Policy & Compliance

  • April 11, 2024

    UnitedHealth Patients' Addiction Coverage Suit Revived, Again

    The Ninth Circuit on Thursday revived for the second time a proposed class action accusing UnitedHealth of wrongly rejecting coverage for outpatient substance use disorder treatments in violation of federal benefits law, finding the plaintiff plausibly alleged the insurer employed an excessively strict review process for those claims.

  • 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.

Expert Analysis

  • SEC Cybersecurity Rule Presents Burden For Health Care Cos.

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    A new rule from the U.S. Securities and Exchange Commission aims to increase cybersecurity resiliency, but may only force regulated entities — particularly those in the health care space — to face a far more complicated environment with increased strategic and litigation risks, say Bess Hinson and Angad Chopra at Holland & Knight.

  • Caregiver Flexibility Is Crucial For Atty Engagement, Retention

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    As the battle for top talent continues post-pandemic, many firms are attempting to attract employees with progressive hybrid working environments — and supporting caregivers before, during and after an extended leave is a critically important way to retain top talent, says Manar Morales at The Diversity & Flexibility Alliance.

  • Online Tracking Tech Brings HIPAA Compliance Risks

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    Amid increasing scrutiny and litigation over uses of online tracking technology, it's critical for companies under the purview of the Health Insurance Portability and Accountability Act to carefully navigate website cookies' collection of protected health information, which may happen without website operators' knowledge, says Richard Sheinis at Hall Booth.

  • Nursing Homes Must Prepare For Ownership Scrutiny

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    Due to the Centers for Medicare & Medicaid Services' designation of nursing home ownership changes as a high risk category, and increased transparency and notice obligations for changes in skilled nursing facility ownership set to take effect in Pennsylvania in October, owners should anticipate a heightened level of review and delays, say Mark Mattioli and Paula Sanders at Post & Schell.

  • In-Office Engagement Is Essential To Associate Development

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    As law firms develop return-to-office policies that allow hybrid work arrangements, they should incorporate the specific types of in-person engagement likely to help associates develop attributes common among successful firm leaders, says Liisa Thomas at Sheppard Mullin.

  • A Judge's Pitch To Revive The Jury Trial

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    Ohio state Judge Pierre Bergeron explains how the decline of the jury trial threatens public confidence in the judiciary and even democracy as a whole, and he offers ideas to restore this sacred right.

  • How To Recognize And Recover From Lawyer Loneliness

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    Law can be one of the loneliest professions, but there are practical steps that attorneys and their managers can take to help themselves and their peers improve their emotional health, strengthen their social bonds and protect their performance, says psychologist and attorney Traci Cipriano.

  • Litigation Funding Disclosure Should Be Mandatory

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    Despite the Appellate Rules Committee's recent deferral of the issue of requiring third-party litigation funding disclosure, such a mandate is necessary to ensure the even-handed administration of justice across all cases, says David Levitt at Hinshaw.

  • 4 Employer Action Steps For New Mental Health Parity Rules

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    A recently released guidance under the Mental Health Parity and Addiction Equity Act reiterated that employers contracting with outside service providers to administer their health plans are not relieved of their compliance obligations — so all employers sponsoring a group health plan should consider four action items for success, say attorneys at Ice Miller.

  • Recalling USWNT's Legal PR Playbook Amid World Cup Bid

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    As the U.S. Women's National Soccer Team strives to take home another World Cup trophy, their 2022 pay equity settlement with the U.S. Soccer Federation serves as a good reminder that winning in the court of public opinion can be more powerful than a victory inside the courtroom, says Hector Valle at Vianovo.

  • Parsing Through The FTC's Proposed Health Privacy Updates

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    The Federal Trade Commission's recently proposed updates to its Health Breach Notification Rule contain subtle but significant changes to key terms that help modernize the agency's health app regulation and provide stakeholders an important opportunity to help shape the future of virtual health care, say attorneys at Arnold & Porter.

  • Indivior Ruling May Affect Rebate Wall Litigation

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    A New Jersey federal court's recent decision in Indivior v. Alvogen, in which a claim that an alleged rebate wall anti-competitively blocked generic competition survived summary judgment, may provide a blueprint for successfully challenging other drug rebating practices, say Peter Herrick and Monsura Sirajee at O'Melveny.

  • Compliance Takeaways From HHS Information Blocking Rule

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    A recently finalized rule from the U.S. Department of Health and Human Services' Office of Inspector General demonstrates a renewed focus on investigating practices that may interfere with patients' access to their electronic health information, and should encourage renewed compliance efforts across a range of processes, say attorneys at Ropes & Gray.