Policy & Compliance

  • September 03, 2026

    Doctor Supervision Regs Unconstitutional In NC, Nurse Says

    North Carolina must do away with regulations requiring nurse practitioners to enter practice agreements with supervising physicians, an owner of several clinics providing menopause-related care argued in a state court complaint, alleging the regulations are arbitrary, costly and violate the state's constitution.

  • September 02, 2026

    States Sue To Block Medicaid Ban On Youth Gender Care

    Twenty state attorneys general on Wednesday challenged the Trump administration's plan to halt Medicaid funding for minors' gender-affirming care, alleging the move would violate federal law and usurp congressional power over government spending.

  • September 02, 2026

    Danish Researcher Pleads Guilty To CDC Grant Money Theft

    A Danish researcher who spent more than 14 years as a fugitive from U.S. authorities pled guilty Tuesday to operating a wire fraud scheme that diverted more than $1 million in grant money intended to fund overseas research into autism and other developmental disorders.

  • September 02, 2026

    2nd Circ. Says PBM Opioid Crisis Suits Belong In Fed. Court

    Local New York governments can't keep dozens of suits alleging two of the nation's largest pharmacy benefit managers contributed to the opioid epidemic in state court, a Second Circuit panel held Wednesday, finding the litigation alleges "indivisible" federal and non-federal conduct by the PBMs.

  • September 02, 2026

    Mylan's Conflict Concerns Halt Antitrust Bellwether Trial Plans

    A Pennsylvania federal judge on Wednesday stayed proceedings and continued the trial date in the sprawling generic drug antitrust case after defendant Mylan alleged that the special discovery master, Saxton & Stump shareholder and former federal judge Lawrence Stengel, has a conflict of interest.

  • September 02, 2026

    Colo. Exits Pharma Group's Challenge Of Drug Discount Law

    A Colorado federal court has thrown out a pharmaceutical industry trade group's challenge of a state law requiring drug manufacturers to sell discounted drugs through contracted pharmacies, finding the group failed to show the law conflicts with federal law or controls business activity beyond Colorado's borders.

  • September 02, 2026

    DOL Backs Aramark Bid To Avoid Aetna ERISA Suit Arbitration

    The U.S. Department of Labor backed Aramark's attempt to keep in court its allegations that Aetna cost the company millions by mismanaging health benefit claims, telling the full Fifth Circuit that a panel correctly held that the case fell under an exception in the arbitration agreement.

  • September 01, 2026

    Mylan Cites 'Immutable Conflict' In 11th Hour Bid To Stay Trial

    Just about a week before the first trial in the sprawling generic drug price-fixing multidistrict litigation, Mylan urged a Pennsylvania federal judge to postpone the trial and stay all proceedings for at least 45 days, claiming that the special master in the case has an "immutable conflict" that impacts not just the pending trial but the entire MDL.

  • September 01, 2026

    'Secret Shoppers' Get ACA Plan Runaround

    Georgetown University researchers shopping incognito for Affordable Care Act insurance plans found misleading claims and even outright falsehoods. Law360 Healthcare Authority talks to lawyer and researcher Amy Killelea about the consequences of misinformation in the insurance market.

  • September 01, 2026

    Treatment Centers Cited Over Unpaid Work By Patients

    Massachusetts' attorney general on Tuesday announced a first-of-its-kind citation of over $1 million against a faith-based substance use treatment program for allegedly having hundreds of participants perform unpaid work, including landscaping and moving, for businesses.

  • September 01, 2026

    Courts Rule On GLP-1 Shortage Row, 340B In Colo. And More

    Law360 Healthcare Authority looks at a Fifth Circuit ruling backing the removal of certain GLP-1 medications from the national drug shortage list, the dismissal of AstraZeneca's challenge to a Colorado law affecting drug distribution under the federal 340B drug discount program and other litigation outcomes impacting the healthcare industry.

  • September 01, 2026

    3 Things To Know: Texas Judge Halts Abortion Drug Suit

    A Texas federal judge has paused a lawsuit challenging the U.S. Food and Drug Administration's approval of abortion medication mifepristone until after the agency has conducted a safety review of the drug. Law360 Healthcare Authority has what you need to know about that order and the legal landscape.

  • September 01, 2026

    Cozen Affiliate Adds 4 From Closed McDermott Shop

    More former staff members of McDermott Will & Schulte's shuttered healthcare lobbying and consulting shop in Washington, D.C., have landed new roles, with Cozen O'Connor Public Strategies announcing Tuesday it hired a four-person team from there.

  • September 01, 2026

    11th Circ. Rules Qui Tam Provisions Don't Violate Constitution

    The Eleventh Circuit on Tuesday held that the False Claims Act's qui tam provisions do not violate the appointments clause of the U.S. Constitution, maintaining private citizens' ability to sue entities on behalf of the United States for allegedly defrauding the federal government.

  • September 01, 2026

    States Curb Healthcare Noncompetes After FTC Ban Fails

    Since a federal court knocked down a national ban on workplace noncompete contracts, states have carried the mantle by passing a wave of new legislation targeting employment restrictions on healthcare workers.

  • August 31, 2026

    3rd Circ. Says History Backs NJ Telehealth License Rule

    The Third Circuit on Monday upheld New Jersey's requirement that out‑of‑state physicians obtain a state medical license before consulting with in-state patients via telemedicine, concluding that the rule fits a centuries‑old tradition of regulating medical practice and does not trigger strict First Amendment scrutiny.

  • August 31, 2026

    Judge Rejects AstraZeneca's Attack On Colo. 340B Law

    A Colorado federal judge on Monday granted the state's motion to dismiss AstraZeneca's complaint challenging a state law that expands distribution of drugs discounted through a federal program, finding that the state law isn't preempted or unconstitutional.

  • August 28, 2026

    Walmart Pays $50M To End DOJ's Suit Over Opioid Crisis

    Walmart has agreed to pay $50 million to settle the U.S. Department of Justice's nearly 6-year-old lawsuit in Delaware federal court alleging the big-box retailer helped spur the nationwide opioid crisis by unlawfully dispensing controlled drugs from its pharmacies, the department announced Friday.

  • August 28, 2026

    Mylan, Lannett, Others Can't Split Up Humana Generics Trial

    A Pennsylvania federal judge refused Friday to let Mylan, Lannett and other generic-drug makers split up Humana's looming price-fixing trial between liability and damages, preferring a single go in front of a single jury for the first trial in the sprawling multidistrict litigation.

  • August 28, 2026

    NJ Says TikTok Is Withholding Key Child Usage Data

    New Jersey urged a state judge to force TikTok to hand over detailed user engagement data the state said was essential in proving that the platform's design harmed children, accusing the company of months of evasive answers, shifting explanations and contradictory statements about whether the information even exists.

  • August 28, 2026

    Medical Marijuana Industry Grapples With DEA's New Role

    After years of allowing the state-sanctioned medical marijuana industry to operate without interference, the U.S. Drug Enforcement Administration is stepping in to regulate a drug it once treated exclusively as contraband, but attorneys and regulators say the cannabis industry's interactions with the agency are off to a rocky start.

  • August 28, 2026

    Fla. Says PBMs Fixed Prices For Prescription Drugs

    Florida's attorney general on Thursday sued two competing pharmacy benefit managers for allegedly colluding to fix prescription drug reimbursement rates to pharmacies, which the state said threatens Floridians' access to affordable medications.

  • August 28, 2026

    4 Arguments For Benefits Attys To Watch In September

    The Fifth Circuit will weigh Louisiana's bid to block telehealth access to the abortion drug mifepristone, while the Fourth Circuit will hear Lockheed Martin's challenge to a trial court decision that kept a pension de-risking suit alive. Here's a look at these and other argument sessions that should be on benefits attorneys' radar next month.

  • August 27, 2026

    PBMs Hammer Opioid Judge In Last-Ditch Gambit At 6th Circ.

    An Ohio federal judge knowingly flouted a Sixth Circuit rebuke by forcing two of the largest remaining defendants in multidistrict opioid litigation to either "settle for enormous sums or litigate for years hundreds of cases," says a Thursday petition urging the appeals court to intervene.

  • August 27, 2026

    Albertsons Loses Bid For Midtrial Win In Wash. Opioid Case

    Albertsons can't escape the state of Washington's lawsuit accusing the pharmacy chain and its Safeway subsidiary of contributing to the state's opioid crisis, a state judge ruled Thursday in denying the company's bid to dismiss the case midtrial.

Expert Analysis

  • How Home Infusion Providers Can Adapt To Enrollment Pause

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    Recent Centers for Medicare & Medicaid Services moratoria on new enrollments of home health agencies, medical equipment companies and hospices make home infusion providers' compliance obligations more complex and ambiguous, requiring new careful consideration of specific enrollment requirements and limitations, say attorneys at Quarles & Brady.

  • AI Data Mining Is Changing FCA Enforcement

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    With False Claims Act investigations increasingly emerging from statistical anomalies identified by data miners, companies need to consider what conclusions an outsider armed with artificial intelligence might draw from public-facing data and be ready to explain any anomalies if questions arise, say attorneys at Cohen & Gresser.

  • Lessons From 5 Months Of DOJ Corporate Policy Deals

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    Recent declinations and prosecution agreements between the U.S. Department of Justice and corporations since the March unveiling of the corporate enforcement and voluntary disclosure policy provide takeaways for management considering how to respond to corporate misconduct, says Brendan Quigley at Baker Botts.

  • A New Era Of Scrutiny For China-Linked Pharma Deals

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    As Congress considers bipartisan legislation that would heighten regulatory scrutiny for life sciences deals involving Chinese biotech entities, companies should reassess the risks and due diligence requirements that will come with using heavily China-dependent pipelines, says Jen Maki at Ankura.

  • Justices' FTC Ruling Weakens Qui Tam's Constitutional Base

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    The U.S. Supreme Court’s holding in Trump v. Slaughter, expanding presidential control over those exercising executive power, suggests that courts may be receptive to arguments challenging the constitutional foundations of the False Claims Act’s qui tam mechanism, says Daniel Passeser at Wiggin.

  • Calif. Drug Ruling Affirms Defect-Centric Liability Framework

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    The California Supreme Court's decision in Gilead Tenofovir Cases this week rejects a novel duty-to-innovate theory of negligence that could have reshaped product liability exposure well beyond the pharmaceutical industry, instead signaling that negligence claims premised on nondefective products are unlikely to succeed, say attorneys at Dechert.

  • DOJ's FCA Push Creates Risks For Construction Contractors

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    The construction industry may be uniquely vulnerable to a new generation of False Claims Act enforcement driven by the U.S. Department of Justice's increasing usage of the FCA to target a much broader category of conduct than it has in decades past, specifically compliance certifications and regulatory representations, say attorneys at Cozen O'Connor.

  • Feds' Mixed Cues On Medicaid Fraud Signal States To Step Up

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    While the federal government has recently delivered four distinct and mutually inconsistent messages regarding Medicaid fraud enforcement, states should focus on improving enforcement, regardless of which federal posture proves correct, says Ken Levine at Stone & Magnanini.

  • A Shift In How Policymakers Are Approaching PBM Regulation

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    Recent federal and state legislative and regulatory activity involving pharmacy benefit managers represent a change in focus from transparency to PBM compensation structures, vertical integration and competitive effects, say attorneys at Barclay Damon.

  • Workplace Menopause Laws Demand New HR Playbooks

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    A recent wave of state and local legislation that makes menopause an expressly protected condition in the workplace creates new compliance obligations amid an already ambiguous federal framework, and demands a workplace culture where employees feel safe asking for support, says Elliot Griffin at Ballard Spahr.

  • States Should Reconsider Forced PBM Divestiture Laws

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    State legislatures are attempting to enact policies intended to force pharmacy benefit managers to divest from pharmacies, but these laws would have the practical effect of reducing patient access and competition, potentially violating the U.S. Constitution in the process, says former Utah Attorney General John Swallow.

  • Noncompete Laws Show States Focusing On Bans, Healthcare

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    The first half of 2026 confirms that state legislatures are driving the most consequential changes in noncompete law, including a few state bans and several healthcare-specific laws, making a one-size-fits-all approach increasingly untenable for multistate employers, say attorneys at Faegre Drinker.

  • Where The Justices Aligned In Appellate Authority Ruling

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    The real story of the U.S. Supreme Court’s recent ruling in T.M. v. University of Maryland Medical System Corp., finding that a doctrine designed to curtail duplicative litigation prevents federal district courts from reviewing state court decisions, is in how the justices together revisited an obscure, century-old jurisdictional doctrine, says Alex Dimitrief at Zeughauser Group.