Policy & Compliance

  • November 04, 2025

    Gov't Subpoena Powers Face Reckoning In Healthcare Battles

    The judicial deference given to the government's power to issue investigative subpoenas is facing an unprecedented challenge in transgender care cases. Willingness by judges to question motives could lead to more subpoena challenges or impede worthy government investigations.

  • November 04, 2025

    Fed. Circ. Denies VA Surgeon's Wrongful Termination Appeal

    The Federal Circuit on Tuesday affirmed the U.S. Merit Systems Protection Board's decision to uphold the firing of a general surgeon by the U.S. Department of Veterans Affairs after he raised concerns about compromised patient care.

  • November 04, 2025

    9th Circ. Revives Ore. Right To Life Suit: 3 Things To Know

    A divided Ninth Circuit panel sided with an Oregon anti-abortion group last week and reinstated its lawsuit challenging a state law that requires health plans to cover abortion and contraceptives.

  • November 04, 2025

    HHS Watchdog Puts Failing Nursing Home Program On Blast

    Hefty fines aren’t enough to turn around the nation's worst nursing homes, a government watchdog has concluded. The findings illustrate the need for new enforcement strategies that promote staffing and other improvements meant to last.

  • November 04, 2025

    End Payors Seek $66M In Atty Fees In Generic Drug MDL

    End payors in a generic drug price-fixing multidistrict litigation are seeking a Pennsylvania federal court's approval for a $66 million award of attorney fees, representing one-third of the $200 million settlement between the classes and Sun Pharmaceutical Industries Inc. and Taro Pharmaceuticals USA Inc.

  • November 03, 2025

    Pharmacies Seek Cert. In Cholesterol Drug Price-Fixing MDL

    A group of indirect reseller plaintiffs urged a Pennsylvania federal judge on Friday to certify a nationwide class of thousands of pharmacies that indirectly purchased the cholesterol medication pravastatin in sprawling multidistrict litigation over alleged price-fixing in the generic drug industry.

  • November 03, 2025

    FDA Official Quits As Aurinia Sues Over 'Personal Vendetta'

    Aurinia Pharmaceuticals on Sunday launched a lawsuit accusing Dr. George Tidmarsh, who that same day resigned as head of the U.S. Food and Drug Administration's drug division, of falsely claiming the biotech's lupus nephritis drug doesn't work amid his "longstanding personal vendetta" against the company's board chair and investor.

  • November 03, 2025

    Judge Denies New Trial In SuperValu Whistleblower Drug Case

    An Illinois federal judge has refused to grant a new trial to whistleblowers who said grocery chain SuperValu systematically overbilled the government for prescription drugs, finding there was no issue with jury instructions on causation.

  • November 03, 2025

    Colorado Judge Denies AbbVie's Bid To Block State Drug Law

    A Colorado federal judge denied AbbVie Inc.'s bid for a preliminary injunction, which would have barred the state from enforcing its laws and penalties surrounding federal 340B drug pricing.

  • October 31, 2025

    Drugmakers Can't End States' Dermatology Price-Fixing Suits

    A Connecticut federal judge on Friday refused to throw out the vast majority of claims in a nationwide antitrust enforcement action accusing a long list of pharmaceutical companies of fixing the prices of generic dermatology drugs, rejecting the companies' argument that the claims were filed too late.

  • October 31, 2025

    Amgen Again Challenges Colo. Price Cap For Arthritis Drug

    Amgen has once again sued Colorado over its price cap for the arthritis drug Enbrel, claiming that the Centennial State's drug price-control statute violates the U.S. Constitution, conflicts with federal patent law and threatens patients' access to lifesaving medications.

  • October 31, 2025

    Hawaii Judge Declares FDA's Mifepristone Regs Unlawful

    The U.S. Food and Drug Administration failed to sufficiently justify restrictions on the abortion drug mifepristone, a Hawaii federal judge ruled in an order declaring the restrictions unlawful under the Administrative Procedure Act.

  • October 31, 2025

    Aetna Strikes $650K Deal In Lipedema Patients' Coverage Suit

    Aetna has agreed to pay up to $650,000 to resolve a class action claiming it unlawfully refused to cover liposuction for over two dozen patients with a rare condition called lipedema, according to a filing in California federal court.

  • October 31, 2025

    Garnet Health Inks $4.6M Deal In Retirement Fee, Fund Suit

    Garnet Health Medical Center has agreed to fork over $4.6 million to end a proposed class action alleging the New York healthcare network mismanaged employee retirement plan fees and investments, according to settlement documents filed by workers Friday in New York federal court.

  • October 31, 2025

    3 Argument Sessions Benefits Attys Should Watch In Nov.

    The Third Circuit will hear a union's appeal in a withdrawal liability battle, a union health plan defends its partial win in a coverage fight at the Ninth Circuit, and pharmacy benefit managers will take a challenge to the Federal Trade Commission's authority to the full Eighth Circuit. Here are three arguments to keep an eye on in November.

  • October 31, 2025

    NC Attorney General, HCA Duel Over Merger Commitments

    The North Carolina Attorney General's Office and HCA Healthcare have offered competing interpretations of a 2019 merger agreement in their efforts to secure a pretrial win in the state's compliance case involving the purchase of an Asheville hospital system.

  • October 30, 2025

    J&J's Janssen Says 3rd Circ. Should Reverse $1.6B FCA Win

    Johnson & Johnson's Janssen Products LP urged the Third Circuit to overturn a $1.6 billion False Claims Act judgment over two of its HIV drugs, arguing the district court allowed whistleblowers to prove fraud based solely on "off-label" marketing rather than any false claim actually submitted to the government.

  • October 30, 2025

    Generic-Drug Firms Want To Fast-Track Conn. Price Cap Fight

    An industry group for generic and biosimilar pharmaceutical companies has asked a Connecticut federal judge to fast-track its lawsuit seeking to block the state's new drug price cap, claiming it will suffer "imminent harm" if the case is delayed.

  • October 30, 2025

    Judge Unpauses 'Important' Suit Over Vax Guidelines

    A Massachusetts federal judge agreed Thursday to lift a government shutdown-related stay of litigation challenging new COVID-19 vaccine recommendations for children and pregnant women, calling the case a "matter of national importance" that warrants keeping the case moving over the U.S. Department of Justice's objection.

  • October 30, 2025

    Health Group Urges 1st Circ. To Deny FCA Suit Fee Challenge

    A Massachusetts health network has asked the First Circuit to deny a whistleblower's attempt to secure more attorney fees for a False Claims Act suit, arguing that a federal judge properly denied numerous claims for fees after a $2.5 million settlement.

  • October 30, 2025

    Surgical Co. Gets Tobacco Fee ERISA Suit Kicked To Texas

    A proposed class action alleging that a surgical center operator discriminated against workers who use tobacco by making them pay more for health coverage belongs in Texas, a Kentucky federal judge said, ruling that the business doesn't have enough connection to Kentucky.

  • October 29, 2025

    DOJ Subpoena Called 'Pressure' To Ax Gender-Affirming Care

    The U.S. Department of Justice issued a subpoena to intimidate a telehealth organization into ending gender-affirming medical care, a Seattle federal judge said in a ruling that found the agency is using the guise of an investigation to further the Trump administration's stated goal of eliminating transgender and gender-diverse patients' access to healthcare.

  • October 29, 2025

    Healthcare Workers Trade HCA For Subsidiaries In Wage Deal

    A respiratory therapist has reached a tentative deal in a proposed collective action against a healthcare facility operator accused of manipulating workers' time sheets to pay them less overtime wages, North Carolina federal court records show.

  • October 29, 2025

    FDA Unveils Plan To Speed Biosimilar Drugs To Market

    The Trump administration on Wednesday said it plans to slash the cost of biologics by shortening the time required to bring a biosimilar drug to market and making it easier for patients to switch to the cheaper products.

  • October 29, 2025

    3 Pharmaceutical Firms Will Pay $4M To Tribes In Opioid MDL

    Indivior, Sun Pharmaceuticals and Zydus Pharmaceuticals have inked deals to compensate tribes for their role in the opioid crisis, according to stipulated dismissals entered on Wednesday in Ohio federal court.

Expert Analysis

  • Criminal Healthcare Fraud Takeaways From 4th Circ. Reversal

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    After the Fourth Circuit reversed a doctor’s postconviction acquittal in U.S. v. Elfenbein last month, defense attorneys should consider three strategies when handling complex criminal healthcare matters, says Jonathan Porter at Husch Blackwell.

  • AG Watch: Texas Embraces The MAHA Movement

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    Attorneys at Kelley Drye examine Texas Attorney General Ken Paxton's actions related to the federal Make America Healthy Again movement, and how these actions hinge on representations or omissions by the target companies as opposed to specific analyses of the potential health risks.

  • 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.