Policy & Compliance

  • February 19, 2025

    Local 11 Must Pay Health Fund's Atty Fees In Sanctions Fight

    An Illinois federal judge on Tuesday granted attorneys' fees in connection with work to file a sanctions motion against a union local in a federal benefits lawsuit against their multiemployer union health fund but reduced the total grant to about half of what was requested.

  • February 19, 2025

    Feds Urge Justices To Undo 5th Circ. Preventive Care Ruling

    The U.S. Department of Health and Human Services and other federal agencies urged the U.S. Supreme Court to reverse a Fifth Circuit decision that members of a task force setting preventive services coverage requirements under the Affordable Care Act were unconstitutionally appointed, arguing the HHS secretary retained sufficient oversight.

  • 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.

Expert Analysis

  • HHS' Updated Tracking Tech Guidance Offers Little Clarity

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    The U.S. Department of Health and Human Services' Office for Civil Rights' updated guidance on the use of online tracking technologies appears more focused on legal issues raised in ongoing litigation with the American Hospital Association and less on practical guidance for covered entities, say attorneys at Sheppard Mullin.

  • Takeaways From The 2023 DOJ Fraud Section Report

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    Attorneys at Wiley discuss notable trends from the U.S. Department of Justice's recently reported Fraud Section activity last year and highlight areas of enforcement to watch for in the future, including healthcare fraud and Foreign Corrupt Practices Act violations.

  • NIST March-In Framework Is As Problematic As 2021 Proposal

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    While the National Institute of Standards and Technology's proposed march-in framework on when the government can seize patents has been regarded as a radical departure that will support lowering prescription drug costs, the language at the heart of it is identical to a failed 2021 notice of proposed rulemaking, says attorney Kelly Morron.

  • Spartan Arbitration Tactics Against Well-Funded Opponents

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    Like the ancient Spartans who held off a numerically superior Persian army at the Battle of Thermopylae, trial attorneys and clients faced with arbitration against an opponent with a bigger war chest can take a strategic approach to create a pass to victory, say Kostas Katsiris and Benjamin Argyle at Venable.

  • The Road Ahead For Florida's Drug Importation Program

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    Though the U.S. Food and Drug Administration approved Florida's drug importation program in January, a series of hurdles — including requisite buy-in from Canada — and potential legal challenges must be addressed before importation can begin, say attorneys at Ropes & Gray.

  • Assessing CDC's Revised Guideline On Opioid Prescriptions

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    Kenneth Weinstein, Nicholas Van Niel and Kate Uthe at Analysis Group look at newly available data to evaluate the impact that the Centers for Disease Control and Prevention's revised opioid monitoring guideline have had on prescription trends in recent years, highlighting both specific and overall decreases.

  • Valeant Ruling May Pave Way For Patent-Based FCA Suits

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    The Ninth Circuit’s recent ruling in Silbersher v. Valeant marks a significant development in False Claims Act jurisprudence, opens new avenues for litigation and potentially raises the stakes for patent applicants who intend to do business with the government, say Joshua Robbins and Rick Taché at Buchalter.

  • Suits Against Insulin Pricing Are Driven By Rebate Addiction

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    A growing wave of lawsuits filed by states, cities and counties against insulin manufacturers and pharmacy benefit managers improperly allocate the blame for rising insulin costs, when in actuality the plaintiffs are partially responsible, says Dan Leonard at Granite Capitol Consulting.

  • When Physician Retirement Arrangements May Be Legal

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    A recent advisory opinion from the Office of Inspector General regarding physician retirement arrangements sheds light on key considerations and mitigating factors that may be useful when attempting to balance healthcare operational needs with statutory conformity, says Magda Rodriguez at Day Pitney.

  • ESG Around The World: Gulf Cooperation Council

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    The Gulf Cooperation Council is in the early stages of ESG policy implementation, but recent commitments by both states and corporations — including increases in sustainable finance transactions, environmental commitments, female representation on boards and human rights enforcement — show continuing progress toward broader ESG goals, say attorneys at Cleary.

  • Navigating ACA Reporting Nuances As Deadlines Loom

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    Stephanie Lowe at Liebert Cassidy walks employers through need-to-know elements of Affordable Care Act reporting, including two quickly approaching deadlines, the updated affordability threshold, strategies for choosing an affordability safe harbor, and common coding pitfalls.

  • Lessons From Rare Post-Verdict Healthcare Fraud Acquittal

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    A Maryland federal court recently overturned a jury verdict that found a doctor guilty of healthcare fraud related to billing levels for COVID-19 tests, providing defense attorneys with potential strategies for obtaining acquittals in similar prosecutions, says attorney Andrew Feldman.

  • ChristianaCare Settlement Reveals FCA Pitfalls For Hospitals

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    ChristianaCare's False Claims Act settlement in December is the first one based on a hospital allegedly providing private physicians with free services in the form of hospital-employed clinicians and provides important compliance lessons as the government ramps up scrutiny of compensation arrangements, say attorneys at Sheppard Mullin.