Policy & Compliance

  • 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.

  • 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.

Expert Analysis

  • FTC Focus: Exploring The Meaning Of Orange Book Letters

    Author Photo

    The Federal Trade Commission recently announced an expansion of its campaign to promote competition by targeting pharmaceutical manufacturers' improper Orange Book patent listings, but there is a question of whether and how this helps generic entrants, say Colin Kass and David Munkittrick at Proskauer.

  • 3rd Circ.'s Geico Ruling May Encourage Healthcare Arbitration

    Author Photo

    The Third Circuit's recent decision in Geico v. Mount Prospect, finding that claims under New Jersey's Insurance Fraud Prevention Act can be arbitrated, strengthens arbitration as a viable alternative to litigation, even though it is not necessarily always a more favorable forum, say Khaled Klele and Jessica Osterlof at McCarter & English.

  • Proposed Cannabis Reschedule Sidesteps State Law Effects

    Author Photo

    The U.S. Department of Justice's recent proposal to move cannabis to Schedule III of the Controlled Substances Act provides certain benefits, but its failure to address how the rescheduling would interact with existing state cannabis laws disappointed industry participants hoping for clarity on this crucial question, says Ian Stewart at Wilson Elser.

  • A Changing Regulatory Landscape For Weight Loss Drugs

    Author Photo

    As drugs originally approved to treat diabetes become increasingly popular for weight loss purposes, federal and state regulators and payors are increasing their focus on how these drugs are prescribed, and industry participants should pay close attention to rapidly evolving compliance requirements, say attorneys at Goodwin.

  • Opioid Suits Offer Case Study In Abatement Expert Testimony

    Author Photo

    Settlements in the opioid multidistrict litigation provide useful insight into leveraging expert discovery on abatement in public nuisance cases, and would not have been successful without testimony on the costs necessary to lessen the harms of the opioid crisis, says David Burnett at DiCello Levitt.

  • How HHS Discrimination Rule Affects Gender-Affirming Care

    Author Photo

    The U.S. Department of Health and Human Services' new final rule, which reinterprets the Affordable Care Act's anti-discrimination provision, greatly clarifies protections for gender-affirming care and will require compliance considerations from sponsors and administrators of most group health plans, say attorneys at McDermott.

  • FTC Noncompete Rule's Impact On Healthcare Nonprofits

    Author Photo

    Healthcare entities that are nonprofit or tax-exempt and thus outside of the pending Federal Trade Commission noncompete rule's reach should evaluate a number of potential risk factors and impacts, starting by assessing their own status, say Ben Shook and Tania Archer at Moore & Van Allen.

  • Key Takeaways From FDA Final Rule On Lab-Developed Tests

    Author Photo

    Michele Buenafe and Dennis Gucciardo at Morgan Lewis discuss potential consequences of the U.S. Food and Drug Administration's recently finalized rule regulating lab-developed tests as medical devices, and explain the rule's phaseout policy for enforcement discretion.

  • Assessing HHS' Stance On Rare Disease Patient Assistance

    Author Photo

    The U.S. Department of Health and Human Services' recent advisory opinion, temporarily blessing manufacturer-supported copay funds for rare disease patients, carves a narrow path for single-donor funds, but charities and their donors may require additional assistance to navigate programs for such patients, says Mary Kohler at Kohler Health Law.

  • Are Concessions In FDA's Lab-Developed Tests Rule Enough?

    Author Photo

    Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.

  • 8 Questions To Ask Before Final CISA Breach Reporting Rule

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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.