Policy & Compliance

Expert Analysis

• 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.

• 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.