Policy & Compliance

  • August 23, 2024

    NY Lawmakers Hit With ADA Suit Over Contentious Mask Ban

    A Long Island, New York, county that recently made it illegal for certain individuals to wear face masks in public has been hit with a lawsuit by a legal advocacy group alleging the ban discriminates against people with disabilities.

  • August 23, 2024

    NC Not Shielded From Racetrack's COVID Shutdown Suit

    The North Carolina Supreme Court on Friday ruled a racetrack owner's lawsuit accusing state officials of violating his constitutional rights with a COVID shutdown order can survive dismissal, reasoning the claims were sufficient to overcome the government's protections from being sued.

  • August 23, 2024

    Hospital Deducted Bogus Meal Breaks From Wages, Suit Says

    A healthcare system automatically deducted 30 minutes per day from workers' wages for meal breaks despite the workers not getting the chance to take uninterrupted meal periods, a proposed collective action filed in Michigan federal court said.

  • August 22, 2024

    Mich. Panel Upholds Block Of 24-Hour Abortion Waiting Period

    Michigan appellate judges have refused to lift a preliminary injunction blocking the enforcement of a 24-hour waiting period and other abortion regulations, leaving in place a lower court decision that found the laws likely violate the state constitution.

  • August 22, 2024

    Texas Tells High Court It's Not Idaho '2.0' In HHS Abortion Row

    Texas and a pair of anti-abortion doctor organizations have urged the U.S. Supreme Court to reject the federal government's appeal of a Fifth Circuit decision blocking the Biden administration's guidance that hospitals must provide emergency stabilizing medical care, including abortions. 

  • August 21, 2024

    Fed. Circ. Won't Rethink IP Safe Harbor Case

    The Federal Circuit on Wednesday declined to review its decision affirming the dismissal of Edwards Lifesciences' infringement suit against Meril Life Sciences after Edwards urged the full court to narrow its interpretation of a U.S. Food and Drug Administration safe harbor that essentially allows patent infringement during drug development.

  • August 21, 2024

    Tobacco Cos. Ask Justices To Review FDA's New Warnings

    R.J. Reynolds Tobacco Co. is urging the U.S. Supreme Court to review a Fifth Circuit decision affirming an FDA rule mandating new health warnings on cigarette packaging and advertisements, arguing that the court created an unjustified circuit split when it found the graphic warnings are "purely factual and uncontroversial."

  • August 21, 2024

    Conn. Justices Back Insurer's Out-Of-Network Patient Bills

    The Connecticut Supreme Court on Wednesday limited an emergency physician group's attempt to require a medical insurer to shoulder patient costs under the state's surprise medical billing law, holding that insurers can charge patients for shared costs, such as deductibles and copayments, at lower levels without violating consumer protection laws.

  • August 21, 2024

    Mich. High Court Asked To Redo Wrongful Death Ruling

    The family of a deceased teen asked the Michigan Supreme Court on Tuesday for another chance to show that future earnings awards should be allowed in wrongful death cases, arguing the court's recent ruling restricting those awards ignored important state law.

  • August 21, 2024

    Union Health Plan Trustees Can't Avoid Fee Claim, Judge Says

    Trustees of a UNITE HERE health plan can't topple a group of Southern California workers' claims that they are facing higher administrative expenses compared to another group of workers in Las Vegas, an Illinois federal court ruled Wednesday.

  • August 21, 2024

    Health Co. Investors Fight To Keep Suit Over Migrant Deal

    Investors in mobile medical provider DocGo are urging a New York federal judge not to toss a suit alleging it deceived stockholders before a $432 million contract with New York City to provide emergency migrant housing came under public scrutiny, saying the complaint sufficiently establishes that the defendants made material misstatements and omissions.

  • August 20, 2024

    Ala. AG Can't Prosecute Aiding Abortion Travel, DOJ Says

    The Alabama attorney general's threats of criminal prosecution against individuals and corporations who assist others in traveling to obtain lawful abortions out of state violates the constitutional right to travel, the U.S. Department of Justice told an Alabama federal judge in a court filing Monday. 

  • August 20, 2024

    Amgen's Drug Price Suit An Issue For Legislature, Judge Told

    A Colorado nonprofit that advocates for the poor told a federal judge Tuesday that Amgen's lawsuit over the state's drug price cap system is little more than a disagreement with lawmakers' policy choices disguised as a constitutional issue.

  • August 20, 2024

    9th Circ. Trans Health Appeal Hints At Supreme Court Fight

    The Ninth Circuit will hear arguments Wednesday in an appeal from the state of Idaho seeking to preserve its ban on gender dysphoria treatment for minors, in a case that involves questions about trans health access that the U.S. Supreme Court is set to consider this fall, attorneys say.

  • August 20, 2024

    Fed Circ. Finds No Fault In Denial Of Flu Vaccine Claim

    The Federal Circuit on Tuesday affirmed the denial of a family's petition for compensation alleging their child developed narcolepsy as a result of the FluMist vaccine, saying the special master's determination that the family hasn't properly established the link was not arbitrary.

  • August 20, 2024

    Did Biden Admin 'Play Nice' In Medicare Drug Price Talks?

    In announcing the first agreements under Medicare's new drug price negotiating authority, the Biden administration took great pains to undermine one of the industry's central legal and rhetorical challenges to the program: that it isn't a negotiation at all.

  • August 20, 2024

    FTC Endorses Push For Broader Access To Biosimilar Drugs

    The Federal Trade Commission is backing a proposal that would make it easier for drugmakers to show biosimilar medicines are safe substitutes for their more expensive counterparts, a move the agency says would boost competition and reduce confusion.

  • August 20, 2024

    Pathology Trade Group 2nd To Sue FDA Over Lab-Test Rule

    A molecular pathology trade group has filed a lawsuit against the U.S. Food and Drug Administration, challenging a recent final rule to regulate laboratory-developed tests as medical devices and arguing the agency has abused its power — the second such case filed in recent months. 

  • August 20, 2024

    'Full Steam Ahead' For Pandemic IG Despite Sunset Fear

    A pandemic watchdog office is poised to shutter in seven months — its pleas for an extension have gone unheeded. But in the meantime, its remaining employees, some working away in their nondescript Alexandria, Virginia, office, others from their homes, are hustling to recover millions of dollars from COVID-19 fraudsters.

  • August 20, 2024

    Deadly Heat: Fighting 'Hidden' Health Crisis With AI, Free ACs

    As extreme heat kills more Americans, the healthcare industry is turning to artificial intelligence and free air conditioners to help protect patients and the bottom line.

  • August 20, 2024

    With Billions At Stake, Texas Suits Target Nursing Home Rule

    Legal clashes moving forward in Texas could reshape the nursing home industry, send ripples through the broader healthcare system and provide an early look at how the fall of Chevron deference will shape federal rulemaking, experts say.

  • August 20, 2024

    A Deep Dive Into Law360 Pulse's 2024 Women In Law Report

    The legal industry continues to see incremental gains for female lawyers in private practice in the U.S., according to a Law360 Pulse analysis, with women now representing 40.6% of all attorneys and 51% of all associates.

  • August 20, 2024

    These Firms Have The Most Women In Equity Partnerships

    The legal industry still has a long way to go before it can achieve gender parity at its upper levels. But these law firms are performing better than others in breaking the proverbial glass ceiling that prevents women from attaining leadership roles.

  • August 20, 2024

    Philadelphia, Insurer Settle Trans Firefighter's Surgery Suit

    The city of Philadelphia, Independence Blue Cross and a firefighters union agreed to settle a transgender firefighter's suit claiming she was unlawfully denied coverage for facial feminization surgery, just weeks after a Pennsylvania federal judge refused to let the insurer out of the case.

  • August 19, 2024

    9th Circ. Told Psilocybin Petition Is Backed By Precedent

    A Ninth Circuit panel on Monday dissected opposing arguments from the U.S. Drug Enforcement Administration and a Seattle doctor over whether there is precedent to allow the dispensing of psilocybin — a psychedelic compound — to treat terminally ill patients.

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.