Policy & Compliance

  • December 03, 2024

    What To Know About High Court's 1st Transgender Care Case

    When the U.S. Supreme Court justices gather for oral arguments on Wednesday, they will hear the court's first transgender healthcare case. Their decision could determine whether Tennessee's ban on affirming healthcare for transgender adolescents is unconstitutional and steer the fate of similar prohibitions across the country.

  • December 03, 2024

    VA Announces Study On MDMA-Assisted Therapy For Vets

    The U.S. Department of Veterans Affairs announced Tuesday it will fund a study on psychedelic-assisted therapy for veterans with post-traumatic stress disorder and alcohol use disorder, alongside researchers from Brown University and Yale University.

  • December 03, 2024

    FCA Whistleblower Provisions Could Face Peril Under Trump

    Over 160 years after enactment of the False Claims Act and its qui tam provisions, the confluence of a conservative U.S. Supreme Court and a second Trump administration has attorneys contemplating a future without whistleblower-led litigation.

  • December 03, 2024

    Veterans Group Challenges Exclusion From DEA Pot Hearing

    A veterans group is challenging the U.S. Drug Enforcement Administration's decision to deny it a spot among 25 participants in hearings exploring whether to reschedule cannabis under the Controlled Substances Act, saying veterans have been deprived of an advocate for a conclusion that would best suit their needs.

  • December 03, 2024

    GOP-Backed Medicaid Job Mandate Could Reshuffle Care

    Medicaid work requirements — a much-debated idea expected to get fresh support in the next Trump administration — could jolt the nation's healthcare system by shrinking the number of people with health coverage and boosting uncompensated care at hospitals.

  • December 02, 2024

    House COVID-19 Probe Points to China 'Lab Leak'

    The Republican-led House Select Subcommittee on the Coronavirus Pandemic published the results of its two-year investigation into the origins of the COVID-19 pandemic Monday, concluding that COVID-19 "most likely" emerged from a laboratory in Wuhan, China, and heavily criticizing the Biden administration, Anthony Fauci and left-leaning organizations for their responses.

  • December 02, 2024

    Newsom Wants $25M For Expected Legal Fights With Trump

    California Gov. Gavin Newsom announced Monday that he wants up to $25 million for litigation and legal fights he foresees with the administration of President-elect Donald Trump, kicking off the first day of a special session the state Legislature held at the governor's request after Trump's win.

  • December 02, 2024

    9th Circ. Partially Upholds Block Of Idaho Abortion Travel Ban

    A split Ninth Circuit panel on Monday upheld part of a lower court's temporary injunction to an Idaho law that criminalizes helping minors travel out of state to receive abortions without parental permission, finding the "recruiting" portion of the law is unconstitutional. 

  • November 27, 2024

    Split Ohio High Court Revives Death Suit Against Pa. Doctor

    An Ohio law that pauses the statute of limitations for lawsuits against parties who leave the state does not violate the dormant commerce clause of the U.S. Constitution because it neither facially discriminates against out-of-state entities nor has some economic protectionist purpose, the state Supreme Court ruled Wednesday.

  • November 27, 2024

    PBM Says Opioid Ruling Ignored High Court's Privilege Stance

    A special master's ruling that internal audit records from Express Scripts Inc. are not protected by attorney-client privilege should be overturned because it contradicts nearly 40 years of U.S. Supreme Court precedent, the pharmacy benefit manager told an Ohio federal court overseeing multidistrict opioid litigation.

  • November 27, 2024

    Nonprofit Warns 3rd Circ. Against 'Abuse' In Merck Vax Case

    The anti-monopoly think tank Open Markets Institute urged the full Third Circuit to rethink a panel's immunization of Merck & Co. Inc. from antitrust claims over its mumps vaccine, arguing in an amicus brief that the doctrine cementing the right to petition the government doesn't justify the use of courts and administration as a "competitive weapon."

  • November 27, 2024

    Up Next At The High Court: Transgender Care, Holocaust Art

    The U.S. Supreme Court will return to the bench Monday for its December arguments session, which will include blockbuster questions about the constitutionality of state laws banning gender-affirming care for transgender minors and whether Hungary can be held liable for property stolen during World War II.

  • November 27, 2024

    Hospital Sued For Firing Tech Who Reported Lax Drugmaking

    A pharmacy technician claims in Illinois state court that she was fired from Lurie Children's Hospital in Chicago for making complaints both internally and to state regulators that the medications for pediatric patients were being compounded in an unsanitary manner and that the facilities weren't being properly cleaned.

  • November 26, 2024

    Trump Taps Bhattacharya For National Institutes Of Health

    President-elect Donald Trump announced Tuesday that he has selected Dr. Jay Bhattacharya, a physician who opposed the use of lockdowns and mask mandates to contain the spread of COVID-19, to lead the National Institutes of Health.

  • November 26, 2024

    NIH Beats 4th Circ. Bid To Unmask COVID Researcher

    National Institutes of Health on Tuesday defeated a circuit court appeal by a whistleblower organization which had sought to uncover the identity of a Wuhan University researcher who submitted sequencing data to an open-access NIH archive.

  • November 26, 2024

    Colo. Panel Weighs In On Faulty Genetic Test Damages

    A long-standing Colorado law limiting healthcare provider liability in certain negligence actions got its first interpretation, issued by a state appellate court panel. 

  • November 26, 2024

    In Court: Abortion, Gender Care, PBMs and Insulin Pricing

    An abortion ban bench trial in Idaho. A Texas high court decision on a "heartbeat" ban. A consumer protection agency delays medical debt guidance amid a legal challenge. Law360 Healthcare Authority looks at those and other significant decisions shaping the healthcare industry.

  • November 26, 2024

    Trump FDA Pick Devoted To Healthcare Price Transparency

    The nomination of surgeon Marty Makary to lead the U.S. Food and Drug Administration elevates a healthcare transparency advocate who authored books on the subject and pushed for hospitals to disclose their standard prices during the first Trump administration.

  • November 26, 2024

    Meet The Attys Arguing Tenn. Trans Care Ban At High Court

    Tennessee's solicitor general and the first openly transgender lawyer to appear before the U.S. Supreme Court are set to face off next week to debate the constitutionality of a state ban on gender-affirming care for minors.

  • November 26, 2024

    Pa. Nursing Home Eying Sale Seeks Fraud Sentencing Delay

    The parent company for a troubled Western Pennsylvania nursing home asked a federal court to postpone a sentencing for defrauding state and federal healthcare programs so the company can keep trying to sell the facility, or at least relocate its residents over a longer period of time.

  • November 25, 2024

    At Trial, Ex-Clinic Head Accuses Seattle Hospital Of Race Bias

    A Black ex-clinical director told a Washington state jury Monday that a Seattle hospital owes him millions of dollars for failing to address a "culture of racism" targeting him and the patients of color he advocated for while leading a clinic with a purported mission of advancing equity.

  • November 25, 2024

    Missouri Gender-Affirming Care Ban Upheld As Constitutional

    A Missouri state judge rejected a legal challenge to the state's ban on providing gender-affirming care to minors and adults, finding Monday the court should defer to the Legislature given that challengers hadn't proven the restrictions violated the U.S. Constitution.

  • November 25, 2024

    5th Circ. Upholds Miss. Ban On Medical Pot Ads

    Marijuana dispensaries do not have protections under the First Amendment to advertise their products because the drug is still illicit under federal law, the Fifth Circuit ruled, tossing a lawsuit that sought to upend the state's tight regulations on cannabis ads.

  • November 22, 2024

    MultiCare $2M Deal Ends Fed's ADA Missing Interpreter Probe

    MultiCare Health Systems of Washington will set aside $2 million in compensation to end a federal civil rights investigation into complaints the hospital operator failed to provide interpreters for deaf-blind patients before and after surgery.

  • November 22, 2024

    Texas Justices Say Court Bungled Ruling In Abortion Case

    The Texas Supreme Court said Friday a lower appellate court tried to "prematurely drag the judiciary into highly contentious and politicized debates" around abortion without analyzing a key standing issue, jeopardizing Planned Parenthood's and other abortion rights groups' bid to invalidate the controversial Texas Heartbeat Act.

Expert Analysis

  • Managing Community Health Needs Assessments: A Checklist

    Excerpt from Practical Guidance
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    To guide nonprofit hospitals and health systems through their required community health needs assessment every three years, this checklist outlines the steps for 12 phases of the process.

  • Pa. Health Employers Must Prep For Noncompete Restrictions

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    Newly enacted legislation in Pennsylvania prohibits certain noncompete covenants for healthcare practitioners in the state beginning next year, creating compliance challenges that both employers and employees should be aware of, say attorneys at Buchanan Ingersoll.

  • FTC Focus: What Access To Patent Settlements Would Mean

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    Settling parties should adopt a series of practice tips, including specifying rationales to support specific terms, as the Federal Trade Commission seeks to expand its access to settlements before the Patent Trial and Appeal Board, say Shannon McGowan and David Munkittrick at Proskauer.

  • Agencies Should Reward Corporate Cyber Victim Cooperation

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    The increased regulatory scrutiny on corporate victims of cyberattacks — exemplified by the U.S. Securities and Exchange Commission's case against SolarWinds — should be replaced with a new model that provides adequate incentives for companies to come forward proactively and collaborate with law enforcement, say attorneys at McDermott.

  • Strategies To Defend Against Healthcare Nuclear Verdicts

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    The healthcare industry is increasingly the target of megaclaims, particularly those alleging medical malpractice, but attorneys representing providers can use a few tools to push back on flimsy litigation and reduce the likelihood of a nuclear verdict, says LaMar Jost at Wheeler Trigg.

  • What Drug Cos. Must Know About NY Price Transparency Law

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    Drug manufacturers must understand the contours of New York's recently implemented law requiring self-reporting of drug price increases, as well as best practices for compliance and challenges against similar laws in other states, say Elizabeth Bierut and Angie Garcia at Friedman Kaplan.

  • Whistleblowers Must Note 5 Key Differences Of DOJ Program

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    The U.S. Department of Justice’s recently unveiled whistleblower awards program diverges in key ways from similar programs at other agencies, and individuals must weigh these differences and look first to programs with stronger, proven protections before blowing the whistle, say Stephen Kohn and Geoff Schweller at Kohn Kohn.

  • The Licensure Landscape For Psychedelics Manufacturers

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    As the need for bulk manufacturing of psychedelic substances grows, organizations aiming to support clinical trials or become commercial suppliers must navigate a rigorous and multifaceted journey to obtaining a license from the U.S. Drug Enforcement Administration, say Kimberly Chew at Husch Blackwell and Jaime Dwight at Promega Corp.

  • OSHA Workplace Violence Citation Highlights Mitigation Steps

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    The Occupational Safety and Health Administration's recent citation against behavioral health company Circles of Care sheds light on the enforcement risks companies may face for failing to prevent workplace violence, and is a reminder of the concrete steps that can help improve workplace safety, say attorneys at Benesch.

  • When Banks Unknowingly Become HIPAA Biz Associates

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    There appears to be significant confusion regarding the application of the Health Insurance Portability and Accountability Act to financial institutions when serving healthcare-related clients, so these institutions should consider undertaking several steps as a starting point in the effort to achieve compliance, say attorneys at Vorys.

  • The Regulatory Headwinds Facing Lab-Developed Tests

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    Though the U.S. Food and Drug Administration's final rule regarding regulation of laboratory-developed tests outlines a four-year plan for ending enforcement discretion, and though this rule is currently being challenged in courts, manufacturers should heed compliance opportunities immediately as enforcement actions are already on the horizon, say attorneys at Kirkland & Ellis.

  • 3 High Court Rulings May Shape Health Org. Litigation Tactics

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    Three separate decisions from the U.S. Supreme Court's most recent term — Loper Bright, Corner Post and Jarkesy — will likely strengthen healthcare organizations' ability to affirmatively sue executive agencies to challenge regulations governing operations and enforcement actions, say attorneys at McDermott.

  • A New Way Forward For COVID Vaccine Lawsuit Immunity

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    As Public Readiness and Emergency Preparedness Act protections for COVID-19 vaccines wane, adding those vaccines to coverage by the National Vaccine Injury Compensation Program would bolster defenses for administrators and manufacturers while also providing stronger remedies for those injured by vaccines, says Altom Maglio at MCT Law.