Policy & Compliance

Expert Analysis

• HHS Enforcement Restructuring Signals Compliance Risks

  

  The U.S. Department of Health and Human Services' recent restructuring of its Office for Civil Rights suggests that, while Health Insurance Portability and Accountability Act enforcement remains central, its priorities have expanded to encompass civil rights, conscience and religious freedom, and data and cybersecurity issues, say attorneys at King & Spalding.

• AG Watch: Oregon's Strategic Civil Enforcement Approach

  

  Oregon Attorney General Dan Rayfield’s recent antitrust litigation activity and proposed staffing increase are the latest in a series of structural and policy changes that signal that the state Department of Justice is taking a more aggressive approach to civil enforcement, says Keturah Taylor at Cozen O'Connor.

• A Decade Later, Escobar Is Still Shaping FCA Cases

  

  The U.S. Supreme Court's decision 10 years ago in Universal Health Services v. U.S. ex rel. Escobar changed the way in which lower courts evaluate False Claims Act cases — and the ruling remains vital in nearly every FCA case filed today, say attorneys at Bradley Arant.

• How FCA, FCPA Risks Are Shifting As Feds Pull Back

  

  As the federal government continues its retreat from white collar enforcement, companies should expect False Claims Act risk to grow through private whistleblower suits and Foreign Corrupt Practices Act scrutiny to shift toward foreign prosecutors, requiring more adaptability as accountability becomes less centralized, says Temidayo Aganga-Williams at Selendy Gay.

• Trump Admin's Agency Records Purge Tests Judicial Notice

  

  While courts commonly take judicial notice of data in government websites and reports, the Trump administration's recent modification or wholesale deletion of these sources means that litigants must look elsewhere to support trial admission of this information, says Jon Gryskiewicz at Lewis Baach.

• West Coast Health Cos. Must Brace For Federal Enforcement

  

  In light of the U.S. Department of Justice's newly established West Coast strike force targeting healthcare fraud across Northern California, Arizona and Nevada, health organizations will need to prioritize knowledge, vigilance and operational discipline to reduce exposure from potentially parallel criminal and civil investigations, says Michael Beckwith at Dickinson Wright.

• High Court's Hikma Decision Reshapes 'Skinny Label' Suits

  

  The U.S. Supreme Court's decision in Hikma v. Amarin marks a significant victory for generic drug manufacturers, but rather than putting an end to so-called skinny label inducement claims, it narrows and refocuses them, say attorneys at Sterne Kessler.

• Turning To The Courts When PBM Reform Falls Short

  

  The effectiveness of state laws intended to regulate pharmacy benefit managers remains uncertain, but litigation — utilizing tried-and-true theories like breach of contract and fair dealing — offers another mechanism through which stakeholders may seek relief from PBMs, say attorneys at Reed Smith.

• High Court's Abortion Pill Stay Reinforces Appellate Principles

  

  The U.S. Supreme Court's recent order in Danco Laboratories v. Louisiana, staying a Fifth Circuit ruling that reinstated an in-person requirement for dispensing the abortion medicine mifepristone, should be seen not as a definitive ruling on reproductive rights, but as an affirmation of a more disciplined jurisdictional reality, says Daniel Nardo at Nardo & Associates.

• Bracing For Enforcers' Growing Focus On Behavioral Health

  

  While recent law enforcement scrutiny of the behavioral health industry has resulted in several settlements, indicating that more enforcement activity is on the way, organizations now have an opportunity to take proactive compliance measures, says Jeffrey Fitzgerald at Polsinelli.

• DOJ Activity Indicates Rising Antitrust Risk For Hospitals

  

  Two civil actions filed by the U.S. Department of Justice against New York-Presbyterian Hospital and OhioHealth, both alleging that the hospital systems used their market power to stifle competition, highlight the government's growing scrutiny of barriers to lower-cost insurance options, say attorneys at Freshfields.

• Engaging With FDA's New Complete Response Letter Policy

  

  A citizen petition filed with the U.S. Food and Drug Administration last month puts renewed focus on the agency's practice of releasing complete response letters in near real time, materially altering the context in which life sciences companies communicate with investors regarding regulatory developments, say attorneys at Debevoise.

• Trump's Psychedelics EO Creates A Regulatory Collision

  

  Sponsors pursuing U.S. Food and Drug Administration approval for psychedelic drug access must tackle how to generate regulatory-grade safety and efficacy data in controlled trials when President Donald Trump's recent executive order on psychedelics mandates uncontrolled access through Right to Try, say Kimberly Chew at Husch Blackwell and Odette Hauke at Odette Alina.