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Policy & Compliance

  • April 07, 2025

    CMS' Nursing Home Staffing Requirements Struck Down

    A Texas federal judge on Monday struck down new staffing standards for nursing homes participating in Medicare or Medicaid, ruling that federal health officials overstepped their authority by establishing a one-size-fits-all requirement.

  • April 07, 2025

    Policy Group Tells 4th Circ. Drug Discount Law Needs Reform

    The Fourth Circuit on Monday allowed a Boston-based think tank to file an amicus brief supporting a district court's injunction against a West Virginia law that pharmaceutical companies and lobbyists claim unconstitutionally expands a federal drug discount program.

  • April 07, 2025

    Drug Buyers, Generics Cos. Fight Over Bellwether Litigation

    Generic drug buyers vied Friday with the pharmaceutical companies they've accused of price-fixing over how to shape the first rounds of long-gestating Pennsylvania federal court litigation that the plaintiffs want heard in separate consecutive trials and that the drugmakers want combined.

  • April 07, 2025

    AGs Announce $335M Opioid Deal With Mylan

    New York Attorney General Letitia James on Monday said her office and those of other states reached a $335 million deal with Mylan to help combat the opioid crisis.

  • April 07, 2025

    Ex-Conn. Budget Official Plans To Testify In Corruption Cases

    Twice-indicted former Connecticut budget official Konstantinos Diamantis plans to testify in two upcoming federal corruption trials, his attorney revealed Monday during a scheduling call that snapped into focus the timeline for both cases.

  • April 07, 2025

    Conn. Judge Pauses 'Staggering' Hospital Data Subpoena

    A Connecticut judge temporarily paused a subpoena seeking what a health nonprofit called "a staggering amount" of confidential patient data by a proposed class of Constitution State residents accusing Hartford HealthCare Corp. of monopolizing the state's healthcare industry, stating that the court must review the subpoena first.

  • April 07, 2025

    11 States Tell 6th Circ. To Ax Mich. Conversion Therapy Ban

    Eleven U.S. states led by Iowa and South Carolina urged the Sixth Circuit to strike down Michigan's ban on conversion therapy for minors, saying the law censors therapists' speech.

  • April 07, 2025

    Feds Say Fla. Doctor Fleeced Medicare With Bogus Charges

    A doctor and his Florida-based business, Vohra Wound Physicians Management LLC, deliberately overbilled Medicare for years, charging it for wound care procedures that were unnecessary or not performed, according to federal prosecutors.

  • April 04, 2025

    Split DC Circ. Denies Calif. Subsidies For Border Hospitals

    A split D.C. Circuit panel on Friday found it was not unconstitutional for California to exclude hospitals bordering the state from a program distributing supplemental payments to providers that serve Medi-Cal beneficiaries.

  • April 04, 2025

    HHS Drops 11th Circ. Fight Over ACA Trans Rule Freeze

    The U.S. Department of Health and Human Services agreed to drop its bid to overturn an order blocking it from enforcing regulations that extend the Affordable Care Act's anti-discrimination provisions to transgender individuals against Florida organizations, according to filings with the Eleventh Circuit.

  • April 04, 2025

    Ohio AG Takes Trans Care Limits Bid To State Justices

    Ohio Attorney General Dave Yost has taken his bid to reinstate limits on gender-affirming care for transgender youths to the state's highest court and wants the law's enforcement to continue throughout his appeal.

  • April 04, 2025

    Seattle Children's Faces Class Action Over Nurse Meal Breaks

    A Washington nurse has filed a proposed class action alleging Seattle Children's Hospital broke state law by failing to schedule or provide mandatory rest and meal breaks, in a state court complaint that said the problem was made worse by understaffing during the COVID-19 pandemic.

  • April 04, 2025

    AGs Sue To Halt Disruptions To NIH Grant Funding

    A coalition of 16 states on Friday sued the National Institutes of Health over delays and cancellations of grant programs linked to vaccines, transgender issues and other areas they say are currently "disfavored" by the Trump administration.

  • April 03, 2025

    Optum, Express Scripts Want Judge Ousted From Opioid MDL

    Pharmacy benefit managers Optum and Express Scripts say the Ohio federal judge overseeing multidistrict opioid litigation should recuse himself because he "regularly communicates" with plaintiffs' attorneys in the litigation and is biased in favor of plaintiffs, according to a motion filed Wednesday.

  • April 03, 2025

    TV Star Dr. Oz Confirmed As New Medicare, Medicaid Leader

    The U.S. Senate on Thursday voted 53 to 43, along party lines, to confirm former talk show host and surgeon Dr. Mehmet Oz to be the next administrator of the Centers for Medicare & Medicaid Services.

  • April 03, 2025

    Swedish Health Services Found Liable For Wage Violations

    A Washington state judge has put Seattle-area hospital system Swedish Health Services on the hook for state wage law violations in an employee class action, finding workers were shortchanged by its timekeeping practices and failure to provide a second meal break on longer shifts.

  • April 03, 2025

    Senate Panel Advances Bills Tackling Drug Patents, Pricing

    A U.S. Senate panel on Thursday approved a group of bills tackling pharmaceutical patents and drug pricing, including measures that claim to address so-called patent thickets and an industry practice called "product hopping."

  • April 03, 2025

    2nd Circ. Judge Thinks Drug Price Fight Sounds Like Antitrust

    A Second Circuit judge on Thursday suggested that the federal government may be insulated from claims over its demand for lower prices for Medicare and Medicaid recipients, musing that Boehringer Ingelheim Pharmaceuticals Inc.'s constitutional challenge to an Inflation Reduction Act provision sounds more like an antitrust allegation.

  • April 03, 2025

    RI Judge Hits Pause On Billions In Health Grant Funding Cuts

    A Rhode Island federal judge on Thursday barred the Trump administration from moving forward, for now, with the termination of billions of dollars in grants supporting state public health programs.

  • April 03, 2025

    Baker Donelson Elevates Health Law And Public Policy Heads

    Three Baker Donelson Bearman Caldwell & Berkowitz PC shareholders have been tapped for leadership roles within the firm's national health law and public policy department.

  • April 02, 2025

    NIH Sued By Researchers Over 'Ideological Purge' On Grants

    The American Public Health Association and others sued the federal government in Massachusetts federal court on Wednesday over the cancellations of billions of dollars worth of National Institutes of Health research grants on such issues as gender identity, diversity, vaccine hesitancy and climate change, claiming the "ideological purge" is illegal.

  • April 02, 2025

    GoodRx, PBM Price-Fixing MDL Set In Rhode Island

    The Judicial Panel on Multidistrict Litigation on Wednesday consolidated in Rhode Island litigation alleging that GoodRx conspired with pharmacy benefit managers, including CVS Caremark and Express Scripts, to suppress reimbursements to independent pharmacies for dispensing generic prescription medications.

  • April 02, 2025

    Sotomayor Seems Wary Of 'Magic Words' For Medicaid Rights

    The U.S. Supreme Court's liberal bloc on Wednesday bristled at the notion that "magic words" were necessary to cement a public insurance program recipient's right to sue, suggesting that a private right of action is inherent in the Medicaid Act's provider choice provision.

  • April 02, 2025

    CVS Asserts DOJ's Opioid Prescription Suit Lacks Facts

    CVS Pharmacy Inc. has told a Rhode Island federal judge that most of the U.S. Department of Justice's claims that it knowingly filed invalid prescriptions for opioids should be tossed, saying the agency failed to adequately allege the company willfully put profits over safety.

  • April 02, 2025

    BakerHostetler Adds Ex-Federal Prosecutor As Partner

    A former assistant U.S. attorney for the Northern District of Illinois has joined BakerHostetler in its Chicago office as a partner in the firm's litigation practice group, where he will focus on white collar matters, internal investigations and civil litigation.

Expert Analysis

  • A Primer On Navigating The Conrad 30 Immigration Program

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    As the Conrad 30 program opens its annual window to help place immigrant physicians in medically underserved areas, employers and physicians engaged in the process must carefully understand the program's nuanced requirements, say Andrew Desposito and Greg Berk at Sheppard Mullin.

  • Class Actions At The Circuit Courts: September Lessons

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    In this month's review of class action appeals, Mitchell Engel at Shook Hardy identifies practice tips from four recent class certification rulings involving denial of Medicare reimbursements, automobile insurance disputes, veterans' rights and automobile defects.

  • Proposed Legislation May Crack Down On Online Drug Ads

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    A bill recently proposed in Congress could serve as a sea change in how the U.S. Food and Drug Administration regulates drug-related speech, with significant trickle-down effects on various corners of not only the drug industry but also on consumers and providers themselves, say Dominick DiSabatino and Arushi Pandya at Sheppard Mullin.

  • What To Expect From Calif. Bill Regulating PE In Healthcare

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    A California bill currently awaiting Gov. Gavin Newsom's approval, intended to increase oversight over private equity and hedge fund investments in healthcare, is emblematic of recent increased scrutiny of investments in the space, and may affect transactions and operations in California in a number of ways, say attorneys at Ropes & Gray.

  • Vertex Suit Highlights Issues For Pharma Fertility Support

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    Vertex Pharmaceuticals' recent lawsuit challenging the U.S. Department of Health and Human Services' interpretation of the Anti-Kickback Statute is influenced by a number of reproductive rights and health equity issues that the Office of Inspector General should address more concretely, including in vitro fertilization and fertility preservation programs, says Mary Kohler at Kohler Health Law.

  • CMS' New 'Breakthrough' Device Policy Shows Little Promise

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    The Centers for Medicare & Medicaid Services’ recent procedural notice outlining a new Medicare coverage pathway for breakthrough medical devices will, at best, be a failed experiment and, at worst, result in Medicare beneficiaries denied access to innovative treatments, say attorneys at King & Spalding.

  • A Preview Of AI Priorities Under The Next President

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    For the first time in a presidential election, both of the leading candidates and their parties have been vocal about artificial intelligence policy, offering clues on the future of regulation as AI continues to advance and congressional action continues to stall, say attorneys at Mintz.

  • Managing Community Health Needs Assessments: A Checklist

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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.