Policy & Compliance

  • January 14, 2025

    New EMTALA Suit in Idaho Seeks To Keep Injunction

    An Idaho health system filed a lawsuit Tuesday alleging that Idaho's strict abortion ban conflicts with an emergency stabilization law and is seeking to keep the ban blocked while it prepares to take up the legal battle once fought by the Biden administration.

  • January 14, 2025

    Dispute Over Eli Lilly Weight Loss Drug Reignited

    Compounding pharmacies have reignited a suit against the U.S. Food and Drug Administration over the removal of a lucrative weight loss drug from the shortage list, with a Texas federal judge ordering both sides to turn in briefing on injunctive relief during a Tuesday hearing.

  • January 14, 2025

    FTC Issues Second Report On PBMs, Expanding Study Scope

    The Federal Trade Commission released a second "interim" report on pharmacy benefit managers and their effects on specialty drug prices Tuesday, claiming that the companies have driven up prices well over acquisition costs and continue to squeeze independent pharmacies out of the market through low reimbursement rates.

  • January 14, 2025

    Both Michigan US Attys Resign Ahead Of Inauguration

    Michigan's U.S. attorneys, Dawn Ison in the Eastern District and Mark Totten in the Western District, announced their departures this week ahead of President-elect Donald Trump's inauguration.

  • January 14, 2025

    Healthcare Laws Taking Effect In 2025

    This year, the healthcare industry will see a host of new laws touching on everything from private equity transactions and oversight to drug price caps and medical leave policies.

  • January 14, 2025

    Whistleblowing Compliance Pro Secures 4th FCA Settlement

    A repeat whistleblower has cost hospitals more than $43 million in federal settlements over the last 18 years, illustrating the increased use of data analysis and other trends in False Claims Act litigation.

  • January 14, 2025

    2nd Circ. Rules Prison Docs Can't Escape Indifference Claims

    A Second Circuit panel on Monday ruled two New York prison doctors must face a former inmate's deliberate indifference claims for allegedly overlooking his cancer symptoms despite medical exam results, while also finding the inmate's claims were not time-barred, though the court said the state and facility are protected by sovereign immunity. 

  • January 14, 2025

    Mass. AG Says Insulin Makers, Middlemen Colluded On Costs

    Insulin makers Eli Lilly, Sanofi and Novo Nordisk conspired with pharmacy benefit managers OptumRX, Express Scripts and CVS Caremark to jack up prices by as much as 1,000%, the Massachusetts attorney general alleged in a suit.

  • January 14, 2025

    Assisted Living Co., Ex-Worker End Race-Based Pay Bias Suit

    An assisted living facility and a former employee have agreed to close her suit claiming she was paid less than colleagues and belittled by her supervisor because she is Indian American, according to a New York federal court filing.

  • January 13, 2025

    Lincare Pays $1.15M To End Wash. Medicaid Fraud Probe

    Lincare Inc. agreed to pay $1.15 million to resolve a Washington probe into allegations the medical equipment supplier overbilled Medicaid for rental payments for patients' oxygen equipment over a six-year period, the Washington State Office of the Attorney General announced Monday.

  • January 13, 2025

    Blue Cross Can't Skirt NC Hospital's Defamation Claims

    A local hospital can pursue some of its defamation claims against Blue Cross and Blue Shield of North Carolina in a suit alleging the health insurer wrongly denied millions of dollars in reimbursements and falsely accused the facility of fraud, a federal judge ruled Monday.

  • January 13, 2025

    Duke Health Worker Agrees To Arbitrate Bias Suit, For Now

    A former Duke University Health System Inc. radiology technologist who accused the healthcare network of firing her for being pregnant with her second child told a North Carolina federal judge Monday she is all right with her former employer's request to take the matter to arbitration.

  • January 13, 2025

    RFK Jr.'s Wash. Anti-Vax Suit Can't Get High Court Save

    The U.S. Supreme Court on Monday rejected Robert F. Kennedy Jr.'s bid for an emergency order to temporarily block a state of Washington medical board investigation into alleged anti-vaccine statements made by retired doctors.

  • January 13, 2025

    Feds Say NC Medical Biz Owner Overbilled For Nutrient Drinks

    A North Carolina businessman who ran a durable medical equipment business under multiple names overbilled the state's Medicaid program $1.85 million for special enteral nutritional formulas used to treat inherited metabolic disorders when he was actually just providing people common nutritional shakes like Ensure, the federal government said.

  • January 13, 2025

    Supreme Court Turns Away IP Safe Harbor Dispute

    The U.S. Supreme Court on Monday said it won't consider whether the Federal Circuit has overexpanded a safe harbor for drug development, in litigation where Meril Life Sciences escaped allegations that it infringed Edwards Lifesciences' heart valve patents.

  • January 10, 2025

    Home Care Co. Must Pay $15M In DOL OT Suit

    An Ohio federal judge granted the U.S. Department of Labor a win in its lawsuit accusing a third-party home care agency of failing to pay employees overtime and ordered the company to pay $15 million in unpaid wages and damages.

  • January 10, 2025

    Justices To Review ACA Preventive Care Fight

    The U.S. Supreme Court agreed Friday to review a Fifth Circuit decision finding a task force setting coverage requirements on preventive care was unconstitutional, setting up a high-stakes battle over the Affordable Care Act that could affect individuals' insurance coverage for things like colon and breast cancer screenings.

  • January 09, 2025

    CFPB Hit With 2nd Suit Over Medical Debt Reporting Rule

    The Consumer Financial Protection Bureau has been hit with a second lawsuit challenging its new rule that would wipe billions of dollars in medical debt off consumer credit reports, with ACA International filing a complaint in Texas federal court arguing healthcare markets are outside the agency's regulatory authority.

  • January 09, 2025

    New Mexico Justices Say Local Gov'ts Can't Restrict Abortion

    New Mexico's highest court on Thursday struck down four local ordinances that restricted abortion access in the state, chastising the cities and counties behind them for running afoul of state laws on reproductive health and medical licensing.

  • January 09, 2025

    Stem Cell Therapy Co. Hit With $5.1M Deceptive Ad Judgment

    A Georgia federal judge has ordered a stem cell therapy company and its co-founders to pay the state $5.1 million for falsely marketing its product as a cure-all miracle treatment for a slew of different medical conditions.

  • January 08, 2025

    UnitedHealth Wants $3.3B Amedisys Deal Challenge Tossed

    UnitedHealth Group and Amedisys Inc. asked a Maryland federal court Wednesday to toss a challenge of their planned $3.3 billion merger, contending that federal and state enforcers are refusing to say what "local" home health and hospice service markets would be hurt by the deal.

  • January 08, 2025

    USTR Warns Of Risks Posed By Counterfeit Pharmacies

    The Office of the U.S. Trade Representative on Wednesday released its latest list of overseas "notorious markets" selling illicit and counterfeit goods, pointing in particular to a boom in counterfeit online pharmacies selling knock-off medications that pose a risk both to public health and businesses' intellectual property interests.

  • January 07, 2025

    Alcohol Warnings Unlikely To Bring Same Fate Tobacco Faced

    The U.S. surgeon general on Friday recommended that alcohol carry warnings about cancer risks, and attorneys say that while warning labels might be warranted, alcohol is unlikely to become the next tobacco.

  • January 07, 2025

    Feds Defend FCA Whistleblower Constitutionality At 11th Circ.

    The federal government has called on the Eleventh Circuit to uphold the constitutionality of the False Claims Act's whistleblower provisions, saying a Florida district court ruling otherwise is an "outlier" that goes against U.S. Supreme Court precedent.

  • January 07, 2025

    FDA Off-Label Drug Guidance: 3 Things to Know

    New guidance from the U.S. Food and Drug Administration walks back constraints the agency previously laid out on how drugmakers and other companies communicate with healthcare providers about off-label uses of approved treatments.

Expert Analysis

  • 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.

  • AI Executive Order's Life Science, Healthcare Industry Effects

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    The recent White House executive order to manage risks associated with artificial intelligence includes provisions specific to healthcare and life sciences that merit special attention, including transparency, human oversight of AI output, and real world performance monitoring, say attorneys at Ropes & Gray.

  • HHS Advisory Highlights Free Product Inducement Risks

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    A recent U.S. Department of Health and Human Services advisory opinion highlights concerns that valuable free products and other inducements may influence patients and providers to choose one manufacturer’s product over another, notwithstanding that such free healthcare products may be a benefit, say attorneys at Morgan Lewis.

  • Attorneys' Busiest Times Can Be Business Opportunities

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    Attorneys who resolve to grow their revenue and client base in 2024 should be careful not to abandon their goals when they get too busy with client work, because these periods of zero bandwidth can actually be a catalyst for future growth, says Amy Drysdale at Alchemy Consulting.

  • In The World Of Legal Ethics, 10 Trends To Note From 2023

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    Lucian Pera at Adams and Reese and Trisha Rich at Holland & Knight identify the top legal ethics trends from 2023 — including issues related to hot documents, artificial intelligence and cybersecurity — that lawyers should be aware of to put their best foot forward.

  • How Attorneys Can Be More Efficient This Holiday Season

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    Attorneys should consider a few key tips to speed up their work during the holidays so they can join the festivities — from streamlining the document review process to creating similar folder structures, says Bennett Rawicki at Hilgers Graben.

  • Top 10 Whistleblowing And Retaliation Events Of 2023

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    The U.S. Securities and Exchange Commission and federal and state courts made 2023 another groundbreaking year for whistleblower litigation and retaliation developments, including the SEC’s massive whistleblower awards, which are likely to continue into 2024 and further incentivize individuals to submit tips, say attorneys at Proskauer.

  • Children's Book Writing Makes Me A Better Lawyer

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    Becoming a children's book author has opened doors to incredible new experiences of which I barely dared to dream, but the process has also changed my life by serving as a reminder that strong writing, networking and public speaking skills are hugely beneficial to a legal career, says Shaunna Bailey at Sheppard Mullin.

  • The State Of CFPB Focus On Credit Reporting Of Medical Debt

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    An increase in credit reporting complaints and the Consumer Financial Protection Bureau's recent annual report on the Fair Debt Collection Practices Act — which focuses on medical debt in credit reporting — are both evidence of the fact that the bureau will continue to prioritize oversight of credit reporting of medical debt, says Kristen Watson at Burr & Forman.

  • FDA's Recent Litigation Records Are Strong, But Imperfect

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    The U.S. Food and Drug Administration has notched its share of litigation wins in recent years thanks to a number of key advantages, but the FDA has been less successful in certain highly visible arenas, Jonathan Berman and Colleen Heisey at Jones Day.

  • 5 Steps For Healthcare Companies After Biden's AI Order

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    Rather than simply monitoring for the issuance of agency guidelines on artificial intelligence in the wake of President Joe Biden's October executive order, health and life sciences companies should take action now and begin building internal operational and technical infrastructures designed to govern the use of AI, says Joy Sharp at Faegre Drinker.

  • Giving The Gov't Drug Patent March-In Authority Is Bad Policy

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    The Biden administration's recent proposal to allow government seizure of certain taxpayer-funded drug patents is a terrible idea that would negate the benefits of government-funded research, to the detriment of patients and the wider economy, says Wayne Winegarden at Pacific Research Institute.