Policy & Compliance

  • July 17, 2024

    U. Miami Climate Leader Sees Chance For Innovation

    With Miami often called the "ground zero" of the climate change crisis, the University of Miami in 2022 launched a Climate Resilience Academy to coordinate an interdisciplinary response. Nearly a year into his tenure, its leader reflects on the opportunity for midsize city innovation in infrastructure in the face of climate challenges.

  • July 17, 2024

    Burr & Forman Accused Of Aiding Health Insurance Fraud

    Burr & Forman LLP has been hit with a malpractice suit in Georgia federal court by the liquidating trustees of two purported health insurance companies after the firm allegedly aided in a scheme to defraud customers by charging exorbitant fees and denying promised coverage, saying the attorneys helped create a web of LLCs to which it siphoned off millions.

  • July 16, 2024

    No Let-Up On DOJ Medicare Advantage Fraud Probes

    Federal scrutiny of Medicare Advantage fraud is showing no signs of abating.

  • July 16, 2024

    Sanford-Marshfield Tie-Up Portends More Cross-Market Deals

    A merger between two Midwest health systems is evidence of hospitals' desire to strike deals with players in other markets, according to experts in the space, who say the trend may be influenced by a tough antitrust environment and larger industry shift to value-based care.

  • July 16, 2024

    FDA Vet Joins Arnold & Porter As Counsel On Healthcare

    After nearly a decade in high-level roles at the U.S. Food and Drug Administration, regulatory pro Andrew Zacher has joined the life sciences and healthcare team at Arnold & Porter.

  • July 16, 2024

    3rd Circ. Backs Tossing Over 1K Suits In Merck Vaccine MDL

    The Third Circuit on Tuesday affirmed the dismissal with prejudice of 1,189 cases in multidistrict litigation alleging Merck & Co. Inc.'s shingles vaccine, Zostavax, caused the disease, saying the district court did not abuse its discretion by requiring medical tests to support the claims.

  • July 16, 2024

    Union Fund Trustees Say Elevance Usurped Fiduciary Power

    The trustees of two union health plans said Elevance Health Inc. and its subsidiaries violated federal benefits law when they overpaid themselves for administrative services and medical providers for patient care, arguing the insurer had significant control over the management of the plans and their assets.

  • July 16, 2024

    Ga. Denied Extension For Medicaid Work Requirement Plan

    Georgia won't get extra time to administer a work requirement Medicaid expansion program in order to make up for federal regulators' illegal delaying of its rollout after a federal judge ruled Monday that the state didn't go through the proper channels in trying to extend the program's timeline.

  • July 16, 2024

    In Chevron's Fall, Attys See Conflicting Rulings, Circuit Splits

    The end of Chevron deference, along with other U.S. Supreme Court decisions weakening the authority of federal agencies, may make the drug regulatory landscape more volatile — not less — as courts wrestle with new limits on federal power.

  • July 16, 2024

    The Risks And Promise Of Medical Debt Reporting Rule

    A proposed federal rule would prevent medical debt from appearing on credit reports of tens of millions of Americans. Legal and debt experts are conflicted over whether it could backfire on some healthcare consumers and potentially kneecap healthcare providers who still need to collect unpaid bills.

  • July 16, 2024

    Vertex Pharma Widens War On Watchdog's Kickback Views

    A lawsuit from gene therapy-drug maker Vertex Pharmaceuticals over fertility treatment access is a new battle over enforcement kickback theories and health officials' interpretation of "inducement."

  • July 16, 2024

    The 2024 Diversity Snapshot: What You Need To Know

    Law firms' ongoing initiatives to address diversity challenges have driven another year of progress, with the representation of minority attorneys continuing to improve across the board, albeit at a slower pace than in previous years. Here's our data dive into minority representation at law firms in 2023.

  • July 16, 2024

    These Firms Have The Most Diverse Equity Partnerships

    Law360’s law firm survey shows that firms' efforts to diversify their equity partner ranks are lagging. But some have embraced a broader talent pool at the equity partner level. Here are the ones that stood out.

  • July 16, 2024

    Health System Strikes Deal To End EEOC Race Bias Suit

    A Michigan healthcare system has agreed to pay a Black home health aid $30,000 to resolve a U.S. Equal Employment Opportunity Commission suit alleging she was immediately fired in contradiction with system policy after a white worker accused her of starting a verbal conflict.

  • July 16, 2024

    North Carolina High Court Has Eyes On Certificate Of Need

    A recent North Carolina Supreme Court decision in a property-owner discrimination suit may have opened the door to new legal challenges to the state's decades-old medical control spending law.

  • July 15, 2024

    Ex-Pfizer Worker Seeks No Time For Paxlovid Insider Trading

    A former Pfizer employee argued that he shouldn't go to prison after a Manhattan federal jury convicted him of insider trading over clinical trial results for the drug Paxlovid, pointing out that a friend of his and co-defendant had dodged a custodial sentence in the case after helping prosecutors.

  • July 15, 2024

    Cigna, Chuck Close Estate Settle Reneged Benefits Suit

    The estate of renowned artist Chuck Close told a New York federal judge that Cigna has agreed to settle a suit claiming the company wouldn't pay for more than $686,000 in at-home skilled nursing care that it claimed was owed to him under his Pace Gallery employee benefit plan.

  • July 15, 2024

    Split 2nd Circ. Nixes Surgeon's Default In Sex Assault Case

    A split panel of the Second Circuit said a Connecticut surgeon should have been fully freed from the default judgment against him in a sex assault suit after a jury concluded his accuser failed to prove the assault happened, with one judge dissenting Monday that parts of the default ruling should remain.

  • July 15, 2024

    Theranos Ex-Exec's Lead Atty Joins Boutique Firm In LA

    A former BigLaw attorney who was lead defense counsel for Theranos' former president Ramesh Balwani has joined Los Angeles boutique Foundation Law Group LLP to lead its white collar practice, the firm announced Monday.

  • July 15, 2024

    Machinery Co. Defends 'Right' To Ax Trans Care In Health Plan

    A turbomachinery company asked to intervene on a transgender worker's New Hampshire federal court claim that its health plan administrators violated Affordable Care Act anti-bias provisions by enforcing a gender dysphoria treatment ban in the company's health plan, arguing that the issue is intertwined with its mission.

  • July 15, 2024

    Wage Cases To Follow As Justices Rein In Agencies

    A trio of U.S. Supreme Court rulings this term that dulled administrative agencies' power are likely to make an impact on how the U.S. Department of Labor enforces wage and hour law. Here, Law360 reviews six cases where their application is already becoming a point of contention.

  • July 15, 2024

    11th Circ. Upholds UMiami's Win In Retaliation Suit

    The Eleventh Circuit affirmed a Miami federal jury's verdict rejecting claims that the University of Miami fired a compliance officer for his refusal to close an investigation into the college's alleged Medicare overcharging, ruling that the officer had "invited" the jury instruction on which he based his appeal.

  • July 12, 2024

    Law360 Names 2024's Top Attorneys Under 40

    Law360 is pleased to announce the Rising Stars of 2024, our list of 158 attorneys under 40 whose legal accomplishments belie their age.

  • July 12, 2024

    Whistleblower's Attys Get $5.9M After Losing $11.5M Fee Ask

    A Massachusetts federal judge awarded a whistleblower's counsel $5.9 million in fees plus $651,845 in costs and expenses after slashing their prior "exorbitant" $11.5 million fee request in May in a decade-old False Claims Act lawsuit alleging Fresenius Medical Care billed Medicare for unnecessary hepatitis tests.

  • July 12, 2024

    Military's IVF Policy Defense Fails Post-Chevron, Group Says

    A nonprofit that's challenging the U.S. military's in vitro fertilization coverage policy for service members told a New York federal judge that federal agencies cannot claim they're entitled to Chevron deference in the wake of the U.S. Supreme Court's recent decision overturning the decades-old precedent.

Expert Analysis

  • Calif. Banking Brief: All The Notable Legal Updates In Q2

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    The second quarter of 2024 in California, which saw efforts to expand consumer protection legislation and enforcement actions in areas of federal focus like medical debt and student loans, demonstrated that the state's role as a trendsetter in consumer financial protection will continue for the foreseeable future, say attorneys at Sheppard Mullin.

  • How Cannabis Rescheduling May Affect Current Operators

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    The U.S. Drug Enforcement Agency's proposal to reschedule marijuana to Schedule III provides relief in the form of federal policy from the stigma and burdens of Schedule I, but commercial cannabis operations will remain unchanged until the federal-state cannabis policy gap is remedied by Congress, say Meital Manzuri and Alexis Lazzeri at Manzuri Law.

  • Air Ambulance Ruling Severely Undermines No Surprises Act

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    A Texas federal court's recent decision in Guardian Flight v. Health Care Service — that the No Surprises Act lacks a judicial remedy when a health insurer refuses to pay the amount established through an independent review — likely throws a huge monkey wrench into the elaborate protections the NSA was enacted to provide, says Mark DeBofsky at DeBofsky Law.

  • Class Actions At The Circuit Courts: June Lessons

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    In this month's review of class action appeals, Mitchell Engel at Shook Hardy considers two recent decisions from the Third and Tenth Circuits, and identifies practice tips around class action settlements and standing in securities litigation.

  • How Congress Is Tackling The US Healthcare Shortage

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    With healthcare shortages continuing across the U.S. despite industry efforts to improve patient access to care, increased Medicare support for graduate medical education could be a crucial component of the solution, say Sarah Crossan and Miranda Franco at Holland & Knight.

  • The Current State Of Healthcare Transaction Reviews In Calif.

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    As of April, certain healthcare transactions in California have been subject to additional notification compliance requirements, and complying with these new rules could significantly delay and discourage some deals, says Andrew Demetriou at Husch Blackwell.

  • High Court's Abortion Pill Ruling Shuts Out Future Challenges

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    The U.S. Supreme Court's unanimous ruling in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine maintains the status quo for mifepristone access and rejects the plaintiffs' standing theories so thoroughly that future challenges from states or other plaintiffs are unlikely to be viable, say Jaime Santos and Annaka Nava at Goodwin.

  • Orange Book Warnings Highlight FTC's Drug Price Focus

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    In light of heightened regulatory scrutiny surrounding drug pricing and the Federal Trade Commission's activity in the recent Teva v. Amneal case, branded drug manufacturers should expect the FTC's campaign against allegedly improper Orange Book listings to continue, say attorneys at Ropes & Gray.

  • A Plaintiffs-Side Approach To Cochlear Implant Cases

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    As the number of cochlear implants in the U.S. continues to grow, some will inevitably fail — especially considering that many recalled implants remain in use — plaintiffs attorneys should proactively prepare for litigation over defective implants, says David Shoop at Shoop.

  • Inside Antitrust Agencies' Rollup And Serial Acquisition Moves

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    The recent request for public comments on serial acquisitions and rollup strategies from the Federal Trade Commission and U.S. Justice Department mark the antitrust agencies' continued focus on actions that fall below premerger reporting thresholds, say attorneys at Paul Weiss.

  • Short-Term Takeaways From CMS' New Long-Term Care Rules

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    The Centers for Medicare & Medicaid Services' new final rule on nursing home staffing minimums imposes controversial regulatory challenges that will likely face significant litigation, but for now, stakeholders will need to prepare for increased staffing expectations and more specialized facility assessments without meaningful funding, say attorneys at Morgan Lewis.

  • FDA's Data Monitoring Guidance Reveals Future Expectations

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    As the world of clinical research grows increasingly complex, the U.S. Food and Drug Administration's recent draft guidance on the use of data monitoring committees in clinical trials reveals how the agency expects such committees to develop, say Melissa Markey and Carolina Wirth at Hall Render.

  • FDA Warning Indicates Scrutiny Of Regenerative Health Cos.

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    The U.S. Food and Drug Administration's recent warning letter to Akan Biosciences is a quintessential example of the agency's enforcement priorities for certain products involving human cells and tissues, and highlights ongoing scrutiny placed on manufacturers, say Dominick DiSabatino and Cortney Inman at Sheppard Mullin.