Policy & Compliance

Expert Analysis

• How 'Most Favored Nation' Regime Affects Biopharma Deals

  

  As M&A activity surges in the biopharma space, companies will need to account for the Trump administration's most-favored-nation pricing proposals — durable in concept, if unsettled in detail — when drafting deals, say attorneys at Gibson Dunn.

• Where DOJ's Fraud Priorities Memo May Actually Matter

  

  The U.S. Department of Justice’s recently released memo outlining priorities for its newly created fraud division will shape how cases are identified, staffed and sequenced, meaning white collar defense work must begin earlier, say David Tarras at Tarras Defense and Trevor Jones at Dynamis.

• DOJ Healthcare Declination Offers Self-Disclosure Checklist

  

  The U.S. Department of Justice's declination of criminal charges against Campus Eye Management signals that its new self-disclosure policy provides a real path for healthcare companies to avoid criminal exposure, but that path is paved with speed, transparency and operational remediation, says Jonathan Porter at Husch Blackwell.

• Correctional Healthcare Requires Clearer Legal Standards

  

  As the correctional healthcare industry increasingly faces financial instability due to litigation, the U.S. Bureau of Prisons should develop clear standards for constitutionally adequate care for incarcerated patients, says Susanne Moore at Blackstone Trial Group.

• How Home Infusion Providers Can Adapt To Enrollment Pause

  

  Recent Centers for Medicare & Medicaid Services moratoria on new enrollments of home health agencies, medical equipment companies and hospices make home infusion providers' compliance obligations more complex and ambiguous, requiring new careful consideration of specific enrollment requirements and limitations, say attorneys at Quarles & Brady.

• AI Data Mining Is Changing FCA Enforcement

  

  With False Claims Act investigations increasingly emerging from statistical anomalies identified by data miners, companies need to consider what conclusions an outsider armed with artificial intelligence might draw from public-facing data and be ready to explain any anomalies if questions arise, say attorneys at Cohen & Gresser.

• Lessons From 5 Months Of DOJ Corporate Policy Deals

  

  Recent declinations and prosecution agreements between the U.S. Department of Justice and corporations since the March unveiling of the corporate enforcement and voluntary disclosure policy provide takeaways for management considering how to respond to corporate misconduct, says Brendan Quigley at Baker Botts.

• A New Era Of Scrutiny For China-Linked Pharma Deals

  

  As Congress considers bipartisan legislation that would heighten regulatory scrutiny for life sciences deals involving Chinese biotech entities, companies should reassess the risks and due diligence requirements that will come with using heavily China-dependent pipelines, says Jen Maki at Ankura.

• Justices' FTC Ruling Weakens Qui Tam's Constitutional Base

  

  The U.S. Supreme Court’s holding in Trump v. Slaughter, expanding presidential control over those exercising executive power, suggests that courts may be receptive to arguments challenging the constitutional foundations of the False Claims Act’s qui tam mechanism, says Daniel Passeser at Wiggin.

• Calif. Drug Ruling Affirms Defect-Centric Liability Framework

  

  The California Supreme Court's decision in Gilead Tenofovir Cases this week rejects a novel duty-to-innovate theory of negligence that could have reshaped product liability exposure well beyond the pharmaceutical industry, instead signaling that negligence claims premised on nondefective products are unlikely to succeed, say attorneys at Dechert.

• DOJ's FCA Push Creates Risks For Construction Contractors

  

  The construction industry may be uniquely vulnerable to a new generation of False Claims Act enforcement driven by the U.S. Department of Justice's increasing usage of the FCA to target a much broader category of conduct than it has in decades past, specifically compliance certifications and regulatory representations, say attorneys at Cozen O'Connor.

• Feds' Mixed Cues On Medicaid Fraud Signal States To Step Up

  

  While the federal government has recently delivered four distinct and mutually inconsistent messages regarding Medicaid fraud enforcement, states should focus on improving enforcement, regardless of which federal posture proves correct, says Ken Levine at Stone & Magnanini.

• A Shift In How Policymakers Are Approaching PBM Regulation

  

  Recent federal and state legislative and regulatory activity involving pharmacy benefit managers represent a change in focus from transparency to PBM compensation structures, vertical integration and competitive effects, say attorneys at Barclay Damon.