Policy & Compliance

  • March 14, 2024

    Feds Say Healthcare Ruling Could Upset Tribal Relationships

    The federal government is urging the U.S. Supreme Court to overturn a lower court's ruling that ordered Indian Health Services to reimburse millions in administrative healthcare costs, saying if the two tribes prevail in the litigation, it would upend 35 years of practice between the agency and its contracting tribes.

  • March 14, 2024

    8th Circ. Weighs If No-Bill Agreements Break Minn. Law

    The Eighth Circuit carefully considered arguments Thursday between six Farmers units and a policyholder class as to whether the carriers' agreements with healthcare providers restricted the class's medical expense coverage in violation of Minnesota law, giving little indication of which way it leaned.

  • March 14, 2024

    Extended Workers' Comp Needs High Bar, NC Justices Told

    The North Carolina Department of Public Safety told the state's top court Wednesday that injured workers must clear a higher hurdle to keep collecting disability benefits after their initial workers' compensation runs out, saying an appellate court got it wrong by applying a more lax standard.

  • March 14, 2024

    8th Circ. Questions Patient Standing In ERISA Claims Dispute

    An Eighth Circuit panel appeared skeptical Thursday of reviving a suit from patients insured by UnitedHealth Group alleging a billing practice known as cross-plan offsetting violated federal benefits law, with judges questioning whether the patients sufficiently established injury.

  • March 14, 2024

    Feds Seek 20 Mos. For Aegerion Fraud 'Puppet Master'

    A pharmaceutical sales representative who gloated about being a "puppet master" for false insurance claims for Aegerion's cholesterol drug should serve 20 months in prison, the U.S. government has told a Boston federal judge.

  • March 14, 2024

    Trial Challenging NC Abortion Restrictions Pushed To July

    A July trial date has been set in a closely watched constitutional challenge seeking to dismantle a state law that restricts access to abortions in North Carolina after 12 weeks, marking a pushback from the court's earlier projected spring timetable for the trial.

  • March 13, 2024

    Planned Parenthood Foe Calls Immunity Claim 'Half-Baked'

    Attorneys for a pseudonymous relator who sued Planned Parenthood over allegations that it improperly billed Medicaid programs urged the Fifth Circuit on Wednesday to reject the group's position that it was shielded by attorney immunity, calling the entity's argument "half-baked."

  • March 13, 2024

    Wash. Hospital Workers Sue Kaiser Over Missed Breaks

    A nursing assistant at Seattle's Kaiser Permanente hospital said understaffing compels her and other healthcare employees to work through their meal breaks, but that the hospital system has not been paying them for that time, according to a proposed class action filed in Washington state court.

  • March 12, 2024

    NYC Hospital Signs $17.3M 'Kickback' Deal With Feds, State

    NewYork-Presbyterian/Brooklyn Methodist Hospital has agreed to pay $17.3 million to resolve allegations that it paid unlawful kickbacks to physicians at its chemotherapy infusion clinic, the U.S. Department of Justice announced Tuesday.

  • March 12, 2024

    NY Jury Rules Some Claims About Prevagen Are Misleading

    A New York federal jury said some statements made by Quincy Bioscience about its memory booster Prevagen were misleading to consumers but found that most statements about the supplement were made on solid grounds.

  • March 12, 2024

    2nd Circ. Revives Parts Of McKesson Whistleblower Suit

    The Second Circuit on Tuesday revived parts of a lawsuit brought by a McKesson Corp. whistleblower who accuses the pharmaceutical company of a kickback scheme, finding that the lower court should reconsider the claims that were brought under state anti-kickback laws.

  • March 12, 2024

    Walgreens, Kenvue Unit Sued Over Benzene In Acne Products

    Walgreens, Kenvue unit Johnson & Johnson Consumer Inc. and Genomma Lab face a trio of proposed consumer fraud class actions in California federal court by customers who alleged their acne treatment products contain unsafe levels of benzene, but that each of the companies failed to disclose its presence in their labeling.

  • March 12, 2024

    4th Circ. Revives Navy Surgery Wrongful Death Claims

    The Fourth Circuit on Tuesday reversed an order dismissing claims from the estate of a woman who died after an allegedly botched surgery at a Navy hospital, saying the trial court was wrong to conclude that Navy regulations for implementing Federal Tort Claims Act procedures created jurisdictional requirements beyond what the FTCA's text includes.

  • March 12, 2024

    Pharmacy Calls $11M False Claims Case A 'House Of Cards'

    A compounding pharmacy and its president trashed the Connecticut attorney general's $11 million false claims and kickback allegations against them as a "house of cards" that awarded "a sweetheart cooperation deal" to an alleged co-conspirator and improperly benefited private attorneys, calling instead for a judgment against the state.

  • March 11, 2024

    FDA Seeks $7.2B For Fiscal Year 2025

    The U.S. Food and Drug Administration on Monday said that it is requesting $7.2 billion as part of the Biden administration's proposed budget, an increase of nearly $500 million from fiscal year 2023's funding, with $15 million aimed at protecting food safety and nutrition.

  • March 11, 2024

    NY Man's COVID Loan 'Greed' Merits 10 Years, Feds Say

    Federal prosecutors have asked a New York judge to sentence a Long Island man to 10 years in prison for his role in a scheme to steal more than $10 million from the Paycheck Protection Program and other pandemic-era disaster relief programs.

  • March 11, 2024

    Biden Proposes More Mental Health Expansion In 2025 Budget

    The Biden administration's $7.3 trillion fiscal year 2025 spending blueprint unveiled Monday maintains a pledge to transform the nation's mental health system, but contains the least ambitious discretionary budget ask for the U.S. Department of Labor in four years.

  • March 11, 2024

    Pfizer Slams Ex-Compliance Officer's Whistleblower Claims

    Pfizer has asked a California federal court to again dismiss the bulk of a discrimination and retaliation lawsuit filed by a former compliance officer for the pharmaceutical giant, arguing his latest suit is "largely a regurgitation of his original complaint."

  • March 11, 2024

    Urologist Seeks Coverage For Defective Penile Implants Suit

    A urologist's medical device company told a California federal court that two insurers must cover it, the doctor and his practice in an underlying class action alleging that a silicone implant invented for penile enlargement, and the procedure that went with it, left patients with permanent damage.

  • March 08, 2024

    Trump 'An Existential Threat' To Rule Of Law, Attys Warn

    Former President Donald Trump represents an "existential threat" to democracy and the rule of law, legal experts said Friday at a conference on white collar crime in San Francisco.

  • March 08, 2024

    Judge Keeps Novel Insider Trading Indictment Alive

    A California federal judge has refused to throw out a novel insider trading indictment against a former healthcare CEO, saying that the federal prosecutors provided sufficient information to sustain their allegations that the executive acted criminally by shedding millions of dollars worth of stock at the same time an important client relationship was nearing its end. 

  • March 08, 2024

    FDA Pumps Brakes On Eli Lilly Alzheimer's Drug Approval

    The U.S. Food and Drug Administration is delaying an approval decision on Eli Lilly and Co.'s Alzheimer's drug donanemab, the company said Friday, throwing a wrench in what was expected to be a smooth approval process for the experimental neurodegenerative treatment.

  • March 08, 2024

    7th Circ. Wants 'Roadmap' For Ill. Workplace Disease Law

    The Seventh Circuit has asked the Illinois Supreme Court to weigh in on the state's Workers' Occupational Diseases Act, saying it needs a "roadmap" to handle claims for asbestos and other diseases that manifest belatedly as it considers a widow's suit alleging her husband's exposure to a toxic chemical while working for Goodrich Corp. led to his death.

  • March 07, 2024

    Abortion, Drug Costs Top Health Issues in State Of The Union

    President Joe Biden laid out a forceful healthcare agenda in his State of the Union address on Thursday, promising to ramp up efforts to control drug prices and pledging to reinstate the federal right to an abortion if voters elect a pro-abortion Congress.

  • March 07, 2024

    Judge Doubts Medicare Drug Pricing Amounts To 'Taking'

    A New Jersey federal judge on Thursday bristled at the position by pharmaceutical companies that Medicare's drug price negotiation program is an unconstitutional "taking" that undercuts their bottom line, suggesting that the drug powerhouses needed more numbers to back their argument.

Expert Analysis

  • 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.

  • Avoid Telehealth Pitfalls In A Post-Pandemic Environment

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    As federal and state governments roll out various changes to regulation of telehealth services, health practitioners should remain vigilant and ensure that necessary professional standards — such as proper note-taking and documentation — are not neglected in a remote environment, say attorneys at Kaufman Borgeest.

  • ABA's Money-Laundering Resolution Is A Balancing Act

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    While the American Bar Association’s recently passed resolution recognizes a lawyer's duty to discontinue representation that could facilitate money laundering and other fraudulent activity, it preserves, at least for now, the delicate balance of judicial, state-based regulation of the legal profession and the sanctity of the attorney-client relationship, say attorneys at Ballard Spahr.

  • 8 Ways Life Sciences Cos. Can Adapt To The Social Media Era

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    As pharmaceutical and medical device companies harness the powerful promotion potential of social media, they must navigate legal, regulatory and reputational risks that can be particularly challenging due to the complex framework of rules that apply to the life sciences industry, say attorneys at Troutman Pepper.

  • FTC Settlements Widen Efforts To Shield Health Data

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    The Federal Trade Commission's recent enforcement actions aim to send a clear message that companies using tracking technologies should carefully monitor the sharing of sensitive data, particularly in the mental health, substance use disorder treatment and reproductive health care fields, say attorneys at Choate.

  • Law Firm Professional Development Steps To Thrive In AI Era

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    As generative artificial intelligence tools rapidly evolve, professional development leaders are instrumental in preparing law firms for the paradigm shifts ahead, and should consider three strategies to help empower legal talent with the skills required to succeed in an increasingly complex technological landscape, say Steve Gluckman and Anusia Gillespie at SkillBurst Interactive.

  • HHS Neuromonitoring Advisory May Have Broad Relevance

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    The Health Department Office of Inspector General's recent advisory opinion rejecting a neuromonitoring service's proposal for a shell arrangement isn't surprising, but it could be a harbinger of more warnings against problematic joint venture arrangements to come, says Mary Kohler at Kohler Health Law.

  • Potential Marijuana Status Change Would Shift Industry Risks

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    Cannabis companies and their insurers should pay close attention to how the U.S. Department of Health and Human Services' move toward marijuana reclassification plays out, and the potential for a shakeup in the landscape for cannabis regulation at the state and federal levels, says Ian Stewart at Wilson Elser.