Policy & Compliance

  • May 16, 2025

    Feds Want Ex-McKinsey Exec To Serve Time For Obstruction

    Prosecutors urged a Virginia federal judge Thursday to sentence a disbarred, former senior McKinsey & Co. partner to one year in prison for obstructing an investigation into the consulting giant's work with opioid-manufacturer Purdue Pharma, while defense counsel pushed for probation so that he can return to his home in Thailand.

  • May 16, 2025

    23 States Win Order Halting Billions In HHS Public Health Cuts

    A Rhode Island federal judge on Friday barred the Trump administration from cutting off billions of dollars in funding to state public health programs, determining the abrupt grant terminations likely violated congressional authority over spending.

  • May 16, 2025

    Trucking Co. Worker Says Tobacco Surcharge Violates ERISA

    An employee of Marten Transport Ltd. is suing the trucking company in Wisconsin federal court, alleging that a tobacco surcharge in its health plan violates federal antidiscrimination law.

  • May 16, 2025

    Surgical Center Operator Inks $15M Deal Over Data Breach

    Shields Health Group Inc., which runs dozens of MRI and surgical centers around New England, has agreed to pay around $15 million to resolve claims in a proposed class action stemming from a data breach that compromised the personal information of over 2 million people.

  • May 16, 2025

    Trump Admin Settles Vaccine Contract Info Suit For $10K

    The Trump administration has reached a $10,000 settlement with a consumer advocacy group over allegedly withholding information about the government's billion-dollar contracts with companies that developed and manufactured the COVID-19 vaccine, including Pfizer and Moderna.

  • May 15, 2025

    Ex-CEO Cops To Conspiracy Charge In $212M Fraud Case

    A New Jersey-based former CEO of a medical billing company has pled guilty to conspiring to commit securities fraud in connection with government claims he was part of a $212.5 million scheme to inflate the value of his company to defraud potential investors in a go-private transaction.

  • May 15, 2025

    Feds Freeze Parity Enforcement As Agencies Rethink Regs

    Federal agencies said Thursday they will hold off on enforcing a rule requiring employer group health plans to analyze how they restrict coverage for mental health and substance use disorder treatments, citing ongoing litigation aimed at blocking the policy and broader plans to reevaluate enforcement priorities.

  • May 14, 2025

    Mont. Court Blocks 'Ideological' Transgender Youth Care Ban

    A Montana judge on Tuesday struck down a state statute that banned gender-affirming care for minors, holding that the state's interest is "ideological rather than medical" and violates the constitutional rights of transgender youth seeking gender-affirming care and of healthcare professionals who provide it.

  • May 14, 2025

    9th Circ. Doubts Wash. Anti-Vaxxers' Stance In Med Board Suit

    A Ninth Circuit judge expressed skepticism on Wednesday that the federal appellate court could revive Robert F. Kennedy Jr.'s suit against the Washington Medical Commission for initiating disciplinary proceedings against physicians who publicly aired anti-vaccination views, pointing out that federal courts generally "don't interfere" with ongoing state litigation.

  • May 14, 2025

    Sage Therapeutics Brass Sued Over Drug Candidate Claims

    The top brass of Sage Therapeutics Inc. have been hit with a shareholder derivative suit in New York federal court alleging they misled investors about the safety, efficacy, durability and commercial prospects of three of the company's drug candidates and overstated their likelihood to be approved by the U.S. Food and Drug Administration.

  • May 14, 2025

    Houston Midwife Says AG Has No Evidence To Close Clinics

    A Houston-area midwife who was arrested earlier this year on a charge of providing an illegal abortion is arguing to a state appellate court that Texas Attorney General Ken Paxton "came nowhere close to meeting the state's burden" in his bid to shut down her clinics.

  • May 14, 2025

    RFK Jr. Defends HHS Cuts, Pledges To 'Spend Smarter'

    In his first appearance on Capitol Hill since his confirmation, U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. on Wednesday characterized a massive reorganization and reductions in workforce as practical moves to optimize the sprawling agency.

  • May 13, 2025

    Healthcare Hires: Ex-DOJ, Fresenius Attys On The Move

    An ex-federal prosecutor who led healthcare fraud investigations in Texas has joined Hicks Thomas LLP, and an attorney with in-house experience at Fresenius Medical Care and GE Healthcare joined King & Spalding LLP in its government investigations practice. Here, Law360 Healthcare Authority looks at the week's most notable lateral hires in the healthcare industry.

  • May 13, 2025

    Health Co. Elevance Faces Suit Over Post-COVID Costs Claims

    Health insurance provider Elevance Health Inc. and some of its executives face a proposed investor class action alleging the company hurt shareholders by mismanaging expectations about its Medicaid business's costs amid the post-pandemic eligibility redetermination process in certain markets it served.

  • May 13, 2025

    A Trump Do-Over On 'Most Favored Nation' Drug Prices

    President Donald Trump's move this week to "equalize" U.S. drug prices with lower overseas prices hearkens back to a similar effort made in his first term that faced a swarm of legal challenges before being shelved.

  • May 13, 2025

    Planned Parenthood Wants Teen Program Fund Rule Blocked

    Planned Parenthood on Monday urged a D.C. federal judge to vacate the U.S. government's "unlawful" requirements to "align" with President Donald Trump's executive orders lest risk losing Teen Pregnancy Prevention Program funding, arguing its facilities will suffer staff cuts and loss of medically accurate, age-appropriate education services absent an injunction.

  • May 13, 2025

    FDA Move On Industry Influence Only 'Cosmetic,' Experts Say

    A Trump administration move to boot pharmaceutical employees off U.S. Food and Drug Administration advisory panels won’t do much to address conflicts of interest or change how regulators interact with the industry, experts say. But that doesn't mean other measures shouldn't be considered.

  • May 13, 2025

    NIH Letters Ending Grants Lack Factual Support, Judge Says

    A Massachusetts federal judge said Tuesday that a "blast" of hundreds of virtually identical letters in March canceling National Institutes of Health-funded research projects appeared to offer no factual basis, only unsupported assertions that the projects were unscientific or discriminatory.

  • May 13, 2025

    Michigan Judge Strikes Down State's Abortion Restrictions

    A Michigan judge struck down several of the state's abortion restrictions Tuesday, including a mandatory waiting period, required counseling materials and a rule that only doctors may perform abortions, finding the laws make it harder for people to access abortion and don't protect patients' health. 

  • May 13, 2025

    PBMs Get Bipartisan Bashing At Hearing On Drug Costs

    Senators across party lines slammed pharmacy benefit managers on Tuesday, sometimes in coarse language, as they wrestled with how to reduce drug prices for patients while also preventing the closure of rural pharmacies.

  • May 13, 2025

    DOJ Puts New Target On Medicare Advantage 'Steering'

    U.S. Department of Justice officials' decision to back whistleblower claims that major health insurance companies paid millions in illegal kickbacks to brokers marks a dramatic escalation of an effort to crack down on Medicare Advantage "steering."

  • May 13, 2025

    Feldesman Grants Atty On 'Chaos' Of HHS Funding Cuts

    Massive cuts in federal funding for healthcare programs are testing the avenues of recourse for safety-net hospitals and others that depend on grants to keep their doors open.

  • May 13, 2025

    Ind. Tells Nonprofit Hospitals To Curb Prices, Or Else

    A new Indiana law gives charitable hospitals a stark choice: Lower prices or face the loss of their nonprofit status.

  • May 13, 2025

    Attys Push 11th Circ. To Weigh Judge Shopping Sanctions

    The Eleventh Circuit can hear three attorneys' appeal of sanctions against them for judge shopping during their legal challenge to an Alabama law criminalizing gender-affirming care, because the underlying case was dismissed, making the jurisdictional question moot, two of those lawyers told the appellate court.

  • May 13, 2025

    Associate GC Of University Hospital In NJ Joins Frier Levitt

    New Jersey-based national healthcare boutique Frier Levitt has hired a former in-house counsel at University Hospital in Newark this week as a partner in the firm's healthcare practice group.

Expert Analysis

  • What Trump's Next Term May Mean For Biz Immigration

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    Leonard D'Arrigo at Harris Beach discusses the employment-based immigration policies businesses can potentially expect during President-elect Donald Trump’s second term, based on policies enacted during his first administration, statements made during his campaign and proposals in Project 2025.

  • Weak Reasoning Underlies Fla. Judge's Bold Qui Tam Ruling

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    U.S. District Judge Kathryn Mizelle's groundbreaking decision in U.S. ex rel. Zafirov v. Florida Medical Associates LLC, holding that qui tam provisions of the False Claims Act are unconstitutional, relies on weak logic to reach a conclusion that differs from every other court that has ruled on the issue, says Ethan Greenberg at Anderson Kill.

  • Medicare Overpayment Rules Are A Mixed Bag For Providers

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    The Centers for Medicare & Medicaid Services' updated rules for handling agency overpayments adopt a more reasonable definition of what it means to have "identified" an overpayment, which is a win for providers, but their new time frame for investigating related overpayments is unrealistic, says Susan Banks at Holland & Knight.

  • Expect More State-Level Scrutiny Of Noncompetes Ahead

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    Despite the nationwide injunction against the Federal Trade Commission’s noncompete ban, and the incoming Republican administration, employers should anticipate that state legislatures will continue to focus on laws that limit or ban noncompetes, including those that target certain salary thresholds or industries, says Benjamin Fryer at FordHarrison.

  • Cos. Should Inventory Issues To Prep For New Congress

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    As the legislative and oversight agendas of the 119th Congress come into sharper focus, corporate counsel should assess and plan for areas of potential oversight risk — from tax policy changes to supply chain integrity — even as much uncertainty remains, say attorneys at WilmerHale.

  • Incoming Admin May Shake Up Life Sciences Regulation

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    Though President-elect Donald Trump has not yet articulated policy priorities regarding the life sciences industry, the sector is positioned to see significant changes that could affect everything from drug exclusivity and generic drug approvals, to the availability of over-the-counter drugs, to laboratory-developed tests and digital health, say attorneys at Morgan Lewis.

  • Navigating DOJ's Patchwork Whistleblower Regime

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    In the past few months, the U.S. Department of Justice and several individual U.S. attorney’s offices have issued different pilot programs aimed at incentivizing individuals to blow the whistle on misconduct, but this piecemeal approach may create confusion and suboptimal outcomes, say attorneys at BakerHostetler.

  • What To Expect Next From Federal Health Tech Regulation

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    Healthcare organizations should pay close attention to federal health information technology regulators' recent guidance concerning barriers to accessing electronic health information, which signals that more enforcement in this area is likely forthcoming, say attorneys at Ropes & Gray.

  • 5 Areas Congress May Investigate After GOP Election Wins

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    With Republicans poised to take control of Congress in addition to the executive branch next year, private companies can expect an unprecedented uptick in congressional investigations focused on five key areas, including cryptocurrency and healthcare, say attorneys at Cahill Gordon.

  • Takeaways From State Votes On Abortion In The 2024 Election

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    Attorneys at Epstein Becker discuss how 10 states voted on ballot initiatives to either protect or restrict access to abortion in the 2024 general election, and analyze overarching trends.

  • Loper Bright Offers New Materiality Defense To FCA Liability

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    The U.S. Supreme Court's decision in Loper Bight Enterprises v. Raimondo, ending Chevron deference, may have created a new defense to False Claims Act liability by providing the opportunity to argue that a given regulation is not material to the government's payment decision, says Tanner Cook at Husch Blackwell.

  • How Expanded Birth Control Coverage May Affect Employers

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    Employers should consider the potential impact of recently proposed regulations that would expand group health plans' required coverage of preventive services and contraceptives, including questions about how the agencies would implement their plans to eliminate the prescription requirement and alter the exceptions process, says Jennifer Rigterink at Proskauer.

  • Legislation Most Likely To Pass In Lame Duck Session

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    As Congress begins its five-week post-election lame duck session, attorneys at Greenberg Traurig break down the legislative priorities and which proposals can be expected to pass.