Policy & Compliance

Expert Analysis

• 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.

• What To Expect For Stem Cell Regulation Under Trump Admin

  

  The new administration's push for deregulation, plus the post-Chevron legal landscape, and momentum from key political and industry players to facilitate stem cell innovation may create an opportune backdrop for a significant reduction in the U.S. Food and Drug Administration's regulatory framework for stem cells, say attorneys at Sheppard Mullin.

• How Importers Can Minimize FCA Risks Of Tariff Mitigation

  

  False Claims Act risks are inherent in many tariff mitigation strategies, making it important for importers to implement best practices to identify and report potential violations of import regulations before they escalate, says Samuel Finkelstein at LMD Trade Law.

• 10 Practical Takeaways From FDA's Biopharma AI Guidance

  

  Recent guidance from the U.S. Food and Drug Administration provides much-needed insight on the usage of artificial intelligence in producing information to support regulatory decision-making regarding drug safety, with implications ranging from life cycle maintenance to AI tool acquisition, say attorneys at Covington.

• Lawmakers Shouldn't Overlook Rare Disease Therapies' Value

  

  As the ORPHAN Cures Act is pending in Congress, policymakers assessing the value of certain drugs for price regulation should consider data beyond what is collected in clinical trials, say Alice Chen at the University of Southern California, and Molly Frean and Yao Lu at Analysis Group.

• What Trump's Order Means For The Legal Status Of IVF

  

  An executive order signed by President Donald Trump last month signals the administration's potential intention to increase protections for in vitro fertilization services, though more concrete actions would be needed to resolve the current uncertainty around IVF access or bring about a binding legal change, says Jeanne Vance at Weintraub Tobin.

• Mitigating Tariff Risks For Healthcare In US And Canada

  

  Healthcare stakeholders should take steps to evaluate the impact of cross-border tariffs, as the historically strong ties between Canada and the U.S. demonstrate the potential for real disruption and harm to the healthcare industry in both countries, say attorneys at Norton Rose.

• What's At Stake In High Court Transgender Care Suit

  

  The outcome of U.S. v. Skrmetti will have critical implications for the rights of transgender youth and their access to gender-affirming care, and will likely affect other areas of law and policy involving transgender individuals, including education, employment, healthcare and civil rights, say attorneys at ArentFox Schiff.

• 6 Laws Transforming Calif.'s Health Regulatory Framework

  

  Attorneys at Hooper Lundy discuss a number of new California laws that raise pressing issues for independent physicians and small practice groups, ranging from the use of artificial intelligence to wage standards for healthcare employees.

• Anticipating Calif. Oversight Of PE Participation In Healthcare

  

  A new bill recently introduced in the California Senate revives last year's attempt to increase oversight of healthcare transactions involving private equity groups and hedge funds, meaning that attorneys may soon need to assess the compliance status of existing management relationships and consider modifying contract terms, says Andrew Demetriou at Husch Blackwell.

• Considering The Future Of AI Regulation On Health Sector

  

  As Texas looks to become the next state to pass a comprehensive law regulating artificial intelligence, the healthcare industry should consider how AI regulation will continue to evolve in the U.S. and how industry members can keep up with compliance considerations, say attorneys at Kirkland & Ellis.