Policy & Compliance

  • 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.

  • August 12, 2025

    States Push Anti-mRNA Bills Amid Growing Public Distrust

    Public distrust was a key motivator for the federal government's decision to cut contracts developing messenger RNA vaccines. The sentiment is apparent in state legislatures considering a slew of vaccine-related bills.

  • August 12, 2025

    Docs Take NJ Telemedicine Restrictions Fight To 3rd Circ.

    A group of doctors and patients have appealed the dismissal of their challenge to a New Jersey law that says out-of-state doctors can't practice telemedicine with Garden State patients unless they're licensed there, telling the Third Circuit that the rule deprives people of potentially life-saving consultation.

  • August 12, 2025

    New Barriers To Health Safety Net Spark Questions, Litigation

    Federal health officials' reinterpretation of a decades-old social welfare law is expected to boot thousands of noncitizens from safety net programs. It has also prompted a wave of enforcement questions from healthcare providers and legal pushback.

  • August 12, 2025

    Worker's Flu Shot Ruling Goes Too Far, 5th Circ. Dissent Says

    A Fifth Circuit judge on Monday said a woman briefly suspended from Texas Children's Hospital over her refusal to get a flu vaccine should be able to pursue her religious discrimination suit even though the hospital ultimately accommodated her beliefs.

  • August 12, 2025

    Sentara Health Must Face Trimmed Stable Value Fund Suit

    A Virginia federal court refused to toss a proposed class action alleging healthcare not-for-profit Sentara Health mismanaged an employee retirement plan, finding workers had sufficiently backed up claims that a stable value fund in the plan underperformed and their employer's investment management process was lacking.

  • August 12, 2025

    Antitrust Actions, Drug Pricing And More

    A federal appeals court revived an antitrust suit against drugmakers, the Federal Trade Commission challenged a heart valve company acquisition, a patient's privacy lawsuit against an urgent care clinic was allowed to proceed, and a Texas federal court upheld Medicare's drug price negotiation program. Here, Law360 Healthcare Authority looks at those and other healthcare litigation developments you may have missed over the past week.

  • August 12, 2025

    NJ Is Key Battleground In Fight Over Newborn Blood Tests

    Newborn blood screening, a cornerstone of modern public health, is the focus of a debate over patient privacy, parental consent and what happens to the samples after initial tests are complete. A New Jersey court recently weighed in.

  • August 12, 2025

    340B Rebate Plan Sparks Questions On Enforcement, Appeals

    The drug industry, long critical of the 340B discount program, appeared to score a win when the Trump administration announced a post-sale rebate model. Hospitals and other buyers have some notes on a potentially deficient appeal process and other uncertainties.

Expert Analysis

  • Considering The Future Of AI Regulation On Health Sector

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    As Texas looks to become the next state to pass a comprehensive law regulating artificial intelligence, the healthcare industry should consider how AI regulation will continue to evolve in the U.S. and how industry members can keep up with compliance considerations, say attorneys at Kirkland & Ellis.

  • What To Expect From 'Make America Healthy Again' Actions

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    The Make America Healthy Again Commission recently established by President Donald Trump and chaired by Robert F. Kennedy Jr. will potentially bring energy and attention to important public health topics, and stakeholders should be aware of pathways for sharing their input and proactively informing proceedings, says Nicholas Manetto at Faegre Drinker.

  • How Citizen Petitions Have Affected Drug Competition

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    In light of recent citizen petitions and proposed legislation regulating such petitions, Omar Robles at Managing Health analyzes the statistics of the extent to which citizen petitions have been filed, and to what extent they have delayed competition in prescription pharmaceuticals.

  • Drug Kickback Ruling Will Make FCA Liability Harder To Prove

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    The First Circuit's ruling in U.S. v. Regeneron Pharmaceuticals, requiring the government to prove but-for causation to establish False Claims Act liability based on violations of the Anti-Kickback Statute, raises the bar for FCA enforcement and deepens a circuit split that the U.S. Supreme Court may need to resolve, say attorneys at Baker Donelson.

  • Assessing PE Risk After Mass. False Claims Act Amendments

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    A law recently passed in Massachusetts amends the commonwealth's False Claims Act by dramatically expanding potential liability for private equity firms and investors, underscoring the importance of robust diligence and risk assessments for private equity firms conducting transactions in the commonwealth, say attorneys at Gibson Dunn.

  • What Trump Actions Mean For Federal Research Funding

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    New guidance from the National Institutes of Health represents a massive policy shift regarding federal funding for researchers at institutions of higher education, contributing to a perfect storm of significant resource shortfalls in upcoming years, say attorneys at Arnold & Porter.

  • A Look At Healthcare Transaction Oversight In Oregon

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    Understanding Oregon's enforcement authority and its impact on proposed transactions last year provides a road map to the state's plans to strengthen its processes this year, though enforcement could be challenged by ongoing litigation, say attorneys at Ropes & Gray.

  • Rethinking 'No Comment' For Clients Facing Public Crises

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    “No comment” is no longer a cost-free or even a viable public communications strategy for companies in crisis, and counsel must tailor their guidance based on a variety of competing factors to help clients emerge successfully, says Robert Bowers at Moore & Van Allen.

  • High Court Must Acknowledge US History Of Anti-Trans Laws

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    Despite Justice Amy Coney Barrett's claim to the contrary during oral arguments in U.S. v. Skrmetti, U.S. governments at every level have systematically discriminated against transgender people, and the U.S. Supreme Court must consider this historical context in upcoming cases about transgender issues, says Paisley Currah at the City University of New York.

  • The Fate Of Biden-Era Clinical Study Guidance Under Trump

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    Draft guidance about the study of sex and gender differences in medical product development issued by the outgoing Biden administration currently faces significant uncertainty and litigation potential due to the Trump administration's executive orders and other actions, say attorneys at Arnold & Porter.

  • 10 Issues To Watch In Aerospace And Defense Contracting

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    This year, in addition to evergreen developments driven by national security priorities, disruptive new technologies and competition with rival powers, federal contractors will see significant disruptions driven by the new administration’s efforts to reduce government spending, regulation and the size of the federal workforce, say attorneys at Thompson Hine.

  • Dispelling 10 Myths About Health Provider-Based Compliance

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    Congress appears intent on requiring hospitals to submit provider-based attestations for all off-campus outpatient hospital locations, so now is the time for hospitals to prepare for this change by understanding common misconceptions about provider-based status and proactively correct noncompliance, say attorneys at McDermott.

  • A Look At HHS' New Opinion On Patient Assistance Programs

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    A recent advisory opinion from the U.S. Department of Health and Human Services' Office of Inspector General follows a recent trend of blessing patient assistance program arrangements that implicate the Anti-Kickback Statute, as long as they are structured with appropriate safeguards to minimize the risk of fraud and abuse, say attorneys at Sheppard Mullin.