Policy & Compliance

  • February 18, 2025

    1st Circ. Backs Strict View Of Kickback Law In Blow To FCA

    In an eagerly awaited ruling, the First Circuit on Tuesday said a major avenue for False Claims Act enforcement requires proof that kickbacks directly changed treatment decisions, a holding that creates a lopsided circuit split as well as significant challenges for the U.S. Department of Justice and the plaintiffs bar.

  • February 18, 2025

    Health Net Pays $11.25M To Settle Cybersecurity FCA Claims

    Health Net and its parent Centene Corp. have reached an $11.25 million False Claims Act settlement to resolve allegations that the health plan administrator falsely certified compliance with cybersecurity requirements under a U.S. Department of Defense contract.

  • February 18, 2025

    Michigan's Top Doc Calls Informed Consent Law 'Cruel'

    Michigan's chief medical executive testified that making abortion seekers review parenting information before terminating a pregnancy is manipulative and even harmful during a trial over the viability of several Michigan laws regulating abortion care.

  • February 18, 2025

    Trump's Sweeping Healthcare Cuts Sow Confusion, Concern

    In recent days, the Trump administration has started to fire thousands of federal health employees, kicking off what is expected to be the first of a series of terminations set to shape the future of healthcare in the U.S.

  • February 18, 2025

    Utah Trans Care Law Stirs Legal Doubt On Informed Consent

    Language in a new Utah law that allows minors receiving gender-affirming care to later revoke informed consent and retroactively sue clinicians could undermine treatment for patients and spill over into other forms of healthcare, researchers say. 

  • February 18, 2025

    Trump Issues Order Calling For Expanded IVF Access

    President Donald Trump signed an executive order Tuesday giving his administration 90 days to develop policy recommendations designed to protect access to in vitro fertilization and sharply reduce out-of-pocket costs for IVF treatment.

  • February 18, 2025

    Trump Trans Order Is Unconstitutional 'End-Run,' Judge Says

    A Washington federal judge has further explained her temporary block on President Donald Trump's executive order targeting funding for gender-affirming care for young people, saying the edict threatens a broad swath of congressionally approved research spending and "amounts to an end-run around the separation of powers."

  • February 18, 2025

    Feds Strike $29M Deal To Settle FCA Overpayment Claims

    Healthcare system SVCMC Inc. will pay $29 million to resolve allegations it held onto erroneous overpayments for medical services provided to retired military members and their families, the U.S. Department of Justice has said.

  • February 18, 2025

    340B Rebate Clash Triggers 5 Suits By Drugmakers

    The federal agency overseeing the 340B drug pricing program faces five distinct legal challenges by drugmakers that say the agency illegally blocked their plans to offer rebates rather than upfront discounts to participating hospitals.

  • February 18, 2025

    State AGs Can't Yet Block Musk From Accessing Agency Data

    A Washington, D.C., federal judge on Tuesday denied a motion from 14 state attorneys general for an emergency order to stop Elon Musk and his Department of Government Efficiency from accessing data systems at seven federal agencies or enacting mass firings of those agencies' employees.

  • February 18, 2025

    White House Says City Can't Show Harm From Anti-DEI Orders

    The Trump administration urged a Maryland federal court Tuesday not to block its executive orders curtailing diversity, equity and inclusion programs, saying the city of Baltimore and other challengers hadn't shown any of their funding has been affected by the orders.

  • February 18, 2025

    FCA Claims Surge As Whistleblowers Eye Pandemic Spending

    The historic influx of federal spending on pandemic relief and infrastructure projects helped fuel a record-breaking wave of whistleblower lawsuits launched under the False Claims Act last year, attorneys say, creating a surge in litigation unlikely to recede anytime soon.

  • February 18, 2025

    In Rare Move, Trump Backs Biden War On Medicare Brokers

    Though the Trump administration has changed direction on a range of legal positions taken by the Justice Department under Biden, it appears to be staying the course on Biden's efforts to stop health insurance companies from paying agents to guide seniors to certain Medicare Advantage plans.

  • February 18, 2025

    Georgia Justices Revive Defamation Suit Against Atty

    An orthopedic surgeon in Georgia will get another chance to prove he was defamed by a defense attorney, after the Supreme Court of Georgia found a state appellate court mistakenly used the well-known "actual malice" standard to toss the case instead of the relevant state law standard.

  • February 18, 2025

    Boston Children's Hospital Settles Retirement Plan Fee Suit

    Boston Children's Hospital has settled a suit with a proposed class of participants in its $1.1 billion retirement plan who alleged the hospital allowed excessive fees.

  • February 14, 2025

    FTC's Ferguson, PBMs Agree: Nix Leader Removal Safeguards

    Federal Trade Commission Chairman Andrew N. Ferguson offered his own support for enabling the president to readily fire independent agency commissioners at the FTC and beyond, a day after pharmacy benefit managers cited the new U.S. Department of Justice policy in their own battle with the FTC.

  • February 14, 2025

    Trump Admin To Cut Thousands Of Federal Health Employees

    The Trump administration has started to cut thousands of federal healthcare employees, following through on its promises to shrink government and enact mass changes to agencies that oversee the health of millions of Americans.

  • February 14, 2025

    VA Fires More Than 1,000 As Part Of Trump Cuts

    The U.S. Department of Veterans Affairs said it dismissed more than 1,000 probationary employees Thursday, part of a wave of layoffs sweeping across federal agencies as the Trump administration pursues "large-scale" cuts to the government workforce.

  • February 14, 2025

    Mich. Abortion Provider Rule Not Evidence-Based, Judge Told

    A professor of midwifery testified Friday that abortions can be safely performed by nondoctor clinicians, on the second day of a trial to determine if certain abortion regulations in Michigan have unconstitutionally limited access to the procedure.

  • February 14, 2025

    Drug Costs, State Laws Fuel Push For Fed. Action On PBMs 

    Skyrocketing prescription drug costs and a proliferation of state laws are driving renewed calls from employers and benefit plan administrators for Congress to enact federal legislation changing how pharmacy benefit managers do business, experts say.

  • February 14, 2025

    Judge Upholds Pay-For-Delay Ban Law, But Only In Calif.

    A California federal judge has upheld part of a new state law that the Association for Accessible Medicines alleged unlawfully restricted "reverse payment" settlements between makers of brand-name and generic drugs, finding that the law's attempt to regulate deals outside of California runs afoul of the Constitution, but is otherwise valid.

  • February 14, 2025

    2nd Judge Blocks Trump Trans Health Order, Chides DOJ Atty

    A Washington federal judge put a second temporary block on President Donald Trump's executive order targeting funding for gender-affirming care for people younger than 19, at a Seattle hearing where the judge said she was extremely frustrated with a federal government attorney's inability to answer questions about the order's discriminatory impact on transgender youth.

  • February 13, 2025

    UnitedHealth Can't Escape All Claims In AI Denial Suit

    A Minnesota federal judge Thursday allowed Medicare Advantage patients and the estates of deceased enrollees to pursue breach of contract claims against UnitedHealth over its alleged use of AI to override physician recommendations, finding they are not preempted by the Medicare Act, but tossed others by holding they are preempted.

  • February 13, 2025

    Mich. Abortion Laws Hinder Access, Clinic Director Testifies

    The director of an abortion clinic testified on Thursday that Michigan's waiting period and mandatory counseling requirement for abortion services have forced the clinic to turn away patients and delay their care, kicking off a trial to determine if the policies should be struck down.

  • February 13, 2025

    Old Dominion Worker's Gender-Affirming Care Suit Dropped

    A transgender woman participating in an Old Dominion employee health plan agreed to drop her suit alleging she was wrongly denied gender-affirming care coverage for facial hair removal after a Washington federal judge dismissed the case in January, citing a settlement of the dispute.

Expert Analysis

  • Bracing For Calif.'s New Health Transaction Framework

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    As California's new cost and market impact review regulations' April 1 date for its updated notice and review process approaches, healthcare entities should ready themselves for dramatic changes to the state's regulatory landscape and prepare for potentially substantial transaction delays, say Jordan Grushkin and Matthew Goldman at Sheppard Mullin.

  • Uncharted Waters Ahead For FCA Litigation In 2024

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    Following a year of significant court decisions, settlements, recoveries and proposed amendments, 2024 promises to be a lively year for False Claims Act actions and litigation, and one that will hopefully provide more clarity as FCA jurisprudence evolves, say attorneys at Crowell & Moring.

  • OIG Report Has Clues For 2024 Healthcare Fraud Enforcement

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    A recent report from the Health Department's Office of the Inspector General reveals healthcare fraud and abuse enforcement trends that will continue in 2024, from increased telehealth oversight to enhanced policing of managed care, say attorneys at Sheppard Mullin.

  • FOIA Exemption Questions On Redacted HHS Cannabis Letter

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    The U.S. Department of Health and Human Services' recent recommendation letter concerning the rescheduling of cannabis was heavily redacted, and based on an analysis on the applicability of Freedom of Information Act Exemption 5 to the letter, it's likely that we will see successful legal challenges to those redactions, say attorneys at Troutman Pepper.

  • A Primer On New Calif. Health Transaction Reporting Rules

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    New California regulations regarding the reporting of certain transactions involving healthcare entities, which took effect on Jan. 1, address some industry feedback about overly broad requirements but still leave several areas of concern, says Andrew Demetriou at Husch Blackwell.

  • In The CFPB Playbook: Rulemaking Rush Before Election Year

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    In this quarterly Consumer Financial Protection Bureau activity recap by former bureau personnel, attorneys at McGuireWoods explain the regulator's recent push to finalize new rules about data aggregators, digital payment apps and more before the election-year Congressional Review Act window opens.

  • What The Law Firm Of The Future Will Look Like

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    As the legal landscape shifts, it’s become increasingly clear that the BigLaw business model must adapt in four key ways to remain viable, from fostering workplace flexibility to embracing technology, say Kevin Henderson and Eric Pacifici at SMB Law Group.

  • 4 PR Pointers When Your Case Is In The News

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    Media coverage of new lawsuits exploded last year, demonstrating why defense attorneys should devise a public relations plan that complements their legal strategy, incorporating several objectives to balance ethical obligations and advocacy, say Nathan Burchfiel at Pinkston and Ryan June at Castañeda + Heidelman.

  • Digging Into The Debate On FDA's Proposed Lab Test Rule

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    A proposed 10-word amendment from the U.S. Food and Drug Administration represents a sea change in device regulation as it would summarily end decades of FDA enforcement discretion for laboratory developed tests, and the public comments offer some insight into the future of this long-running saga, say attorneys at Mintz.

  • Law Firm Strategies For Successfully Navigating 2024 Trends

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    Though law firms face the dual challenge of external and internal pressures as they enter 2024, firms willing to pivot will be able to stand out by adapting to stakeholder needs and reimagining their infrastructure, says Shireen Hilal at Maior Consultants.

  • AI In Health Law: The Top Guest Articles Of 2023

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    As the use of artificial intelligence accelerated this year, Expert Analysis writers examined AI's significant impact on the healthcare sector, ranging from key compliance considerations for companies utilizing AI tools to regulators' efforts to keep up with rapidly evolving technologies.

  • 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.