Policy & Compliance

  • September 16, 2025

    CVS Caremark Takes $290M Overbilling Judgment To 3rd Circ.

    CVS's pharmacy benefits manager will appeal a judgment against the company that was recently increased from $95 million to $290 million in a suit alleging it overbilled Medicare Part D-sponsored drugs, according to a notice of appeal filed in Pennsylvania federal court.

  • September 16, 2025

    WellSpan Health Elevates Atty To Legal Chief

    Regional healthcare provider WellSpan Health has tapped one of the company's in-house attorneys to lead its law department in its south central Pennsylvania headquarters.

  • September 16, 2025

    For Cahill Atty, Rare Disease Pro Bono Work Is Personal

    John MacGregor of Cahill Gordon & Reindel LLP didn't have any experience in healthcare law before taking on a pro bono client that supports people with a rare form of epilepsy. MacGregor's son is one of them.

  • September 16, 2025

    HHS OIG Senior Counsel Joins Polsinelli As Shareholder

    A former senior counsel in the U.S. Department of Health and Human Services' Office of Counsel to the Inspector General, who spent more than a decade in private practice before his most-recent six years in public service, has joined Polsinelli PC.

  • September 15, 2025

    Mich. Says HHS Can't Justify $195M Medicaid Clawback

    The state of Michigan urged a federal judge to find that the U.S. Department of Health and Human Services cannot catch a payday for its yearslong delay in affirming a decision to disallow $195 million in Medicaid payments to two state-operated psychiatric hospitals, arguing that the delay runs afoul of federal law and the department's own policies.

  • September 15, 2025

    Stewart Says New Policies Seek Fairness For Patent Owners

    Acting U.S. Patent and Trademark Office Director Coke Morgan Stewart said Monday the numerous changes to patent reviews she has implemented are intended to provide "more balance and fairness" for patent owners, and bring the reviews "back to how they were originally intended."

  • September 15, 2025

    Corcept Can't Escape Teva's Mifepristone Antitrust Suit

    Corcept Therapeutics must face most of Teva Pharmaceuticals' lawsuit alleging it suppressed generic competition for its brand-name medication used to treat a rare cortisol disorder, a California federal judge ruled, saying the claims are not time-barred and Teva has adequately alleged unlawful monopolization.

  • September 15, 2025

    Mich. Ordered To Clarify Stance On Clinic's Trans Care Policy

    A federal magistrate judge on Monday ordered Michigan civil rights enforcers to clarify in discovery responses whether a Christian medical clinic's opposition to gender-affirming care violates the state's antidiscrimination law.

  • September 12, 2025

    AbbVie Can't Halt Miss. Discount Drug Law, 5th Circ. Says

    AbbVie and other pharmaceutical manufacturers that participate in Medicaid cannot preliminarily block a Mississippi law barring their interference with the distribution of discounted prescriptions to pharmacies serving low-income patients, the Fifth Circuit ruled Friday, saying the drugmakers haven't shown that the statute likely effectuates a taking of their property.

  • September 12, 2025

    Ex-Conn. Assistant AG Faces DQ Bid In Price-Fixing Case

    Drug companies accused of fixing prices for generics are seeking to disqualify former Connecticut Assistant Attorney General Joseph Nielsen and his law firm from representing insurers in a multidistrict litigation, arguing Nielsen had access to confidential information as a government attorney that he could unfairly use against them now.

  • September 11, 2025

    States Push Conn. Court To Ban Generic Drug Price-Fixing

    A court order is necessary to prevent pharmaceutical companies and their executives from illegally fixing the prices of generic drugs, a coalition of state enforcers have told a Connecticut federal judge, arguing there is a "reasonable expectation" that the allegedly anticompetitive behavior at the center of multidistrict litigation will happen again.

  • September 11, 2025

    Medicare Drug Pricing Plan Survives Novartis' 3rd Circ. Appeal

    The Third Circuit ruled Thursday that the Centers for Medicare & Medicaid Services' ability to negotiate "maximum fair prices" with drugmakers doesn't violate their constitutional rights, rejecting an argument by Novartis Pharmaceuticals Corp. that the practice amounted to a raw deal for the pharmaceutical industry.

  • September 11, 2025

    Expert's AI Hallucinations Blamed On Attys' 'Willful Blindness'

    Utah anesthesiologists facing a False Claims Act fraudulent billing suit doubled down Wednesday on their bid to sanction and disqualify the whistleblower's counsel for not catching an expert witness report with numerous AI-generated fabrications, arguing the errors were so obvious that the failure to catch them constitutes "willful blindness."

  • September 11, 2025

    1st Circ. OKs Freeze Of Planned Parenthood Medicaid Funding

    The First Circuit on Thursday allowed the Trump administration to halt Medicaid reimbursements to Planned Parenthood and its affiliates, pausing a pair of lower court rulings that had blocked the funding cut.

  • September 11, 2025

    7th Circ. Backs $183M FCA Award Over Eli Lilly Drug Rebates

    The Seventh Circuit refused on Thursday to unwind a whistleblower's $183 million trial win against Eli Lilly in a false claims case targeting more than a decade of drug rebate miscalculations, saying a jury reasonably found that the company knowingly "hid the truth" about how much it charged for Medicaid-covered drugs.

  • September 11, 2025

    LifePoint Must Face Workers' 401(k) Mismanagement Suit

    A Tennessee federal judge refused to toss a proposed class action against LifePoint Health Inc. from participants in the healthcare company's employee 401(k) plan who alleged their retirement savings were dragged down by excessive recordkeeping and administrative fees, concluding allegations were sufficiently backed up to proceed to discovery.

  • September 10, 2025

    Feds Barred From Axing 30-Year Noncitizen Services, For Now

    A Rhode Island federal judge Wednesday blocked the Trump administration from enacting a policy change requiring immigration status checks for a number of federally funded community services, saying a coalition of Democratic-led states is likely to succeed in its assertion that the move is unconstitutional, as well as arbitrary and capricious.

  • September 10, 2025

    FTC Urged To Probe Microsoft Over Ascension Data Breach

    U.S. Sen. Ron Wyden, D-Ore., is calling on the Federal Trade Commission to open an investigation into Microsoft's "gross cybersecurity negligence" that has allegedly contributed to cyberattacks against critical infrastructure providers, including a 2024 ransomware hack that targeted hospital system Ascension.

  • September 10, 2025

    FTC Warns Healthcare Employers About Noncompetes

    The Federal Trade Commission has sent letters warning healthcare employers and staffing companies not to include overly broad noncompete restrictions in their employment contracts and urged them to conduct a review to ensure they comply with the law.

  • September 10, 2025

    Medical Equipment Co. Settles County Claims In Opioid MDL

    Medical equipment company Henry Schein Inc. and its related entities have settled claims by Virginia counties brought against it in the sprawling national opioid litigation, according to a notice filed Wednesday.

  • September 09, 2025

    4th Circ. Debates Whether 'Silence' In 340B Empowers States

    Two states told a Fourth Circuit panel on Tuesday that "silence" in the law governing the federal government's drug discount program permits state enforcers to step in and regulate the delivery of those drugs to their communities.

  • September 09, 2025

    Trump Admin Blocked From Boston Hospital Trans Care Docs

    A Massachusetts federal judge on Tuesday blocked the Trump administration's bid to gain access to a wide array of documents related to gender-affirming care at Boston Children's Hospital, finding that the request is a veiled attempt to limit such care in the state.

  • September 09, 2025

    Colo. Justices Rule Interest Not Covered By $1M Med Mal Cap

    The Colorado Supreme Court has ruled that the state's $1 million cap on medical malpractice damages doesn't encompass certain interest awards when the so-called good cause exception applies, in a suit accusing a doctor of causing a baby's severe brain injury.

  • September 09, 2025

    Omni Must Pay Atty Fees Over 'Troubling' Conduct In FCA Suit

    A Massachusetts federal judge has ordered a medical practice to pay legal fees to a lab it accused of False Claims Act violations, ruling its claims were "clearly vexatious" because the provider knowingly ordered medically unnecessary tests to support its suit.

  • September 09, 2025

    MAHA Report Calls For Increased Scrutiny Of Drug Advertising

    The Trump administration on Tuesday pledged to ramp up federal oversight of drug advertising, update dietary guidelines and slash unnecessary regulations as part of its strategy to boost the health of America's children and curb the rise in childhood chronic disease.

Expert Analysis

  • 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.

  • Loper Bright Offers New Materiality Defense To FCA Liability

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    The U.S. Supreme Court's decision in Loper Bight Enterprises v. Raimondo, ending Chevron deference, may have created a new defense to False Claims Act liability by providing the opportunity to argue that a given regulation is not material to the government's payment decision, says Tanner Cook at Husch Blackwell.

  • How Expanded Birth Control Coverage May Affect Employers

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    Employers should consider the potential impact of recently proposed regulations that would expand group health plans' required coverage of preventive services and contraceptives, including questions about how the agencies would implement their plans to eliminate the prescription requirement and alter the exceptions process, says Jennifer Rigterink at Proskauer.