Policy & Compliance

  • January 29, 2025

    RFK Jr. Disputes Anti-Vax Label In HHS Confirmation Hearing

    Robert F. Kennedy Jr. attempted Wednesday morning to convince Republican and Democratic lawmakers that he is not anti-vaccine, despite many of his past comments to the contrary, as he hopes to convince them to confirm his appointment as head of the U.S. Department of Health and Human Services.

  • January 28, 2025

    Trump Targets Gender-Affirming Care For Minors In New Order

    President Donald Trump ordered federal agencies late Tuesday to take steps to halt gender-affirming care for minors, including by cutting off Medicaid and military health coverage for what he called a "stain on our nation's history."

  • January 28, 2025

    Minn. AG Settles Novo Nordisk Insulin Claims With Price Cap

    Minnesota's attorney general has reached a settlement resolving a long-running lawsuit accusing Novo Nordisk of inflating insulin prices, with the company agreeing to a $35 per month cap on out-of-pocket costs for state residents.

  • January 28, 2025

    Wash. Judge Asks If Dr.'s Ivermectin Discipline Was Political

    A Washington appellate judge asked Tuesday if a doctor who was disciplined by a medical board for prescribing the controversial drug ivermectin to COVID-19 patients was targeted for his political views, while another judge asked if "all lies" about medical information are protected speech.

  • January 28, 2025

    Questions To Watch For In RFK Jr.'s Confirmation Hearing

    Robert F. Kennedy Jr. is set to appear on Capitol Hill as he tries to secure the top position at the U.S. Department of Health and Human Services. Here are some of the questions healthcare lawyers and others want to see addressed about his "Make America Healthy Again" pledge.

  • January 28, 2025

    Feds Say Health System Can't Ditch Fraud Suit Over Surgeries

    The federal government and state of Washington urged a judge on Monday to allow their suit against a hospital operator to move forward, saying they have provided more than enough detail to support allegations that the health system knew a doctor was performing unnecessary surgeries.

  • January 28, 2025

    Trump's CMS Suit U-Turn, Sacklers Settle, And Trans Suit Stay

    Law360 Healthcare Authority recaps the significant cases and decisions that shaped the healthcare industry over the past week, including the Trump administration’s reversal on a case challenging the Medicare Advantage star rating system, a freeze on a lawsuit over a Biden-era gender dysphoria rule, and the Sackler family’s $7.4 billion opioid settlement.

  • January 28, 2025

    Hospitals Brace For Immigration Agents, Legal Clashes

    The Trump administration’s move to allow immigration enforcement at "sensitive" locations is pushing hospitals to scrutinize their legal obligations under HIPAA and other state and federal laws.

  • January 28, 2025

    CFPB's Medical Debt Rule In Peril Under Trump

    A last-minute effort by the Biden administration to ease the burden of medical debt could face a perfect storm of regulatory and legal challenges under President Donald Trump, potentially quashing momentum to achieve relief for those saddled with unpaid healthcare bills.

  • January 27, 2025

    VA To Nix $6.1M In Contracts Under Trump's DEI Order

    The U.S. Department of Veterans Affairs announced Monday that it has placed dozens of employees on paid leave and will cancel $6.1 million worth of contracts as part of efforts to root out diversity, equity and inclusion activities.

  • January 25, 2025

    Trump Revives Federal Anti-Abortion Policies

    President Donald Trump issued two executive orders Friday targeting abortion inside and outside the United States, reinstating a ban on federal funding for certain international family planning groups and revoking a pair of Biden-era directives supporting abortion access.

  • January 24, 2025

    Anti-Abortion Group Seeks High Court Review Of NJ Probe

    An anti-abortion pregnancy center operator wants the U.S. Supreme Court to revive its federal court challenge to a subpoena from the New Jersey attorney general that seeks information about its donors, urging the court in a petition for certiorari to resolve a legal "Catch-22."

  • January 24, 2025

    J&J Escapes Part Of Worker's Drug Benefits Suit, For Now

    A suit alleging Johnson & Johnson overcharged employees through a prescription drug benefits program was partially tossed Friday, with a New Jersey federal judge ruling the suing worker failed to show the court could provide any remedies on her claims that plan members overpaid for medicine.

  • January 24, 2025

    Feds Drop HIPAA Charges Against Houston Surgeon

    The federal government has dropped criminal charges against a Texas surgeon accused of improperly accessing patient information and sharing information about the hospital's gender-affirming care practices with the press.

  • January 24, 2025

    Employer Groups Back Tossing Pension Annuity Suit In NY

    Three employer trade groups are backing Bristol-Myers Squibb and investment manager State Street as they fight claims brought by retirees of the pharmaceutical giant that the companies violated federal benefits law by converting workers' pension benefits into annuity insurance contracts.

  • January 24, 2025

    5th Circ. Upholds Tossing Medicare Rate Policy Challenge

    A Fifth Circuit panel said it agrees with a Texas federal judge that a lawsuit brought by four anesthesia practices claiming a Centers for Medicare and Medicaid Services policy will cost them $4 million in reduced reimbursements is statutorily barred.

  • January 24, 2025

    Greenberg Traurig Health Ace Joins Polsinelli In LA

    Polsinelli PC is expanding its California team, bringing in a Greenberg Traurig LLP healthcare corporate attorney as a principal in its Los Angeles office.

  • January 24, 2025

    Dentons Adds 2 Healthcare Attys From Katten In NY

    Dentons announced that it has added two attorneys with extensive experience in Medicare and Medicaid reimbursement, regulatory compliance and False Claims Act defense as New York-based partners in its healthcare practice.

  • January 23, 2025

    Marlboro Smoker Was Target Of Deception, Jury Hears

    Philip Morris targeted a Massachusetts preteen as a "replacement" customer for others who were dying of lung disease, a Springfield jury heard Thursday, though the company's lawyer said the woman had free will and knew enough to stop smoking.

  • January 23, 2025

    4th Circ. Reads Kickback Law Broadly In Loss For Big Pharma

    The Fourth Circuit on Thursday affirmed a Virginia federal judge's ruling against a pharmaceuticals industry-backed charity looking to weaken the Anti-Kickback Statute, holding that a proposed program for helping patients cover the cost of drugs could indeed constitute a quid pro quo.

  • January 23, 2025

    Georgia Pain Doctor To Pay Feds $3.5M In FCA Settlement

    A Georgia doctor and his pain management clinic have agreed to pay $3.5 million to end a yearslong civil probe into False Claims Act allegations of billing fraud and violations of opioid prescription protocols, the U.S. Department of Justice said Thursday.

  • January 23, 2025

    Conn. Lawmakers Target Healthcare After Hospital's Ch. 11

    In the lead-up to and aftermath of California hospital operator Prospect Medical Holdings Inc.'s $1 billion bankruptcy, Connecticut lawmakers are considering new regulatory powers, promising and penning oversight bills for hospitals owned by private equity firms and real estate trusts while seeking to stabilize the state's healthcare markets.

  • January 23, 2025

    UnitedHealthcare Settles Proton Beam Coverage Suit

    UnitedHealthcare has agreed to resolve a proposed class action claiming it unlawfully denied coverage of a proton beam cancer treatment after wrongly labeling it as experimental, the insurance company and plan participants told a Massachusetts federal court.

  • January 23, 2025

    15 States Reach $7.4B Settlement With Sackler Family

    A bipartisan coalition of states on Thursday announced a $7.4 billion settlement in principle with the Sackler family and their company Purdue Pharma Inc., representing the largest settlement to date with the family accused of contributing significantly to the opioid epidemic.

  • January 22, 2025

    RFK Filings Show Biopharma Stakes, Millions In Firm Income

    Robert F. Kennedy Jr. plans to sell off his stakes in two biopharmaceutical companies and step back from lucrative roles at a handful of law firms if he is confirmed to lead the U.S. Department of Health and Human Services, according to new financial disclosures.

Expert Analysis

  • 10 Takeaways From New HHS Federal Compliance Guidelines

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    The U.S. Department of Health and Human Services' recently issued general compliance program guidance is the first of its kind that would apply across all health care stakeholders, and signals the agency’s first step to improve and update existing compliance guidance, says Melissa Wong at Holland & Knight.

  • 2 HHS Warnings Highlight Anti-Kickback Risks For Physicians

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    Two recent advisory opinions issued by the U.S. Department of Health and Human Services' Office of Inspector General involve different scenarios and rationales, but together they illustrate the OIG's focus on and disapproval of contractual joint ventures and other revenue-maximizing physician arrangements, say Robert Threlkeld and Elliott Coward at Morris Manning.

  • Attorneys Have An Ethical Duty To Protect The Judiciary

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    The tenor of public disagreement and debate has become increasingly hostile against judges, and though the legislative branch is trying to ameliorate this safety gap, lawyers have a moral imperative and professional requirement to stand with judges in defusing attacks against them and their rulings, says Deborah Winokur at Cozen O'Connor.

  • Cross-Market Implications In FTC's Anesthesia Complaint

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    The Federal Trade Commission's recent complaint against a private equity firm's acquisition of anesthesiology practices highlights the controversial issue of cross-market harm in health care provider mergers, and could provide important insights into how a court may view such theories of harm, say Christopher Lau and Dina Older Aguilar at Cornerstone Research.

  • AI Can Help Lawyers Overcome The Programming Barrier

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    Legal professionals without programming expertise can use generative artificial intelligence to harness the power of automation and other technology solutions to streamline their work, without the steep learning curve traditionally associated with coding, says George Zalepa at Greenberg Traurig.

  • Preparing Law Students For A New, AI-Assisted Legal World

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    As artificial intelligence rapidly transforms the legal landscape, law schools must integrate technology and curricula that address AI’s innate challenges — from ethics to data security — to help students stay ahead of the curve, say Daniel Garrie at Law & Forensics, Ryan Abbott at JAMS and Karen Silverman at Cantellus Group.

  • ESG Around The World: South Korea

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    Numerous ESG trends have materialized in South Korea in the past three years, with impacts ranging from greenwashing prevention and carbon neutrality measures to workplace harassment and board diversity initiatives, say Chang Wook Min and Hyun Chan Jung at Jipyong.

  • General Counsel Need Data Literacy To Keep Up With AI

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    With the rise of accessible and powerful generative artificial intelligence solutions, it is imperative for general counsel to understand the use and application of data for myriad important activities, from evaluating the e-discovery process to monitoring compliance analytics and more, says Colin Levy at Malbek.

  • A Look At Healthcare Timelines Set By Biden's AI Order

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    President Joe Biden's artificial intelligence executive order establishes standards for using AI in the healthcare industry, including a number of staggered deadlines that should help coordinate a more unified federal approach to AI governance, say attorneys at Holland & Knight.

  • A Look At Successful Bid Protests In FY 2023

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    Attorneys at Sheppard Mullin look beyond the statistics in the U.S. Government Accountability Office’s recent annual report on bid protests, sharing their insights about nine categories of sustained protests, gained from reading every fiscal year 2023 decision in which the protester had a positive result.

  • Navigating Discovery Of Generative AI Information

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    As generative artificial intelligence tools become increasingly ubiquitous, companies must make sure to preserve generative AI data when there is reasonable expectation of litigation, and to include transcripts in litigation hold notices, as they may be relevant to discovery requests, say Nick Peterson and Corey Hauser at Wiley.

  • FDA's Lab-Developed Test Rule May Bring Historic Challenges

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    If finalized, the U.S. Food and Drug Administration's proposed rule for regulating laboratory-developed tests will provoke some of the most interesting legal challenges that the agency has faced in decades, with outcomes that will likely reverberate across the agency's product centers, says Stacy Amin at MoFo.

  • Finding Focus: Strategies For Attorneys With ADHD

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    Given the prevalence of ADHD among attorneys, it is imperative that the legal community gain a better understanding of how ADHD affects well-being, and that resources and strategies exist for attorneys with this disability to manage their symptoms and achieve success, say Casey Dixon at Dixon Life Coaching and Krista Larson at Stinson.