Expert Analysis

• 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  New draft guidance from the U.S. Food and Drug Administration, indicating that the agency may no longer routinely require comparative efficacy studies when other evidence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.

• Steps For Healthcare Providers After Cigna ERISA Settlement

  

  Following the Cigna class action's settlement, where Employee Retirement Income Security Act violations arose from Cigna's online provider directory advertising providers as in-network who were actually out-of-network, providers should routinely audit their contract status and directory listings, and proactively coordinate with plans and payor partners, say attorneys at ArentFox Schiff.

• What's New In FDA's Latest Cell And Gene Therapy Guidance

  

  New draft guidance from the U.S. Food and Drug Administration, along with other recent initiatives, come together to promote cell and gene therapy product development by streamlining development and review pathways, say attorneys at Holland & Knight.

• Adapting To Enforcement Focus On Wound Care Fraud

  

  As federal agencies target wound care industry fraud as a top enforcement priority, attorneys advising industry stakeholders should evaluate business relationships for Anti-Kickback Statute violations, emphasize appropriate product use and documentation, and use internal data analytics to monitor billing patterns, say David Tarras at Tarras Defense and Jay McCormack at Verrill Dana.

• AG Watch: Illinois A Key Player In State-Level Enforcement

  

  Illinois Attorney General Kwame Raoul has systematically strengthened his office to fill federal enforcement gaps, oppose Trump administration mandates and advance state policy objectives, particularly by aggressively pursuing labor-related issues, say attorneys at Troutman.

• Organ Transplant System Reforms Mark Regulatory Overhaul

  

  Recent oversight, enforcement and operational developments in the U.S. organ procurement and transplantation system, alongside challenges like the federal shutdown, highlight heightened regulatory scrutiny and the need for compliance to maintain public trust, say attorneys at Hall Render.

• Federal Grantees May Soon Face More Limitations On Speech

  

  If courts accept the administration’s new interpretation of preexisting case law, which attempts to graft onto grant recipients the existing limitations on government contractors' free speech, a more deferential standard may soon apply in determining whether an agency’s refusal or termination of a grant was in violation of the First Amendment, say attorneys at Venable.