Policy & Compliance

  • May 06, 2024

    UChicago Can't Ditch Data Sharing Privacy Claim

    A University of Chicago Medical Center patient accusing the hospital of illegally sharing her and other patients' identifying information with Meta can pursue her claims that the info sharing constitutes a federal wiretap violation, an Illinois federal judge said.

  • May 06, 2024

    Hooper Lundy Adds Government Relations Director

    An attorney who worked in-house for healthcare industry trade and advocacy associations has joined healthcare boutique Hooper Lundy & Bookman PC as director of government relations and public policy.

  • May 03, 2024

    Ala. High Court Won't Rethink Decision On Frozen Embryos

    The Alabama Supreme Court on Friday refused to revisit its February decision finding that frozen embryos count as children, a first-of-its-kind decision that has been received as potentially ruinous for in vitro fertilization services in the Yellowhammer State.

  • May 03, 2024

    Aetna To Pay $2M To End LGBTQ Fertility Coverage Suit

    A group of Aetna policyholders said Friday that the insurance giant has agreed to pay $2 million and revise certain health insurance guidelines to settle a proposed class action alleging its definition of infertility made it difficult and expensive for LGBTQ couples to obtain coverage for fertility treatments.

  • May 03, 2024

    Ohio Statehouse Catch-Up: Trans, Abortion Laws Face Battles

    Ohio lawmakers have shepherded controversial bills impacting healthcare, social media and other matters into law in recent months, prompting lawsuits and even a veto from Gov. Mike DeWine.

  • May 03, 2024

    6 States Strike $270M Opioid Deal With Amneal

    The New York state attorney general on Friday said that a $270 million multistate deal had been reached with opioid manufacturer Amneal Pharmaceuticals for its role in the addiction epidemic over allegations that the company failed to report suspicious orders of the narcotics.

  • May 02, 2024

    7th Circ. Mostly Backs Ill. Home Health Kickbacks Judgment

    The Seventh Circuit on Thursday largely left intact an Illinois federal judge's $6 million ruling that a home health care company broke federal kickback laws, refusing to reverse the lower court's liability finding but directing it to ensure its damages award was calculated correctly.

  • May 02, 2024

    Endo Judge Hopes Criminal Sentence Warns Opioid Makers

    A Michigan federal judge said Thursday she hoped Endo's criminal sentence for falsely advertising a pain medication as "abuse deterrent" would itself be a deterrent for other opioid makers, as she accepted the company's recent $200 million settlement deal with federal prosecutors. 

  • May 02, 2024

    Feds Call Out Gilead's Efforts To Revise HIV Drug IP Judgment

    The U.S. Department of Justice has asked a Delaware federal judge to reject Gilead Sciences' motion to modify a judgment finding that two medications in its HIV prevention regimen directly infringe voided patents owned by the government, arguing that the pharmaceutical company's attempt to rewrite the judgment is "unnecessary as well as improper."

  • May 02, 2024

    Lawmaker Wants Antitrust Probe Of Health Insurance Data Co.

    Sen. Amy Klobuchar, D-Minn., is calling for antitrust enforcers to investigate concerns that MultiPlan and other healthcare data companies are hurting competition by helping health insurers effectively collude when making pricing decisions.

  • 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.

Expert Analysis

  • Bracing For Calif.'s New Health Transaction Framework

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    As California's new cost and market impact review regulations' April 1 date for its updated notice and review process approaches, healthcare entities should ready themselves for dramatic changes to the state's regulatory landscape and prepare for potentially substantial transaction delays, say Jordan Grushkin and Matthew Goldman at Sheppard Mullin.

  • Uncharted Waters Ahead For FCA Litigation In 2024

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    Following a year of significant court decisions, settlements, recoveries and proposed amendments, 2024 promises to be a lively year for False Claims Act actions and litigation, and one that will hopefully provide more clarity as FCA jurisprudence evolves, say attorneys at Crowell & Moring.

  • OIG Report Has Clues For 2024 Healthcare Fraud Enforcement

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    A recent report from the Health Department's Office of the Inspector General reveals healthcare fraud and abuse enforcement trends that will continue in 2024, from increased telehealth oversight to enhanced policing of managed care, say attorneys at Sheppard Mullin.

  • FOIA Exemption Questions On Redacted HHS Cannabis Letter

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    The U.S. Department of Health and Human Services' recent recommendation letter concerning the rescheduling of cannabis was heavily redacted, and based on an analysis on the applicability of Freedom of Information Act Exemption 5 to the letter, it's likely that we will see successful legal challenges to those redactions, say attorneys at Troutman Pepper.

  • A Primer On New Calif. Health Transaction Reporting Rules

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    New California regulations regarding the reporting of certain transactions involving healthcare entities, which took effect on Jan. 1, address some industry feedback about overly broad requirements but still leave several areas of concern, says Andrew Demetriou at Husch Blackwell.

  • In The CFPB Playbook: Rulemaking Rush Before Election Year

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    In this quarterly Consumer Financial Protection Bureau activity recap by former bureau personnel, attorneys at McGuireWoods explain the regulator's recent push to finalize new rules about data aggregators, digital payment apps and more before the election-year Congressional Review Act window opens.

  • What The Law Firm Of The Future Will Look Like

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    As the legal landscape shifts, it’s become increasingly clear that the BigLaw business model must adapt in four key ways to remain viable, from fostering workplace flexibility to embracing technology, say Kevin Henderson and Eric Pacifici at SMB Law Group.

  • 4 PR Pointers When Your Case Is In The News

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    Media coverage of new lawsuits exploded last year, demonstrating why defense attorneys should devise a public relations plan that complements their legal strategy, incorporating several objectives to balance ethical obligations and advocacy, say Nathan Burchfiel at Pinkston and Ryan June at Castañeda + Heidelman.

  • Digging Into The Debate On FDA's Proposed Lab Test Rule

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    A proposed 10-word amendment from the U.S. Food and Drug Administration represents a sea change in device regulation as it would summarily end decades of FDA enforcement discretion for laboratory developed tests, and the public comments offer some insight into the future of this long-running saga, say attorneys at Mintz.

  • Law Firm Strategies For Successfully Navigating 2024 Trends

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    Though law firms face the dual challenge of external and internal pressures as they enter 2024, firms willing to pivot will be able to stand out by adapting to stakeholder needs and reimagining their infrastructure, says Shireen Hilal at Maior Consultants.

  • AI In Health Law: The Top Guest Articles Of 2023

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    As the use of artificial intelligence accelerated this year, Expert Analysis writers examined AI's significant impact on the healthcare sector, ranging from key compliance considerations for companies utilizing AI tools to regulators' efforts to keep up with rapidly evolving technologies.

  • The Most-Read Legal Industry Law360 Guest Articles Of 2023

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    A range of legal industry topics drew readers' attention in Law360's Expert Analysis section this year, from associate retention strategies to ethical billing practices.

  • Inside Higher Education's New FCA Liability Challenges

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    As the educational sector expands its use of government funding, schools are at increased risk under the False Claims Act, but recent settlements offer valuable lessons about new theories of liability they may face and specific procedures to reduce their exposure, say James Zelenay and Jeremy Ochsenbein at Gibson Dunn.