Policy & Compliance

Expert Analysis

• 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.

• Wage-Based H-1B Rule Amplifies Lottery Risks For Law Firms

  

  Under the wage-based H-1B lottery rule taking effect Feb. 27, law firms planning to hire noncitizen law graduates awaiting bar admission should consider their options, as the work performed by such candidates may sit at the intersection of multiple occupational classifications with differing chances of success, says Jun Li at Reid & Wise.

• Assessing Compliance Risks Around TrumpRx Participation

  

  As there are novel compliance obligations and potential political opposition related to the new TrumpRx online drug platform, companies intending to participate on the site should consider the pressure points that are likely to draw enforcement scrutiny, say attorneys at Sheppard.

• Predicting Actual Impact From CDC's New Vaccine Guidance

  

  Recent federal changes to the childhood immunization schedule, reducing the number of vaccine recommendations from 18 to 11, do not automatically create enforceable obligations for parents, schools or healthcare providers, but may spur litigation and other downstream effects on school policies and state guidelines, says Mehdi Sinaki at Michelman & Robinson.

• What Rescheduling Means For Cannabis Labels, Marketing

  

  The proposed reclassification of cannabis is expected to bring heightened scrutiny of labeling, advertising and marketing from the U.S. Food and Drug Administration and the Federal Trade Commission, but the brands that tighten evidence, standardize operations and professionalize marketing controls now will see fewer surprises and better outcomes, say attorneys at Wilson Elser.

• What's At Stake In Possible Circuit Split On Medicaid Rule

  

  A recent Eleventh Circuit decision, reviving Florida's lawsuit against a federal rule that reduces Medicaid funding based on agreements between hospitals, sets up a potential circuit split with the Fifth Circuit, with important ramifications for states looking to private administrators to run provider tax programs, say Liz Goodman, Karuna Seshasai and Rebecca Pitt at FTI Consulting.

• Courts' Rare Quash Of DOJ Subpoenas Has Lessons For Cos.

  

  In a rare move, three federal courts recently quashed or partially quashed expansive U.S. Department of Justice administrative subpoenas issued to providers of gender-affirming care, demonstrating that courts will scrutinize purpose, cabin statutory authority and acknowledge the profound privacy burdens of overbroad government demands for sensitive records, say attorneys at ArentFox Schiff.