Policy & Compliance

Expert Analysis

• Navigating FDA Supply Rule Leeway For Small Dispensers

  

  As the November compliance deadline for the U.S. Food and Drug Administration's new pharmaceutical distribution supply chain rules draws closer, small dispensers should understand the narrow flexibilities that are available, and the questions to consider before taking advantage of them, say attorneys at Faegre Drinker.

• 1st Gender Care Ban Provides Context For High Court Case

  

  The history of Arkansas' ban on gender-affirming medical care — the first such legislation in the U.S. — provides important insight into the far-reaching ramifications that the U.S. Supreme Court's decision in U.S. v. Skrmetti next term will have on transgender healthcare, says Tyler Saenz at Baker Donelson.

• 6 Lessons From DOJ's 1st Controlled Drug Case In Telehealth

  

  Following the U.S. Department of Justice’s first-ever criminal prosecution over telehealth-prescribed controlled substances in U.S. v. Ruthia He, healthcare providers should be mindful of the risks associated with restricting the physician-patient relationship when crafting new business models, says Jonathan Porter at Husch Blackwell.

• After Chevron: Scale Tips Favor Away From HHS Agencies

  

  The loss of Chevron deference may indirectly aid parties in challenging the U.S. Department of Health and Human Services' interpretations of regulations and could immediately influence several pending cases challenging HHS on technical questions and agency authority, say attorneys at Ropes & Gray.

• After Chevron: FDA Overreach May Find Itself In Crosshairs

  

  The U.S. Supreme Court's overturning of the Chevron doctrine is likely to unleash an array of challenges against the U.S. Food and Drug Administration, focusing on areas of potential overreach such as the FDA's authority under the Federal Food, Drug and Cosmetic Act, say attorneys at Debevoise.

• USPTO Disclaimer Rule Would Complicate Patent Prosecution

  

  The U.S. Patent and Trademark Office's proposed changes to terminal disclaimer practice could lead to a patent owner being unable to enforce a valid patent simply because it is indirectly tied to a patent in which a single claim is found anticipated or obvious in view of the prior art, say attorneys at Sterne Kessler.

• Navigating Scrutiny Of Friendly Professional Corps. In Calif.

  

  In light of ongoing scrutiny and challenges to private equity participation in the California healthcare marketplace, particularly surrounding the use of the friendly professional corporation model, management services organizations should consider implementing four best practices, say attorneys at Holland & Knight.

• Takeaways From New HHS Substance Use Disorder Info Rules

  

  A new U.S. Department of Health and Human Services rule continues the agency's efforts to harmonize complex rules surrounding confidentiality provisions for substance use disorder patient records, though healthcare providers will need to remain mindful of different potentially applicable requirements and changes that their compliance structures may require, say attorneys at Ropes & Gray.

• Calif. Banking Brief: All The Notable Legal Updates In Q2

  

  The second quarter of 2024 in California, which saw efforts to expand consumer protection legislation and enforcement actions in areas of federal focus like medical debt and student loans, demonstrated that the state's role as a trendsetter in consumer financial protection will continue for the foreseeable future, say attorneys at Sheppard Mullin.

• How Cannabis Rescheduling May Affect Current Operators

  

  The U.S. Drug Enforcement Agency's proposal to reschedule marijuana to Schedule III provides relief in the form of federal policy from the stigma and burdens of Schedule I, but commercial cannabis operations will remain unchanged until the federal-state cannabis policy gap is remedied by Congress, say Meital Manzuri and Alexis Lazzeri at Manzuri Law.

• Air Ambulance Ruling Severely Undermines No Surprises Act

  

  A Texas federal court's recent decision in Guardian Flight v. Health Care Service — that the No Surprises Act lacks a judicial remedy when a health insurer refuses to pay the amount established through an independent review — likely throws a huge monkey wrench into the elaborate protections the NSA was enacted to provide, says Mark DeBofsky at DeBofsky Law.

• Class Actions At The Circuit Courts: June Lessons

  

  In this month's review of class action appeals, Mitchell Engel at Shook Hardy considers two recent decisions from the Third and Tenth Circuits, and identifies practice tips around class action settlements and standing in securities litigation.

• How Congress Is Tackling The US Healthcare Shortage

  

  With healthcare shortages continuing across the U.S. despite industry efforts to improve patient access to care, increased Medicare support for graduate medical education could be a crucial component of the solution, say Sarah Crossan and Miranda Franco at Holland & Knight.