Policy & Compliance

  • December 19, 2025

    AstraZeneca Unit Ducks Patent Fraud, Not Sham Suit Claims

    A Massachusetts federal judge spared AstraZeneca unit Alexion on Friday from half of a nonprofit insurer's proposed class action, finding the plaintiff too far removed from anticompetitive patent fraud that allegedly propped up blood disorder treatment Soliris, while preserving accusations that Alexion brought sham infringement allegations against would-be rivals.

  • December 19, 2025

    EEOC Sues Over Christian Nurse's Denied Vax Exemption

    An Illinois-based hospital system bucked civil rights law when it denied a Christian nurse's request for an exemption to its COVID-19 vaccination policy and then fired her, the U.S. Equal Employment Opportunity Commission has told a federal court.

  • December 19, 2025

    Trump Admin Appeals Harvard Win In $2B Fund Freeze Case

    The Trump administration will ask the First Circuit to overturn a federal judge's ruling that prevented the government from withholding $2.2 billion in federal grants from Harvard University over concerns about antisemitism on campus.

  • December 18, 2025

    Split 6th Circ. Blocks Michigan's Ban On Conversion Therapy

    A split Sixth Circuit panel ordered an injunction on Michigan's conversion therapy ban, ruling the law likely places an unconstitutional restriction on the First Amendment rights of a Catholic charitable organization and a therapist whose faith-based psychotherapy practices fall under the ban.

  • December 18, 2025

    SF Must Reinstate Worker Fired For Violating COVID Vax Rule

    A California federal judge ordered San Francisco to reinstate a 311 call center agent who was fired for violating a COVID-19 vaccination mandate after he sought an exemption based on his Muslim faith, ruling Thursday that the plaintiff has made a "prima facie case for religious discrimination."

  • December 18, 2025

    AstraZeneca Can't Block Colo. Law Over Drug Discount Rules

    A Colorado federal judge rejected AstraZeneca's effort to block enforcement of a Colorado law surrounding federal 340B drug pricing that requires manufacturers to sell drugs at discounted prices to certain safety net healthcare facilities, ruling Wednesday the law isn't preempted by 340B drug pricing. 

  • December 18, 2025

    HHS Proposes Hospital Ban On Gender Care For Minors

    The Trump administration moved to block all hospitals that receive federal funding from providing gender-affirming care to minors and issued warning letters to a dozen companies Thursday as part of a sweeping push to halt the care nationwide, even in states with legal protections in place.

  • December 17, 2025

    Lighting Co. Strikes Deal In 401(k) Forfeiture, Tobacco Fee Suit

    An automotive lighting company told an Illinois federal court Wednesday that it has settled an ex-worker's proposed class action claiming the business mismanaged forfeited 401(k) funds and failed to inform workers who used tobacco how to avoid paying an extra health plan fee.

  • December 17, 2025

    Braidwood Asks For Judgment In ACA Preventive Care Fight

    Christian-owned, for-profit management company Braidwood Management Inc. asked a Texas federal judge Tuesday to end its challenge to an Affordable Care Act provision that requires coverage of lung cancer screenings and preexposure prophylaxis for HIV/AIDS, citing a U.S. Supreme Court finding upholding the provision.

  • December 17, 2025

    Doctors Not Harmed By CDC's Vaccine Guidance, Feds Say

    The federal government argued Wednesday that doctors lack standing to challenge the overhaul of a key federal vaccine committee that has since downgraded the COVID-19 shot, saying healthcare providers haven't been harmed by the policy shifts.

  • December 16, 2025

    Ex-NIAID Director Claims Retaliation in Trump Admin Suit

    The former director of the National Institute of Allergy and Infectious Diseases filed suit in Maryland federal court on Tuesday alleging Trump administration appointees violated her constitutional rights by illegally terminating her employment and that she cannot expect her claims to be fairly heard by the "undermined" U.S. Office of Special Counsel.

  • December 16, 2025

    DOD To Reevaluate Discharges Over COVID Vax Refusal

    The U.S. Department of Defense said on Tuesday that Secretary of Defense Pete Hegseth ordered a reevaluation of the discharge status of service members who were involuntarily removed from the military after they refused to receive the COVID-19 vaccine. 

  • December 16, 2025

    Vax Skeptics Cite High Court In New Challenge To NY Mandate

    A vaccine skepticism advocacy group once tied to Secretary of Health and Human Services Robert F. Kennedy Jr. is revamping its fight against New York's school vaccination mandate, arguing recent activity by the U.S. Supreme Court necessitates a fresh analysis.

  • December 16, 2025

    Qui Tam Challenge At 11th Circuit: 4 Takeaways

    An appellate panel weighed the constitutionality of the False Claim Act's whistleblower mechanism. Law360 Healthcare Authority has what you need to know about the closely watched hearing.

  • December 16, 2025

    Bazelon Center Dir. On Disabilities And Medicaid 'Barriers'

    Law360 Healthcare Authority talks to Jennifer Mathis of the Bazelon Center for Mental Health Law about Medicaid, disability law and what states should do to stop people with impairments from being disenrolled improperly.

  • December 16, 2025

    Ex-Harvard Morgue Manager Gets 8 Years In Body Parts Case

    Former Harvard Medical School morgue manager Cedric Lodge was sentenced Tuesday in Pennsylvania federal court to eight years in prison after pleading guilty earlier this year to trafficking body parts from donated cadavers.

  • December 16, 2025

    Hospital Owners Sue HHS Over Medicare Payment Rule

    Allina Health System and other nonprofit hospital owners have sued the U.S. Department of Health and Human Services, telling a D.C. federal judge it unlawfully enacted a rule that will cause safety-net hospitals to lose out on billions of dollars of Medicare payments.

  • December 16, 2025

    FCA In 2025: Trump, A Qui Tam Clash And Whopping Penalties

    From a 10-figure verdict to shifting Justice Department enforcement priorities, Law360 looks at the major FCA developments of the year.

  • December 15, 2025

    States Fight Sandoz Bid To Argue Duplication In Generics Row

    Multiple attorneys general have told a Connecticut federal court that Sandoz Inc. and Fougera Pharmaceuticals Inc. can't claim the states' grievances over allegations of price fixing are duplicative of claims that were already settled, since there are some claims and forms of relief that only state plaintiffs can seek.

  • December 15, 2025

    DOJ Raises Accreditation Concerns In Vet School Case

    The U.S. Department of Justice waded into a Tennessee veterinary school's antitrust case challenging the American Veterinary Medical Association's accreditation requirements, raising concerns about the risk posed by professional groups that play gatekeeping functions.

  • December 15, 2025

    NC Panel Says State's Hospital Law Is Constitutional

    North Carolina's "certificate of need" law hasn't created a monopoly nor has it restricted an eye surgeon's right to earn a living, a state court panel ruled Friday, ending for now the surgeon's yearslong suit arguing the law is facially unconstitutional.

  • December 15, 2025

    Formula Suits An 'Undue Burden' On Cook County, Panel Says

    An Illinois appellate court Friday agreed with Abbott Laboratories that 23 lawsuits alleging the company failed to warn of important risks associated with infant formulas and caused premature babies to develop necrotizing enterocolitis should not have been filed in Cook County, where the infants at the center of those cases were not born and have never lived.

  • December 15, 2025

    Connecticut 'Likely' To Settle Generic Drug Price Cap Dispute

    A pharmaceutical industry trade group and the state of Connecticut have signaled their intent to settle a feud over the interpretation of the state's generic drug price cap law, and a federal judge gave them until Monday to say more about their plan.

  • December 15, 2025

    Yale Hospital Hit With $32M Baby Formula Death Verdict

    A Connecticut judge has hit Yale University and Yale New Haven Hospital with a nearly $32 million verdict over the death of a premature baby, finding doctors failed to obtain either informed consent, or any consent, before feeding the infant a diet fortified by a product produced from cow's milk.

  • December 15, 2025

    Feds Deny Breaking Plea Deal With Ex-Morgue Manager

    Prosecutors told a Pennsylvania federal judge Monday that they did not breach a plea deal between the government and Cedric Lodge by seeking a harsh sentence for the former head of Harvard University's morgue who admitted to theft and trafficking of human remains, claiming that Lodge's arguments to the contrary amounted to buyer's remorse.

Expert Analysis

  • Takeaways From State Votes On Abortion In The 2024 Election

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    Attorneys at Epstein Becker discuss how 10 states voted on ballot initiatives to either protect or restrict access to abortion in the 2024 general election, and analyze overarching trends.

  • Loper Bright Offers New Materiality Defense To FCA Liability

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    The U.S. Supreme Court's decision in Loper Bight Enterprises v. Raimondo, ending Chevron deference, may have created a new defense to False Claims Act liability by providing the opportunity to argue that a given regulation is not material to the government's payment decision, says Tanner Cook at Husch Blackwell.

  • How Expanded Birth Control Coverage May Affect Employers

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    Employers should consider the potential impact of recently proposed regulations that would expand group health plans' required coverage of preventive services and contraceptives, including questions about how the agencies would implement their plans to eliminate the prescription requirement and alter the exceptions process, says Jennifer Rigterink at Proskauer.

  • Legislation Most Likely To Pass In Lame Duck Session

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    As Congress begins its five-week post-election lame duck session, attorneys at Greenberg Traurig break down the legislative priorities and which proposals can be expected to pass.

  • Preserving The FCA Is Crucial In Trump's 2nd Term

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    While the Trump administration may pursue weaker False Claims Act enforcement, it remains an essential tool in safeguarding public funds and maintaining corporate accountability, so now is not the time to undermine ethical behavior, or reduce protections and incentives for whistleblowers, says Adam Pollock at Pollock Cohen.

  • PREVAIL Bill Is Another Misguided Attempt To Restrict PTAB

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    The decade-long campaign against the U.S. Patent and Trademark Office's Patent Trial and Appeal Board — currently focused on the PREVAIL Act that's slated for markup in the Senate — is not really about procedural issues, and it is not aimed at securing more accurate patentability decisions, says Clear IP's Joseph Matal, former acting director at the USPTO.

  • Justices Face Tough Question On HHS Hospital Pay Formula

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    In Advocate Christ Medical Center v. Becerra, the U.S. Supreme Court will determine whether the U.S. Department of Health and Human Services properly applied certain Medicare reimbursement adjustments to hospitals — a decision that could significantly affect hospitals' ability to seek higher Medicare reimbursement for low-income patients, say attorneys at Sheppard Mullin.

  • Key Healthcare Issues That Hinge On The Election Outcome

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    The 2024 presidential race, while not heavily dominated by healthcare issues compared to past elections, holds significant implications for the direction of healthcare policy in a potential Harris or Trump administration, encompassing issues ranging from Medicare to artificial intelligence, says Miranda Franco at Holland & Knight.

  • The Key To Solving High Drug Costs Is Understanding Causes

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    One-sided views on who or what contributes to the high cost of pharmaceuticals render possible solutions much harder to discover and implement, and a better approach would be to examine history and learn why costs have increased and what legislation has and hasn't helped, says Nancy Linck at NJ Linck Consulting.

  • Next Steps For FCA Defendants After Fla. Qui Tam Ruling

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    Because a Florida federal court's recent decision in Zafirov v. Florida Medical Associates could eventually prove to be a watershed event for False Claims Act suits, defendants should consider potential next steps to ensure that their litigation benefits from the court's reasoning and further developments, says Scott Gallisdorfer at Bass Berry.

  • A Look At Calif.'s New AI Law For Health Insurers

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    A newly enacted California law prohibits artificial intelligence tools from making medical necessity determinations for healthcare service plans or disability insurers, addressing core questions that have arisen around AI's role in coverage decisions, say attorneys at DLA Piper.

  • New HHS Research Misconduct Rules Bring Seismic Changes

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    The U.S. Department of Health and Human Services' new rule regarding research misconduct investigations brings significant changes that focus on remediation, appeals and confidentiality, while other changes could result in institutions causing undue harm to scientists accused of such misconduct, say attorneys at Cohen Seglias.

  • Fla. Ruling May Undermine FCA Whistleblowers' Authority

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    A Florida federal court's decision in Zafirov v. Florida Medical Associates last month will deprive relators of their ability to bring suits under the False Claims Act, limiting their capability to expose and rectify wrongdoings and potentially affecting billions in FCA recoveries, say Matthew Nielsen and Lily Johnson at Bracewell.