Policy & Compliance

  • March 25, 2025

    UBH Patients On Remand, CMS Audits And J&J Investor Suit

    Patients challenging United Behavioral Health coverage guidelines for mental health treatment filed their first brief in the case since the Ninth Circuit clarified the scope of the remanded proceedings.

  • March 25, 2025

    Anthem Can't Escape Family's Mental Health Parity Claims

    Anthem Blue Cross Blue Shield must face a Virginia family's claim that the company violated a federal benefits law by refusing to cover an adolescent girl's stay in a residential mental health facility, with a Virginia federal judge deeming the suit strong enough to survive a dismissal motion Tuesday.

  • March 25, 2025

    Trans Military Ban Rests On 'Unconvincing' Proof, Judge Says

    A Washington federal judge hinted Tuesday he might block the Trump administration's ban on transgender troops later this week, expressing doubt that the U.S. Department of Defense has evidence to back its stance that gender dysphoria alone makes people unfit for military service.

  • March 25, 2025

    ND Justices Weigh Liberty Rights In Abortion Ban Challenge

    North Dakota's top court on Tuesday wrestled with whether a recently passed anti-abortion law violates personal liberty rights and questioned both sides about the meaning of exceptions to the ban written into the law.

  • March 25, 2025

    Amid Abortion Fight, Idaho Bolsters Moral Objection Rights

    A new law in Idaho — already the epicenter of a national clash over emergency abortion care — expands the conscientious objection rights of doctors and health professionals.

  • March 25, 2025

    Antitrust In Healthcare: 3 Cases To Watch

    Amid a Congressional probe into a long-standing antitrust exemption for a national medical resident matching system, a handful of healthcare groups are in court with allegations that trade organizations have violated antitrust laws.

  • March 25, 2025

    Experts Warn Of 'Slippery Slope' In Judge Shopping Sanctions

    A federal judge's judge shopping sanctions on lawyers challenging an Alabama transgender care ban were unusually harsh, legal experts said, and raise concerns about a chilling effect on advocates litigating similar cases in other jurisdictions.

  • March 25, 2025

    BU Law Prof On The Evolution Of Med Mal Standard Of Care

    Boston University law professor Christopher Robertson talks about the American Law Institute's first update on medical malpractice law in 60 years and the state law evolution towards a “reasonable” care standard.

  • March 25, 2025

    Hartford HealthCare Fights Disclosure Of Antitrust Settlement

    Hartford HealthCare Corp. says it cannot be forced to reveal a confidential January antitrust settlement with another Connecticut hospital at the behest of a Teamsters health plan and a public transit agency separately accusing the consortium of creating a monopoly.

  • March 24, 2025

    Trump Picks Acting CDC Head After Weldon Nomination Fails

    President Donald Trump on Monday nominated acting Centers for Disease Control and Prevention head Susan Monarez to take over as the agency's director, a move that comes after Trump pulled his nomination of Dr. Dave Weldon for the position when it became clear Weldon lacked needed support.

  • March 24, 2025

    Wells Fargo Prescription Cost Suit Axed Over Standing

    Wells Fargo has beaten back allegations that it violated federal benefits law by letting workers on its healthcare plan overpay for prescription drugs, with a Minnesota federal judge ruling Monday that the ex-workers behind the proposed class action lacked standing to sue.

  • March 24, 2025

    Investors Blame Electrotherapy Co.'s Practices For Stock Drop

    Electrotherapy device maker Zynex Inc. faces a proposed investor class action claiming it harmed shareholders after it was booted from at least one insurer network for U.S. military members, allegedly due to oversupplying its customers.

  • March 24, 2025

    Patients Say UBH Limits On Mental Health Violated ERISA

    Employee health benefit plan participants who sought coverage for mental health and substance use disorder treatments from United Behavioral Health urged a California federal court to rule that the company violated federal benefits law by implementing overly restrictive guidelines, arguing the insurer's interest in narrowing coverage wrongly limited patients' access.

  • March 24, 2025

    Residents Rip Hospital Co.'s 'Scorched-Earth' Sanctions Bid

    A proposed class of Connecticut residents pursuing antitrust claims against Hartford HealthCare Corp. slammed the company's bid to sanction them for seeking judicial enforcement of a document exchange deal the parties had reached, arguing that sanctions would only complicate discovery rather than help it along.

  • March 21, 2025

    Judge Says Anti-Abortion Group's Clinic Blockades Are Illegal

    A New York federal judge ruled Thursday that an anti-abortion group violated federal and New York state laws prohibiting interference with reproductive health services, saying evidence made clear group members physically obstructed access to three reproductive health care clinics in New York City.

  • March 21, 2025

    Novartis Urges Court To Make FDA Block Entresto Generic

    Novartis says the U.S. Food & Drug Administration has made a drug marketing exclusivity window "meaningless" and wants a D.C. federal judge to block a rival from selling a generic drug that would compete with its blockbuster heart medication Entresto.

  • March 21, 2025

    NC Top Court Revives Constitutional Claim In Forced Vax Suit

    The North Carolina Supreme Court Friday partially revived a family's lawsuit alleging a 14-year-old was given a COVID-19 vaccine without his parents' consent, saying a federal law that shields certain activity aimed at resolving the spread of disease during a public health emergency covers tort injuries, not state constitutional violations.

  • March 21, 2025

    New Mexico Lawmakers Approve Medical Psilocybin Bill

    New Mexico lawmakers have given final approval to legislation to create a regulated medical psilocybin program, sending the proposal to the governor's desk.

  • March 21, 2025

    Idaho Hospital Wins Reprieve From State Abortion Ban

    Idaho's near-total abortion ban "must yield" to a federal requirement that doctors provide emergency abortions for pregnant women facing severe injuries, an Idaho federal judge ruled.

  • March 20, 2025

    Texas Says Planned Parenthood Can't Get Atty Immunity

    Texas has urged the full Fifth Circuit to reconsider 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, saying state-law attorney immunity doesn't apply.

  • March 20, 2025

    8th Circ. Won't Pause FTC's Insulin Pricing Case

    The Eighth Circuit refused Thursday to pause the Federal Trade Commission's in-house case accusing Caremark Rx, Express Scripts and OptumRx of artificially inflating insulin prices while the pharmacy benefit managers challenge the constitutionality of the proceedings.

  • March 20, 2025

    MiMedx Challenges FDA Classification Of Wound Care Powder

    Biomedical company MiMedx Group urged a Georgia federal judge on Thursday to overturn the U.S. Food and Drug Administration's classification of a wound care treatment as a biological product, arguing the agency misapplied its own regulations.

  • March 20, 2025

    4th Circ. Seems Open To Reviving Pregnant Worker's Bias Suit

    The Fourth Circuit seemed receptive Thursday to a former hospital worker's argument that she was unlawfully fired for a pregnancy-related disability, pondering whether the lower court had relied on an outdated interpretation of disability bias law when it tossed her case.

  • March 20, 2025

    6th Circ. Judge Skeptical Of Mich. Newborn Screening Ruling

    A Sixth Circuit panel questioned Thursday if Michigan's practice of holding onto blood samples collected through a newborn health screening program violates parents' rights to make medical decisions for their children, with one judge saying he didn't see evidence for that proposition.

  • March 19, 2025

    Abortion Case May Be Just The Start For Empowered Paxton

    Texas Attorney General Ken Paxton's announcement of the first criminal charges under the state's abortion ban comes amid a political shift in which lawmakers are increasingly willing to empower the state's top legal office, potentially setting up a court battle over how much clout the AG should wield.

Expert Analysis

  • 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.

  • What Trump's Order Means For The Legal Status Of IVF

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    An executive order signed by President Donald Trump last month signals the administration's potential intention to increase protections for in vitro fertilization services, though more concrete actions would be needed to resolve the current uncertainty around IVF access or bring about a binding legal change, says Jeanne Vance at Weintraub Tobin.

  • Mitigating Tariff Risks For Healthcare In US And Canada

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    Healthcare stakeholders should take steps to evaluate the impact of cross-border tariffs, as the historically strong ties between Canada and the U.S. demonstrate the potential for real disruption and harm to the healthcare industry in both countries, say attorneys at Norton Rose.

  • What's At Stake In High Court Transgender Care Suit

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    The outcome of U.S. v. Skrmetti will have critical implications for the rights of transgender youth and their access to gender-affirming care, and will likely affect other areas of law and policy involving transgender individuals, including education, employment, healthcare and civil rights, say attorneys at ArentFox Schiff.

  • 6 Laws Transforming Calif.'s Health Regulatory Framework

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    Attorneys at Hooper Lundy discuss a number of new California laws that raise pressing issues for independent physicians and small practice groups, ranging from the use of artificial intelligence to wage standards for healthcare employees.

  • Anticipating Calif. Oversight Of PE Participation In Healthcare

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    A new bill recently introduced in the California Senate revives last year's attempt to increase oversight of healthcare transactions involving private equity groups and hedge funds, meaning that attorneys may soon need to assess the compliance status of existing management relationships and consider modifying contract terms, says Andrew Demetriou at Husch Blackwell.

  • 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.