Policy & Compliance

  • 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.

  • April 01, 2025

    Unregulated Health Cost 'Ministries' Attract State Scrutiny

    Offering a cheap alternative to traditional health insurance and a faith-based approach, health cost "sharing ministries" operate across the country with little oversight. But consumer complaints have prompted regulators in California and a number of other states to take action.

  • April 01, 2025

    Ala. Ruling Won't End Interstate Fights Over Abortion Travel

    A federal court order blocking Alabama from prosecuting doctors for helping women seek out-of-state abortions won't end legal conflicts between states with abortion bans and those without.

  • April 01, 2025

    Takeda Antitrust Trial Over Actos Generics Set For July

    A New York federal court refused a bid from Takeda Pharmaceuticals Co. to escape a long-running case accusing it of unlawfully delaying generic versions of its diabetes treatment Actos and scheduled a trial to start in July.

  • April 01, 2025

    Enforcement Delays Ahead Amid HHS Regional Closures

    The Trump administration's overhaul of the U.S. Department of Health and Human Services' in-house legal team is likely to slow enforcement proceedings and other compliance activities involving Medicare providers.

  • April 01, 2025

    Fla. Defends Sandoz Price-Fixing Settlement Terms

    Florida defended its deal with Sandoz Inc. on Monday, saying the other states suing the generic-drug maker over price-fixing have no right to object to the settlement, which does not require court approval and does not affect the states objecting to it.

  • April 01, 2025

    Tenn. PBM Statute Conflicts With ERISA, Judge Says

    Tennessee law requiring pharmacy benefits managers to accept "any willing pharmacies" into their network clashes with the Employee Retirement Income Security Act, a federal judge ruled, saying the state can't enforce its statute against McKee Foods Corp. or other plans governed by the federal benefits law.

  • April 01, 2025

    Ex-Biotech CEO Wrongly Sentenced To 7 Years, DC Circ. Told

    A former biotech executive who pled guilty to misleading investors about a blood-based COVID-19 test urged the D.C. Circuit to order a redo of his seven-year prison sentence on Tuesday, telling an appeals panel that the trial court miscalculated the sentencing guidelines.

  • April 01, 2025

    Top Court Abortion Case Sets High Stakes For Medicaid

    The U.S. Supreme Court is set to hear arguments Wednesday in a case over South Carolina's attempt to exclude a Planned Parenthood chapter from Medicaid, weighing whether patients can take state officials to court over the Medicaid Act's "free choice of provider" provision. Experts say the outcome could have a broad impact on state authority to say which providers can or cannot treat low-income patients, and how.

  • April 01, 2025

    Medicaid Changes May Intensify State AG FCA Enforcement

    After decades of increasing False Claims Act enforcement in the healthcare industry, relators and defense counsel alike are now bracing for even more activity by state attorneys general as a federal push to cut spending could leave state taxpayers bearing more Medicaid costs.

  • April 01, 2025

    23 States Sue HHS To Stop $11B In Health Grant Funding Cuts

    Twenty-three states and the District of Columbia on Tuesday accused the Trump administration of illegally terminating about $11 billion in public health funding, causing layoffs and "chaos" in public health agencies across the country.

  • March 31, 2025

    Doc Loses Redo On Claims Hospital Lies Fueled Murder Case

    A Michigan federal judge has dismissed a former Ohio physician's second attempt at suing the parent company of his ex-employer on allegations it fed prosecutors lies about his opioid prescribing practices that led to him being charged with 25 counts of murder, saying the lawsuit didn't fix the gaps left in the first case.

  • March 31, 2025

    Despite 'Admirable' Effort, Vertex Kickback Challenge Fails

    A D.C. federal judge dealt a loss on Monday to gene therapy drugmaker Vertex Pharmaceuticals, ruling in favor of a U.S. Department of Health and Human Services advisory opinion that found the company's fertility preservation program could potentially violate the Anti-Kickback Statute.

  • March 31, 2025

    DocGo Can't Nix Investor Suit Over 'Indisputably False' Claims

    A New York federal judge has trimmed a proposed class action alleging that mobile medical provider DocGo and its top brass misled stockholders before its $432 million migrant-services contract with New York City faced public scrutiny, but the judge found that claims stemming from the former CEO's "indisputably false" statements can proceed.

Expert Analysis

  • Rank-And-File DOJ Attorneys Will Keep Calm And Carry On

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    Career prosecutors at the U.S. Department of Justice often pride themselves on their ability to remain apolitical in order to ensure consistency and keep the department’s mission afloat, and the incoming Trump administration is unlikely to upend this tradition, says Michael Landman at Bird Marella.

  • Unpacking Arguments From High Court's Rural Hospital Case

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    During oral arguments in Advocate v. Becerra, the U.S. Supreme Court justices focused questions on the meaning of being "entitled to" supplementary security income assistance, and there's reason for optimism that the likely split decision will break in favor of hospitals, say attorneys at King & Spalding.

  • Health Policy Predictions For Trump's Second Administration

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    As President-elect Donald Trump's nominations for health policy and enforcement heads work their way through the confirmation process, healthcare organizations can look at nominee backgrounds, campaign statements and actions from Trump's previous presidency to predict incoming priorities, say attorneys at McDermott.

  • What Trump's Next Term May Mean For Biz Immigration

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    Leonard D'Arrigo at Harris Beach discusses the employment-based immigration policies businesses can potentially expect during President-elect Donald Trump’s second term, based on policies enacted during his first administration, statements made during his campaign and proposals in Project 2025.

  • Weak Reasoning Underlies Fla. Judge's Bold Qui Tam Ruling

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    U.S. District Judge Kathryn Mizelle's groundbreaking decision in U.S. ex rel. Zafirov v. Florida Medical Associates LLC, holding that qui tam provisions of the False Claims Act are unconstitutional, relies on weak logic to reach a conclusion that differs from every other court that has ruled on the issue, says Ethan Greenberg at Anderson Kill.

  • Medicare Overpayment Rules Are A Mixed Bag For Providers

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    The Centers for Medicare & Medicaid Services' updated rules for handling agency overpayments adopt a more reasonable definition of what it means to have "identified" an overpayment, which is a win for providers, but their new time frame for investigating related overpayments is unrealistic, says Susan Banks at Holland & Knight.

  • Expect More State-Level Scrutiny Of Noncompetes Ahead

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    Despite the nationwide injunction against the Federal Trade Commission’s noncompete ban, and the incoming Republican administration, employers should anticipate that state legislatures will continue to focus on laws that limit or ban noncompetes, including those that target certain salary thresholds or industries, says Benjamin Fryer at FordHarrison.

  • Cos. Should Inventory Issues To Prep For New Congress

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    As the legislative and oversight agendas of the 119th Congress come into sharper focus, corporate counsel should assess and plan for areas of potential oversight risk — from tax policy changes to supply chain integrity — even as much uncertainty remains, say attorneys at WilmerHale.

  • Incoming Admin May Shake Up Life Sciences Regulation

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    Though President-elect Donald Trump has not yet articulated policy priorities regarding the life sciences industry, the sector is positioned to see significant changes that could affect everything from drug exclusivity and generic drug approvals, to the availability of over-the-counter drugs, to laboratory-developed tests and digital health, say attorneys at Morgan Lewis.

  • Navigating DOJ's Patchwork Whistleblower Regime

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    In the past few months, the U.S. Department of Justice and several individual U.S. attorney’s offices have issued different pilot programs aimed at incentivizing individuals to blow the whistle on misconduct, but this piecemeal approach may create confusion and suboptimal outcomes, say attorneys at BakerHostetler.

  • What To Expect Next From Federal Health Tech Regulation

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    Healthcare organizations should pay close attention to federal health information technology regulators' recent guidance concerning barriers to accessing electronic health information, which signals that more enforcement in this area is likely forthcoming, say attorneys at Ropes & Gray.

  • 5 Areas Congress May Investigate After GOP Election Wins

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    With Republicans poised to take control of Congress in addition to the executive branch next year, private companies can expect an unprecedented uptick in congressional investigations focused on five key areas, including cryptocurrency and healthcare, say attorneys at Cahill Gordon.

  • Takeaways From State Votes On Abortion In The 2024 Election

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    Attorneys at Epstein Becker discuss how 10 states voted on ballot initiatives to either protect or restrict access to abortion in the 2024 general election, and analyze overarching trends.