Policy & Compliance

  • July 05, 2024

    9th Circ. Backs Remand Of Cedars-Sinai Patient Data Suits

    The Ninth Circuit held Friday that a trio of proposed class actions accusing Cedars-Sinai of improperly sharing patients' personal information with tech companies indeed belong in California state court, agreeing with a lower court that the health provider wasn't acting at the direction of the federal government.

  • July 05, 2024

    How Reshaped Circuit Courts Are Faring At The High Court

    Seminal rulings from the U.S. Supreme Court's latest term will reshape many facets of American society in the coming years. Already, however, the rulings offer glimpses of how the justices view specific circuit courts, which have themselves been reshaped by an abundance of new judges.

  • July 05, 2024

    Breaking Down The Vote: The High Court Term In Review

    The U.S. Supreme Court's lethargic pace of decision-making this term left the justices to issue a slew of highly anticipated and controversial rulings during the term's final week — rulings that put the court's ideological divisions on vivid display. Here, Law360 takes a data dive into the numbers behind this court term.

  • July 05, 2024

    High Court Flexes Muscle To Limit Administrative State

    The U.S. Supreme Court's dismantling of a 40-year-old judicial deference doctrine, coupled with rulings stripping federal agencies of certain enforcement powers and exposing them to additional litigation, has established the October 2023 term as likely the most consequential in administrative law history.

  • July 05, 2024

    The Sharpest Dissents From The Supreme Court Term

    The U.S. Supreme Court's session ended with a series of blockbuster cases that granted the president broad immunity, changed federal gun policy and kneecapped administrative agencies. And many of the biggest decisions fell along partisan lines.

  • July 05, 2024

    5 Moments That Shaped The Supreme Court's Jan. 6 Decision

    When the high court limited the scope of a federal obstruction statute used to charge hundreds of rioters who stormed the Capitol, the justices did not vote along ideological lines. In a year marked by 6-3 splits, what accounts for the departure? Here are some moments from oral arguments that may have swayed the justices.

  • July 05, 2024

    The Funniest Moments Of The Supreme Court's Term

    In a U.S. Supreme Court term teeming with serious showdowns, the august air at oral arguments filled with laughter after an attorney mentioned her plastic surgeon and a justice seemed to diss his colleagues, to cite just two of the term's mirthful moments. Here, we look at the funniest moments of the term.

  • July 05, 2024

    Hackensack Meridian Sues Feds, Citing Chevron Ruling

    After the U.S. Supreme Court overturned the Chevron deference last month, making it easier to challenge federal regulators in court, New Jersey's largest healthcare network became one of the first to seek remedies citing the ruling.

  • July 05, 2024

    The Firms That Won Big At The Supreme Court

    This U.S. Supreme Court term featured high-stakes oral arguments on issues including gerrymandering, abortion and federal agency authority, and a hot bench ever more willing to engage in a lengthy back-and-forth with advocates. Here's a look at the law firms that argued the most cases and how they fared.

  • July 03, 2024

    HHS Scores Early Win In Boehringer's Medicare Pricing Suit

    A Connecticut federal judge on Wednesday sided with the U.S. Department of Health and Human Services in Boehringer Ingelheim's challenge to a new Medicare drug price negotiation program, rejecting the pharmaceutical company's claim that the program is unconstitutional.

  • July 03, 2024

    Red States Get ACA Trans Discrimination Rule Blocked

    Federal judges in Mississippi and Texas granted conservatives states' requests Wednesday to freeze a new rule protecting access to healthcare for the LGBTQ+ community, with both judges ruling that states are likely to succeed in showing that the U.S. Department of Health and Human Services overstepped when it created the regulations.

  • July 03, 2024

    Contentious Ala. Gender Care Case Partly Paused

    Favoring "judicial efficiency," an Alabama federal court has partially granted the Biden administration's opposed motion to stay a case challenging the state's ban on gender-affirming healthcare for transgender youth while the U.S. Supreme Court reviews a similar Tennessee ban, though some briefing, including for summary judgment, was permitted to proceed.

  • July 03, 2024

    4 Mass. Rulings You Might Have Missed In June

    Massachusetts state courts last month dealt with thorny contract disputes, mistakenly disclosed emails between a defendant and an attorney, and a company's overtime policy change that may not have been spelled out to workers.

  • July 03, 2024

    Gov't Says Justices' Decision Doesn't Fully Solve OT Suit

    The recent U.S. Supreme Court decision pushing deadlines to challenge federal regulations doesn't entirely solve an overtime dispute between three home care companies and the U.S. Department of Labor, the government told the Third Circuit.

  • July 03, 2024

    NC Appeals Court OKs Hospital's 'Facility Fees' For ER Patient

    The North Carolina Court of Appeals has found that Novant Health was allowed to charge an emergency room patient "facility fees" because a contract she signed for healthcare included language requiring payment for anything not covered by insurance.

  • July 03, 2024

    Steward Health Downfall Prompts Calls For Tighter Regs

    The magnitude of the financial troubles plaguing bankrupt hospital operator Steward Health Care has turned the Chapter 11 case into a flash point that should prompt a regulatory overhaul, according to a new report released by advocacy group Private Equity Stakeholder Project.

  • July 02, 2024

    Chamber, Pharma Slam Colorado Drug Price Controls

    The U.S. Chamber of Commerce and a prominent pharmaceutical industry group have urged a Colorado federal court to bar a state review board from setting price controls on prescription drugs, arguing that the practice is "irreconcilable" with federal patent law.

  • July 02, 2024

    Ga. Justices Say COVID Order Tolls Med Mal Repose Statute

    The Georgia Supreme Court on Tuesday said that a judicial emergency order handed down during the COVID-19 pandemic can be used to toll the state's five-year medical malpractice statute of repose.

  • July 02, 2024

    Abortion, Trans Healthcare Top Lower Court Litigation

    Major healthcare decisions at the U.S. Supreme Court dominated the headlines in recent weeks. But there has also been significant movement in state and other appellate courts on the Affordable Care Act, Medicaid coverage, and transgender care, and among other weighty matters. Law360 Healthcare Authority looks at the significant disputes and decisions that shaped the industry over the last week.

  • July 02, 2024

    4 Takeaways From FDA's Clinical Trial Diversity Guidance

    Long-awaited U.S. Food and Drug Administration guidance sheds new light on clinical trial action plans meant to improve health outcomes for more populations. Here are four takeaways from the FDA's latest clinical trial diversity guidelines.

  • July 02, 2024

    Arizona AG Abortion Opinion May Influence Courts, Doctors

    A new advisory opinion reassuring Arizona doctors they can use their good-faith judgment to provide an emergency abortion, despite a 15-week state ban, isn’t binding on the courts. But it may still exert influence on judges and prosecutors in a state with a fast-changing abortion landscape.

  • July 02, 2024

    Veteran Medicare Advocate Judy Stein Welcomes 'New Cadre'

    In 1986, Connecticut attorney Judy Stein took out a loan to launch the Center for Medicare Advocacy in a one-room office above a bakery. Today, she's reflecting on a career fighting for people in need of healthcare support, including the landmark Jimmo settlement, as she welcomes new leadership to the group.

  • July 02, 2024

    3rd Circ. Asked To Remand OT Suit After Justices' Ruling

    Three home care companies in overtime disputes with the U.S. Department of Labor urged the Third Circuit to reverse and remand a ruling that they waited too long to challenge a 2013 ruling on in-home caregivers' ability to earn minimum wage under a new U.S. Supreme Court precedent.

  • July 01, 2024

    Ill., Northshore Say Anti-Vax Case Not About Religious Liberty

    A nurse working for a Northshore Health unit in Illinois should be permanently blocked from pursuing employment deprivation claims over her initial denial of a COVD-19 religious vaccine exemption, the health facility said, arguing she is using a state conscience law as a "sword" against COVID-19 protections. 

  • July 01, 2024

    House Republicans Call For ACA Enrollment Probe

    Three House Republican committee chairs are asking government watchdogs to investigate Affordable Care Act enrollments after a third-party report alleged a significant number of Americans are fraudulently accessing low-income healthcare subsidies. 

Expert Analysis

  • 8 Questions To Ask Before Final CISA Breach Reporting Rule

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    The Cybersecurity and Infrastructure Security Agency’s recently proposed cyber incident reporting requirements for critical infrastructure entities represent the overall approach CISA will take in its final rule, so companies should be asking key compliance questions now and preparing for a more complicated reporting regime, say Arianna Evers and Shannon Mercer at WilmerHale.

  • Mid-2024 FCA Enforcement And Litigation Trends To Watch

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    Reviewing notable False Claims Act trends and enforcement efforts in the last year and a half reveals that healthcare is a key enforcement priority for the U.S. Department of Justice, and the road ahead may bring clarification on Anti-Kickback Statute causation and willfulness standards, along with increased focus on private equity, cybersecurity and self-disclosure, say attorneys at Epstein Becker.

  • Online Portal Helps Fortify Feds' Unfair Health Practices Fight

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    The Federal Trade Commission, U.S. Justice Department and the U.S. Department of Health and Human Services recently launched an online portal where the public can report potentially unfair healthcare practices, effectively maximizing enforcers' abilities to police anti-competitive actions that can drive up healthcare costs and chill innovation, say attorneys at Seyfarth.

  • McKesson May Change How AKS-Based FCA Claims Are Pled

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    The Second Circuit’s analysis in U.S. v. McKesson, an Anti-Kickback Statute-based False Claims Act case, provides guidance for both relators and defendants parsing scienter-related allegations, say Li Yu at Dicello Levitt, Ellen London at London & Stout, and Erica Hitchings at Whistleblower Law.

  • 9th Circ. Ruling Puts Teeth Into Mental Health Parity Claims

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    In its recent finding that UnitedHealth applied an excessively strict review process for substance use disorder treatment claims, the Ninth Circuit provided guidance on how to plead a Mental Health Parity and Addiction Equity Act violation and took a step toward achieving mental health parity in healthcare, says Mark DeBofsky at DeBofsky Law.

  • Breaking Down DOJ's Individual Self-Disclosure Pilot Program

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    The U.S. Department of Justice’s recently announced pilot program aims to incentivize individuals to voluntarily self-disclose corporate misconduct they were personally involved in, complementing a new whistleblower pilot program for individuals not involved in misconduct as well as the government's broader corporate enforcement approach, say attorneys at Paul Weiss.

  • FDA Warning Letter Tightens Reins On 'Research Only' Labels

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    A recent warning letter from the U.S. Food and Drug Administration to Agena Bioscience alleged the company’s diagnostic devices were labeled for research use only, but improperly promoted for human clinical purposes, signifying a reinforcement — and a potential narrowing — of the agency's policy on products labeled “research only,” say attorneys at Sheppard Mullin.

  • First 10b5-1 Insider Trading Case Raises Compliance Issues

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    The ongoing case against former Ontrak CEO Terren Peizer is the U.S. Department of Justice's first insider trading prosecution based primarily on the filing of 10b5-1 plans, and has important takeaways for attorneys reviewing corporate policies on the possession of material nonpublic information, say attorneys at Cadwalader.

  • Policy Misrepresentations Carry Insurance Rescission Risks

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    The Second Circuit's recent decision in Medical Mutual v. Gnik, finding that material misrepresentation in a clinic's insurance applications warranted policy rescission, is a clear example of the far-reaching effects that misrepresentations can have and provides a reminder that policyholders should employ relatively straightforward steps to decrease risks, say attorneys at Hunton.

  • The Pros And Cons Of NIST's Proposed March-In Framework

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    Recent comments for and against the National Institute of Standards and Technology’s proposed guidance on march-in rights — which permit the government to seize federally funded patents — highlight how the framework may promote competition, but could also pose a risk to contractors and universities, say Nick Lee and Paul Ragusa at Baker Botts.

  • 2 Recent Suits Show Resiliency Of Medicare Drug Price Law

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    Though pharmaceutical companies continue to file lawsuits challenging the Inflation Reduction Act, which enables the federal government to negotiate for lower prescription drug prices, recent decisions suggest that the reduced drug prices are likely here to stay, says Jose Vela Jr. at Clark Hill.

  • Defense Attys Must Prep For Imminent AI Crime Enforcement

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    Given recent statements by U.S. Department of Justice officials, white collar practitioners should expect to encounter artificial intelligence in federal criminal enforcement in the near term, even in pending cases, say Jarrod Schaeffer and Scott Glicksman at Abell Eskew.

  • Lessons For Nursing Facilities From DOJ Fraud Settlement

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    The U.S. Department of Justice's recent settlement with the owner of skilled nursing and assisted living facilities in Florida provides a cautionary tale of potential fraud risks, and lessons on how facilities can mitigate government enforcement actions, say Callan Stein and Rebecca Younker at Troutman Pepper.