Policy & Compliance

Expert Analysis

• 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.

• 4 Trends Shaping Drug And Medical Device Law For 2026

  

  2025 saw some significant legal developments with potential impact for drug and device manufacturers, ranging from growing skepticism in science and regulatory entities to new regulation of artificial intelligence, say attorneys at Faegre Drinker.

• Preparing For Congressional Investigations In A Midterm Year

  

  2026 will be a consequential year for congressional oversight as the upcoming midterm elections may yield bolder investigations and more aggressive state attorneys general coalitions, so companies should consider adopting risk management measures to get ahead of potential changes, say attorneys at Morgan Lewis.

• A Meaningful Shift In FDA's Biosimilarity Analysis

  

  The U.S. Food and Drug Administration's potential pivot away from routinely requiring comparative efficacy studies for interchangeable biosimilar applications would not lower regulatory standards, but instead allow applicants to allocate resources toward establishing more probative evidence, says Theodore Thompson at Stinson.

• Top 5 Antitrust Issues For In-House Counsel To Watch In 2026

  

  With Trump administration enforcement policy having largely taken shape last year, antitrust issues that in-house counsel should have on the radar range from scrutiny of technology-assisted pricing to the return of merger remedies, say attorneys at Squire Patton.

• 2025 Legal Milestones That Will Shape Psychedelics Sector

  

  As 2025 draws to a close, psychedelic drug development stands at an inflection point, experiencing unprecedented momentum through recent sweeping regulatory changes and landmark clinical milestones, amid rapidly evolving regulatory expectations, say Odette Hauke at Odette Alina LLC and Kimberly Chew at Husch Blackwell.

• 2025 State AI Laws Expand Liability, Raise Insurance Risks

  

  As 2025 nears its end, claims professionals should be aware of trends in state legislation addressing artificial intelligence use, as insurance claims based on some of these liability-expanding statutes are a certainty, say attorneys at Wiley.