Policy & Compliance

  • September 12, 2025

    AbbVie Can't Halt Miss. Discount Drug Law, 5th Circ. Says

    AbbVie and other pharmaceutical manufacturers that participate in Medicaid cannot preliminarily block a Mississippi law barring their interference with the distribution of discounted prescriptions to pharmacies serving low-income patients, the Fifth Circuit ruled Friday, saying the drugmakers haven't shown that the statute likely effectuates a taking of their property.

  • September 12, 2025

    Ex-Conn. Assistant AG Faces DQ Bid In Price-Fixing Case

    Drug companies accused of fixing prices for generics are seeking to disqualify former Connecticut Assistant Attorney General Joseph Nielsen and his law firm from representing insurers in a multidistrict litigation, arguing Nielsen had access to confidential information as a government attorney that he could unfairly use against them now.

  • September 11, 2025

    States Push Conn. Court To Ban Generic Drug Price-Fixing

    A court order is necessary to prevent pharmaceutical companies and their executives from illegally fixing the prices of generic drugs, a coalition of state enforcers have told a Connecticut federal judge, arguing there is a "reasonable expectation" that the allegedly anticompetitive behavior at the center of multidistrict litigation will happen again.

  • September 11, 2025

    Medicare Drug Pricing Plan Survives Novartis' 3rd Circ. Appeal

    The Third Circuit ruled Thursday that the Centers for Medicare & Medicaid Services' ability to negotiate "maximum fair prices" with drugmakers doesn't violate their constitutional rights, rejecting an argument by Novartis Pharmaceuticals Corp. that the practice amounted to a raw deal for the pharmaceutical industry.

  • September 11, 2025

    Expert's AI Hallucinations Blamed On Attys' 'Willful Blindness'

    Utah anesthesiologists facing a False Claims Act fraudulent billing suit doubled down Wednesday on their bid to sanction and disqualify the whistleblower's counsel for not catching an expert witness report with numerous AI-generated fabrications, arguing the errors were so obvious that the failure to catch them constitutes "willful blindness."

  • September 11, 2025

    1st Circ. OKs Freeze Of Planned Parenthood Medicaid Funding

    The First Circuit on Thursday allowed the Trump administration to halt Medicaid reimbursements to Planned Parenthood and its affiliates, pausing a pair of lower court rulings that had blocked the funding cut.

  • September 11, 2025

    7th Circ. Backs $183M FCA Award Over Eli Lilly Drug Rebates

    The Seventh Circuit refused on Thursday to unwind a whistleblower's $183 million trial win against Eli Lilly in a false claims case targeting more than a decade of drug rebate miscalculations, saying a jury reasonably found that the company knowingly "hid the truth" about how much it charged for Medicaid-covered drugs.

  • September 11, 2025

    LifePoint Must Face Workers' 401(k) Mismanagement Suit

    A Tennessee federal judge refused to toss a proposed class action against LifePoint Health Inc. from participants in the healthcare company's employee 401(k) plan who alleged their retirement savings were dragged down by excessive recordkeeping and administrative fees, concluding allegations were sufficiently backed up to proceed to discovery.

  • September 10, 2025

    Feds Barred From Axing 30-Year Noncitizen Services, For Now

    A Rhode Island federal judge Wednesday blocked the Trump administration from enacting a policy change requiring immigration status checks for a number of federally funded community services, saying a coalition of Democratic-led states is likely to succeed in its assertion that the move is unconstitutional, as well as arbitrary and capricious.

  • September 10, 2025

    FTC Urged To Probe Microsoft Over Ascension Data Breach

    U.S. Sen. Ron Wyden, D-Ore., is calling on the Federal Trade Commission to open an investigation into Microsoft's "gross cybersecurity negligence" that has allegedly contributed to cyberattacks against critical infrastructure providers, including a 2024 ransomware hack that targeted hospital system Ascension.

  • September 10, 2025

    FTC Warns Healthcare Employers About Noncompetes

    The Federal Trade Commission has sent letters warning healthcare employers and staffing companies not to include overly broad noncompete restrictions in their employment contracts and urged them to conduct a review to ensure they comply with the law.

  • September 10, 2025

    Medical Equipment Co. Settles County Claims In Opioid MDL

    Medical equipment company Henry Schein Inc. and its related entities have settled claims by Virginia counties brought against it in the sprawling national opioid litigation, according to a notice filed Wednesday.

  • September 09, 2025

    4th Circ. Debates Whether 'Silence' In 340B Empowers States

    Two states told a Fourth Circuit panel on Tuesday that "silence" in the law governing the federal government's drug discount program permits state enforcers to step in and regulate the delivery of those drugs to their communities.

  • September 09, 2025

    Trump Admin Blocked From Boston Hospital Trans Care Docs

    A Massachusetts federal judge on Tuesday blocked the Trump administration's bid to gain access to a wide array of documents related to gender-affirming care at Boston Children's Hospital, finding that the request is a veiled attempt to limit such care in the state.

  • September 09, 2025

    Colo. Justices Rule Interest Not Covered By $1M Med Mal Cap

    The Colorado Supreme Court has ruled that the state's $1 million cap on medical malpractice damages doesn't encompass certain interest awards when the so-called good cause exception applies, in a suit accusing a doctor of causing a baby's severe brain injury.

  • September 09, 2025

    Omni Must Pay Atty Fees Over 'Troubling' Conduct In FCA Suit

    A Massachusetts federal judge has ordered a medical practice to pay legal fees to a lab it accused of False Claims Act violations, ruling its claims were "clearly vexatious" because the provider knowingly ordered medically unnecessary tests to support its suit.

  • September 09, 2025

    MAHA Report Calls For Increased Scrutiny Of Drug Advertising

    The Trump administration on Tuesday pledged to ramp up federal oversight of drug advertising, update dietary guidelines and slash unnecessary regulations as part of its strategy to boost the health of America's children and curb the rise in childhood chronic disease.

  • September 09, 2025

    Nursing Exec Says $10.5M Fraud Penalty Excessive

    A nurse staffing executive convicted of wage-fixing told a Nevada federal court the U.S. Department of Justice's request for a $10.5 million forfeiture order for allegedly failing to disclose the antitrust investigation when selling his business is excessive.

  • September 09, 2025

    Morgan Lewis Attys Talk Key FDA AI Policies Of 2025

    The U.S. Food and Drug Administration's internal artificial intelligence tool, new medical device guidance and a warning about wearable technology. Law360 Healthcare Authority explores these and other issues highlighted by Morgan Lewis lawyers at an event focused on the intersection of AI and health policy.

  • September 09, 2025

    Lambda Legal Attorney Indicted Over Judge Shopping Probe

    An attorney with LGBTQ rights nonprofit Lambda Legal has been charged in Alabama federal court in connection with an alleged judge-shopping scandal in Alabama, with prosecutors claiming he lied to a panel of federal judges investigating the episode.

  • September 09, 2025

    DOJ, FTC Urged To Probe Drugmakers' Rebate Models

    The American Hospital Association asked the Trump administration to investigate whether major pharmaceutical companies violated antitrust laws as they push out new rebate models for a program that offers discounted drugs to healthcare providers serving low-income patients.

  • September 09, 2025

    Families Gain Ground In Wilderness Therapy Coverage Fight

    Families seeking insurance coverage for youth wilderness therapy are gaining ground. A handful of courts have recently backed claims that insurers may be violating a federal law banning them from imposing stricter limits on mental health treatments than on medical or surgical treatments.

  • September 08, 2025

    Walgreens Fired Pharmacy Heads After Union Vote, Suits Say

    Two ex-pharmacy managers have accused Walgreens of firing them for refusing to spy on their employees amid a campaign to unionize at a store in southwest Washington state, according to two new lawsuits launched in federal court in the Evergreen State.

  • September 08, 2025

    NY AG To Fight Texas Bid To Enforce Abortion Ban Ruling

    New York Attorney General Letitia James on Monday moved to intervene in a lawsuit brought by the state of Texas that seeks to enforce a money judgment against a New York doctor for providing abortion-inducing drugs to a woman via telemedicine in the Lone Star state.

  • September 08, 2025

    Nurses Seek Final OK Of $724K Deal Over HCA Training Costs

    About 2,390 nurses urged a California federal judge Monday to give the final OK to a nearly $756,000 settlement they reached with HCA Healthcare and related entities over claims that the healthcare provider required them to repay it for its training program.

Expert Analysis

  • How States Are Regulating Health Insurers' AI Usage

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    The absence of a federal artificial intelligence framework positions states as key regulators of health insurers’ AI use, making it important for payors and service providers to understand the range of state AI legislation being passed in California and elsewhere, and consider implementing an AI-focused compliance infrastructure, say attorneys at Ropes & Gray.

  • HHS Plan To Cut Immigrant Benefits Spurs Provider Questions

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    A recent notice from the U.S. Department of Health and Human Services identifying new federal public benefit programs for which nonqualified aliens are not eligible may have a major impact on entities that participate in these programs — but many questions remain unanswered, say attorneys at Foley.

  • Noncompete Forecast Shows Tough Weather For Employers

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    Several new state noncompete laws signal rough conditions for employers, particularly in the healthcare sector, so employers must account for employees' geographic circumstances as they cannot rely solely on choice-of-law clauses, say lawyers at McDermott.

  • Previewing State Efforts To Regulate Mental Health Chatbots

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    New York, Nevada and Utah have all recently enacted laws regulating the use of artificial intelligence to deliver mental health services, offering early insights into how other states may regulate this area, say attorneys at Goodwin.

  • How DOJ's New Data Security Rules Leave HIPAA In The Dust

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    The U.S. Department of Justice's recently effective data security requirements carry profound implications for how healthcare providers collect, store, share and use data — and approach vendor oversight — that go far beyond the Health Insurance Portability and Accountability Act, say attorneys at Nelson Mullins.

  • Texas Med Spas Must Prepare For 2 New State Laws

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    Two new laws in Texas — regulating elective intravenous therapy and reforming healthcare noncompetes — mark a pivotal shift in the regulatory framework for medical spas in the state, which must proactively adapt their operations and contractual practices, says Brad Cook at Munsch Hardt.

  • DOJ-HHS Collab Crystallizes Focus On Health Enforcement

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    The recently announced partnership between the U.S. Department of Justice and U.S. Department of Health and Human Services to combat False Claims Act violations, following a multiyear trend of high-dollar DOJ recoveries, signals a long-term enforcement horizon with major implications for healthcare entities and whistleblowers, say attorneys at RJO.

  • How The Healthline Privacy Settlement Redefines Ad Tech Use

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    The Healthline settlement is the first time California has drawn a clear line in the sand around how website tracking must function in practice, so if your site uses tracking technologies, especially around sensitive content like health or finance, regulators are inspecting your website's back end, not just its banner, say attorneys at Baker Donelson.

  • How Sweeping Budget Bill Shakes Up Health Industry

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    With the recently passed One Big Beautiful Bill Act marking one of the most significant overhauls of federal health policy since the passage of the Affordable Care Act, providers, managed care organizations and life sciences companies must now shift focus from policy review to implementation planning, say advisers at Holland & Knight.

  • New DOJ Penalty Policy Could Spell Trouble For Cos.

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    In light of the U.S. Department of Justice’s recently published guidance making victim relief a core condition of coordinated resolution crediting, companies facing parallel investigations must carefully calibrate their negotiation strategies to minimize the risk of duplicative penalties, say attorneys at Debevoise.

  • A Look At Key 5th Circ. White Collar Rulings So Far This Year

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    In the first half of 2025, the Fifth Circuit has decided numerous cases of particular import to white collar practitioners, which collectively underscore the critical importance of meticulous recordbuilding, procedural compliance and strategic litigation choices at every stage of a case, says Joe Magliolo at Jackson Walker.

  • What US Medicine Onshoring Means For Indian Life Sciences

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    Despite the Trump administration's latest moves to onshore essential medicine manufacturing, India will likely remain an indispensable component of the U.S. drug supply chain, but Indian manufacturers should prepare for stricter compliance checks, says Jashaswi Ghosh at Holon Law Partners.

  • FCA Working Group Reboot Signals EHR Compliance Risk

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    The revival of the False Claims Act working group is an aggressive expansion of enforcement efforts by the Justice Department and the U.S. Department of Health and Human Services targeted toward technology-enabled fraud involving electronic health records and other data, say attorneys at ArentFox Schiff.