Policy & Compliance

  • June 27, 2024

    EU High Court Upends Servier Decrease Of Pay-For-Delay Fine

    French pharmaceutical giant Servier is back on the hook for all but €2.4 million ($2.57 million) of a more than €300 million European Union antitrust fine after the European Court of Justice upended a lower court decision that had reduced the penalty by over €100 million.

  • June 27, 2024

    Hospitals' Charity Care Does Not Equal Taking, NJ Panel Rules

    A New Jersey appellate panel Thursday rejected a group of Garden State hospitals' challenge to a lower court's finding that a state requirement to treat patients regardless of the patient's ability to pay does not amount to constitutional taking, ruling that they failed to show evidence of physical taking of hospital property.

  • June 27, 2024

    6th Circ. Dismisses Doctors' ACA Trans Healthcare Appeal

    The Sixth Circuit dismissed on Thursday an appeal from a group of doctors attempting to block the U.S. Department of Health and Human Services from enforcing prohibitions on gender-identity discrimination under the Affordable Care Act, finding subsequent agency action overruled the doctors' claims.

  • June 26, 2024

    Moms For America Sues Biden Admin Over Vax Liability Law

    Conservative nonprofit Moms for America has sued the Biden administration over a law that shields companies from COVID-19 vaccine injury lawsuits, saying the law is unconstitutional because it circumvents judicial review and violates fundamental rights, including due process and trial by jury.

  • June 26, 2024

    Justices Chide 5th Circ. In Biden Social Media Case

    The Fifth Circuit relied on "clearly erroneous" facts and an overgeneralized view of standing when it ordered the Biden administration to stop working with social media platforms to combat COVID-19 and election misinformation, the U.S. Supreme Court ruled Wednesday as it threw out a challenge to the government's actions.

  • June 26, 2024

    Device Maker To Fork Over $3.5M In Tax Dodge Suit

    A man who manufactured a purported health device will pay the IRS nearly $3.5 million under an agreement endorsed by a Florida federal court after the agency claimed he hadn't filed a tax return since 1999.

  • June 26, 2024

    Nurses Say Mich. Hospitals Owe OT For Meal Break Work

    Two locations of a Michigan healthcare system unlawfully require employees to work through their meal breaks without pay in violation of federal wage law, according to two separate proposed collective actions filed in federal court.

  • June 26, 2024

    Feds' 5th Circ. Win On Preventive Care May Imperil ACA

    The Fifth Circuit's decision to knock out a national injunction against preventive services coverage requirements under the Affordable Care Act left healthcare advocates breathing a sigh of relief, but attorneys say even more of those requirements may be on the chopping block.

  • June 26, 2024

    High Court 'Inadvertently' Posts Order Punting Abortion Case

    The U.S. Supreme Court mistakenly released a draft order Wednesday that would allow emergency abortions in Idaho, with a majority saying the court was wrong to consider a state challenge at this time.

  • June 26, 2024

    High Court Axes Challenge To Biden Admin's Social Media Work

    The U.S. Supreme Court wiped out a Fifth Circuit order prohibiting the Biden administration and several federal agencies from working with social media platforms to combat the spread of misinformation Wednesday, finding the states and individuals challenging the collaboration don't have standing to sue.

  • June 25, 2024

    Mich. Judge Blocks State Abortion Waiting Period, Counseling

    A Michigan state judge on Tuesday temporarily blocked a 24-hour waiting period, mandatory counseling and other requirements on people seeking abortions in the state, finding they likely violate an amendment in the state constitution guaranteeing the right to an abortion.

  • June 25, 2024

    Supreme Court Sets Stage For Crucial Ruling On Trans Rights

    The U.S. Supreme Court's plunge into the legal clash over gender-affirming care for minors could determine the fate of restrictions enacted in 25 states and shape the future of transgender rights for years to come.

  • June 25, 2024

    NBA Fraud Trial, An HHS Loss, And An Ivy League Doc Settles

    A Texas federal judge dinged the Biden administration over a rule restricting hospitals' use of online tracking technology. The NBA healthcare fraud scheme saga continues. A Harvard fertility doc settled claims he used his own sperm to impregnate a patient. Law360 Healthcare Authority examines the lawsuits and decisions that have shaped the industry over the last week. 

  • June 25, 2024

    In High Court Loss, Anti-Abortion Atty Sees Win For Objectors

    Erin Hawley of Alliance Defending Freedom, a top attorney of the anti-abortion movement, sees a "silver lining" in the recent U.S. Supreme Court opinion that maintained broad access to the abortion medication mifepristone: an endorsement of robust conscience protections for healthcare providers.

  • June 25, 2024

    For Pharma, High Court Abortion Drug Ruling Averts 'Chaos'

    The pharmaceutical industry's relief over the recent U.S. Supreme Court decision on mifepristone goes well beyond the abortion medication at the center of the case.

  • June 25, 2024

    Tracking The FTC's Latest Moves In Healthcare

    The Federal Trade Commission has its eye on the healthcare industry, targeting a range of deals the agency says would hurt competition and drive up prices. Law360 Healthcare Authority tracks recent FTC actions targeting hospital systems, digital health entities and pharmaceutical companies.

  • June 25, 2024

    Gov't Asks Ala. Fed. Court To Stay Gender Care Case

    The Biden administration has asked an Alabama federal court to stay a suit challenging a state law criminalizing gender-affirming care for transgender youth, which has drawn attention because of judge-shopping allegations leveled against plaintiff's counsel, as the U.S. Supreme Court has agreed to hear a separate but potentially precedential suit.

  • June 25, 2024

    The Federal Judge At The Center Of NC Abortion Battles

    A lone federal judge in North Carolina is playing an outsize role in abortion access cases critical to women seeking the procedures across much of the American South.

  • June 25, 2024

    Longtime Pediatrix Atty Joins Envision Healthcare As GC

    The longtime top attorney for Pediatrix Medical Group Inc. has joined Nashville, Tennessee-based national medical group Envision Healthcare as its new general counsel.

  • June 24, 2024

    NYC Pharmacy Owners Get Jail Time For $18M Med Fraud

    Two brothers who own several New York pharmacies will each have to pay over $18 million in restitution in addition to serving jail time for submitting fraudulent claims to Medicare for pricey cancer medication and funneling illicit proceeds through several shell companies, the U.S. Department of Justice announced Monday.

  • June 24, 2024

    Health Co. Narrows Doctor's Reneged Benefits Suit

    An Arizona federal judge trimmed a doctor's suit claiming her healthcare system employer refused to let her use her benefits to take time off to undergo cancer treatments, but kept alive claims that the company violated state and federal law by misleading her about paid leave.

  • June 24, 2024

    LA Schools Says Pseudoscience Infected 9th Circ. Vax Ruling

    The Los Angeles Unified School District said Friday that a split Ninth Circuit panel leaned on pseudoscience when ruling that a rescinded employee COVID-19 vaccination mandate implicated the right of district employees to refuse medical treatment, urging an en banc panel to correct the "fatally flawed" decision.

  • June 24, 2024

    Ark. AG Sues Pharmacy Benefit Managers Over Opioids

    The Arkansas attorney general said Monday that he had sued pharmacy benefit managers Optum Inc. and Express Scripts Inc. in state court, claiming they contributed to the opioid crisis and profited from the drug epidemic.

  • June 24, 2024

    Justices Pass On Conn. School Vaccine Mandate Fight

    The U.S. Supreme Court on Monday declined to review a Second Circuit decision that largely upheld the dismissal of a suit challenging a Connecticut law passed during the COVID-19 pandemic that revoked religious exemptions to student vaccine mandates.

  • June 24, 2024

    Justices Pass On Rutgers COVID-19 Vax Mandate Case

    The U.S. Supreme Court declined on Monday to review a split Third Circuit ruling that Rutgers University students cannot challenge the school's COVID-19 vaccine policy because, under the high court's 1905 precedent in Jacobson v. Massachusetts, there is no fundamental right to refuse vaccinations.

Expert Analysis

  • 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.

  • Patent Waiver For COVID Meds Would Harm US Biopharma

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    If the Biden administration backs the World Trade Organization in waiving patent rights on COVID-19 treatments, it would negatively affect the U.S. biopharmaceutical industry and help foreign competitors, without necessarily expanding global access to COVID-19 care, says clinical pathologist Wolfgang Klietmann.

  • New CMS Rule Will Change Nursing Facility Disclosures

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    A new rule from the Centers for Medicare & Medicaid Services significantly expands disclosure requirements for nursing facilities backed by private equity companies or real estate investment trusts, likely foreshadowing increased oversight that could include more targeted audits, say Janice Davis and Christopher Ronne at Morgan Lewis.