Policy & Compliance

Expert Analysis

• Key Takeaways As HRSA Aims To Revive 340B Rebate Pilot

  

  The U.S. Department of Health and Human Services' recent request for feedback on the 340B Rebate Model Pilot Program demonstrates that it intends to correct the model's procedural defects, which is positive news for participating manufacturers, but a setback for covered entities, say attorneys at Manatt.

• Unique Issues Facing Brand-Compounder Patent Litigation

  

  Recent litigation and potential enforcement action against Hims & Hers Health raise questions about how compounders and branded pharmaceuticals companies would be positioned in patent litigation as compared to generics companies, which would require strategies different from those that would be used in traditional Hatch-Waxman Act litigation, say attorneys at Morgan Lewis.

• Pros And Cons Of FDA's Push For Nonprescription Drugs

  

  The U.S. Food and Drug Administration's recent moves to shift more prescription drugs to over-the-counter status could increase access to important medications, but also bring potential safety risks and other trade-offs for drug companies, say attorneys at Hogan Lovells.

• Prepping For The Future Of No Surprises Act Enforcement

  

  This year is expected to be a transition point for the No Surprises Act framework from regulatory delay to operational enforcement, so stakeholders should use this time to stress-test systems, clean up processes and prepare for enforcement, say attorneys at Akerman.

• High Court's 'Skinny Label' Case May Tackle Wider Questions

  

  The U.S. Supreme Court's upcoming decision in Hikma v. Amarin will have important ramifications for broader debates over what defines a generic version of a drug, and the pending case is already altering patent practice, say attorneys at Taft.

• Unpacking Key Themes From NY's New Healthcare Strategy

  

  New York Gov. Kathy Hochul's 2026 State of the State agenda, read together with the state's fiscal year 2027 executive budget, reflect a clear framework to utilize Medicaid as the state's operating platform for healthcare reform, say attorneys at Sheppard.

• Trans Care Enforcement Landscape Is Evolving Quickly

  

  The recent coordinated federal effort to reshape pediatric gender-affirming care through enforcement and funding pressure has created a rapidly evolving regulatory environment marked by shifting risk assessments and potential downstream market effects for healthcare institutions and life sciences companies, say attorneys at Arnall Golden.

• 11th Circ. May Bring Tectonic Shift To FCA Qui Tam Actions

  

  The Eleventh Circuit's upcoming decision in Zafirov v. Florida Medical Associates, assessing whether the False Claims Act permits ordinary citizens to stand as officers of the federal government, could significantly limit private relators' ability to bring FCA actions, say attorneys at Saul Ewing.

• To Survive FCA Actions, Small Cos. Must Take Offensive Steps

  

  A fumbled response to False Claims Act allegations can doom lower-middle-market businesses, and with FCA enforcement hitting record levels for two years, smaller companies must have offensive strategies ready that focus their limited resources on defeating civil qui tam and federal criminal actions, says Derrelle Janey at Olshan Frome.

• Record FCA Recoveries Signal Intensified Healthcare Focus

  

  In its recently released False Claims Act statistics, the U.S. government's emphasis on record healthcare recoveries and government-initiated healthcare matters last year indicates robust enforcement ahead, though the administration's focus on current policy objectives also extends beyond the healthcare sector, say attorneys at Epstein Becker.

• A Potential Shift In FDA's Approach To Drug Trial Design

  

  Recent guidance released by the U.S. Food and Drug Administration clarifying how Bayesian approaches — which combine prior knowledge with new data — may be used in clinical trials reflects the agency's continued interest in innovative trial designs that may accelerate drug approvals, say attorneys at Alston & Bird.

• What FDA Guidance Means For Future Of Health Software

  

  Two significant final guidance documents released by the U.S. Food and Drug Administration last month reflect a targeted effort to ease innovation friction around specific areas, including singular clinical decision support recommendations and sensor-based wearables, while maintaining established regulatory boundaries, say attorneys at Covington.

• How State FCA Activity May Affect Civil Fraud Enforcement

  

  A growing trend of state attorneys general enforcing their False Claims Act analogues independently of the U.S. Department of Justice carries potential repercussions for civil fraud enforcement and qui tam litigation considerations, say Li Yu at Bernstein Litowitz, Ellen London at London & Naor and Gwen Stamper at Vogel Slade.