Policy & Compliance

Expert Analysis

• 7 Considerations For Conducting Drug Clinical Trials Abroad

  

  With continuing cuts to U.S. Food and Drug Administration staffing motivating some pharmaceutical companies to consider developing drugs abroad, it's important to understand the additional risks and compliance requirements associated with conducting clinical studies in other countries, say attorneys at Morgan Lewis.

• Compliance Lessons From Warby Parker's HIPAA Fine

  

  The U.S. Department of Health and Human Services' civil money penalty against Warby Parker highlights the emerging challenges that consumer-facing brands encounter when expanding into healthcare-adjacent sectors, with Health Insurance Portability and Accountability Act compliance being a potential focus of regulatory attention, say attorneys at Saul Ewing.

• 5th Circ. Ruling Is Latest Signal Of Shaky Qui Tam Landscape

  

  In his recent concurring opinion in U.S. v. Peripheral Vascular Associates, a Fifth Circuit judge joined a growing list of jurists suggesting that the False Claims Act's whistleblower provisions are unconstitutional, underscoring that acceptance of qui tam relators can no longer be taken for granted, say attorneys at Miller & Chevalier.

• Medicare Advantage Enforcement Strong Amid Agency Cuts

  

  The second Trump administration's actions thus far suggest that Medicare Advantage enforcement remains a bipartisan focus despite challenges presented by evolving trends in federal agency staffing and resources, say attorneys at Ropes & Gray.

• A New Tool For Assessing Kickback Risks In Health Marketing

  

  The Seventh Circuit's recent decision in U.S. v. Sorensen, reversing a conviction after trial of a durable medical equipment distributor, highlights two principle considerations for determining whether payments to marketers in healthcare are unlawful under the Anti-Kickback Statute, says Elisha Kobre at Sheppard Mullin.

• How Trump Orders Affect Health Orgs.' Care For Trans Minors

  

  Two recent executive orders issued by President Donald Trump regarding gender-affirming care for minors have put healthcare organizations in a precarious situation, and these institutions should prepare for various implications and potential scenarios, say attorneys at ArentFox.

• Reproductive Health Under Trump So Far, And What's Next

  

  Based on priorities stated so far, the Trump administration will likely continue to weaken Biden-era policies that protect reproductive health, with abortion, in vitro fertilization and contraception all being issues to watch closely amid a post-Dobbs shift, say attorneys at McDermott.

• What's Next For Lab Test Regulation Without FDA Authority

  

  A recent Texas federal court decision vacating the U.S. Food and Drug Administration's final rule that would apply FDA regulations to laboratory-developed tests signals potential positive impacts in the diagnostic space, and could inspire more healthcare entities to litigate against the government, say attorneys at Hooper Lundy.

• 6 Criteria Can Help Assess Executive Branch Actions

  

  With new executive policy changes announced seemingly every day, several questions can help courts, policymakers and businesses determine whether such actions are proper, effective and in keeping with our democratic norms, say Marc Levin and Khalil Cumberbatch at the Council on Criminal Justice.

• Learning From COVID-19 Enforcement Against Nursing Homes

  

  Five years after the COVID-19 outbreak caused a high number of deaths in nursing homes, an examination of enforcement actions against nursing homes in New York and elsewhere in the country highlights obstacles that may arise when bringing cases of this type, and ways to overcome them, says Kenneth Levine at Stone & Magnanini.

• How Plan Sponsors Can Mitigate Risk In PBM Contracts

  

  A recent lawsuit in New York federal court alleges that JPMorgan caused exorbitant prescription costs by mishandling the pharmacy benefit manager arrangement, adding to a growing body of Employee Retirement Income Security Act fiduciary breach litigation and affirming that fiduciaries must proactively manage their healthcare plan vendors, say attorneys at Hall Benefits Law.

• 4th Circ. Health Data Ruling Opens Door To State Law Claims

  

  In Real Time Medical v. PointClickCare, the Fourth Circuit recently clarified that state law claims can rest in part on violations of a federal law that prohibits electronic health information blocking, expanding legal risks for health IT companies and potentially creating exposure to a range of competitive implications, say attorneys at BCLP.

• Unpacking Trump Admin Plans For Value-Based Care

  

  Recent developments from the Center for Medicare and Medicaid Innovation suggest the Trump administration intends to put its own stamp on value-based care, emphasizing cost savings assessment in particular, with its recent cancellation of several payment models that had supported primary care, says Miranda Franco at Holland & Knight.