Policy & Compliance

  • August 28, 2025

    J&J Unit Can't Shake $442M Loss In Catheter Antitrust Suit

    A California federal judge has refused to upend the $442 million trial loss of Johnson & Johnson's Biosense Webster health tech unit to Innovative Health, finding the jury was presented with sufficient evidence to fault Biosense for conditioning product support for its cardiac mapping systems on the purchase of cardiac catheters.

  • August 28, 2025

    Bid For DQ From FCA Suit Over AI Use 'Drastic,' Relator Says

    The unexpected disclosure that an expert witness misused artificial intelligence should not be enough to essentially doom a False Claims Act fraudulent billing suit, the case's relator told a Salt Lake City federal judge, arguing a sanctions bid brought by the anesthesiologist defendants is "grossly disproportional" to the error he already sought to rectify.

  • August 28, 2025

    Bradley Arant Taps Parker Hudson Healthcare Atty In Atlanta

    Bradley Arant Boult Cummings LLP announced Thursday that it continued its Atlanta growth with the addition of a new healthcare practice group partner from Parker Hudson Rainer & Dobbs LLP.

  • August 28, 2025

    SC Ends Sandoz, Novartis Price-Fixing Claims For $2.4M

    A Connecticut federal judge on Thursday approved South Carolina's request to dismiss its generic drug price-fixing claims from three multistate lawsuits against Sandoz Inc., Sandoz AG, Novartis AG and Fougera Pharmaceuticals Inc., four months after the parties filed a notice of settlement.

  • August 28, 2025

    Fed. Circ. Won't Upend Toss Of Flu Vaccine Injury Claim

    The Federal Circuit won't revive a man's vaccine injury claim after it was rejected by a special master at the U.S. Court of Federal Claims, finding the decision that his injuries were caused by a separate infection was not arbitrary or capricious.

  • August 27, 2025

    HHS Says CDC Head Has Been Fired. She Says Otherwise.

    Centers for Disease Control and Prevention director Susan Monarez said Wednesday that she's not resigning and also that she cannot be terminated except by the president himself, issuing a statement after CDC parent agency U.S. Department of Health and Human Services said she was "no longer director."

  • August 27, 2025

    DOJ Throws Lifeline To J&J At 3rd Circ. After $1.6B FCA Loss

    A district judge made multiple errors in an opinion and jury instructions underpinning a staggering False Claims Act verdict tied to Johnson & Johnson's drug marketing practices, and a fresh look is needed "under a correct view of the law," the U.S. Department of Justice told the Third Circuit on Wednesday.

  • August 27, 2025

    7th Circ. Denies Alcoa's Bid To Stay Health Benefits Injunction

    An aluminum manufacturer must comply with an injunction ordering it to reinstate union-represented retirees' healthcare benefits while it argues in court that it was allowed to transition them to health reimbursement accounts in 2021, the Seventh Circuit held, rejecting the company's request for the court to pause the injunction.

  • August 27, 2025

    CVS To Pay $12M To Settle Mass. Medicaid Overbilling Claims

    CVS Pharmacy Inc. will pay more than $12 million to settle allegations that it charged Massachusetts' Medicaid program higher prices than it offered to the public for the same drugs, the state attorney general announced Wednesday.

  • August 27, 2025

    6th Circ. Says Hospital Waived Arbitration In Pronoun Dispute

    The Sixth Circuit reversed an order Wednesday allowing a University of Michigan hospital to arbitrate an ex-worker's suit claiming she was fired out of religious bias for refusing to use preferred pronouns for certain LGBTQ patients, ruling the institution waited too long to invoke an arbitration pact.

  • August 27, 2025

    Scholars Tell High Court To Back Conversion Therapy Ban

    A group of health law experts told the U.S. Supreme Court that Colorado's conversion therapy ban doesn't violate healthcare providers' First Amendment rights, arguing that the law is consistent with states' and the federal government's ability to regulate healthcare.

  • August 27, 2025

    Boehringer Wins Another Zantac Cancer Trial In Ill.

    An Illinois state court jury sided with Boehringer Ingelheim on Wednesday in a man's lawsuit claiming over-the-counter Zantac use contributed to his colorectal cancer development, adding another tally on the German drugmaker's list of victories over similar accusations.

  • August 26, 2025

    Split 9th Circ. Upholds Oregon Pharmaceutical Reporting Law

    A split Ninth Circuit panel on Tuesday vacated a lower court's order blocking an Oregon law requiring drug manufacturers to report information related to certain prescription drugs to the state, ruling that the law is indeed constitutional under both the First and Fifth amendments.

  • August 26, 2025

    DC Circ. Backs HHS In Low-Income Patient Payment Dispute

    The D.C. Circuit has delivered a blow to a group of hospitals in a recent decision finding they had challenged a key component of their Medicare reimbursements too early, despite hospital associations' warnings that such a ruling could slow healthcare providers' ability to seek review and "ultimately harm" patients.

  • August 26, 2025

    Mich. AG Lambasts UMich For Halting Trans Youth Care

    Michigan's attorney general publicly warned the University of Michigan Tuesday that her office was "considering all of our options" after the university's hospital system said it would cease providing gender-affirming care to minors under pressure from the Trump administration. 

  • August 26, 2025

    Maine Medicaid Cuts, Medicare Radiation Ruling And More

    A Maine federal court turned down a family planning organization's request to temporarily block a congressional mandate withdrawing Medicaid funds to abortion providers. In South Carolina, Planned Parenthood filed a new complaint challenging a state policy kicking the provider out of the state's Medicaid program for providing abortions. 

  • August 26, 2025

    Doctors Press 5th Circ. To Reverse Surprise Billing Ruling

    Three physician trade associations urged the full Fifth Circuit to reverse a panel's ruling on how qualifying payments are calculated under the No Surprises Act, writing that the current decision harms underserved communities by narrowing provider networks.

  • August 26, 2025

    Cigna Strikes ERISA Ghost Network Suit Settlement Deal

    Cigna Health and Life Insurance Co. has agreed to settle a proposed class action alleging the health plan administrator violated federal benefits law by advertising providers as in-network who were out-of-network to participants in employer-sponsored health benefit plans that Cigna administered, according to filings in Illinois federal court.

  • August 26, 2025

    Frier Levitt Adds FDA Regulation Specialist Duo

    New Jersey-based national healthcare law boutique Frier Levitt added a partner and senior counsel pair from a life science law boutique this week to expand its expertise in Food and Drug Administration regulation and compliance and the cannabis and hemp industries.

  • August 26, 2025

    TikTok Takes State's Addictive App Case To NC Top Court

    TikTok and its Chinese parent company are taking the state of North Carolina's lawsuit accusing it of intentionally designing the app to addict young users to the state's highest court after a Business Court judge rejected their early exit bid.

  • August 26, 2025

    Foley Hoag Adds Healthcare Co-Leader From Manatt

    Foley Hoag LLP has hired the former president and CEO of the National Hospice and Palliative Care Organization as the new co-chair of its healthcare department.

  • August 25, 2025

    DOJ Wants $10.5M From Convicted Nursing Exec For Fraud

    U.S. Department of Justice prosecutors asked a Nevada federal judge Friday for a $10.5 million preliminary forfeiture order against a nurse staffing executive convicted of wage-fixing, an amount that matches what he was paid for his staffing company after deceiving the buyer into thinking there was no criminal antitrust investigation.

  • August 25, 2025

    Greenberg Traurig Adds Healthcare Atty From Baker Donelson

    Greenberg Traurig LLP has brought on a shareholder from Baker Donelson Bearman Caldwell & Berkowitz PC at its Tallahassee office, adding an experienced attorney to its healthcare and U.S. Food and Drug Administration practice, the firm announced Monday.

  • August 25, 2025

    Generic-Drugs Group Asks 9th Circ. To Nix Pay-For-Delay Law

    A trade group for generic drugmakers urged the Ninth Circuit to fully scrap a California law banning brand pharmaceutical companies from paying to delay generics competition, in a brief targeting both the law's in-state features upheld by a district court and the extraterritorial reach the state wants revived.

  • August 22, 2025

    Texas, Fla. Want In On Abortion Medication Challenge

    Texas and Florida have asked a Lone Star State federal court to allow them to intervene in litigation challenging federal approvals for the abortion medication mifepristone, arguing that their interests may "no longer be adequately represented" by Missouri, Kansas and Idaho, which are currently leading the suit.

Expert Analysis

  • Plan Sponsors Must Prep For New Mental Health, Drug Rules

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    To comply with newly published health insurance rules requiring parity between access to mental health and substance use services compared to medical and surgical services, employers with self-insured plans will need to update third-party administrator agreements and collect data, among other compliance steps, say attorneys at Kilpatrick.

  • A Primer On Navigating The Conrad 30 Immigration Program

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    As the Conrad 30 program opens its annual window to help place immigrant physicians in medically underserved areas, employers and physicians engaged in the process must carefully understand the program's nuanced requirements, say Andrew Desposito and Greg Berk at Sheppard Mullin.

  • Class Actions At The Circuit Courts: September Lessons

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    In this month's review of class action appeals, Mitchell Engel at Shook Hardy identifies practice tips from four recent class certification rulings involving denial of Medicare reimbursements, automobile insurance disputes, veterans' rights and automobile defects.

  • Proposed Legislation May Crack Down On Online Drug Ads

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    A bill recently proposed in Congress could serve as a sea change in how the U.S. Food and Drug Administration regulates drug-related speech, with significant trickle-down effects on various corners of not only the drug industry but also on consumers and providers themselves, say Dominick DiSabatino and Arushi Pandya at Sheppard Mullin.

  • What To Expect From Calif. Bill Regulating PE In Healthcare

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    A California bill currently awaiting Gov. Gavin Newsom's approval, intended to increase oversight over private equity and hedge fund investments in healthcare, is emblematic of recent increased scrutiny of investments in the space, and may affect transactions and operations in California in a number of ways, say attorneys at Ropes & Gray.

  • Vertex Suit Highlights Issues For Pharma Fertility Support

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    Vertex Pharmaceuticals' recent lawsuit challenging the U.S. Department of Health and Human Services' interpretation of the Anti-Kickback Statute is influenced by a number of reproductive rights and health equity issues that the Office of Inspector General should address more concretely, including in vitro fertilization and fertility preservation programs, says Mary Kohler at Kohler Health Law.

  • CMS' New 'Breakthrough' Device Policy Shows Little Promise

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    The Centers for Medicare & Medicaid Services’ recent procedural notice outlining a new Medicare coverage pathway for breakthrough medical devices will, at best, be a failed experiment and, at worst, result in Medicare beneficiaries denied access to innovative treatments, say attorneys at King & Spalding.

  • A Preview Of AI Priorities Under The Next President

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    For the first time in a presidential election, both of the leading candidates and their parties have been vocal about artificial intelligence policy, offering clues on the future of regulation as AI continues to advance and congressional action continues to stall, say attorneys at Mintz.

  • Managing Community Health Needs Assessments: A Checklist

    Excerpt from Practical Guidance
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    To guide nonprofit hospitals and health systems through their required community health needs assessment every three years, this checklist outlines the steps for 12 phases of the process.

  • Pa. Health Employers Must Prep For Noncompete Restrictions

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    Newly enacted legislation in Pennsylvania prohibits certain noncompete covenants for healthcare practitioners in the state beginning next year, creating compliance challenges that both employers and employees should be aware of, say attorneys at Buchanan Ingersoll.

  • FTC Focus: What Access To Patent Settlements Would Mean

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    Settling parties should adopt a series of practice tips, including specifying rationales to support specific terms, as the Federal Trade Commission seeks to expand its access to settlements before the Patent Trial and Appeal Board, say Shannon McGowan and David Munkittrick at Proskauer.

  • Agencies Should Reward Corporate Cyber Victim Cooperation

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    The increased regulatory scrutiny on corporate victims of cyberattacks — exemplified by the U.S. Securities and Exchange Commission's case against SolarWinds — should be replaced with a new model that provides adequate incentives for companies to come forward proactively and collaborate with law enforcement, say attorneys at McDermott.

  • Strategies To Defend Against Healthcare Nuclear Verdicts

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    The healthcare industry is increasingly the target of megaclaims, particularly those alleging medical malpractice, but attorneys representing providers can use a few tools to push back on flimsy litigation and reduce the likelihood of a nuclear verdict, says LaMar Jost at Wheeler Trigg.