Policy & Compliance

  • May 01, 2026

    5th Circ. Pauses Mail-Order Access To Abortion Pills

    The Fifth Circuit on Friday reinstated an in-person dispensing requirement for the abortion medication mifepristone, blocking mail-order access while a challenge to a Biden administration regulation brought by Louisiana officials moves forward.

  • May 01, 2026

    Calif. Sued Over Ballot Measure For Health Clinic Fund Use

    Federally designated community health clinics that serve vulnerable populations sued the California secretary of state and a union to keep an initiative off the November 2026 ballot that would control their budgets and expenditures, warning it could lead to shutdowns, disrupt patients' access to services and have other devastating consequences.

  • May 01, 2026

    DOJ Asks 4th Circ. To Revive Children's Hospital Subpoena

    The U.S. Department of Justice is asking the Fourth Circuit to reverse a district court order quashing its subpoena of transgender minor records from Children's National Hospital in Maryland, arguing that the patients' families — who sued to block the subpoena — lacked standing to bring a HIPAA challenge.

  • May 01, 2026

    Med Groups Say HHS Stalling Challenge To Vax Changes

    A Massachusetts federal judge on Friday rejected the government's request to pause discovery in a challenge by medical groups to the Trump administration's new childhood vaccination schedule while it appeals his March order blocking the changes.

  • May 01, 2026

    Medical Practice's Assets Targeted After $49M Verdict

    The Westchester Medical Group PC has only disclosed $2 million worth of insurance against a $49 million malpractice verdict that could nearly double during an expected appeal, a Connecticut cancer patient and her husband said in seeking to secure the defendant's property and other assets now.

  • May 01, 2026

    Mylan Inks $11M Deal With NC Over EpiPen Pricing

    North Carolina Attorney General Jeff Jackson announced Thursday that the state has inked an $11 million settlement with EpiPen distributor Mylan Pharmaceuticals, resolving claims of anticompetitive conduct and funneling millions back into public healthcare programs.

  • April 30, 2026

    Gov't Pauses Medicaid Data Use For ICE Amid Injunction Fight

    The Trump administration agreed at a hearing Thursday to temporarily halt the use of 22 states' Medicaid data for immigration enforcement purposes until a San Francisco federal judge clarifies the boundaries of an injunction that the largely Democratic-controlled states had accused the government of flouting.

  • April 30, 2026

    Debt Collectors Owe Charity Care Notice, Wash. Justices Say

    Just as hospitals must inform low-income patients they might qualify for financial assistance, so too must agencies collecting on medical debt, the Washington Supreme Court clarified Thursday.

  • April 30, 2026

    Jury Begins Mulling If Doctors Are Liable For Fatal Overdose

    A Philadelphia jury on Thursday began deliberations in a lawsuit accusing two doctors of enabling a 26-year-old man with chronic back pain to become hooked on opioid painkillers and fatally overdose.

  • April 30, 2026

    Trump Taps 3rd Surgeon General Pick, Drops Casey Means

    President Donald Trump nominated his third pick to be surgeon general on Thursday, withdrawing consideration for Casey Means after her confirmation stalled in the Senate. 

  • April 30, 2026

    Supplement Industry Says FDA Wrongly Muzzled Label Claims

    A coalition of dietary supplement companies and an alternative medicine advocacy group filed suit Wednesday against the U.S. Food and Drug Administration, claiming that the agency violated First Amendment commercial speech protections when it blocked product label claims connecting certain nutrients or ingredients to health outcomes.

  • April 30, 2026

    Mental Health Co. Can't Undo Jury Verdict In NC Wage Suit

    A mental healthcare company's bid to throw out a jury verdict finding it willfully violated federal and state wage laws fell short because its post-trial arguments lacked supporting evidence, a North Carolina federal judge ruled Thursday.

  • April 30, 2026

    NC Biz Court Bulletin: Corporate Raid, MV Realty Settlement

    A major case settled in the North Carolina Business Court in April as new lawsuits emerged, including a complaint by health information technology company IQVIA Holdings Inc. accusing its former top brass of orchestrating a corporate raid and defecting to a competitor. In case you missed this story and others, here are the highlights.

  • April 30, 2026

    Express Scripts, Cigna Seek End To Ohio PBM Price Suit

    After the Sixth Circuit ruled that a legal dispute between Ohio and a group of pharmacy benefit managers belongs in federal court, Express Scripts and Cigna now want dismissed the lawsuit accusing them of participating in an antitrust conspiracy that is driving up prescription drug prices. 

  • April 30, 2026

    Kroger's Health Plan Tobacco Fee Shirks ERISA, Suit Says

    Supermarket giant Kroger violated federal benefits law by requiring workers to pay an extra fee through their health plan if they used tobacco while failing to give them a fair opportunity to avoid the charge, according to a proposed class action filed in Ohio federal court.

  • April 30, 2026

    Feds Appeal Order Freezing CDC Childhood Vaccine Changes

    The Trump administration said late Wednesday that it's appealing a court order that stopped its pared-down childhood vaccine schedule from going into effect.

  • April 29, 2026

    CEO Stole From His Company To Buy Mansion, SEC Says

    The former CEO of a California-based pharmaceutical company agreed Wednesday to pay the U.S. Securities and Exchange Commission $30,000 to end a lawsuit accusing him of misappropriating $3.2 million in company funds partly to buy a Beverly Hills mansion.

  • April 29, 2026

    Novo Nordisk Rejects Claim It Influences GLP-1 Market

    Pharmaceutical giant Novo Nordisk told a Texas federal judge that it does not control the GLP-1 market and has not attempted to crush its competition in a bid to dismiss an antitrust suit it is facing.

  • April 29, 2026

    PBMs Say Michigan AG Price-Fixing Suit Is Unsound

    Pharmacy benefit managers Express Scripts, Evernorth Health and Prime Therapeutics have bolstered their effort to escape a federal price-fixing suit brought against them by Michigan's attorney general by arguing the statutes cited in the complaint do not apply to them.

  • April 29, 2026

    Mass. AG, Insurer Settle Deceptive Marketing Claims For $5M

    A Texas-headquartered health insurance agency will pay $5 million to settle allegations that it engaged in deceptive and unfair marketing to sell plans and other types of health programs to thousands of Massachusetts consumers, the state's attorney general announced on Wednesday.

  • April 29, 2026

    5th Circ. Will Rehear Aetna Arbitration Bid In Aramark Suit

    The full Fifth Circuit will reconsider insurance company Aetna's bid to force uniform and food services company Aramark to arbitrate its dispute over employee health benefit claims, staying a panel's ruling from December that had kept proceedings in court.

  • April 29, 2026

    AbbVie Seeks Early Win Over HHS In Botox Drug Price Suit

    When the federal government included Botox in Medicare's drug price negotiation program, which allows Medicare officials to negotiate for lower drug prices, it overstepped its authority, drugmaker AbbVie Inc. told a D.C. federal court, arguing the cosmetic drug and migraine treatment is a "plasma-derived" product ineligible for price controls.

  • April 29, 2026

    Medical Equipment Co. Settles Patient Overbilling Claims

    Patients who claim Pennsylvania-based AdaptHealth Corp. overcharged them for returned medical equipment have reached the final version of a class settlement and will soon submit it to a North Carolina federal court for approval, they told the court this week.

  • April 29, 2026

    Justices Rule NJ Info Demand Chilled Anti-Abortion Speech

    The U.S. Supreme Court on Wednesday unanimously revived an anti‑abortion pregnancy center network's constitutional challenge to a New Jersey subpoena seeking years of donor information, holding that the state's demand infringed free speech.

  • April 28, 2026

    Ohio Justices Nix 'Would Have Been Married' Obergefell Test

    The Ohio Supreme Court held Tuesday that a state law establishing parental rights for the spouse of a woman who conceives a child through artificial insemination doesn't retroactively apply to same-sex couples when a child was born before gay marriage was legalized by the U.S. Supreme Court in 2015.

Expert Analysis

  • The Challenge Of Stabilizing Rural Hospitals On The Brink

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    The outlook for rural hospitals has grown more concerning, as recent policy and regulatory developments are decreasing hospital revenues and increasing the cost of uncompensated care, which may result in additional hospital closures, service reductions, or mergers and acquisitions, say Omur Celmanbet, Kristy Piccinini and Sabiha Quddus at FTI Consulting.

  • Fraud Enforcement, Sentencing Face Unusual Convergence

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    The Trump administration’s newly created task force to eliminate fraud and the U.S. Sentencing Commission’s recent proposals to scale back certain elements of the federal sentencing framework seem to point in opposite directions, creating a collision of policy priorities that may reshape how fraud cases are charged, negotiated and sentenced for years to come, says David Tarras at Tarras Defense.

  • Peptide Policy Is Shifting Toward Sanctioned Compounding

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    The policy landscape for peptides is undergoing a significant shift under the Trump administration, moving toward a complex system of verified compounding and complementary enforcement that will likely bring peptides firmly back into the sphere of legitimate consumer products, say attorneys at Sheppard.

  • Trump Order Signals Tougher Benefits Fraud Probes

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    A recent order from President Donald Trump establishing a federal taskforce for addressing fraud in federally funded benefit programs emphasizes interagency information sharing, potentially affecting a broad range of areas including government contracts, administrative law considerations and False Claims Act cases, say attorneys at Morgan Lewis.

  • The Evolution Of States' Workplace Violence Prevention Laws

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    Utah's new law requiring hospitals to implement comprehensive workplace violence reporting systems continues a broader trend of state efforts to expand workplace protections in the absence of sufficient federal regulations, say attorneys at Ogletree.

  • FDA Guidance May Move Goalposts For Form 483 Responses

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    New draft guidance from the U.S. Food and Drug Administration provides formal insight on how drug manufacturers are expected to respond to Form 483s, raising some concerns about the agency's timelines and expectations, say attorneys at Cooley.

  • 2 Strands Of Patent Law In High Court's 'Skinny Label' Case

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    Amarin v. Hikma, which is set for oral argument in the U.S. Supreme Court this month, highlights the distinction between two different strands of intellectual property law — analogizing a patent to either a property deed or a home, says Jonas McDavit at Spencer West.

  • A Check-Up On HHS' Push To Implement AI Infrastructure

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    The U.S. Department of Health and Human Services has made some headway in its efforts to implement artificial intelligence across its agencies, but will have to overcome a number of near-term tests in order to be successful, says Theodore Thompson at Stinson.

  • Mich. Banking Brief: All The Notable Legal Updates In Q1

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    Michigan's financial services sector saw several significant developments in 2026's first quarter, including the state Department of Insurance and Financial Services' issuance of a bulletin on the use of artificial intelligence and the Michigan House's introduction of a bill based on the Model Money Transmission Modernization Act, say attorneys at Dykema.

  • The Road Ahead For Drug Development In The US

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    Against the backdrop of drug manufacturers potentially looking to move development efforts overseas, the U.S. Food and Drug Administration's latest guidance on new approach methodologies signals the FDA is likely to be receptive to industry innovation that makes U.S.-based drug development faster or less expensive, creating opportunities and compliance risks for tech companies, say attorneys at Morgan Lewis.

  • FDA's Crackdown On Drug Ads Conflicts With Precedent

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    Recent U.S. Food and Drug Administration warning letters to drug manufacturers targeting direct-to-consumer advertising raise significant constitutional concerns, and directly clash with prior FDA stances, say attorneys at Sidley.

  • Informal Announcements Are Reshaping FDA Regulations

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    The U.S. Food and Drug Administration's recent shift toward using press releases, podcasts and other informal channels to announce major policy changes reflects a valid desire to modernize and accelerate regulatory efforts, but it could lead to diminished transparency, increased industry burden and reduced policy durability, says Rachel Turow at Skadden.

  • A Shift In Fed. Circ.'s Approach To Patent Summary Judgment

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    The Federal Circuit's recent decision in Range of Motion v. Armaid may come to be seen as a seminal opinion for potentially exposing and entrenching the Federal Circuit's movement away from its previous framework for identifying obvious noninfringement cases, says Nicholas Nowak at Nowak IP Group.