Policy & Compliance

Expert Analysis

• 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  New draft guidance from the U.S. Food and Drug Administration, along with other recent initiatives, come together to promote cell and gene therapy product development by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.

• HHS Wound Care Report Highlights Need For Payment Reform

  

  The U.S. Department of Health and Human Services' recent report on potential abuse in Medicare Part B payments for skin substitutes highlights specific fraud schemes, but more importantly emphasizes that broader changes are needed for the wound care sector's fundamentally flawed payment system, say attorneys at Paul Hastings.

• Assessing The Future Of The HIPAA Reproductive Health Rule

  

  In light of a Texas federal court's recent decision to strike down a U.S. Department of Health and Human Services rule aimed to protect the privacy of patients seeking abortions and gender-affirming care, entities are at least temporarily relieved from compliance obligations, but tensions are likely to continue for the foreseeable future, says Liz Heddleston at Woods Rogers.

• DOJ's Tracing Rule For Pandemic Loan Fraud Is Untenable

  

  In conducting investigations related to COVID-19 relief fraud, the government's assertion that loan proceeds are nonfungible and had to have been segregated from other funds is unsupported by underlying legislation, precedent or the language establishing similar federal relief programs, say Sharon McCarthy, Jay Nanavati and Lasya Ravulapati at Kostelanetz.

• New Health AI Guidance Features A Provider-Centric Approach

  

  New guidance from the Joint Commission and Coalition for Health AI regarding the responsible use of artificial intelligence in healthcare deviates from preexisting guidance by recommending a comprehensive framework for using AI tools, focusing on healthcare provider organizations rather than on AI developers, say attorneys at Ropes & Gray.

• Mass. Ruling May Pave New Avenue To Target Subpoenas

  

  A Massachusetts federal court’s recent decision to quash a subpoena seeking information on gender-affirming care at Boston Children’s Hospital is a significant departure from courts' deferential approach to subpoena enforcement, and may open a new pathway for practitioners challenging investigative tools in the future, say attorneys at Gibson Dunn.