Policy & Compliance

  • April 11, 2024

    Full 8th Circ. Hears Ark. Bid To Revive Youth Trans Care Ban

    An en banc panel of the Eighth Circuit weighing whether to revive an Arkansas state law that banned gender-affirming care for children and teens heard oral arguments Thursday, as Arkansas officials sought to demonstrate that the law does not unconstitutionally discriminate based on sex.

  • April 11, 2024

    Medtronic Can't Ditch Ex-Sales Rep's Retaliation Claim

    Medical device maker Medtronic can't avoid a whistleblower retaliation claim by a former sales rep who says he was pushed out after reporting what he suspected to be a kickback scheme to the U.S. Food and Drug Administration, a federal judge said Wednesday.

  • April 10, 2024

    Pfizer Unit Cuts $39M Deal Ending Effexor Antitrust Claims

    A proposed class of direct buyers asked a New Jersey federal judge on Tuesday to approve a $39 million settlement to end allegations that Pfizer Inc. unit Wyeth engaged in a scheme with Teva Pharmaceuticals to delay generic competition for the antidepressant drug Effexor XR.

  • April 10, 2024

    Wash. Healthcare Workers Owed $100M In Wages, Jury Told

    Counsel for two classes encompassing more than 30,000 current and former healthcare workers told a Washington state jury on Wednesday that Providence Health & Services should pay nearly $100 million in damages for using an illegal time clock rounding method that shortchanged employees and failing to provide required meal breaks.

  • April 10, 2024

    DOJ Hits Regeneron With False Claims Act Suit Over Eylea

    The federal government has brought a False Claims Act intervenor complaint in Massachusetts against Regeneron, alleging the pharmaceutical giant fraudulently withheld information from its Medicare reports seeking reimbursement for its drug Eylea, the U.S. Department of Justice announced Wednesday. 

  • April 10, 2024

    4th Circ. Sides With CMS' Definition Of 'Line-Extension Drug'

    The Fourth Circuit on Wednesday affirmed a summary judgment ruling in favor of the Centers for Medicare & Medicaid Services in a rule challenge by Vanda Pharmaceuticals, which took issue with the agency's criteria for what constitutes a line-extension drug.

  • April 10, 2024

    Pharmacy Gets Eli Lilly's Mounjaro Suit Tossed

    A Florida federal judge has thrown out Eli Lilly & Co.'s suit accusing an online pharmacy of wrongly selling a compounded version of its drug Mounjaro, saying Eli Lilly was "using state law to enforce the terms of" federal law.

  • April 10, 2024

    Justices Asked To Ban FCA Suits Relying On Patent Reviews

    Valeant Pharmaceuticals is going to the U.S. Supreme Court to argue that information cited in Patent Trial and Appeal Board reviews cannot later be used by whistleblowers in False Claims Act lawsuits.

  • April 09, 2024

    Sanofi Sees End To 4,000 Suits Over Zantac

    The consequences of the demise of Roe rippled through state courts, big employers say they didn't get the generic-drug bargain they signed up for, and pharmaceutical giant Sanofi moved closer to resolving thousands of claims centering on the heartburn drug Zantac. Here, Law360 looks at the major healthcare litigation from the past week.

  • April 09, 2024

    Philips, Feds Enter Consent Decree Over Sleep Apnea Devices

    Philips Respironics can't make sleep apnea breathing machines until it hires an independent monitor, undergoes inspections and meets its obligations under a plan to remediate patients affected by a 2021 recall of such devices, the U.S. Department of Justice and U.S. Food and Drug Administration announced Tuesday.

  • April 09, 2024

    3 Years In, 'No Surprises' Gets Mixed Reviews From Providers

    It's been more than three years since President Joe Biden signed federal "surprise" medical billing legislation. But after a rocky roll-out and several successful legal challenges, some are giving the No Surprises Act mixed reviews, including its particularly contentious independent dispute resolution process.

  • April 09, 2024

    Calif. Healthcare Attys Working Late Thanks To New Regs

    Attorneys working on healthcare deals in California are logging longer hours and getting less sleep as they grapple with new regulations that came into effect this month.

  • April 09, 2024

    Doctors 'On Notice': Liability And The Ariz. Abortion Decision

    The Arizona Supreme Court on Tuesday dropped a dense statutory examination concluding that an abortion ban passed before Arizona became a state had not been supplanted by a modern statute allowing abortions until 15 weeks of pregnancy. Law360 looks at how the court addressed doctor liability.

  • April 09, 2024

    Court Axes Subpoena Of Ex-Wife In 1st Abortion Death Suit

    The woman at the center of the nation's first abortion wrongful death suit since the landmark Dobbs decision need not produce info about how she allegedly obtained abortion-inducing drugs from two women, a Texas appeals court ruled Tuesday, saying doing so would violate the woman's Fifth Amendment right against self-incrimination.

  • April 09, 2024

    6th Circ. Ruling May Alter State Certificate Of Need Laws

    A Sixth Circuit finding that part of Kentucky's certificate of need law is unconstitutional shows that circuit courts are still figuring out how medical spending control statutes fit with modern U.S. Supreme Court case law.

  • April 09, 2024

    Idaho Abortion Ban Tees Up Battle On 'Trafficking' Restrictions

    As Idaho officials prepare to defend a near-total abortion ban at the U.S. Supreme Court this month, a state abortion "trafficking" statute is also heading for a federal court challenge that forecasts future constitutional battles over attempts to criminalize out-of-state travel.

  • April 09, 2024

    Tighter Limits On 'Junk' Insurance May Spur New Legal Fights

    The Biden administration's new rule limiting short-term insurance plans isn't likely to end debates over how strictly to regulate health coverage that falls outside Affordable Care Act protections.

  • April 09, 2024

    White House, Senate Dems Want $1.3B To Fight COVID Fraud

    The White House has been working with Senate Democrats on a $1.3 billion plan to expand the federal government's toolkit for going after pandemic fraudsters who took advantage of the influx of aid made available to different facets of the public during the COVID-19 pandemic.

  • April 09, 2024

    Life Sciences GCs On Tighter Regs, Outside Counsel Advice

    General counsel at life sciences venture capital firms are navigating increased regulation in healthcare and looking to outside counsel to act as true advisers and problem-solvers as the healthcare industry becomes more complex.

  • April 09, 2024

    Health Equity Advocates Notch Win with Dental Coverage Rule

    A new rule from the Department of Health and Human Services aimed at getting more adult dental care covered as an "essential" Affordable Care Act benefit promises to help close a critical healthcare equity gap.

  • April 09, 2024

    Ariz. High Court Restores Civil War-Era Abortion Ban

    The Arizona Supreme Court on Tuesday revived the state's nearly 160-year-old abortion ban, concluding that a far more recent law that had allowed abortion through 15 weeks of pregnancy did not replace the older prohibition.

  • April 09, 2024

    Crowell & Moring Hires Senior Health Atty From Capitol Hill

    Crowell & Moring LLP has hired a health care attorney from the U.S. House of Representatives who most recently served as a senior counsel in that body's Committee on Energy & Commerce, the firm announced Tuesday.

  • April 08, 2024

    Walmart Beats Investor Suit Over Opioid Probe Disclosures

    Walmart beat back an investor class action on Monday alleging it failed to properly disclose that it was the subject of parallel criminal and civil investigations over its opioid sales, with a Delaware federal judge ruling that the suit's challenged statements were not false or misleading.

  • April 08, 2024

    Feds Say Philly Clinics Billed For 'Impossible' No. Of Visits

    The head psychiatrist at a group of Philadelphia mental health clinics allegedly billed Medicaid for enough "med check" patient visits that he would have exceeded the hours in a day if he had taken the state-mandated minimum of 15 minutes per patient, according to a federal False Claims Act suit filed Monday.

  • April 08, 2024

    High Court Creating DEI Headwinds, Colo. AG Says

    Colorado Attorney General Phil Weiser said Monday that the state's major losses last year in cases involving gay rights and prosecuting threatening speech were part of what he views as a trend at the U.S. Supreme Court of hampering efforts to increase diversity, equity and inclusion.

Expert Analysis

  • Preparing For The Future Of Virtual Direct Supervision

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    The Centers for Medicare & Medicaid Services are expected to make an announcement soon about the future of virtual direct supervision, which has the potential to either add permanent flexibility to Medicare payment policy or cause some satellite centers to become unviable virtually overnight, say attorneys at Bass Berry.

  • Ghosting In BigLaw: How To Come Back From Lack Of Feedback

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    Junior associates can feel powerless when senior colleagues cut off contact instead of providing useful feedback, but young attorneys can get back on track by focusing on practical professional development and reexamining their career priorities, says Rachel Patterson at Orrick.

  • How Spending Clause Ruling May Affect Medicaid Litigation

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    The U.S. Supreme Court's decision in Health and Hospital Corp. v. Talevski preserves an important avenue for health providers and beneficiaries to use the Civil Rights Act to sue state Medicaid agencies in a landscape that has steadily narrowed potential paths for challenging state violations of spending clause legislation, say attorneys at Hooper Lundy.

  • Steps To Success For Senior Associates

    Excerpt from Practical Guidance
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    Adriana Paris at Rissman Barrett discusses the increased responsibilities and opportunities that becoming a senior associate brings and what attorneys in this role should prioritize to flourish in this stressful but rewarding next level in their careers.

  • Legal Profession Must Do More For Lawyers With Disabilities

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    At the start of Disability Pride month, Rosalyn Richter at Arnold & Porter looks at why lawyers with disabilities are significantly underrepresented in private practice, asserting that law firms and other employers must do more to conquer the implicit bias that deters attorneys from seeking accommodations.

  • Scope Of FTC's Health Info Enforcement May Expand

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    The Federal Trade Commission's proposed amendments to the Health Breach Notification Rule signal the agency's mounting efforts to regulate consumer health information beyond the reaches of the Health Information Portability and Accountability Act, which does not cover many recent health apps and technologies, say Jodi Daniel and Brandon Ge at Crowell & Moring.

  • Appellate Funding Disclosure: No Mandate Is Right Choice

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    The Advisory Committee on Appellate Rules' recent decision, forgoing a mandatory disclosure rule for litigation funding in federal appeals, is prudent, as third-party funding is only involved in a minuscule number of federal cases, and courts have ample authority to obtain funding information if necessary, says Stewart Ackerly at Statera Capital.

  • How NY Law Affects Scrutiny Of Health Care PE Transactions

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    A recently passed New York law will strengthen pretransanction notification requirements for health care entities — particularly those backed by private equity — but contains several ambiguities that will hopefully be clarified before the law takes effect in August, say attorneys at Norton Rose.

  • Health Care Info Blocking Rule Changes To Watch For

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    As the Office of the National Coordinator for Health Information Technology proposes certain revisions to the federal information blocking rules, health IT developers should be aware of the potentially beneficial changes to come, but frustrated stakeholders continue to endure the current environment while awaiting the final enforcement rules, say attorneys at Sheppard Mullin.

  • Drug Pricing Law Could Have Unintended Consequences

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    Though the Inflation Reduction Act was intended to lower prescription drug prices, it may have a number of unintended economic effects on drug pricing and access, particularly for biologics and biosimilars, and could even lead to certain price increases, say Alice Chen at the University of Southern California and Andrew Elzinga and Penka Kovacheva at Cornerstone Research.

  • How Attys Can Avoid Exposing Their Firms To Cyberattacks

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    Attorneys are the weakest link in their firms' cyberdefenses because hackers often exploit the gap between individuals’ work and personal cybersecurity habits, but there are some steps lawyers can take to reduce the risks they create for their employers, say Mark Hurley and Carmine Cicalese at Digital Privacy & Protection.

  • CMS Stark Law Waiver Fixes Gap In COVID Era Protections

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    Recently, the Centers for Medicare & Medicaid Services retroactively included independent freestanding emergency departments in Section 1135 waivers applicable to the Stark Law during the pandemic, a welcome correction to a regulatory shortcoming inconsistent with CMS' initial assurances of protection, say attorneys at McDermott.

  • Virginia 'Rocket Docket' Slowdown Is Likely A Blip

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    After being the fastest or second-fastest federal civil trial court for 14 straight years, the Eastern District of Virginia has slid to 18th place, but the rocket docket’s statistical tumble doesn't mean the district no longer maintains a speedy civil docket, says Robert Tata at Hunton.