Policy & Compliance

  • 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.

  • July 01, 2026

    Big Pharma Cos. Want 340B Drug Price FCA Suit Tossed

    Four major pharmaceutical companies Wednesday urged a California federal court to toss False Claims Act allegations revived by the Ninth Circuit claiming they filed false ceiling prices for drugs and overcharged entities covered by a federal discount program, saying the suit is precluded by the FCA's public disclosure bar.

  • July 01, 2026

    Gov't Officials Tout Unprecedented Healthcare Fraud Push

    It's been an unprecedented year for healthcare fraud enforcement, senior government officials from the U.S. Justice Department and Department of Health and Human Services told conference attendees gathered in a ballroom Wednesday morning at the Midtown Hilton in Manhattan.

  • July 01, 2026

    Amgen Wins Order Blocking Colorado's Enbrel Price Cap

    Colorado is preliminarily blocked from enforcing its price cap on Amgen's rheumatoid arthritis drug Enbrel, a federal judge ruled Wednesday, saying the biotech company is likely to succeed on its claim that federal patent law preempts the state's effort to limit the price of patented medications.

  • July 01, 2026

    8th Circ. Keeps Missouri's 340B Contract Pharmacy Law Alive

    The Eighth Circuit declined Wednesday to temporarily block a Missouri law that bars drugmakers from imposing restrictions on federally funded providers that contract with pharmacies to distribute discount drugs in the 340B drug discount program.

  • June 30, 2026

    Health Attys Talk Cooperation In Gov't Fraud Investigations

    For attorneys defending healthcare clients hit with grand jury subpoenas and other enforcement actions investigating potential cases of fraud, cooperation with federal prosecutors is key.

  • June 30, 2026

    AIDS Group Says Cigna-Owned Express Scripts Hurts Patients

    AIDS Healthcare Foundation says its nonprofit wellness centers are going to be run out of business if Cigna-owned pharmacy benefit manager Express Scripts isn't stopped from using its muscle in the market to steer pharmacy patients toward specialty pharmacies it's affiliated with.

  • June 30, 2026

    What To Know As Sen. Cassidy Proposes Changes To 340B

    Newly introduced Senate legislation could radically change the scope of the 340B drug discount program, including by altering how providers tap discounts and provider deals with pharmacies.

  • June 30, 2026

    Remedies, Not Suits: How FTC Approaches Health Mergers

    The Federal Trade Commission has not sued over any healthcare provider mergers since President Donald Trump's return to the White House. Attorneys at the American Health Law Association annual meeting say that's not a signal that the agency is backing off.

  • June 30, 2026

    Judge To Mull Surgeon's Dismissal Bid In 'No Surprises' Suit

    A New Jersey court will soon decide whether allegations that a plastic surgeon abused No Surprises Act arbitration can move forward. Law360 looks at a closely watched case testing what role courts play in this and other NSA disputes.

  • June 30, 2026

    Cigna, Others Fight Ohio AG's Drug Price-Fixing Suit

    Ohio pharmacy benefit managers and their corporate parents urged a federal judge to toss the state's drug price-fixing lawsuit, saying in a series of briefs that the state is trying to skirt federal pleading standards, collapse corporate separateness and stretch Ohio's antitrust law beyond its limits.

  • June 30, 2026

    GEO Still Blocking Parts Of NJ Detention Center, State Says

    New Jersey and its Department of Health told a federal judge that despite consent from U.S. Immigration and Customs Enforcement to tour its Newark detention center, facility operator GEO Group Inc. is still barring entrance to certain areas.

  • June 30, 2026

    Patience Thin On Bench For Dragged-Out FCA Probes

    Judicial frustration was on display in recent rulings in which judges took issue with repeated DOJ requests for sealed records. A desire to speed up fraud cases factors into a fish-or-cut-bait policy for federal prosecutors.

  • June 29, 2026

    Feds Sue Mich., Other States For Not Sharing SNAP Records

    The U.S. Department of Justice is asking federal courts to force Kentucky, Michigan, Minnesota and Pennsylvania to turn over their Supplemental Nutrition Assistance Program applicant data that the Trump administration claims it needs to uncover billions of dollars in overpayments and fraud.

  • June 29, 2026

    26 States Sue To Nix Medicaid Work Rule For Medically Frail

    More than two dozen states sued the Trump administration Monday in Massachusetts federal court in a bid to strike down new Medicaid work requirements for certain enrollees, saying the administration did not consider the consequences the requirements would have on vulnerable Medicaid enrollees.

  • June 29, 2026

    AstraZeneca To Pay $34M In Texas Kickbacks Settlement

    AstraZeneca has agreed to pay nearly $34 million to the state of Texas to put to rest allegations the pharmaceutical company gave kickbacks to providers for prescribing its drugs, many of which were covered by the Lone Star State's Medicaid program, according to an announcement made Monday.

  • June 29, 2026

    Hospital That Halted Gender Care Must Show Cause

    A Colorado state court judge issued a citation on Friday to Children's Hospital Colorado ordering it to show cause for why the hospital refuses to provide gender-affirming care to patients in violation of a preliminary injunction order issued by the Colorado Supreme Court. 

  • June 29, 2026

    Insurers Seek NJ Mass Tort For No Surprises Act Suits

    Five of the largest health insurers in the Garden State have asked the New Jersey Supreme Court to designate 160 pending cases seeking the enforcement of alleged independent dispute resolution payment determinations issued under the federal No Surprises Act as multicounty litigation, according to a notice to the Bar Association.

  • June 29, 2026

    8th Circ. Backs Tossing Ark. Worker's Pharmacy Network Suit

    The Eighth Circuit on Monday turned down an employee health plan participant's bid to revive a proposed class action alleging CVS Caremark unjustly enriched itself by failing to comply with Arkansas laws on pharmacy network adequacy, holding a lower court didn't err in tossing the dispute.

  • June 29, 2026

    Supreme Court To Review Wash. Youth Gender Care Law

    The U.S. Supreme Court will hear a challenge to Washington state's law permitting shelters not to notify the parents of runaway teens who seek gender-affirming treatment, reviving a lawsuit that a Ninth Circuit panel unanimously shot down after a district judge found the plaintiffs could only show speculative injury.

  • June 29, 2026

    Justices Skip New York Health Workers' Fight Over Vax Rule

    The U.S. Supreme Court refused Monday to take up religious healthcare workers' challenge to a pandemic-era New York state policy requiring healthcare providers to make their employees get vaccinated against COVID-19, drawing a dissent from Justices Neil Gorsuch, Clarence Thomas and Samuel Alito.

  • June 26, 2026

    Conn. Provider Must Share Takeover Data After $49M Verdict

    A Connecticut state court has ordered Westchester Medical Group PC to produce corporate takeover documents and leadership information as the court contemplates the provider's bid to set aside a $49 million jury verdict over claims its staff failed to diagnose a woman with cervical cancer.

Expert Analysis

  • Wage-Based H-1B Rule Amplifies Lottery Risks For Law Firms

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    Under the wage-based H-1B lottery rule taking effect Feb. 27, law firms planning to hire noncitizen law graduates awaiting bar admission should consider their options, as the work performed by such candidates may sit at the intersection of multiple occupational classifications with differing chances of success, says Jun Li at Reid & Wise.

  • Assessing Compliance Risks Around TrumpRx Participation

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    As there are novel compliance obligations and potential political opposition related to the new TrumpRx online drug platform, companies intending to participate on the site should consider the pressure points that are likely to draw enforcement scrutiny, say attorneys at Sheppard.

  • Predicting Actual Impact From CDC's New Vaccine Guidance

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    Recent federal changes to the childhood immunization schedule, reducing the number of vaccine recommendations from 18 to 11, do not automatically create enforceable obligations for parents, schools or healthcare providers, but may spur litigation and other downstream effects on school policies and state guidelines, says Mehdi Sinaki at Michelman & Robinson.

  • What Rescheduling Means For Cannabis Labels, Marketing

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    The proposed reclassification of cannabis is expected to bring heightened scrutiny of labeling, advertising and marketing from the U.S. Food and Drug Administration and the Federal Trade Commission, but the brands that tighten evidence, standardize operations and professionalize marketing controls now will see fewer surprises and better outcomes, say attorneys at Wilson Elser.

  • What's At Stake In Possible Circuit Split On Medicaid Rule

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    A recent Eleventh Circuit decision, reviving Florida's lawsuit against a federal rule that reduces Medicaid funding based on agreements between hospitals, sets up a potential circuit split with the Fifth Circuit, with important ramifications for states looking to private administrators to run provider tax programs, say Liz Goodman, Karuna Seshasai and Rebecca Pitt at FTI Consulting.

  • Courts' Rare Quash Of DOJ Subpoenas Has Lessons For Cos.

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    In a rare move, three federal courts recently quashed or partially quashed expansive U.S. Department of Justice administrative subpoenas issued to providers of gender-affirming care, demonstrating that courts will scrutinize purpose, cabin statutory authority and acknowledge the profound privacy burdens of overbroad government demands for sensitive records, say attorneys at ArentFox Schiff.

  • Remote Patient Monitoring Is At Regulatory Inflection Point

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    With remote patient monitoring at the center of new federal pilot programs and a recent report from the U.S. Department of Health and Human Services' Office of Inspector General examining Medicare billing for those services, it is clear that balancing innovation and risk will be a central challenge ahead for digital health stakeholders, say attorneys at Morgan Lewis.

  • Utah's AI Prescription Renewal Pilot Could Inform Policy

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    Utah recently became the first state to approve an artificial intelligence system for autonomously renewing certain prescription medicines, providing a test case for how regulators may be able to draw boundaries between administrative automation and medical judgment, say Jashaswi Ghosh at Holon Law Partners and Bryant Godfrey at Foley Hoag.

  • Ramped Up Psychedelic Production Carries Opportunity, Risk

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    Kimberly Chew at Husch Blackwell discusses the key legal implications of the U.S. Drug Enforcement Administration's recent dramatic increases in the production quotas for a range of psychedelic substances, offering guidance on compliance, risk management and strategic opportunities for practitioners navigating this rapidly evolving landscape.

  • New Biotech Nat'l Security Controls May Have Blunted Impact

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    While the newly enacted federal prohibition against contracting with certain biotechnology providers associated with countries of concern may have consequences on U.S. companies' ability to develop drugs, the restrictions may prove to be less problematic for the industry than the significant publicity around their passage would suggest, say attorneys at Wilson Sonsini.

  • Takeaways From The DOJ Fraud Section's 2025 Year In Review

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    Former acting Principal Deputy Chief Sean Tonolli of the U.S. Department of Justice's Fraud Section, now at Cahill Gordon, analyzes key findings from the section’s annual report — including the changes implemented to adapt to the new administration’s priorities — and lays out what to watch for this year.

  • Traditional FCA Enforcement Surges Amid Shifting Priorities

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    The U.S. Department of Justice’s January report on False Claims Act enforcement in fiscal year 2025 reveals that while the administration signaled its intent to expand FCA enforcement into new areas such as tariffs, for now the greatest exposure remains in traditional areas like healthcare — in which the risk is growing, say attorneys at Debevoise.

  • 3 Key Ohio Financial Services Developments From 2025

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    Ohio's banking and financial services sector saw particularly notable developments in 2025, including a significant Ohio Supreme Court decision on creditor disclosure duties to guarantors in Huntington National Bank v. Schneider, and some major proposed changes to the state's Homebuyer Plus program, says Alex Durst at Durst Kerridge.