Policy & Compliance

  • September 18, 2026

    6th Circ. Undoes Ky. State Court Remand Of PBM Fight

    The Sixth Circuit on Friday ruled that Kentucky's lawsuit accusing pharmacy benefit managers of conspiring with drug manufacturers to increase the prescription opioid supply belongs in federal court, given the appellate court's precedential ruling from January reversing remand of another state's dispute against PBMs.

  • September 17, 2026

    Opioid MDL Judge Fears 'Chaos' If PBMs Derail 100s Of Suits

    The federal judge steering multidistrict opioid litigation is lacing into major pharmacy benefit managers for asking the Sixth Circuit to abruptly reverse a key ruling, denouncing their "spurious insinuations" about his motives and warning of disarray if they successfully break up the MDL's consolidated suits.

  • September 17, 2026

    Ore. Judge Denies HHS' Attempt To Amend Gender Care Order

    An Oregon federal judge on Thursday rejected the Trump administration's bid to narrow an earlier order that voided a policy declaration central to the government's crackdown on gender-affirming care for minors.

  • September 17, 2026

    Kennedy Taps 8 For Panel Guiding ACA Preventive Care

    Eight new members have been appointed to a key federal health task force that determines which preventive healthcare services insurers must cover, Health Secretary Robert F. Kennedy Jr. announced Thursday. 

  • September 17, 2026

    NIH Grant Terminations Violate First Amendment, Court Told

    The National Institutes of Health is violating the First Amendment by terminating research grants based on policies aimed at suppressing "disfavored" viewpoints on gender identity, climate change and a host of other topics, researchers told a California federal court in a proposed class action suit.

  • September 17, 2026

    Cole Schotz Gains Brach Eichler Health Corporate Pro In NJ

    Cole Schotz PC expanded its New Jersey office with a corporate law special counsel specializing in healthcare industry clients who joined from Brach Eichler LLC, the firm announced this week.

  • September 16, 2026

    Fecal Testing Startup Founders Reach $250K Deal With SEC

    Two founders of a now-shuttered fecal testing startup have agreed to pay $125,000 each to put to rest the U.S. Securities and Exchange Commission's allegations that they used a fraudulent insurance billing scheme to get $60 million from investors, according to an announcement made Wednesday.

  • September 16, 2026

    Express Scripts Seeks To Exit AIDS Group's Drug Rate Suit

    Express Scripts called on a Washington federal judge to toss a lawsuit accusing it of using its market power to bully the AIDS Healthcare Foundation into accepting lower reimbursement rates for life-saving drugs, contending Tuesday that the case rehashes allegations a Missouri federal court has already rejected twice.

  • September 16, 2026

    1st Circ. Seems Torn Over Health Plan Surcharge For Smokers

    A First Circuit panel appeared divided Wednesday over whether a casino company is required to refund tobacco use fees after smokers on the company's health plan complete a tobacco cessation program.

  • September 15, 2026

    8th Circ. Revives Doctor's Suit Over COVID Speech Probes

    An Eighth Circuit panel on Tuesday revived a doctor's suit seeking an order limiting a Minnesota state medical board's ability to investigate him for his public statements related to the COVID-19 pandemic, finding a district court "set the bar too high" at the dismissal stage.

  • September 15, 2026

    Urology Tech Co. Can't Duck Antitrust Suit

    A New Hampshire federal judge has refused to let Laborie Medical Technologies Corp. escape a proposed class action accusing it of anticompetitively locking healthcare providers already using its urology devices into also using its single-use catheters instead of cheaper alternatives.

  • September 15, 2026

    Connecticut Wins Fight Over School Vaccine Exemptions

    Connecticut has won the dismissal of a challenge to its mandatory school vaccination laws, beating through both litigation and legislative amendments allegations by parents that the state's rollback of vaccine exemptions violated religious freedom statutes and the state and federal constitutions.

  • September 15, 2026

    Meet The Attys In The 340B Battle At 1st Circ.

    Gibson Dunn and Dunn Isaacson Rhee attorneys presented arguments Tuesday at the First Circuit over whether drug manufacturers can intervene in a challenge to a now-suspended drug rebate program for hospitals. Law360 profiles the attorneys.

  • September 15, 2026

    Mich. AG Says PBMs Put Opioid Profits Before Patient Safety

    Michigan Attorney General Dana Nessel has asked a federal court not to dismiss the state's lawsuit accusing pharmacy benefit managers including Express Scripts and Optum of abetting the opioid epidemic, arguing the PBMs are not passive administrators, but profit-driven architects of the crisis.

  • September 15, 2026

    7th Circ. Debates Federalism, Bad-Faith Prosecution Limits

    A case deemed moot by the Seventh Circuit nonetheless drew commentary Monday from several judges on the court, with four calling an injunction that blocked Florida from pursuing a state court suit over youth gender-affirming care a "grievous blow" to federalism, while others said federal intervention is a "constitutional safety valve" against bad-faith prosecutions.

  • September 15, 2026

    FDA Seeks Applications For Project To Speed Up Human Trials

    Federal regulators on Tuesday launched a pilot program that will pair pharmaceutical companies with research institutions in an effort to make it faster and easier to conduct clinical trials on humans in the United States.

  • September 15, 2026

    1st Circ. Suggests Appeal In Drug Rebate Case May Be Moot

    A First Circuit panel raised mootness concerns as it heard arguments Tuesday from drug companies appealing a ruling that prevented them from intervening in a now-dismissed case to defend a rebate model for a federal drug-pricing program. 

  • September 14, 2026

    Albertsons Owes $2.2B For Opioids, Wash. Says As Trial Ends

    Albertsons should pay $2.2 billion to address opioid-related harms in Washington, attorneys for the state argued at the close of a two-month bench trial Monday in contending that the pharmacy failed for years to appropriately identify and review suspicious prescriptions that fueled the state's overdose crisis.

  • September 14, 2026

    DOD's HIV-Positive Enlistee Ban Is 'Irrational,' 4th Circ. Told

    An attorney for people barred from joining the military for being HIV-positive called the policy irrational at a Monday en banc hearing at the Fourth Circuit, as some judges asked why they should scuttle that policy and overstep deference normally afforded to military leaders.

  • September 14, 2026

    9th Circ. Rejects Challenge To Wash. Abortion Coverage Law

    Revisiting a church's First Amendment challenge to a Washington law mandating that certain health insurance plans include abortion coverage, a divided Ninth Circuit panel Monday concluded that the Cedar Park Assembly of God failed to point to evidence that Washington's Reproductive Parity Act targets religious conduct.

  • September 14, 2026

    ERISA Smoking Suit Must Be Arbitrated, Dollar General Says

    The Sixth Circuit should scuttle a proposed Employee Retirement Income Security Act class action against Dollar General by reviving and granting the company's motion to compel individual arbitration, Dollar General argued, saying a Tennessee federal judge didn't follow the right procedure when dispensing with the motion.

  • September 14, 2026

    DOJ Suit Over NY Medicaid Program Is 'Baseless,' Court Told

    New York officials and the state's chosen steward for managing its $10 billion Medicaid home-care program fired back at U.S. Justice Department allegations that the bidding process for that contract was a sham, telling a federal court the suit is politically motivated and legally deficient.

  • September 14, 2026

    Eli Lilly's $200M Fraud Suit Is Still Defective, Church Cos. Say

    Companies affiliated with the Church of God in Christ urged a Florida federal judge to dismiss Eli Lilly's amended lawsuit alleging a $200 million-plus fraud scheme to resell the Trulicity diabetes drug on the secondary market, saying the latest complaint still lacks specificity despite including more claims. 

  • September 14, 2026

    Aetna Tells 5th Circ. DOL Can't Block Aramark Suit Arbitration

    Aetna Life Insurance Co. urged the Fifth Circuit on Monday against the U.S. Department of Labor's argument that uniform company Aramark Services Inc.'s health claims dispute with the insurer should remain in court, arguing a Texas judge erred in declining to enforce the parties' binding arbitration agreement.

  • September 11, 2026

    Dems Demand Info From DeSantis On $10M Fraud

    Democratic federal lawmakers sent a letter to Florida Republican Gov. Ron DeSantis seeking more information on $10 million in misappropriated settlement funds, demanding answers to why the money was diverted to a nonprofit founded by his wife and not allocated to support healthcare in the state. 

Expert Analysis

  • 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.

  • West Coast Health Cos. Must Brace For Federal Enforcement

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    In light of the U.S. Department of Justice's newly established West Coast strike force targeting healthcare fraud across Northern California, Arizona and Nevada, health organizations will need to prioritize knowledge, vigilance and operational discipline to reduce exposure from potentially parallel criminal and civil investigations, says Michael Beckwith at Dickinson Wright.

  • High Court's Hikma Decision Reshapes 'Skinny Label' Suits

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    The U.S. Supreme Court's decision in Hikma v. Amarin marks a significant victory for generic drug manufacturers, but rather than putting an end to so-called skinny label inducement claims, it narrows and refocuses them, say attorneys at Sterne Kessler.

  • Turning To The Courts When PBM Reform Falls Short

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    The effectiveness of state laws intended to regulate pharmacy benefit managers remains uncertain, but litigation — utilizing tried-and-true theories like breach of contract and fair dealing — offers another mechanism through which stakeholders may seek relief from PBMs, say attorneys at Reed Smith.

  • High Court's Abortion Pill Stay Reinforces Appellate Principles

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    The U.S. Supreme Court's recent order in Danco Laboratories v. Louisiana, staying a Fifth Circuit ruling that reinstated an in-person requirement for dispensing the abortion medicine mifepristone, should be seen not as a definitive ruling on reproductive rights, but as an affirmation of a more disciplined jurisdictional reality, says Daniel Nardo at Nardo & Associates.