Policy & Compliance

  • August 19, 2025

    Judge Backs Deal To Overhaul NY Kids' Mental Healthcare

    A New York federal judge has given the green light to allow the state to revamp its Medicaid mental health services for children to expand greater in-home and crisis care to prevent the institutionalization of kids. 

  • August 19, 2025

    Hawaii Abortion Drug Fight: 3 Things To Know

    The drug mifepristone has emerged as a key flash point in legal battles over state abortion restrictions, drug prescribing rules and the legalities of sending abortion medications across state lines. This week, a federal court in Hawaii will hear arguments in a challenge to the FDA's changes to the drug safety review process.

  • August 19, 2025

    Trump's 'Abnormal' Use Of FCA Could Get Tricky In Court

    The Trump administration is wielding the False Claims Act in unusually narrow ways to drive policies on social and cultural issues — including gender-affirming care and diversity, equity and inclusion programs — but the government's potential theories of liability under the federal law remain largely untested and might not hold up in court, experts say.

  • August 18, 2025

    Most Ozempic, Wegovy Claims Survive MDL Dismissal Bid

    Eli Lilly & Co. and Novo Nordisk will have to face most of a multidistrict litigation accusing them of misleading consumers over the risks and benefits of popular weight loss drugs like Ozempic and Trulicity, after a Pennsylvania federal judge only trimmed a few of the dozen claims the drugmakers tried to have tossed.

  • August 18, 2025

    Judge Known For Nixing ACA To Lead Texas' Northern District

    A conservative judge known for declaring Obamacare unconstitutional, among other high-profile rulings, took over as chief judge of the U.S. District Court for the Northern District of Texas on Monday, according to an announcement from the court.

  • August 15, 2025

    DOJ Backs Small Biz In Gender Dysphoria Coverage Dispute

    The U.S. Department of Justice told a New Hampshire federal court Friday that employers are not required under federal anti-discrimination laws to provide medical coverage for gender dysphoria, and that federal religious freedom law protects a turbomachinery company from covering a transgender employee's treatment for the disorder.

  • August 15, 2025

    Microsoft Unit Agrees To Pay $8.5M In MOVEIt Hack MDL

    A Massachusetts federal judge has preliminarily signed off on an $8.5 million settlement reached between Nuance Communications and more than 1 million patients in multidistrict litigation over a 2023 malware attack that exploited a vulnerability in Progress Software's MOVEIt transfer file tool. 

  • August 15, 2025

    Wholesalers Want Final OK For $51M AstraZeneca Settlement

    Drug wholesalers asked a Delaware federal judge Thursday for the final stamp of approval on a combined $51.4 million in settlements AstraZeneca Pharmaceuticals LP and Handa Pharmaceuticals LLC agreed to pay to resolve allegations AstraZeneca paid off generic-drug makers, including Handa, to protect its brand antipsychotic Seroquel XR.

  • August 15, 2025

    AbbVie's Key RICO Claims In Drug Cost Fraud Suit Survive

    An Illinois federal judge on Friday ruled that AbbVie could move ahead with the bulk of its racketeering, tortious interference and fraud claims against a behind-the-scenes healthcare company that the drugmaker alleges colluded with pharmacy benefit managers to fraudulently obtain drugs meant for patients in AbbVie's charitable programs.

  • August 15, 2025

    Home Chain Got OT Math Wrong For 1,000 Nurses, Court Told

    A group of nursing homes operating as one company left shift differentials and bonus pay out of certified nursing assistants' overtime math, a former employee alleged in a suit in Mississippi federal court, saying the violations affected more than 1,000 workers.

  • August 15, 2025

    1st Wrongful Death Suit Filed In Deadly Mass. Rest Home Fire

    The first of what are expected to be multiple wrongful death lawsuits stemming from a July 13 fire that killed 10 elderly and disabled residents of a Fall River, Massachusetts, assisted living facility was filed late Thursday in state court.

  • August 14, 2025

    OptumRx Flags Email Accidentally Sent To Opioid MDL Parties

    UnitedHealth subsidiary OptumRx Inc. is seeking a ban on secret communications with the Ohio federal judge overseeing sprawling national opioid litigation after the court-appointed special master accidentally sent the company an email, intended for the judge, celebrating a "gambit" that prevented objections to his decision.

  • August 14, 2025

    Calif. Justices Say No Arb. For Nursing Home Death Claim

    The California Supreme Court on Thursday reversed a decision sending to arbitration a wrongful death claim by parents who allege their son was neglected at the 24-hour skilled nursing facility he was admitted to.

  • August 14, 2025

    Fired Nurse Accused Of Stealing Drugs Can't Revive Bias Suit

    The Seventh Circuit declined Thursday to reinstate a fired Salvadoran nurse's suit claiming she was accused of stealing and using opioids at work out of bias for her nationality, stating she failed to put forward evidence that her national origin drove concerns rather than her sluggish behavior.

  • August 14, 2025

    20 States Win Injunction Against ICE's Use Of Medicaid Data

    A California federal judge has blocked the federal government from using Medicaid information from 20 states for immigration enforcement purposes, marking a partial victory for the coalition of states challenging a new data-sharing arrangement between the U.S. Department of Health and Human Services and the Department of Homeland Security.   

  • August 14, 2025

    Conn. Lab To Pay $1.25M In False Claims Settlement

    A Connecticut reference laboratory and its operators have struck a deal with federal and state authorities to settle False Claims Act allegations for more than $1.25 million after they allegedly sought payments for medically unnecessary drug tests, federal prosecutors said.

  • August 14, 2025

    AP Says DOJ Can't Turn Info Sharing Into Views Suppression

    The Associated Press, The Washington Post, Reuters and the BBC hit back Wednesday on Justice Department efforts to back a lawsuit from the anti-vaccine group once tied to Secretary of Health and Human Services Robert F. Kennedy Jr., alleging they colluded with social media platforms to censor rivals.

  • August 14, 2025

    AGs' Dermatology Price-Fixing Case Not A Copy, Judge Says

    A nationwide antitrust enforcement action alleging that pharmaceutical companies fixed prices of generic dermatology drugs can proceed despite the defendants' contention that it's virtually the same as two others that were filed first, a Connecticut federal judge has ruled.

  • August 13, 2025

    Trump Axes Biden Competition Order And Eases Rocket Regs

    President Donald Trump on Wednesday evening revoked an expansive Biden-era executive order that aimed to boost competition across the U.S. economy, lower prices for consumers and increase pay for workers, while issuing his own order to ease regulations on the commercial space industry to boost American rocket launches.

  • August 13, 2025

    High Court's Trans Ruling Doesn't Change Insurer's ACA Loss

    A Washington federal judge has reaffirmed his finding that Premera Blue Cross' coverage policy for gender-affirming chest surgery violates the Affordable Care Act, rejecting the insurer's bid for a redo following the Supreme Court's decision in U.S. v. Skrmetti.

  • August 13, 2025

    8th Circ. Revives Ark. Ban On Youth Gender-Affirming Care

    A split Eighth Circuit en banc panel revived an Arkansas state law banning gender-affirming care for minors, finding that a district court erred in blocking the law because it does not discriminate based on sex but instead classifies based only on age and medical procedure.

  • August 13, 2025

    Texas Woman Says Marine Laced Her Drink With Abortion Pills

    A Texas woman has filed a wrongful death lawsuit in federal court alleging a Marine pilot with whom she had an intimate relationship tricked her into taking abortion pills by putting them in her drink, causing her to lose her pregnancy.

  • August 13, 2025

    Wash. Agencies Must Give Up Docs In Medicaid Fraud Case

    A Washington federal judge has ordered the state attorney general's office to hand over certain records to a hospital system accused of overbilling Medicaid in connection to a neurosurgeon's fraud scheme, rejecting the argument that the documents at issue belong to other state agencies that must be subpoenaed.

  • August 13, 2025

    Pa. Judge Ends Employers' Expanded Birth Control Exemptions

    A Pennsylvania federal judge on Wednesday struck down rules set by the first Trump administration enabling employers to refuse coverage of employees' contraceptives on moral and religious grounds, holding that the government failed to provide a good reason for the broadening of exemptions.

  • August 12, 2025

    Loper Bright Neutered In 6th Circ., Tenn. Tells Supreme Court

    There is "growing confusion among the circuits" regarding the U.S. Supreme Court's rejection of judicial deference to regulators, as evidenced by a Sixth Circuit ruling that negates much of the high court's Loper Bright ruling, Tennessee told the justices in a new petition.

Expert Analysis

  • Learning From COVID-19 Enforcement Against Nursing Homes

    Author Photo

    Five years after the COVID-19 outbreak caused a high number of deaths in nursing homes, an examination of enforcement actions against nursing homes in New York and elsewhere in the country highlights obstacles that may arise when bringing cases of this type, and ways to overcome them, says Kenneth Levine at Stone & Magnanini.

  • How Plan Sponsors Can Mitigate Risk In PBM Contracts

    Author Photo

    A recent lawsuit in New York federal court alleges that JPMorgan caused exorbitant prescription costs by mishandling the pharmacy benefit manager arrangement, adding to a growing body of Employee Retirement Income Security Act fiduciary breach litigation and affirming that fiduciaries must proactively manage their healthcare plan vendors, say attorneys at Hall Benefits Law.

  • 4th Circ. Health Data Ruling Opens Door To State Law Claims

    Author Photo

    In Real Time Medical v. PointClickCare, the Fourth Circuit recently clarified that state law claims can rest in part on violations of a federal law that prohibits electronic health information blocking, expanding legal risks for health IT companies and potentially creating exposure to a range of competitive implications, say attorneys at BCLP.

  • Unpacking Trump Admin Plans For Value-Based Care

    Author Photo

    Recent developments from the Center for Medicare and Medicaid Innovation suggest the Trump administration intends to put its own stamp on value-based care, emphasizing cost savings assessment in particular, with its recent cancellation of several payment models that had supported primary care, says Miranda Franco at Holland & Knight.

  • What To Expect For Stem Cell Regulation Under Trump Admin

    Author Photo

    The new administration's push for deregulation, plus the post-Chevron legal landscape, and momentum from key political and industry players to facilitate stem cell innovation may create an opportune backdrop for a significant reduction in the U.S. Food and Drug Administration's regulatory framework for stem cells, say attorneys at Sheppard Mullin.

  • How Importers Can Minimize FCA Risks Of Tariff Mitigation

    Author Photo

    False Claims Act risks are inherent in many tariff mitigation strategies, making it important for importers to implement best practices to identify and report potential violations of import regulations before they escalate, says Samuel Finkelstein at LMD Trade Law.

  • 10 Practical Takeaways From FDA's Biopharma AI Guidance

    Author Photo

    Recent guidance from the U.S. Food and Drug Administration provides much-needed insight on the usage of artificial intelligence in producing information to support regulatory decision-making regarding drug safety, with implications ranging from life cycle maintenance to AI tool acquisition, say attorneys at Covington.

  • Lawmakers Shouldn't Overlook Rare Disease Therapies' Value

    Author Photo

    As the ORPHAN Cures Act is pending in Congress, policymakers assessing the value of certain drugs for price regulation should consider data beyond what is collected in clinical trials, say Alice Chen at the University of Southern California, and Molly Frean and Yao Lu at Analysis Group.

  • What Trump's Order Means For The Legal Status Of IVF

    Author Photo

    An executive order signed by President Donald Trump last month signals the administration's potential intention to increase protections for in vitro fertilization services, though more concrete actions would be needed to resolve the current uncertainty around IVF access or bring about a binding legal change, says Jeanne Vance at Weintraub Tobin.

  • Mitigating Tariff Risks For Healthcare In US And Canada

    Author Photo

    Healthcare stakeholders should take steps to evaluate the impact of cross-border tariffs, as the historically strong ties between Canada and the U.S. demonstrate the potential for real disruption and harm to the healthcare industry in both countries, say attorneys at Norton Rose.

  • What's At Stake In High Court Transgender Care Suit

    Author Photo

    The outcome of U.S. v. Skrmetti will have critical implications for the rights of transgender youth and their access to gender-affirming care, and will likely affect other areas of law and policy involving transgender individuals, including education, employment, healthcare and civil rights, say attorneys at ArentFox Schiff.

  • 6 Laws Transforming Calif.'s Health Regulatory Framework

    Author Photo

    Attorneys at Hooper Lundy discuss a number of new California laws that raise pressing issues for independent physicians and small practice groups, ranging from the use of artificial intelligence to wage standards for healthcare employees.

  • Anticipating Calif. Oversight Of PE Participation In Healthcare

    Author Photo

    A new bill recently introduced in the California Senate revives last year's attempt to increase oversight of healthcare transactions involving private equity groups and hedge funds, meaning that attorneys may soon need to assess the compliance status of existing management relationships and consider modifying contract terms, says Andrew Demetriou at Husch Blackwell.