Policy & Compliance

Expert Analysis

• Regulatory Uncertainty Ahead For Organ Transplant System

  

  Pending court cases against a Centers for Medicare and Medicaid Services final rule that introduced a competition-centric model for assessing organ procurement organizations' performance will significantly influence the path forward for such organizations and transplant hospitals, say attorneys at Crowell & Moring.

• Key False Claims Act Trends From The Last Year

  

  The False Claims Act remains a powerful enforcement tool after some record verdicts and settlements in 2025, and while traditional fraud areas remain a priority, new initiatives are raising questions about its expanding application, says Veronica Nannis at Joseph Greenwald.

• It's Too Soon To Remove Suicide Warnings From GLP-1 Drugs

  

  The U.S. Food and Drug Administration's decision this month to order removal of warnings about the risk of suicidal thoughts from GLP-1 weight-loss drugs is premature — and from a safety and legal standpoint, the downside of acting too soon could be profound, says Sean Domnick at Rafferty Domnick.

• What To Know About DOL's New FLSA, FMLA Opinion Letters

  

  The U.S. Department of Labor kicked off 2026 by releasing several opinion letters addressing employee classification, incentive bonuses and intermittent leave, reminding employers that common practices can create significant risk if they are handled inconsistently or without careful documentation, say attorneys at Woods Rogers.

• What Changed For Healthcare Transaction Law In 2025

  

  Though much of the legislation introduced last year to expand state scrutiny of healthcare transactions did not pass, investors should pay close attention to the overarching trends, which are likely to continue in this year's legislative sessions, say attorneys at Ropes & Gray.

• Expect State Noncompete Reforms, FTC Scrutiny In 2026

  

  Employer noncompete practices are facing intensified federal scrutiny and state reforms heading into 2026, with the Federal Trade Commission pivoting to case-by-case enforcement and states continuing to tighten the rules, especially in the healthcare sector, say attorneys at DLA Piper.

• CMS 2027 Proposal Is Mixed Bag For Medicare Advantage

  

  The Centers for Medicare and Medicaid Services' recent proposed rule for the Medicare Advantage and Part D programs gives small organizations reason for optimism, although certain elements may be inconsistent with the Centers' desire to enhance competition, says Christine Clements at Sheppard Mullin.

• 3 Key Takeaways From Planned Rescheduling Of Cannabis

  

  An executive order reviving cannabis rescheduling represents a monumental change for the industry and, while the substance will remain illegal at the federal level, introduces several benefits, including improving state-legal cannabis operators' tax treatment, lowering the industry's legal risk profile, and leaving state-regulated markets largely intact, say attorneys at Dentons.

• 6 Issues That May Follow The 340B Rebate Pilot Challenge

  

  Though the Health Resources and Services Administration withdrew a pending case to reconsider the controversial 340B rebate pilot program, a number of crucial considerations remain, including the likelihood of a rework and questions about what that rework might look like, say attorneys at Spencer Fane.

• 2026 State AI Bills That Could Expand Liability, Insurance Risk

  

  State bills legislating artificial intelligence that are expected to pass in 2026 will reshape the liability landscape for all companies incorporating AI solutions into their business operations, as any novel private rights of action authorized under AI-related statutes signal expanding exposures, say attorneys at Wiley.

• How 11th Circ.'s Zafirov Decision Could Upend Qui Tam Cases

  

  Oral argument before the Eleventh Circuit last month in U.S. ex rel. Zafirov v. Florida Medical Associates suggests that the court may affirm a lower court's opinion that the qui tam provisions of the False Claims Act are unconstitutional — which could wreak havoc on pending and future qui tam cases, say attorneys at Morgan Lewis.

• Key Trends For Life Sciences Cos. To Watch In 2026

  

  Following a year of drastic change at the U.S. Food and Drug Administration, two themes are likely to drive the coming year — a commitment to lowering the cost of drugs and an inherent tension between the priorities of the health agencies and the broader administration, say attorneys at Sheppard Mullin.

• The Next Pressure Point In Digital Health: Informed Consent

  

  Two new federal digital health initiatives will usher in a new era where virtual care, software-enabled devices and home-based monitoring are integrated into care and reimbursement models, with the impact of shifting rules and opportunities felt most immediately in the context of informed consent, says Kimberly Chew at Husch Blackwell.