Policy & Compliance

  • July 07, 2026

    Fla. Hospital Says Lilly's 340B Data Requirement Is Onerous

    A Florida hospital pushed back against pharmaceutical giant Eli Lilly over the drugmaker's requirement that providers hand over drug dispensing data before federal price discounts are applied, saying the policy is overly burdensome.

  • July 07, 2026

    Mayo Sacked Research Director For Flagging Flaws, Suit Says

    Mayo Clinic retaliated against and eventually terminated its director of research operations after she brought up concerns about security, safety and privacy regarding the medical center's use of artificial intelligence and other protocols, according to a lawsuit filed in Minnesota federal court on Monday.

  • July 07, 2026

    Courts Rule On Amgen Drug Price Cap, 340B Laws And More

    Despite the short break in the summer for America's 250th birthday, judges continued doling out important healthcare decisions. Here, Law360 takes a quick look at noteworthy healthcare litigation over the past week. 

  • July 07, 2026

    Groups Tell 4th Circ. Not To Let Sandoz 'Relitigate' Enbrel

    Pharmaceutical groups and the Washington Legal Foundation backed Amgen in amicus briefs Monday urging the Fourth Circuit not to revive Sandoz's antitrust claims, arguing that if Sandoz wanted to litigate blocked biosimilar competition to Enbrel, it needed to do so when Amgen sued it for patent infringement.

  • July 07, 2026

    Feds Push 3rd Circ. To Restore ACA Birth Control Exemptions

    Lawyers for the Trump administration and a Catholic religious order Tuesday asked the Third Circuit to restore broad exemptions to the Affordable Care Act's birth control coverage mandate, arguing federal agencies had discretion to pass rules that effectively enabled employers to "opt in" to the mandate rather than opt out.

  • July 07, 2026

    NY Hospital Reaches Deal To End Tobacco Surcharge Suit

    An upstate New York hospital has agreed to settle an employee's proposed class action alleging it unlawfully charged workers who used tobacco hundreds of dollars more per year for health benefits, according to a federal court filing.

  • July 07, 2026

    DOJ Backs Private Claims Against NewYork-Presbyterian

    The U.S. Department of Justice has thrown its support behind claims from union benefit funds in New York federal court that mirror the government's own case accusing NewYork-Presbyterian Hospital of blocking cheaper insurance plans.

  • July 07, 2026

    5th Circ. Again Nixes Challenge To La. 340B Drug Delivery Law

    A Fifth Circuit panel doubled down on its decision to uphold a Louisiana law prohibiting drug manufacturers from blocking contracts between pharmacies and providers in the federal 340B drug discount program, reiterating that conclusion upon rehearing but this time allowing intervention by an advocacy group.

  • July 07, 2026

    HHS Swerves After Ruling On RFK Jr.'s Gender Edict

    The Trump administration wants a federal judge to amend a decision blocking a policy declaration by Health and Human Services Secretary Robert F. Kennedy Jr. Experts say the move signals HHS' intent to look for other legal avenues to target gender-affirming care.

  • July 06, 2026

    5,000 Pharmacies Accuse Prime Therapeutics Of Price-Fixing

    Nearly 5,000 pharmacies accuse Prime Therapeutics LLC of entering into an unlawful price-fixing agreement with rival pharmacy benefit manager Express Scripts Inc. to deflate pharmacies' reimbursement rates and inflate their fees, according to a new lawsuit filed in Seattle federal court.

  • July 06, 2026

    Mich. Medicaid Services Dispute Sent Back To Mediation

    A Michigan federal judge on Monday ordered the parties back to mediation in a long-running dispute over Medicaid-funded services for people with intellectual and developmental disabilities after disagreements emerged over compliance with a court-approved settlement agreement. 

  • July 06, 2026

    After Tense Terms, Hints Of High Court Harmony With Circuits

    Following several U.S. Supreme Court terms teeming with reversals and rebukes of lower appeals courts, the justices this term found fault less often with rulings by circuit judges, who are likely becoming better attuned to the conservative supermajority, attorneys say.

  • July 06, 2026

    The Moments That Shaped The Monsanto Decision

    U.S. Supreme Court justices forged unusual alliances when they ruled a federal statute preempts claims Monsanto failed to warn consumers its Roundup weed killer may cause cancer. Oral arguments provided insights on the 7-2 outcome, highlighting issues the jurists were grappling with and showcasing rationales that found their way into the opinion.

  • July 06, 2026

    The Funniest Moments Of The Supreme Court's Term

    When one of the U.S. Supreme Court's most talkative members suddenly struggled to speak, the atmosphere at oral arguments grew increasingly anxious — until the justice deadpanned that it was an advocate's golden opportunity to avoid a grilling.

  • July 06, 2026

    Illumina Looks To Duck DNA Rival's Renewed Antitrust Case

    Illumina told a California federal court an antitrust case from DNA sequencing startup Element Biosciences should be tossed for good because it continues to attack legitimate discounts that do nothing to block competition.

  • July 06, 2026

    DOD, Humana Seek Toss Of $270K Tricare Coverage Row

    The U.S. Department of Defense and a Humana unit urged a D.C. federal court to toss allegations that they wrongfully denied Tricare coverage for a minor's inpatient mental health treatment, arguing the minor's parents lack standing because they weren't billed for the treatment at issue.

  • July 02, 2026

    The Sharpest Dissents From The Supreme Court Term

    The sharpest dissents this term often involved the president, and pitted conservative and liberal justices against each other on core constitutional issues and questions about the limits to executive power, with nearly a quarter of cases being decided squarely along ideological lines.

  • July 02, 2026

    The Firms That Won Big At The Supreme Court

    This U.S. Supreme Court term featured high-stakes oral arguments on issues including presidential power, immigration and voting regulations. Here's a look at the law firms that argued the most cases and how they fared.

  • July 02, 2026

    The Year Donald Trump Won Big At The High Court

    The Supreme Court's conservative supermajority and President Donald Trump largely aligned this year on issues of executive power, resulting in a series of decisions that significantly expanded presidential authority.

  • July 02, 2026

    DOJ Has 'Negligible Interest' In Trans Patient Info, Judge Says

    A California federal judge on Thursday blocked the U.S. Department of Justice from trying to identify individuals who received gender-affirming care from a Stanford Medicine hospital as minors, finding grand jury subpoena demands seeking that information likely violated the Fifth Amendment.

  • July 02, 2026

    8th Circ. Revives Local Conversion Therapy Ban Challenge

    The Eighth Circuit revived a case Thursday challenging local ordinances passed in Kansas City and Jackson County, Missouri, that prohibited the practice of conversion therapy, as it is commonly known, with minors.

  • July 02, 2026

    Judge Questions Imminent Harm In Light Of Valid Passport

    A district judge on Thursday questioned whether a transgender woman suing the government over a new federal policy targeting gender identification was facing an impending threat since her passport with her chosen identity is valid for another six years.

  • July 02, 2026

    Breaking Down The Vote: The High Court Term In Review

    The U.S. Supreme Court's stark ideological divisions were on full display this term, particularly as it issued long-awaited rulings in the last few days of June. Here, Law360 dives into the numbers behind this court term.

  • July 02, 2026

    CMS Proposes Cut To Hospitals' 340B Drug Reimbursements

    Federal health officials on Thursday proposed a Medicare spending plan that would slash reimbursement for hospitals participating in the 340B drug pricing program and reduce how much all hospitals receive for certain imaging tests.

  • July 01, 2026

    Alibaba Cos. Ink $600M Nonprosecution Deal Over Drug Sales

    Alibaba Group Holding Ltd. and its U.S.-based payment processor AUS Merchant Services Inc. will avoid prosecution and pay $600 million to end the U.S. Department of Justice's allegations that they allowed merchants to sell and import illegal pharmaceuticals and controlled substances into the U.S., the DOJ announced Wednesday.

Expert Analysis

  • Legal Risks Of Using AI To Screen Psychedelic Trial Patients

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    Though using artificial intelligence to preemptively identify drug trial participants likely to experience placebo effects could produce clearer research results, sponsors will need to be ready for the new legal questions these methods raise about informed consent, accountability for algorithmically derived criteria, and potential bias in data training sets, says Kimberly Chew at Husch Blackwell.

  • How 6th Circ. Tightened NLRB Injunction Standard

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    The Sixth Circuit's recent ruling in Kerwin v. Trinity Health Grand Haven Hospital, dissolving a Section 10(j) injunction obtained by the National Labor Relations Board against an employer that refused to bargain, will make it harder for the NLRB to obtain injunctions while prosecuting unfair labor practice proceedings, say attorneys at Bass Berry.

  • Md. Ruling Reflects Classic Administrative Law Principle

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    A Maryland federal court's recent decision in Columbus v. Kennedy significantly limits how far the Centers for Medicare & Medicaid Services can go in reshaping the Affordable Care Act through regulation, highlighting a principle that will likely be applied in similar Administrative Procedure Act challenges, says Michael King at Brownstein Hyatt.

  • Healthcare Orgs Should Prep For Greater Grant Oversight

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    The U.S. Department of Health and Human Services' new Audit Enforcement and Risk Oversight initiative, and a proposed overhaul of the governmentwide framework for grants management, signal an aggressive and data-driven approach to federal grant enforcement, and could significantly expand the pathways leading to enforcement actions and private litigation, say attorneys at Norton Rose.

  • 3rd Circ. Decision Sheds Light On BIPA Bank Exemption

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    The Third Circuit's recent decision in McGoveran v. Amazon illuminates how courts are extending the Illinois Biometric Information Privacy Act's financial institution carveout beyond banks and insurers to technology vendors and other businesses handling biometric data, a defendant-friendly shift that still casts uncertainty around BIPA's enforcement, say attorneys at Dorsey & Whitney.

  • Data Reveals Pivot In Feds' Financial Fraud Priorities

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    Recent Justice Department data shows fraud prosecutions fell to their lowest rate in a decade in 2025, illustrating a move away from traditional financial cases and toward a targeted mix of healthcare, government program, consumer and sanctions matters, say Paul Hinton and Adrienna Huffman at The Brattle Group.

  • New Timeline For Benefits Cases May Increase FCA Litigation

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    Recent reforms designed to speed enforcers’ intervention decisions in False Claims Act suits involving state-administered benefits will likely encourage more qui tam relators to litigate cases without the government’s imprimatur, and increase defendants’ discovery burdens, defense costs and business disruptions, say attorneys at Morgan Lewis.

  • FTC's Clinical Trial Requirement Threatens Food Claim Rules

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    The Federal Trade Commission's general requirement for randomized controlled trials for most health-benefit claims, recently embraced by the National Advertising Review Board, lacks legal basis and endangers the existing statutory framework Congress created for marketing food and dietary supplements versus drugs, say attorneys at Keller & Heckman.

  • HHS Enforcement Restructuring Signals Compliance Risks

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    The U.S. Department of Health and Human Services' recent restructuring of its Office for Civil Rights suggests that, while Health Insurance Portability and Accountability Act enforcement remains central, its priorities have expanded to encompass civil rights, conscience and religious freedom, and data and cybersecurity issues, say attorneys at King & Spalding.

  • AG Watch: Oregon's Strategic Civil Enforcement Approach

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    Oregon Attorney General Dan Rayfield’s recent antitrust litigation activity and proposed staffing increase are the latest in a series of structural and policy changes that signal that the state Department of Justice is taking a more aggressive approach to civil enforcement, says Keturah Taylor at Cozen O'Connor.

  • A Decade Later, Escobar Is Still Shaping FCA Cases

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    The U.S. Supreme Court's decision 10 years ago in Universal Health Services v. U.S. ex rel. Escobar changed the way in which lower courts evaluate False Claims Act cases — and the ruling remains vital in nearly every FCA case filed today, say attorneys at Bradley Arant.

  • How FCA, FCPA Risks Are Shifting As Feds Pull Back

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    As the federal government continues its retreat from white collar enforcement, companies should expect False Claims Act risk to grow through private whistleblower suits and Foreign Corrupt Practices Act scrutiny to shift toward foreign prosecutors, requiring more adaptability as accountability becomes less centralized, says Temidayo Aganga-Williams at Selendy Gay.

  • Trump Admin's Agency Records Purge Tests Judicial Notice

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    While courts commonly take judicial notice of data in government websites and reports, the Trump administration's recent modification or wholesale deletion of these sources means that litigants must look elsewhere to support trial admission of this information, says Jon Gryskiewicz at Lewis Baach.