Policy & Compliance

  • 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.

  • July 03, 2025

    HHS Ordered To Restore Data Axed Under 'Gender Ideology' EO

    The U.S. Department of Health and Human Services must restore a swath of webpages and datasets it took down following a Trump administration executive order seeking to root out references to so-called gender ideology, a D.C. federal judge ruled.

  • July 03, 2025

    Mich. Justices Turn Down Challenge To Med Mal Damage Cap

    Michigan's highest court won't weigh in on the constitutionality of the state's caps on medical malpractice awards, rejecting a federal district court's certified question Thursday.

  • July 03, 2025

    The Firms That Won Big At The Supreme Court

    The number of law firms juggling three or more arguments before the U.S. Supreme Court this past term nearly doubled from the number of firms that could make that claim last term.

  • July 03, 2025

    Breaking Down The Vote: The High Court Term In Review

    The U.S. Supreme Court once again waited until the term's closing weeks — and even hours — to issue some of its most anticipated and divided decisions.

  • July 03, 2025

    Supreme Court Takes Up Transgender Sports Bans

    The U.S. Supreme Court agreed Thursday to hear challenges to West Virginia and Idaho laws barring transgender athletes from competing on sports teams consistent with their gender identity, putting yet more anti-trans legislation to the test after upholding Tennessee's ban on gender-affirming care for minors this term. 

Expert Analysis

  • A Primer On EU's Updated Human Substance Regulations

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    The European Union's updated standards regarding quality and safety of substances of human origin meant for human application carry significant implications for companies that work with cells and tissues, and U.S. companies active in the EU market should pay particular attention to the import and export rules, say Geneviève Michaux and Georgios Symeonidis at King & Spalding.

  • CFPB's Medical Debt Proposal May Have Side Effects

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    The Consumer Financial Protection Bureau’s recent proposal to prevent medical debt information from appearing on consumer reports and creditors from basing lending decisions on such information may have initial benefits for some consumers, but there are potential negative consequences that should also be considered, say attorneys at Cooley.

  • 15 Areas That Would Change Under Health Data Rule Proposal

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    If finalized, the Office of the National Coordinator for Health Information Technology's proposed rule will significantly progress its efforts to advance interoperability, respond to stakeholder concerns and clarify compliance with the health IT certification program, say attorneys at Ropes & Gray.

  • 3 Healthcare FCA Deals Provide Self-Disclosure Takeaways

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    Several civil False Claims Act settlements of alleged healthcare fraud violations over the past year demonstrate that healthcare providers may benefit substantially from voluntarily disclosing potential misconduct to both the U.S. Department of Justice and the U.S. Department of Health and Human Services, say Brian Albritton and Raquel Ramirez Jefferson at Phelps Dunbar.

  • Takeaways From High Court's Tribal Health Admin Cost Ruling

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    The U.S. Supreme Court's recent determination that the government must reimburse two Native American tribes for administrative healthcare costs will help tribes maintain equal footing with the Indian Health Service when administering programs, and continues a pattern of how the current court aligns on tribal concerns, say attorneys at Lewis Roca.

  • FTC Focus: Private Equity Investments In Healthcare

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    As the Federal Trade Commission is tightening its scrutiny of private equity investment in healthcare, the agency is finding novel grounds to challenge key focus areas, including rollup acquisitions, the flip-and-strip approach and minority investments in rival providers, say attorneys at Proskauer.

  • High Court's Expert Ruling May Help Health Fraud Defendants

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    The U.S. Supreme Court's decision in Diaz v. U.S. appears to give the government a powerful new tool in calling its own agents as expert witnesses, but it could also benefit defense counsel in criminal healthcare fraud and other white collar criminal cases that arise in complex legal or regulatory environments, say attorneys at Holland & Knight.

  • Unpacking HHS' Opinion On Cell Therapy Refund Programs

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    A recent advisory opinion from the U.S. Department of Health and Human Services, determining that a biopharma company's refund program for its cell therapy will not be penalized, indicates an encouraging willingness to engage, but the regulator's assumptions about the program's limited term warrant a closer look, says Mary Kohler at Kohler Health.

  • DOJ Innovasis Settlement Offers Lessons On Self-Disclosure

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    The recent $12 million settlement with Innovasis and two of its executives demonstrates the U.S. Department of Justice's continued prioritization of Anti-Kickback Statute enforcement amid the growing circuit split over causation, and illustrates important nuances surrounding self-disclosure, say Denise Barnes and Scott Gallisdorfer at Bass Berry.

  • How Orange Book Antitrust Scrutiny Is Intensifying

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    Pharmaceutical patent holders should be reviewing Orange Book listing practices, as the Federal Trade Commission takes a more aggressive antitrust approach with actions such as the Teva listing probe, and the U.S. Food and Drug Administration calls attention to potentially improper listings, say attorneys at McDermott.

  • After Chevron: Slowing Down AI In Medical Research

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    The U.S. Supreme Court's recent decision overturning the Chevron doctrine may inhibit agencies' regulatory efforts, potentially slowing down the approval and implementation of artificial intelligence-driven methodologies in medical research, as well as regulators' responses to public health emergencies, say Ragini Acharya and Matthew Deutsch at Husch Blackwell.

  • FDA's Multifaceted Role On Display In MDMA Therapy Scrutiny

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    Ongoing deliberations at the U.S. Food and Drug Administration regarding MDMA-assisted therapy for post-traumatic stress disorder serves as a window into the intricate balance of scientific innovation and patient safety oversight, and offers crucial insights into regulatory nuances, say Kimberly Chew at Husch Blackwell and Kevin Lanzo at Pharmaka Clinical Consulting.

  • Analyzing FDA Draft Guidance On Clinical Trial Diversity

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    In light of the U.S. Food and Drug Administration's draft guidance on clinical trial diversity action plans, there are several important considerations for sponsors and clinical researchers to keep in mind to prevent delay in a drug or device application, say attorneys at Crowell & Moring.