suggesting that different legal challenges may still apply to blanket exclusions for such care, say attorneys at Smith Gambrell.

• State AGs May Extend Their Reach To Nat'l Security Concerns

  

  Companies with foreign supply-chain risk exposure need a comprehensive risk-management strategy to address a growing trend in which state attorneys general use broadly written state laws to target conduct that may not violate federal regulations, but arguably constitutes a national security threat, say attorneys at Wiley.

• Unique Aspects Of Texas' Approach To AI Regulation

  

  The Texas Responsible AI Governance Act — which will soon be the sole comprehensive artificial intelligence law in the U.S. — pulls threads from EU and Colorado laws but introduces more targeted rules with fewer obligations on commercial entities, say attorneys at MVA Law.

• Surveying The Healthcare Policy Landscape Post-Shutdown

  

  With last week's agreement to reopen the federal government, at least through the end of January, key healthcare legislation that has been in limbo since a December 2024 spending bill fell apart may recapture the attention of Congress, say attorneys at Faegre Drinker.

• FDA Biosimilar Guidance Should Ease Biologics Development

  

  New draft guidance from the U.S. Food and Drug Administration, indicating that the agency may no longer routinely require comparative efficacy studies when other evidence provides sufficient assurance of biosimilarity, underscores the FDA's trust in analytical technology as a driver of biologics access, say attorneys at Hogan Lovells.

• Prison Body Cams Raise Health Privacy Compliance Issues

  

  The increasing use of prison staff body cameras to enhance transparency and safety presents correctional healthcare partners with new risk management questions where they must carefully reconcile the benefits of surveillance with the imperative to protect patient privacy, say attorneys at Gordon Rees.

• Employer Considerations After 11th Circ. Gender Care Ruling

  

  The Eleventh Circuit's en banc decision in Lange v. Houston County, Georgia, finding that a health plan did not violate Title VII by excluding coverage for gender-affirming care, shows that plans must be increasingly cognizant of federal and state liability as states pass varying mandates, say attorneys at Miller & Chevalier.

• How Healthcare Practices Can Prepare For ICE Visits

  

  Healthcare providers that may face encounters with immigration enforcement should familiarize themselves with compliance obligations beyond ensuring employment authorization, and mitigate risk by establishing clear policies and specific procedures that safeguard patient rights and manage staff interactions with agents, say attorneys at Roetzel & Andress.

• Adapting To Calif.'s Enhanced Regulation Of PE In Healthcare

  

  New California legislation enhances oversight on the role of private equity groups and hedge funds in healthcare transactions, featuring both a highly targeted nature and vague language that will require organizations to carefully evaluate existing practices, says Andrew Demetriou at Husch Blackwell.

• Lessons From 7th Circ. Decision Affirming $183M FCA Verdict

  

  The Seventh Circuit's decision to uphold a $183 million False Claims Act award against Eli Lilly engages substantively with recurring materiality and scienter questions and provides insights into appellate review of complex trial court judgments, say Ellen London at London & Naor, Li Yu at Bernstein Litowitz and Kimberly Friday at Osborn Maledon.

• Calif. Justices Continued Anti-Arbitration Trend This Term

  

  In the 2024-2025 term, the California Supreme Court justices continued to narrow arbitration's reach under state law, despite state courts' extreme caseload backlog and even as they embraced contractual autonomy in other contexts, says Josephine Petrick at The Norton Law Firm.