Policy & Compliance

  • July 30, 2024

    Medicare Rules Face Double Punch From High Court Cases

    A pair of administrative law decisions from the U.S. Supreme Court this past term will equip ambitious plaintiffs with more ammo to challenge regulations implementing federal healthcare programs.

  • July 30, 2024

    PBMs Urge Justices To Reject Review Of Okla. Law Dispute

    An industry trade group representing pharmacy benefits managers urged the U.S. Supreme Court not to disturb its Tenth Circuit victory, which held that an Oklahoma statute regulating PBMs ran afoul of preemption provisions in both the Employee Retirement Income Security Act and Medicare Part D.

  • July 30, 2024

    HHS' New AI Leader Talks Next Chapter For Health IT

    More than two decades ago, the federal government created an office to support healthcare's shift from analog to digital recordkeeping. Today, that office and its leader, Micky Tripathi, are tasked with steering the industry as it faces a new digital turning point: artificial intelligence.

  • July 30, 2024

    5 Podcasts For Health, Life Sciences Lawyers

    For healthcare and life sciences attorneys who have been in the throes of their work this summer, have no fear: There is still time for leisure. And what better way to relax or stay informed than listening to a podcast while exercising, lounging by the pool or decompressing between meetings?

  • July 30, 2024

    Psychedelics And The Law: A Midyear Review

    A groundbreaking effort to secure federal approval for a psychedelic medication hit an unexpected snag. Religious groups asserting the right to access controlled substances had mixed success in federal court. Physicians seeking to administer psilocybin to terminally ill patients will finally have their day in court. Here are the major developments in psychedelics law from the first half of 2024.

  • July 30, 2024

    Former Prosecutor 'Coming Back Home' To NJ Boutique

    After prosecuting federal healthcare crimes in New Jersey, a former assistant U.S. attorney has returned to boutique firm Calcagni & Kanefsky LLP to guide clients as part of the firm's white collar criminal and regulatory defense and investigations practice with a focus on healthcare litigation and licensing, the firm announced Tuesday.

  • July 30, 2024

    Mich. COVID-19 Liability Law Shields Regular Healthcare Too

    A 2020 law protecting healthcare providers and facilities from liability for their response to the early COVID-19 pandemic also applies to regular care provided during that time, a Michigan appellate panel said, finding that resources diverted because of the state's response affected other areas of care.

  • July 29, 2024

    Feds Say Tenn., NC Hospitals Overpaid Doctors For Referrals

    A Tennessee-based hospital system violated the False Claims Act by taking $27.8 million in public healthcare allotments while overpaying doctors, sometimes by three times the average physician's pay, to make internal referrals, according to a lawsuit the U.S. Department of Justice has joined.

  • July 29, 2024

    Wash. Says At-Home Rape Kit Law Targets Harm, Not Speech

    Washington pushed back against a company's bid to pause enforcement of a ban on the sale of "DIY" DNA collection kits to sexual assault survivors, saying the prohibition is meant to prevent victims from being tricked into thinking the kit results will stand up in court.

  • July 29, 2024

    Boehringer Appeals HHS Win In Medicare Drug Price Suit

    Boehringer Ingelheim Pharmaceuticals Inc. notified a Connecticut federal court Friday that it will appeal its loss in a lawsuit challenging a new Medicare drug price negotiation program on the grounds that it unlawfully compels the pharmaceutical giant to declare prices "fair," takes its property and imposes an excessive fine.

  • July 29, 2024

    Cardiologist Hits Mass. Hospital With Equal Pay Suit

    A cardiologist at Boston's Brigham and Women's Hospital says a less experienced male colleague whom she helped train is being paid $95,000 more, in violation of the Massachusetts Equal Pay Act, according to a lawsuit filed in state court.

  • July 29, 2024

    Healthcare Atty Switches Sides With Move To Saxton & Stump

    After nearly a decade as a plaintiffs attorney representing clients facing off against medical providers, a lawyer specializing in healthcare matters has moved her practice to the other side of the courtroom and joined Saxton & Stump's Lancaster, Pennsylvania, office.

  • July 26, 2024

    Apple Commits To White House Guidelines For Responsible AI

    Apple Inc. has signed onto the Biden administration's voluntary guidelines for "responsible" artificial intelligence innovation, joining the likes of Amazon.com Inc., Google LLC, Microsoft Corp. and a dozen other leading tech companies, the White House announced Friday.

  • July 26, 2024

    Fla. Top Court Petitioned To Review 'Misleading' Abortion Info

    A Florida coalition petitioned the state's high court to review a proposed financial impact statement that officials attached to an upcoming ballot measure legalizing abortions up to 24 weeks of pregnancy, saying the language is misleading and shouldn't be used to manipulate voters one way or the other.

  • July 26, 2024

    Judge Allows Emotional Damages In Deaf Patient's Bias Suit

    A Michigan federal judge has reversed course in a suit by a deaf woman who alleges she was discriminated against when Henry Ford Health System denied her an interpreter, saying she'd been mistaken in a prior order when she only considered if compensatory emotional distress damages were available under federal law.

  • July 26, 2024

    Indivior To Pay $86M To Settle Opioid Claims By 5 States

    Indivior will pay $86 million to settle claims by a group of state attorneys general over the drugmaker's alleged contributions to the American opioid crisis.

  • July 25, 2024

    Mich. Jury Awards $8.5M For Missed Cancer Diagnosis

    A Michigan federal jury awarded more than $8.5 million in damages Wednesday to a man who died of kidney cancer, finding that a doctor at a cancer clinic missed an opportunity to diagnose the cancer before it spread to his brain.

  • July 25, 2024

    'AntiVaxMomma' Gets Jail Time, Despite Duress Claim

    A Manhattan judge sentenced a woman to at least 1½ years in jail Thursday for selling fake COVID-19 immunization credentials under the Instagram handle "AntiVaxMomma," rejecting the defendant's claim that she didn't have enough time to weigh a plea offer before admitting her guilt.

  • July 24, 2024

    Native Hawaiian Midwives Gain Relief From Licensing Law

    A Hawaii judge blocked parts of a state law regulating midwives Tuesday, ruling it violates the constitutional rights of Native Hawaiians by denying them a reasonable pathway to securing approval for traditional prenatal care.

  • July 24, 2024

    DC Circ. Nixes Medicare Hospital Inpatient Payment Rule

    The D.C. Circuit has vacated a U.S. Department of Health and Human Services rule that inflated Medicare reimbursements for inpatient care at low-wage hospitals, saying the agency made an "unprecedented, expensive, broad, and possibly never-ending" change to a policy articulated by Congress.

  • July 24, 2024

    GOP States Still Can't Intervene In Wash. Abortion Pill Suit

    The Ninth Circuit rejected a bid by Idaho and other Republican-led states to intervene in Washington's lawsuit seeking to expand access to the abortion pill mifepristone, ruling Wednesday the states lacked standing and only speculated about how they were injured.

  • July 23, 2024

    Meet The Lead Ozempic Lawyers

    The recently deceased U.S. District Judge Gene E.K. Pratter this past spring appointed plaintiff leadership in litigation over Ozempic and similar drugs over allegations that the medications cause gastrointestinal issues. Here's who's who in the list of plaintiffs' leaders.

  • July 23, 2024

    Kickback Risk Remains For Gene Therapy Fertility Programs

    Federal health officials this week declined to relieve two companies of potential liability under the Anti-Kickback Statute concerning their fertility support programs for patients receiving gene therapies.

  • July 23, 2024

    Wash. AG Says 'Abortion Reversal' Clinic's Suit Still Deficient

    Washington state's attorney general said Monday an anti-abortion clinic group being investigated for marketing an "abortion reversal pill" cannot blame his two-year-old document demands for a recent insurance rate hike, pushing a Tacoma federal judge to reject the group's legal effort to shield itself from future consumer protection enforcement.

  • July 23, 2024

    Healthcare Dealmaking Trends Of 2024: A Midyear Review

    While each deal is unique, transactions don't occur in a vacuum. Here, Law360 Healthcare Authority reviews five trends that helped shape some of those deals and the wider healthcare industry so far this year.

Expert Analysis

  • 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.

  • Merger Proposals Reflect Agency Leaders' Antitrust Principles

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    Attorneys at Covington trace the recently proposed Hart-Scott-Rodino and merger guidelines changes to certain foundational concerns of the Federal Trade Commission and U.S. Department of Justice Antitrust Division leadership, including issues related to concentration associated with horizontal and vertical mergers.

  • The Basics Of Being A Knowledge Management Attorney

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    Michael Lehet at Ogletree Deakins discusses the role of knowledge management attorneys at law firms, the common tasks they perform and practical tips for lawyers who may be considering becoming one.

  • A Look At The Tribal Health Reimbursements Circuit Split

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    A circuit split regarding whether Native American tribes are entitled to contract support costs on health care services paid by third-party revenues sets the stage for potential review by the U.S. Supreme Court, and could result in the Indian Health Service paying hundreds of millions more in much-needed funding to tribal health programs, say Geoffrey Strommer and Steve Osborne at Hobbs Straus.

  • What Big Tobacco's Cannabis Investments Mean For Market

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    The tobacco industry appears to be shoring up investments in the cannabis market, most recently with Philip Morris’ purchase of an Israeli cannabis tech company, pointing to a bright future for vaped and noncombustible products, and signaling that marijuana rescheduling may be on the horizon, say Slates Veazey and Whitt Steineker at Bradley Arant.

  • To Hire And Keep Top Talent, Think Beyond Compensation

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    Firms seeking to appeal to sophisticated clients and top-level partners should promote mentorship, ensure that attorneys from diverse backgrounds feel valued, and clarify policies about at-home work, says Patrick Moya at Quaero Group.

  • How Merger Review Overhaul Could Affect Health Industry

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    For those in the health care industry considering growth and expansion strategies, the antitrust agencies' recent proposals for new Hart-Scott-Rodino rules and more complex merger guidelines will increase deal timelines, the merging parties' burden, and overall uncertainty and potential antitrust risk as to the outcome, say attorneys at Husch Blackwell.

  • What Circuit Split May Mean For FCA Kickback Liability

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    The recent circuit split on the meaning of the resulting-from provision in False Claims Act kickback cases could have significant ramifications for FCA liability, as it could affect the standard of causation that plaintiffs must meet to establish liability, say former federal prosecutors Li Yu, Ellen London and Gregg Shapiro.