Policy & Compliance

  • July 09, 2025

    Red Cross Vax Refuser Decries Firing Over Religious Beliefs

    A former nurse for the American Red Cross suffered physically and economically after she was fired from the organization for not receiving the COVID-19 vaccine, counsel for the nurse told a Detroit federal jury Wednesday, arguing that, in the United States, the Red Cross should not be the arbiter of sincerely held religious beliefs.

  • July 09, 2025

    Sandoz, Buyers Defend $275M Deal Amid State Objections

    Counsel for consumers, insurers and others urged a Pennsylvania federal court on Tuesday to approve Sandoz and its subsidiaries' $275 million deal settling claims it conspired with other companies to fix some generic drug prices, with Sandoz separately calling states' objections "a paternalistic desire to control private class action settlements."

  • July 09, 2025

    FDA Gets Early Win In Blue States' Abortion Pill Suit

    A Washington federal judge has granted an early win to the federal government in a lawsuit from 17 Democratic attorneys general challenging the U.S. Food and Drug Administration's restrictions on access to the abortion drug mifepristone, finding the agency has properly reviewed the drug when issuing regulations.

  • July 09, 2025

    Mich. Judge Tosses Challenge To State Medicaid Abortion Ban

    A Michigan judge has dismissed a challenge to the state's ban on Medicaid coverage for abortions, finding a nonprofit organization that offers financial assistance to women seeking abortions lacked standing.

  • July 08, 2025

    Insurer Fights ACA Loss, Citing Justices' Trans Care Ruling

    Premera Blue Cross urged a Washington federal court to rethink an early win it granted against the insurer over its coverage policy for gender dysphoria surgery, arguing the U.S. Supreme Court's recent decision in U.S. v. Skrmetti is dispositive of a sex discrimination claim in the case.

  • July 08, 2025

    Omnicare, CVS Tab In FCA Case Increases To $949M

    A New York federal judge on Monday raised a False Claims Act judgment against Omnicare and CVS to a combined $949 million following a jury's finding that they submitted millions of false prescription claims for long-term care patients.

  • July 08, 2025

    Calif.'s PE Healthcare Oversight Bill: 3 Things To Know

    A California bill expanding the power of a state healthcare affordability board is moving through the Legislature amid opposition from key industry organizations. Here, Law360 Healthcare Authority examines three key aspects of the legislation.

  • July 08, 2025

    Utah Doc Heads To Trial Over Bogus Vax Card Claims

    A Utah plastic surgeon accused in a fake COVID vaccine card conspiracy headed to trial in Salt Lake City this week. Dr. Michael Kirk Moore won't be able to argue his actions were necessary to protect patients who feared taking the vaccine after the court foreclosed a "necessity" defense.

  • July 08, 2025

    Sweeping Medicaid Cuts Leave Health Attys With Questions

    Healthcare attorneys coming back to their offices after the long weekend have had a busy few days fielding phone calls from clients looking for help digesting the One Big Beautiful Bill Act, the sweeping legislation recently signed into law by President Donald Trump that would have far-reaching ramifications for the healthcare industry.

  • July 08, 2025

    HHS Conscience Probes Face Post-Chevron Hurdles

    As the Trump administration promotes the rights of healthcare providers to deny gender-affirming care on religious or moral grounds, legal experts say the effort may be frustrated by a U.S. Supreme Court decision that undercuts judicial deference to agencies' statutory interpretations.

  • July 08, 2025

    Biosimilars Industry Group Backs Interchangeability Bill

    The current law on how biosimilars are deemed interchangeable or not with their name-brand biologic equivalents has led to public confusion over how safe biosimilars are, a coalition of healthcare industry groups told lawmakers in a letter Monday.

  • July 08, 2025

    Pa. Panel Grants Immunity To Nursing Board In Exam Dispute

    A Pennsylvania appellate court on Tuesday narrowly rejected a lawsuit filed by an ex-nurse who contends a state board violated her rights by ordering her to undergo a mental health exam, finding instead that the board members are entitled to quasi-judicial immunity.

  • July 08, 2025

    HHS Can't Dodge Suit Over Nixed LGBTQ Bias Protections

    A New York federal judge declined Tuesday to toss a transgender woman's suit challenging President Donald Trump's decision to roll back anti-discrimination regulations for LGBTQ patients during his first term, rejecting arguments from the government that the case is moot given that a Biden-era rule restored the protections.

  • July 08, 2025

    High Court Allows Trump's Gov't Cuts And Restructuring

    The U.S. Supreme Court on Tuesday ruled the Trump administration can move forward with its plans for large-scale layoffs and reorganizations at various federal departments and agencies, lifting a California federal judge's order that had paused the efforts while a legal challenge continues.

  • July 08, 2025

    Merits Not At Issue For Health Co. Wage Collective, Court Told

    A healthcare facility operator is focusing too much on the merits of unpaid wages claims rather than whether it had common policies that detracted from employees' pay, a respiratory therapist told a North Carolina federal court, saying collective status is appropriate.

  • July 08, 2025

    Ore. Weighs Tough New Requirements For Long-Term Care

    Two years ago, an Oregon woman died in the cold after leaving, unseen, from a memory care facility. Today, state lawmakers are moving to strengthen oversight of long-term care facilities that serve older adults, including those with dementia.

  • July 07, 2025

    Pregnant Doc, Medical Orgs. Sue To Block RFK's Vax Directive

    A pregnant doctor who fears she will be denied a COVID-19 vaccination, along with a coalition of medical associations, sued Health and Human Services Secretary Robert F. Kennedy Jr. in Massachusetts federal court on Monday challenging his directive recommending against the shot for pregnant women and children.

  • July 07, 2025

    Planned Parenthood Wins Block of 'Catastrophic' Defunding

    A Massachusetts federal judge late Monday agreed to temporarily block the Trump administration's plans to prohibit Planned Parenthood health centers from receiving Medicaid reimbursements, issuing a temporary restraining order just hours after Planned Parenthood sued, saying the consequences would be "catastrophic."

  • July 07, 2025

    Mich. Top Court Won't Hear COVID-19 Immunity Appeal

    A split Michigan Supreme Court has decided to leave in place an appellate panel's ruling that a state pandemic-response law shields a hospital from malpractice and negligence claims brought by a woman who was admitted for COVID-19-related stress, with dissenting justices saying they have concerns with the lower court's rationale.

  • July 07, 2025

    Atty-Client Shield Null In HIV Drug Fraud Case Docs, Feds Say

    Two alleged distributors of sham HIV drugs can't shield more than 1,000 documents related to legal advice from discovery, U.S. prosecutors told a Florida federal judge Monday, asserting that any attorney-client privilege is invalidated because the advice was used to facilitate a $90 million fraud.

  • July 07, 2025

    Ex-Leerink Banker Can't Get Redo On Unpaid Bonuses Claim

    A Massachusetts federal judge declined on Monday to rethink partially tossing a former Leerink Partners employee's suit alleging she was cheated out of millions of dollars in bonuses, rejecting the worker's argument that new evidence should change the court's mind.

  • July 07, 2025

    J&J Unit Looks To Wipe Out $442M Catheter Antitrust Loss

    Johnson & Johnson health tech unit Biosense Webster has asked a California federal court to throw out Innovative Health's $442 million trial win in a case accusing Biosense of conditioning product support for its cardiac mapping systems on the purchase of cardiac catheters.

  • July 03, 2025

    States Still Oppose Florida's Generic Drug Deal With Sandoz

    States accusing generic-drug makers of fixing prices are continuing to object to a $10 million settlement struck between Florida and Sandoz, arguing that it limits their ability to negotiate deals while letting the Sunshine State benefit without participating in the litigation.

  • July 03, 2025

    Natera Inks $8.25M Deal To End Prenatal Tests Suit

    A proposed class of buyers of Natera Inc.'s noninvasive prenatal tests has asked a California federal court to give preliminary approval to an $8.25 million settlement to resolve claims that the company knew the tests were unreliable but failed to tell buyers.

  • July 03, 2025

    High Court Passes On Mont. Abortion, Parental Consent Case

    The U.S. Supreme Court declined Thursday to hear a case focused on parental consent and abortion in Montana, as two conservative justices said the decision shouldn't be seen as a rejection by the justices of the parental-rights question itself.

Expert Analysis

  • The IRS Shouldn't Go To War Over Harvard's Tax Exemption

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    If the Internal Revenue Service revokes Harvard's tax-exempt status for violating established public policy — a position unsupported by currently available information — the precedent set by surviving the inevitable court challenge could undercut the autonomy and distinctiveness of the charitable sector, says Johnny Rex Buckles at Houston Law Center.

  • New Hospice Regulations Should Enforce Core Principles

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    As the U.S. Department of Health and Human Services' Office of Inspector General prepares to research and expand on oversight of Medicare hospice care, the OIG should keep in mind certain core principles, such as an emphasis on preventing the entry of hospices that raise red flags, says Bill Dombi at Arnall Golden.

  • 7 Considerations For Conducting Drug Clinical Trials Abroad

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    With continuing cuts to U.S. Food and Drug Administration staffing motivating some pharmaceutical companies to consider developing drugs abroad, it's important to understand the additional risks and compliance requirements associated with conducting clinical studies in other countries, say attorneys at Morgan Lewis.

  • Compliance Lessons From Warby Parker's HIPAA Fine

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    The U.S. Department of Health and Human Services' civil money penalty against Warby Parker highlights the emerging challenges that consumer-facing brands encounter when expanding into healthcare-adjacent sectors, with Health Insurance Portability and Accountability Act compliance being a potential focus of regulatory attention, say attorneys at Saul Ewing.

  • 5th Circ. Ruling Is Latest Signal Of Shaky Qui Tam Landscape

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    In his recent concurring opinion in U.S. v. Peripheral Vascular Associates, a Fifth Circuit judge joined a growing list of jurists suggesting that the False Claims Act's whistleblower provisions are unconstitutional, underscoring that acceptance of qui tam relators can no longer be taken for granted, say attorneys at Miller & Chevalier.

  • Medicare Advantage Enforcement Strong Amid Agency Cuts

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    The second Trump administration's actions thus far suggest that Medicare Advantage enforcement remains a bipartisan focus despite challenges presented by evolving trends in federal agency staffing and resources, say attorneys at Ropes & Gray.

  • A New Tool For Assessing Kickback Risks In Health Marketing

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    The Seventh Circuit's recent decision in U.S. v. Sorensen, reversing a conviction after trial of a durable medical equipment distributor, highlights two principle considerations for determining whether payments to marketers in healthcare are unlawful under the Anti-Kickback Statute, says Elisha Kobre at Sheppard Mullin.

  • How Trump Orders Affect Health Orgs.' Care For Trans Minors

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    Two recent executive orders issued by President Donald Trump regarding gender-affirming care for minors have put healthcare organizations in a precarious situation, and these institutions should prepare for various implications and potential scenarios, say attorneys at ArentFox.

  • Reproductive Health Under Trump So Far, And What's Next

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    Based on priorities stated so far, the Trump administration will likely continue to weaken Biden-era policies that protect reproductive health, with abortion, in vitro fertilization and contraception all being issues to watch closely amid a post-Dobbs shift, say attorneys at McDermott.

  • What's Next For Lab Test Regulation Without FDA Authority

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    A recent Texas federal court decision vacating the U.S. Food and Drug Administration's final rule that would apply FDA regulations to laboratory-developed tests signals potential positive impacts in the diagnostic space, and could inspire more healthcare entities to litigate against the government, say attorneys at Hooper Lundy.

  • 6 Criteria Can Help Assess Executive Branch Actions

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    With new executive policy changes announced seemingly every day, several questions can help courts, policymakers and businesses determine whether such actions are proper, effective and in keeping with our democratic norms, say Marc Levin and Khalil Cumberbatch at the Council on Criminal Justice.

  • Learning From COVID-19 Enforcement Against Nursing Homes

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    Five years after the COVID-19 outbreak caused a high number of deaths in nursing homes, an examination of enforcement actions against nursing homes in New York and elsewhere in the country highlights obstacles that may arise when bringing cases of this type, and ways to overcome them, says Kenneth Levine at Stone & Magnanini.

  • How Plan Sponsors Can Mitigate Risk In PBM Contracts

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    A recent lawsuit in New York federal court alleges that JPMorgan caused exorbitant prescription costs by mishandling the pharmacy benefit manager arrangement, adding to a growing body of Employee Retirement Income Security Act fiduciary breach litigation and affirming that fiduciaries must proactively manage their healthcare plan vendors, say attorneys at Hall Benefits Law.