Policy & Compliance

  • June 27, 2025

    Feds Prevail Over J&J In Another 340B Rebate Dispute

    A D.C. federal judge granted a summary judgment win Friday to the U.S. Health Resources and Services Administration over Johnson & Johnson, finding the agency acted within its discretion when it rejected the company's program to offer rebates instead of discounts in a decades-old drug pricing program.

  • June 27, 2025

    Patient Monitoring Co. To Pay Feds $1.3M To Settle FCA Suit

    A Georgia healthcare patient monitoring company has agreed to pay nearly $1.3 million to resolve a False Claims Act suit alleging it gave referral kickbacks to doctors' offices in half a dozen states, ripping off Medicare and Medicaid in the process.

  • June 27, 2025

    Judge Lets DOGE Access Go On But Cites 'Grave' Concerns

    A D.C. federal judge Friday voiced his "grave" concerns about the White House's Department of Government Efficiency obtaining personal information, but the district court declined to stop the U.S. Department of Labor and U.S. Department of Health and Human Services from giving this access.

  • June 27, 2025

    Feds Say Transnational Crime Ring Stole $10B From Medicare 

    New York federal prosecutors have charged 11 members of a "transnational criminal organization, based in Russia and elsewhere," with submitting more than $10 billion worth of fraudulent Medicare claims over the last three years and funneling the proceeds overseas, according to a newly unsealed indictment.

  • June 27, 2025

    Pregnancy Loss Draws Police Scrutiny Following Dobbs

    The nation's abortion debate has played out in civil courtrooms and state capitols across the country since the overturning of Roe v. Wade three years ago. But the battle is also emerging in another arena: the criminal courts.

  • June 27, 2025

    Full 5th Circ. To Hear Planned Parenthood Atty Immunity Row

    The full Fifth Circuit will rehear a panel's decision concluding that Planned Parenthood is entitled to attorney immunity in a whistleblower suit accusing the organization of improperly billing Medicaid programs.

  • June 27, 2025

    DC Judge Says Teen Health Projects Can 'Shutter' Temporarily

    Five Planned Parenthood affiliates will not be irreparably harmed by changes to federal guidance for teen health programs instructing grantees to demonstrate alignment with executive orders from the Trump administration rejecting transgender identity and diversity programs, a D.C. federal judge has ruled.

  • June 27, 2025

    Justices Back Task Force That Sets ACA Care Requirements

    The U.S. Supreme Court ruled Friday that the U.S. Department of Health and Human Services' secretary had authority over a preventive care task force, rejecting a constitutional challenge to an Affordable Care Act clause that requires health insurers to cover certain treatments at no cost to patients.

  • June 26, 2025

    Nurse Wins $27M In Retaliation Case Against Dignity Health

    A former chief nursing officer who sued the West Coast hospital system Dignity Health alleging she was illegally terminated for raising serious safety concerns was awarded $27.5 million from a Los Angeles jury, her attorneys announced Thursday. 

  • June 26, 2025

    Hims & Hers Face Investor Suits Over Wegovy Collab

    Telehealth company Hims & Hers Health Inc. has been hit with investors' proposed class actions accusing it of exploiting its partnership with Novo Nordisk, the distributor of weight loss drug Wegovy, to sell "knockoff" drugs, causing Hims shares to fall 35% when Novo Nordisk announced earlier this week the collaboration had been terminated.

  • June 26, 2025

    UHC Accused Of Withholding $2M In Claims From NC Provider

    UnitedHealthcare Insurance Co. siphoned millions of dollars from a North Carolina emergency medicine provider in an "extortionate scheme" by refusing to pay its customers' emergency medical claims, the provider has alleged in North Carolina federal court.

  • June 26, 2025

    6th Circ. Backs Mich. Newborn Blood Testing Program

    A Sixth Circuit panel reversed a win for a group of parents challenging a Michigan newborn health screening program, finding that the way blood samples are stored and used in the program does not violate the parents' right to make medical decisions for their children.

  • June 26, 2025

    Judge Casts Doubt On Plea Deals In Blood Test Defect Case

    A set of plea agreements between Massachusetts federal prosecutors and former Magellan Diagnostics executives has been thrown into uncertainty amid a dispute over whether the executives admitted to fraud related to defective blood tests or merely an intent to mislead, a question a judge said Thursday might be "a very expensive rabbit hole."

  • June 26, 2025

    Ex-FDA Regulator Joins ArentFox Schiff's Pharma Practice

    ArentFox Schiff LLP has hired a career U.S. Food and Drug Administration compliance professional, whose oversight focused on ensuring pharmaceutical industry participants' compliance with drug supply chain rules and other governing regulations, as counsel in the firm's food, drug, medical device and cosmetic practice in Washington.

  • June 26, 2025

    Former Hoops Star Telfair Gets 6 Mos. For Violating Release

    A Manhattan federal judge sentenced former high school basketball star and ex-NBA player Sebastian Telfair to six months in prison Thursday for violating the terms of his supervised release, after sparing him prison last year for defrauding the league's health plan.

  • June 26, 2025

    Justices Say SC Medicaid Patient Can't Sue To Pick Provider

    The U.S. Supreme Court on Thursday ruled that a patient can't challenge South Carolina's decision to kick Planned Parenthood from the state Medicaid program because it includes abortions among its services.

  • June 25, 2025

    Cigna Says Bristol-Myers Delayed Cancer Drug Generic

    Cigna has launched an antitrust suit in New York federal court accusing Bristol-Myers Squibb Co. and its Celgene subsidiary of fraudulently obtaining patents, filing sham litigation and paying off generic-drug makers to maintain a monopoly on their blockbuster blood-cancer drug Pomalyst.

  • June 25, 2025

    Trans Worker Says Metal Co.'s Health Plan Discriminatory

    A subsidiary of Kaiser Aluminum discriminated against transgender employees by including an exclusion in its health plan barring coverage for medical treatments related to gender-affirming care, according to a new suit filed in Washington federal court.

  • June 25, 2025

    CVS PBM Hit With $95M Judgment For Overbilling Medicare

    A Pennsylvania federal judge on Wednesday ruled that CVS's pharmacy benefits manager owes the government $95 million for overbilling Medicare Part D-sponsored drugs, leaving the door open for the amount to be tripled later.

  • June 24, 2025

    Arkansas Insurance Dept. Fights Teamsters Plan's ERISA Suit

    The Arkansas Insurance Department is looking to sink a challenge to a state insurance regulation filed by a Teamsters healthcare plan, telling an Illinois federal judge that the regulation isn't preempted by the Employee Retirement Income Security Act and, besides, the plan can't sue the department.

  • June 24, 2025

    Health Data Co. Must Face Revised Investor Fraud Suit

    A Connecticut federal judge won't toss an amended class action claiming a healthcare technology company misled investors about a data platform it claimed to operate that didn't actually exist, ruling that statements about the platform's capabilities are not inactionable, forward-looking statements.

  • June 24, 2025

    4th Circ. Tosses Trans Man's Appeal Over Canceled Surgery

    The Fourth Circuit declined to revive a transgender man's constitutional claims against a religious hospital run by the University of Maryland Medical System over a canceled hysterectomy for gender dysphoria, concluding Tuesday that it couldn't grant further relief, and refused to consider a "late-breaking" argument for emotional distress damages.

  • June 24, 2025

    Calif. AG Asks 9th Circ. To Undo Limits On Pay-For-Delay Ban

    California enforcers on Monday asked the Ninth Circuit to overturn a district court's decision that a state law restricting "reverse payment" settlements between brand-name and generic-drug makers cannot be used to regulate deals that were struck outside the Golden State.

  • June 24, 2025

    Healthcare In Court: 5 Rulings You May Have Missed

    A D.C. federal judge rejected a challenge to the federal government's approval of an audit by Johnson & Johnson into five hospitals' compliance with the 340B drug discount program. In Texas, a state appellate court has blocked San Antonio from going forward with a program that could fund travel for residents to access abortion care in other states. Here, Law360 Healthcare Authority looks at those and other healthcare rulings you may have missed over the last week.

  • June 24, 2025

    Nichols Liu Co-Founder Andy Liu Launches Solo Venture

    Boutique firm Nichols Liu LLP's co-founding partner Andy Liu has launched a solo practice to continue representing government contractors and healthcare industry clients in civil and criminal enforcement matters, telling Law360 Pulse Tuesday he wanted to go out on his own for greater control.

Expert Analysis

  • A New Tool For Assessing Kickback Risks In Health Marketing

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    The Seventh Circuit's recent decision in U.S. v. Sorensen, reversing a conviction after trial of a durable medical equipment distributor, highlights two principle considerations for determining whether payments to marketers in healthcare are unlawful under the Anti-Kickback Statute, says Elisha Kobre at Sheppard Mullin.

  • How Trump Orders Affect Health Orgs.' Care For Trans Minors

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    Two recent executive orders issued by President Donald Trump regarding gender-affirming care for minors have put healthcare organizations in a precarious situation, and these institutions should prepare for various implications and potential scenarios, say attorneys at ArentFox.

  • Reproductive Health Under Trump So Far, And What's Next

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    Based on priorities stated so far, the Trump administration will likely continue to weaken Biden-era policies that protect reproductive health, with abortion, in vitro fertilization and contraception all being issues to watch closely amid a post-Dobbs shift, say attorneys at McDermott.

  • What's Next For Lab Test Regulation Without FDA Authority

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    A recent Texas federal court decision vacating the U.S. Food and Drug Administration's final rule that would apply FDA regulations to laboratory-developed tests signals potential positive impacts in the diagnostic space, and could inspire more healthcare entities to litigate against the government, say attorneys at Hooper Lundy.

  • 6 Criteria Can Help Assess Executive Branch Actions

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    With new executive policy changes announced seemingly every day, several questions can help courts, policymakers and businesses determine whether such actions are proper, effective and in keeping with our democratic norms, say Marc Levin and Khalil Cumberbatch at the Council on Criminal Justice.

  • Learning From COVID-19 Enforcement Against Nursing Homes

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    Five years after the COVID-19 outbreak caused a high number of deaths in nursing homes, an examination of enforcement actions against nursing homes in New York and elsewhere in the country highlights obstacles that may arise when bringing cases of this type, and ways to overcome them, says Kenneth Levine at Stone & Magnanini.

  • How Plan Sponsors Can Mitigate Risk In PBM Contracts

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    A recent lawsuit in New York federal court alleges that JPMorgan caused exorbitant prescription costs by mishandling the pharmacy benefit manager arrangement, adding to a growing body of Employee Retirement Income Security Act fiduciary breach litigation and affirming that fiduciaries must proactively manage their healthcare plan vendors, say attorneys at Hall Benefits Law.

  • 4th Circ. Health Data Ruling Opens Door To State Law Claims

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    In Real Time Medical v. PointClickCare, the Fourth Circuit recently clarified that state law claims can rest in part on violations of a federal law that prohibits electronic health information blocking, expanding legal risks for health IT companies and potentially creating exposure to a range of competitive implications, say attorneys at BCLP.

  • Unpacking Trump Admin Plans For Value-Based Care

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    Recent developments from the Center for Medicare and Medicaid Innovation suggest the Trump administration intends to put its own stamp on value-based care, emphasizing cost savings assessment in particular, with its recent cancellation of several payment models that had supported primary care, says Miranda Franco at Holland & Knight.

  • What To Expect For Stem Cell Regulation Under Trump Admin

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    The new administration's push for deregulation, plus the post-Chevron legal landscape, and momentum from key political and industry players to facilitate stem cell innovation may create an opportune backdrop for a significant reduction in the U.S. Food and Drug Administration's regulatory framework for stem cells, say attorneys at Sheppard Mullin.

  • How Importers Can Minimize FCA Risks Of Tariff Mitigation

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    False Claims Act risks are inherent in many tariff mitigation strategies, making it important for importers to implement best practices to identify and report potential violations of import regulations before they escalate, says Samuel Finkelstein at LMD Trade Law.

  • 10 Practical Takeaways From FDA's Biopharma AI Guidance

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    Recent guidance from the U.S. Food and Drug Administration provides much-needed insight on the usage of artificial intelligence in producing information to support regulatory decision-making regarding drug safety, with implications ranging from life cycle maintenance to AI tool acquisition, say attorneys at Covington.

  • Lawmakers Shouldn't Overlook Rare Disease Therapies' Value

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    As the ORPHAN Cures Act is pending in Congress, policymakers assessing the value of certain drugs for price regulation should consider data beyond what is collected in clinical trials, say Alice Chen at the University of Southern California, and Molly Frean and Yao Lu at Analysis Group.