Policy & Compliance

  • 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.

  • January 07, 2025

    PBMs And Health Insurers Back In Court In New Year

    In the first week of the New Year, courts got busy dishing out a tough discovery decision to pharmacy benefit managers and hearing arguments over insurance denials from Humana and Blue Cross Blue Shield. Here, Law360 Healthcare Authority takes a look at some of the key decisions, arguments and lawsuits from the first week of 2025. 

  • January 07, 2025

    Child Advocates Push For Mandatory Reporting Law Reform

    An effort to reform mandatory reporting laws for suspected child abuse or neglect is gaining momentum amid concerns that too many families are being needlessly entangled in welfare investigations.

  • January 07, 2025

    6th Circ. Declines To Send Publix Questions To Ga. High Court

    The Sixth Circuit won't certify a set of questions about Georgia state nuisance law to the state's Supreme Court, after ruling that Publix Super Markets Inc. hasn't shown the appeals court needs to step in before a bellwether trial in the national opioid multidistrict litigation.

  • January 07, 2025

    4th Circ. Revives Christian Vax Refuser's Religious Bias Suit

    The Fourth Circuit reinstated Tuesday a lawsuit from a Christian nurse who claimed she was unlawfully fired for refusing to get vaccinated against COVID-19, ruling a trial court jumped the gun when it tossed her case.

  • January 07, 2025

    Biden Aide Klein On White House Gender Council's Legacy

    As a member of the Biden administration, Jennifer Klein led the Gender Policy Council at the White House as federal abortion rights fell after the Dobbs decision and legal fights erupted over in vitro fertilization, putting her on the front lines of some of the nation's most politically charged debates.

  • January 07, 2025

    CFPB Adopts Rule To Take Medical Debt Off Credit Reports

    The Consumer Financial Protection Bureau moved ahead Tuesday with plans to restrict the use of medical debt information in credit scoring and lending, finalizing a rule that it said will take an estimated $49 billion in unpaid medical bills off consumers' credit reports.

  • January 06, 2025

    Athira Inks $4M FCA Deal Over Ex-CEO's Research Fraud

    Athira Pharma Inc. has agreed to pay $4 million to resolve allegations it used falsified academic research papers on neurological disorders like Alzheimer's to secure federal grants from the National Institute of Health, the U.S. Department of Justice announced Monday.

  • January 06, 2025

    Sheppard Mullin Hires University Of Calif. Health Counsel

    Sheppard Mullin Richter & Hampton LLP announced Monday that it has hired two attorneys who previously served in-house at the University of California to bolster its healthcare industry practice group.

  • January 03, 2025

    Hospital Org Inks $135M Deal To End Ex-CFO's Fraud Claims

    Community Health Network has agreed to pay $135 million to end federal healthcare fraud claims brought by its former chief financial officer, a deal reached two years after the Indiana healthcare system agreed to pay $345 million to settle False Claims Act allegations from the government in the qui tam action, the ex-CFO's counsel announced Thursday.

  • January 03, 2025

    DOJ Wants Oct. Amedisys Trial, UnitedHealth Wants Aug.

    The U.S. Department of Justice sparred with UnitedHealth Group in a Maryland federal court filing Friday over when to hold a trial on the government challenge to the $3.3 billion purchase of home health and hospice services company Amedisys Inc.

  • January 03, 2025

    PBMs 'Wasting' Time in Opioid MDL Discovery Spat: Judge

    An Ohio federal judge overseeing multidistrict opioid litigation on Friday denied pharmacy benefit managers a stay to appeal a discovery order and said he believed the PBMs were "wasting" the court's time.

  • January 03, 2025

    Insurers Ordered To Pay $165M For Deceptive Marketing

    Insurance companies banned from selling policies in Massachusetts due to alleged deceptive marketing practices have been ordered to pay $165 million for selling the plans anyway and using similar false advertising in their pitches to consumers, a state judge has ruled.

  • January 02, 2025

    Issa Again Selected To Lead House IP Subcommittee

    Rep. Darrell Issa, R-Calif., will again lead the House subcommittee overseeing intellectual property in the upcoming Congress, a role in which he has sponsored bills seeking to limit how many patents can be asserted in biosimilar cases and require disclosure of litigation funding.

Expert Analysis

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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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.