Policy & Compliance

  • May 02, 2024

    Biden Announces $3B To Fund Lead Pipe Replacement

    The Biden administration is distributing $3 billion to states so they can replace lead water pipes that pose a health risk to those who rely on them for drinking water, as part of the larger goal to remove all lead service lines nationwide.

  • May 02, 2024

    State Legislators Urge Feds To Change Cannabis' Status

    A coalition of state lawmakers on Thursday urged the heads of the U.S. Department of Justice and its drug enforcement agency to prioritize changing cannabis' status as a highly restricted drug.

  • May 01, 2024

    Sens. Slam UnitedHealth's Security Lapses, Breach Response

    UnitedHealth's top executive faced heavy criticism during his first appearance before a U.S. Senate committee since a cyberattack rocked its Change Healthcare subsidiary, with lawmakers blasting the company for lacking basic security measures and for still not being able to confirm the scale and scope of the incident.

  • May 01, 2024

    Ariz. AG Warns Repeal Of 1864 Abortion Ban May Be Too Late

    Legislation narrowly adopted Wednesday to repeal Arizona's 1864 abortion law won't be enough on its own to keep the near-total ban from taking effect this summer, the state attorney general warned, because the bill lacks an emergency clause.

  • May 01, 2024

    J&J Unit Cuts Deal To End Cancer Drug Trade Secret Fight

    A New Jersey federal judge has signed off on a consent judgment that permanently bars Chinese drugmaker Jiangsu Hengrui Pharmaceuticals Co. from misappropriating Johnson and Johnson's pharmaceutical subsidiary Janssen's trade secrets for its popular chemotherapy drug Yondelis.

  • May 01, 2024

    5th Circ. Judge Skeptical Of Medicare Drug 'Price-Setting'

    A Fifth Circuit judge on Wednesday sharply criticized the Biden administration's Medicare drug pricing program, characterizing it as government "price-setting" and questioning "what possible procompetitive justification" there can be for penalizing companies that don't participate.

  • April 30, 2024

    Ex-Olympus Exec Says He Was Fired For Flagging FDA Issue

    The former global head of product development at medical manufacturer Olympus Corp. said he was fired earlier this year after he reported multiple compliance concerns regarding the company's practices and related to nearly 100 products, according to a suit filed Monday in Pennsylvania federal court.

  • April 30, 2024

    Judge Strikes Parts Of NC Law Restricting Abortion Drug

    A North Carolina federal judge struck down parts of a state law Tuesday that restricts access to the abortion medication mifepristone, finding some provisions violate the U.S. Constitution's supremacy clause by enacting safety regulations already considered by the U.S. Food and Drug Administration, such as requiring in-person prescribing, dispensing and scheduling around the drug.

  • April 30, 2024

    BCBS Says Federal Drug Law Preempts NM Medical Weed Row

    A group of insurers, including Blue Cross and Blue Shield of New Mexico, urged a New Mexico federal judge to reject a proposed class action seeking to compel them to cover their policyholders' medical marijuana costs, arguing that state law doesn't require it and federal law forbids it.

  • April 30, 2024

    Aetna Resists State Court Remand In Provider Payment Suit

    A lawsuit alleging Aetna units have underpaid emergency healthcare workers' benefit claims should be heard in an Ohio federal court, the insurer said in opposing a remand to the state level, based in part on the argument that two of the corporate defendants don't belong in the case.

  • April 30, 2024

    Biden Rocks Healthcare Space With Rule After Rule

    Using federal agencies as its instrument, the Biden administration pumped out numerous healthcare and life sciences rules in the past week, ranging from addressing discrimination in healthcare to requiring health apps to report data breaches to consumers.

  • April 30, 2024

    FTC Continues To Target 'Junk' Drug Patents

    Federal trade officials told a series of pharmaceutical companies — including the makers of the controversial diabetes and weight loss drug Ozempic — that they may have listed faulty patents in a key register of a federal drug database.

  • April 30, 2024

    High Court's Conscience Concerns Offer Docs Little Guidance

    At oral arguments in both abortion cases to reach the nation's top court this term, justices parried with the federal government over the knotty topic of doctors raising a personal objection to providing an abortion to a patient suffering a medical crisis.

  • April 30, 2024

    'Global' Budgets May Fix Hospital Spending. Will States Try It?

    An ambitious experiment is underway that could shake up healthcare spending by moving providers away from a traditional fee-for-service model in favor of "global" hospital budgets. But with deadlines looming, the voluntary, "total cost of care" model can't deliver without state buy-in.

  • April 30, 2024

    6th Circ. Weighs Merits, Procedure In NLRB Severance Case

    The Sixth Circuit grappled Tuesday with a hospital's challenge to the National Labor Relations Board's ruling that it unlawfully offered severance agreements that muzzled workers, with one judge questioning how the agreements interfered with workers' rights and another whether the hospital was even entitled to oppose the new standard.

  • April 30, 2024

    New Staffing Minimums Rattle Nursing Home Industry

    A new Biden administration rule that sets minimum staffing standards for nursing homes could reshape the industry, intensifying the competition to hire nurses and exposing the facilities to new litigation and financial risks, healthcare attorneys say.

  • April 30, 2024

    Tougher Privacy Rule Won't End Abortion Data Fight

    Healthcare attorneys welcomed enhanced federal protections for patient abortion records. But the new rule likely won't release providers from the bind of complying with federal privacy law while potentially facing out-of-state probes into sensitive patient information.

  • April 30, 2024

    Texas, Washington Spar In Rare Interstate Gender Care Clash

    An investigation launched by the Texas attorney general into medical care 1,700 miles away in Washington triggered an unusual burst of litigation and a settlement, illustrating a potential new front in the legal fight over transgender rights.

  • April 29, 2024

    ReNew Health To Pay $7M To Settle COVID-19 FCA Claims

    ReNew Health Group LLC has agreed to pay the federal government and California $7 million to settle whistleblower allegations that the healthcare provider misused a COVID-19 waiver intended to free up hospital beds by submitting fraudulent claims for nursing home residents, the U.S. Department of Justice announced Friday.

  • April 29, 2024

    Pfizer Inks $25M Deal Ending Leftover Effexor Antitrust Claims

    A proposed class of indirect buyers have asked a New Jersey federal judge to greenlight a $25.5 million settlement to end allegations that Pfizer unit Wyeth engaged in a scheme with Teva Pharmaceuticals to delay generic competition for the antidepressant Effexor XR.

  • April 29, 2024

    Judge Rejects 2 Challenges To Medicare Drug Price Talks

    A New Jersey federal judge on Monday shot down a pair of challenges to the Medicare drug price negotiations, extending a string of court victories for the Biden administration as it defends the talks as entirely voluntary.

  • April 29, 2024

    9th Circ. Scraps Trans Law Opinion After High Court Ruling

    The Ninth Circuit on Monday scrapped its 2023 opinion blocking an Idaho law that would have banned transgender women from competing in sports following the U.S. Supreme Court's recent decision allowing enforcement of another Idaho law permitting a ban on gender-affirming care for minors, explaining that a revised opinion is needed.

  • April 29, 2024

    UnitedHealth's Cyberattack Response Is 'Inadequate,' AGs Say

    Nearly two dozen state attorneys general urged UnitedHealth Group and its subsidiary Change Healthcare "to do more" to address the fallout from a February cyberattack by Russian ransomware group Blackcat that breached their systems and services, noting their response efforts to the outage "have been inadequate."

  • April 29, 2024

    Trans Patients In NC, W.Va. Prevail In 4th Circ. Health Fight

    The Fourth Circuit on Monday affirmed two lower court decisions ordering North Carolina and West Virginia to end discriminatory exclusions for coverage of gender-affirming medical care for transgender people in both states, finding the lower courts properly struck down the policies as "textbook sex discrimination."

  • April 29, 2024

    Judge Rejects Class Certification Of Seizure Drug Customers

    An Illinois federal judge has rejected a class certification bid in a suit against drugmaker Mallinckrodt and prescription delivery platform Express Scripts, ruling that the plaintiffs were unable to meet their predominance burden as a class.

Expert Analysis

  • An Overview Of 6 PBM Bills Moving Through Congress

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    As legislators turn to pharmacy benefit manager reform as a potential next step in addressing the cost of prescription drugs, six congressional committees have recently advanced PBM-related legislation with generally high bipartisan support, suggesting that a final package is likely to advance through Congress, say Rachel Stauffer and Katie Waldo at McDermott+Consulting.

  • 10th Circ. ERISA Ruling Is Promising For Self-Funded Plans

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    Though some recent appellate decisions have seemingly narrowed application of Employee Retirement Income Security Act preemption, which generally helps protect self-funded health plans from state regulation, the Tenth Circuit's decision in PCMA v. Mulready takes a big step toward reaffirming preemption, say attorneys at Bass Berry.

  • What Large Language Models Mean For Document Review

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    Courts often subject parties using technology assisted review to greater scrutiny than parties conducting linear, manual document review, so parties using large language models for document review should expect even more attention, along with a corresponding need for quality control and validation, say attorneys at Sidley.

  • Checking In On How SuperValu Has Altered FCA Litigation

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    Four months after the U.S. Supreme Court's ruling in U.S. ex rel. Chutte v. SuperValu, the decision's reach may be more limited than initially anticipated, with the expansion of the scienter standard counterbalanced by some potential defense tools for defendants, say Elena Quattrone and Olivia Plinio at Epstein Becker.

  • Participating In Living History Makes Me A Better Lawyer

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    My role as a baron in a living history group, and my work as volunteer corporate counsel for a book series fan association, has provided me several opportunities to practice in unexpected areas of law — opening doors to experiences that have nurtured invaluable personal and professional skills, says Matthew Parker at the Nebraska Department of Health and Human Services.

  • Private Equity Owners Can Remedy Law Firms' Agency Issues

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    Nonlawyer, private-equity ownership of law firms can benefit shareholders and others vulnerable to governance issues such as disparate interests, and can in turn help resolve agency problems, says Michael Di Gennaro at The Law Practice Exchange.

  • Cos. Must Overhaul Data Privacy Approach To Avoid Lawsuits

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    With the proliferation of third-party trackers and the increasing complexity of privacy laws, companies need to significantly change their approach to online privacy to avoid litigation by focusing on responsible data collection practices and ongoing monitoring of ad tech tools, says Ian Cohen at LOKKER.

  • Biden Admin's Mental Health Proposal May Not Be Enough

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    The Biden administration's recent proposed updates to federal mental health care rules acknowledge the difficulty that Americans face in finding and affording care, but may have limited impact due to enforcement challenges, a lack of providers and other issues, say Khaled Klele and Jessica Osterlof at Riker Danzig.

  • How To Protect Atty-Client Privilege While Using Generative AI

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    When using generative artificial intelligence tools, attorneys should consider several safeguards to avoid breaches or complications in attorney-client privilege, say Antonious Sadek and Christopher Campbell at DLA Piper.

  • How New Lawyers Can Leverage Feedback For Growth

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    Embracing constructive criticism as a tool for success can help new lawyers accelerate their professional growth and law firms build a culture of continuous improvement, says Katie Aldrich at Fringe Professional Development.

  • ESG Around The World: Australia

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    Clive Cachia and Cathy Ma at K&L Gates detail ESG-reporting policies in Australia and explain how the country is starting to introduce mandatory requirements as ESG performance is increasingly seen as a key investment and corporate differentiator in the fight for global capital.

  • Info Exchanges Must Stay Inside Now-Invisible Antitrust Lines

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    While the antitrust agencies recently withdrew long-standing enforcement policy statements for being "overly permissive" on information exchanges, we should not assume that all information exchanges are inherently suspect — they are still permissible if carefully constructed and vigorously managed, say attorneys at Nelson Mullins.

  • Twitter Legal Fees Suit Offers Crash Course In Billing Ethics

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    X Corp.'s suit alleging that Wachtell grossly inflated its fees in the final days of Elon Musk’s Twitter acquisition provides a case study in how firms should protect their reputations by hewing to ethical billing practices and the high standards for professional conduct that govern attorney-client relationships, says Lourdes Fuentes at Karta Legal.