Policy & Compliance

Expert Analysis

• FDA Framework For Personalized Therapies Raises Questions

  

  The U.S. Food and Drug Administration's new plausible mechanism framework for developing individualized therapies reflects the agency's focus on rare-disease drugs, but numerous significant, unresolved issues cast uncertainty on how effective the framework will be in practice, say attorneys at Ropes & Gray.

• Scrutiny Of Nursing Home Practices Marks Inflection Point

  

  Recent congressional inquiries into UnitedHealth Group's Medicare Advantage-linked nursing home practices raise questions about whether financial metrics are allowed to influence decisions governed by the standard of care, and could implicate duties imposed by federal regulations, state negligence laws and elder abuse statutes, says Lindsey Gale at Rafferty Domnick.

• 7 Steps For Gov't Contractors In Post-IEEPA Tariff Landscape

  

  In response to U.S. Supreme Court's recent decision to strike down tariffs issued by the Trump administration under the International Emergency Economic Powers Act, there are several actions federal contractors should take to preserve their place in any refund waterfall, and to manage audit, overpayment and False Claims Act risk, say attorneys at Holland & Knight.

• CMS Healthcare Enforcement Initiatives May Cause Disruption

  

  The Centers for Medicare & Medicaid Services' recently announced enforcement actions against healthcare fraud mark a significant escalation, and CMS' prior approach in the hospice sector suggests that even compliant providers and suppliers should brace for impact, say attorneys at Morgan Lewis.

• What We Know About DOJ's New FCA Enforcement Priorities

  

  Recent remarks from the leader of the Justice Department’s commercial litigation branch provide key insights on how False Claims Act cases — especially healthcare fraud, trade fraud, antidiscrimination and cybersecurity claims — will be evaluated, prioritized and pursued as heightened enforcement becomes the new normal, say attorneys at Latham.

• How PBMs Can Adapt To Plan Sponsors' Disclosure Demands

  

  As federal reforms, growing state regulation and litigation threats push plan sponsors to expect visibility into revenue streams, pharmacy benefit managers should leverage transparency strategically, including by simplifying how they get paid, offering clients audit-ready data and co-designing contracts that are easy for fiduciaries to explain and defend, says Kristie Blase at Frazer + Blase.

• How To Engage With Gov't's Direct-To-Consumer Drug Policy

  

  The U.S. Department of Health and Human Services' recent request for industry input on manufacturers' direct-to-consumer drug sales reflects the government's caution in this arena, and allows stakeholders a rare opportunity to help shape policy, says Mary Kohler at Kohler Health Law.

• When Fraud Involvement Disqualifies FCA Whistleblowers

  

  A Massachusetts federal court's recent dismissal of a False Claims Act relator in U.S. ex rel. Perry v. First Psychiatric Planners provides instructive insight into when whistleblowers may be denied their share of settlement proceeds, even if their involvement in the underlying fraud is a step removed, say attorneys at Holland & Knight.

• Lessons From Justices' Split On Major Questions Doctrine

  

  The justices' varied opinions in Learning Resources v. Trump, which held the International Emergency Economy Powers Act did not confer the power to impose tariffs, offer a meaningful window into the U.S. Supreme Court's perspective on the major questions doctrine that will likely shape lower courts' approach to executive action challenges, say attorneys at Venable.

• Drug Wholesaler's DPA Shows Imperfect Efforts Still Count

  

  Atlantic Biologicals’ recent deferred prosecution agreement with federal prosecutors for allegedly distributing controlled substances to pill mill pharmacies demonstrates that even subpar cooperation, when combined with genuine remediation and strategic advocacy, can yield outcomes that protect a company's long-term interests, says Jonathan Porter at Husch Blackwell.

• 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.