Policy & Compliance

  • 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. 

  • July 01, 2024

    NC Doctor Takes Abortion Drug Limits Fight To 4th Circ.

    A North Carolina doctor who challenged the state's restrictions on abortion drug mifepristone asked the Fourth Circuit to review a district court's decision to allow certain limits to stand.

  • July 01, 2024

    Jury Sides With Amazon In Suit Over Post-Surgery Leave

    Amazon didn't have to give a former employee additional time off after gum disease surgery because she wasn't entitled to medical leave and didn't have a disability under federal law, a Florida federal jury found as it sided with the company.

  • June 28, 2024

    Chevron's End Is Just The Start For Energized Agency Foes

    By knocking down a powerful precedent that has towered over administrative law for 40 years, the U.S. Supreme Court's right wing Friday gave a crowning achievement to anti-agency attorneys. But for those attorneys, the achievement is merely a means to an end, and experts expect a litigation blitzkrieg to materialize quickly in the aftermath.

  • June 28, 2024

    Texas Justices Back Ban On Gender Affirming Care For Minors

    The Texas Supreme Court upheld a state ban on medical treatments that affirm the gender identity of transgender youths, saying Friday that the legislature "made a permissible, rational policy choice," though a dissenting justice said the court allowed the state "to legislate away fundamental parental rights."

  • June 28, 2024

    In Chevron Case, Justices Trade One Unknown For Another

    The U.S. Supreme Court's decision to overrule a decades-old judicial deference doctrine may cause the "eternal fog of uncertainty" surrounding federal agency actions to dissipate and level the playing field in challenges of government policies, but lawyers warn it raises new questions over what rules courts must follow and how judges will implement them.

  • June 28, 2024

    Ontrak Exec Conviction Shows Trading Plans Aren't Shields

    Executives who use so-called Rule 10b5-1 trading plans to buy and sell shares of their company's stock don't have an automatic shield against insider trading charges, attorneys said following the first criminal conviction of an executive based exclusively on his use of the plans, which are facing increased scrutiny from financial regulators.

  • June 28, 2024

    Health Regulators Likely To Tread Carefully Post-Chevron

    The demise of Chevron deference at the U.S. Supreme Court on Friday will likely encourage or fortify challenges to agency rulemaking on matters of health policy in the U.S., from Medicare reimbursement decisions to FDA rules on laboratory-developed tests.

  • June 28, 2024

    Shifting Legal Positions Behind High Court Abortion Punt

    Rapid developments in Idaho abortion law paved the way for a fractured U.S. Supreme Court decision that leaves doctors in the state in murky legal waters around providing abortions to patients in medical crisis.

  • June 28, 2024

    Iowa Supreme Court Approves 6-Week Abortion Ban

    The Iowa Supreme Court narrowly ruled Friday that the state can enforce a law restricting abortion after about six weeks of pregnancy, finding the state has a "legitimate interest in protecting unborn life," according to the majority opinion.

  • June 28, 2024

    Supreme Court Strikes Down Chevron Deference

    The U.S. Supreme Court on Friday overturned a decades-old precedent that instructed judges about when they could defer to federal agencies' interpretations of law in rulemaking, depriving courts of a commonly used analytic tool and leaving lots of questions about what comes next.

  • June 27, 2024

    Texas DAs Escape Defendant Class Cert. In Abortion Case

    A Texas federal judge on Wednesday rejected a bid to force state prosecutors to become a certified class of defendants in a suit aimed to curb retaliation against advocates who help women get an abortion outside the state, saying there was no risk of varying adjudications.

  • June 27, 2024

    Rape Kit Co. Wants Wash. Ban Lifted During Free Speech Suit

    A company that sells self-administered sexual assault DNA collection kits is urging a Washington federal judge to stop the enforcement of a new state law that it claims stifles its First Amendment rights by barring the marketing of its kits as an alternative to resources offered by law enforcement and the government.

  • June 27, 2024

    ACLU Says Mich. Can't Ban Medicaid Coverage Of Abortions

    The American Civil Liberties Union on Thursday lodged a suit challenging a Michigan law barring Medicaid coverage of abortions, claiming that the ban is a violation of the state constitution's newly enacted right to reproductive freedom.

  • 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.

Expert Analysis

  • 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.

  • 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.