Policy & Compliance

  • October 30, 2026

    Botox Exempt From Medicare Price Talks, Judge Rules

    The Centers for Medicare & Medicaid Services can't subject AbbVie's Botox to Medicare price negotiations under the Inflation Reduction Act, a D.C. federal judge held, finding CMS misinterpreted an IRA exclusion concerning biological products derived from human plasma.

  • October 30, 2026

    Philly Health System's Time Rounding Shorted OT, Suit Says

    A former hospital supervisor has accused a Philadelphia health system in Pennsylvania state court of shortchanging hourly workers on overtime by rounding their clock-in and clock-out times to the nearest 15 minutes while expecting them to start work early and stay late.

  • October 30, 2026

    Home Care Cos. Win Partial Block Of DOL Overtime Rule

    The U.S. Department of Labor exceeded its authority by barring third-party employers of live-in domestic workers from claiming a federal overtime exemption, a Pennsylvania federal judge ruled, but he kept in place a similar restriction for companionship workers.

  • October 29, 2026

    Colo. Justices Won't Review Hospital's Injunction Compliance

    The Colorado Supreme Court declined Thursday to take up transgender youth patients' challenge to a Denver judge's ruling that discharged their contempt citation against Children's Hospital Colorado for not resuming providing medical gender-affirming care to transgender adolescents.

  • October 29, 2026

    GEO Says Colo. Health Inspection Law Suit Should Survive

    The federal contractor that runs an immigration detention center near Denver is coming out swinging against Colorado's attempt to kill its suit challenging a state law requiring extra inspections, saying its claims cannot be considered premature just because the state has not enforced the law yet.

  • October 29, 2026

    EMT Immunity Doesn't Cover Driving, Wash. Justices Say

    Emergency medical technicians' qualified immunity from negligence claims in Washington does not extend to driving ambulances, a divided state Supreme Court held Thursday, ruling that the transportation of patients falls outside EMTs' statutory immunity for rendering emergency services.

  • October 29, 2026

    Nursing Home Says Union Too Late To Arbitrate Grievance

    A Service Employees International Union affiliate's tardiness while challenging a nursing home employee's firing barred the union's grievance from arbitration, the nursing home argued in Minnesota federal court, asking the judge to toss the union's bid to compel arbitration.

  • October 29, 2026

    Judge Rejects Extra Hurdle For Medicaid Frailty Exemption

    A Trump administration bid to create additional barriers to Medicaid eligibility was rejected Thursday by a Massachusetts federal judge, who ruled that Congress did not delegate to the executive branch the task of deciding who is too medically frail to meet work requirements.

  • October 29, 2026

    DOL Finalizes Pharmacy Benefit Manager Fee Disclosure Rule

    The U.S. Department of Labor's employee benefits arm unveiled a final rule Thursday that requires pharmacy benefit managers — which act as intermediaries between drugmakers, pharmacies and insurers — to make new disclosures on their fees and compensation to employer-sponsored group health plans.

  • October 28, 2026

    TB Outbreak In Wash. Prisons Yields $52M Damages Verdict

    Washington jurors returned a $52 million verdict in favor of 23 plaintiffs who accused the state's Department of Corrections of allowing an active tuberculosis outbreak to fester and spread to hundreds of people at its prison facilities over nearly two years.

  • October 28, 2026

    Patients Tell Colo. Justices Hospital Defied Gender Care Order

    Transgender youth patients of Children's Hospital Colorado are challenging a judge's discharge of their contempt citation against the hospital for not resuming the provision of medical gender-affirming care to them, urging Colorado's justices to decide whether the hospital complied with an injunction prohibiting it from refusing to provide the care.

  • October 28, 2026

    Cruise Co. Settles Fla. Doc's Whistleblower Suit Over Billing

    A Florida doctor said he reached a quick settlement with Norwegian Cruise Lines Holdings Ltd. one month after filing his lawsuit alleging he was fired for opposing the company's practice of overbilling passengers, the state's federal court records show.

  • October 28, 2026

    Pharma Co. Settles Workers' 401(k) Forfeiture Suit

    Boehringer Ingelheim USA Corp. and workers who accused the pharmaceutical company of misusing forfeitures from an employee 401(k) plan have settled their federal benefits dispute, parties told a Connecticut federal court Wednesday.

  • October 28, 2026

    Sanofi Settles Insulin Pen Antitrust Suit, Avoiding Trial

    Sanofi-Aventis US and a group of drug wholesalers have told a Massachusetts federal judge they have reached a settlement to resolve long-running antitrust litigation alleging that the drugmaker improperly sought to thwart competition for its single-use insulin injector pen.

  • October 28, 2026

    Celgene Defends Dismissal Of Cancer Drug Antitrust Suit

    Bristol-Myers Squibb Co. and its subsidiary Celgene Corp. urged the Second Circuit to uphold the dismissal of health plans' proposed antitrust class action alleging that the drugmaker fraudulently obtained patents for the cancer drug Pomalyst, saying it properly disclosed materials to the patent office and filed valid patent infringement lawsuits against generic-drug makers. 

  • October 28, 2026

    Nurses Union Cannot Escape Strike Dispute, Kaiser Says

    Kaiser Permanente has urged a California federal court to reject a National Nurses United affiliate's bid to toss the company's claims alleging that the union organized an unlawful strike, saying it plausibly alleged an "arbitrable dispute" over whether the union breached its collective bargaining agreement with the company.

  • October 28, 2026

    4th Circ. Judge Wary Of NC Abortion Drug Law Challenge

    A Fourth Circuit judge on Wednesday sharply questioned the attorney for a physician challenging North Carolina restrictions on the abortion medication mifepristone, citing case law he said treats federal rules as a "floor and not a ceiling" on what states can require.

  • October 27, 2026

    Mass. Hospitals Sue Lilly Over 340B Discount Data 'Extortion'

    A group of Massachusetts hospitals claim drugmaker Eli Lilly & Co. unlawfully holds hostage medication discounts meant to benefit low-income patients by demanding that hospitals hand over sensitive patient claims data or pay "exorbitant" inflated prices, according to a lawsuit filed Tuesday in Boston federal court.

  • October 27, 2026

    CVS Says Faulty Medicare Advantage Ratings Will Cost It $2B

    Insurance giant CVS Health sued the Trump administration in Georgia federal court Monday, alleging that federal quality ratings for its Medicare Advantage contracts were calculated using methods a judge rejected last year and will cost the company more than $2 billion in bonus payments and rebates in 2028.

  • October 27, 2026

    Courts Take On Lilly GLP-1 Ads, J&J Mesothelioma Trial, More

    Law360 Healthcare Authority looks at a Novo Nordisk loss in its challenge to Eli Lilly's GLP-1 advertising, an Ohio verdict in wrongful death litigation over Johnson & Johnson's talc baby powder and other legal news from the past week.

  • October 27, 2026

    NC Health Plan, Atrium Settle Spat Over Cost-Sharing Program

    The North Carolina state health plan said on Tuesday that it will add Atrium Health to its list of in-network providers next year after a public showdown over the nonprofit health system's exclusion from the plan's new preferred provider program.

  • October 27, 2026

    3 Cases To Watch In The 340B Battles

    A program that determines prescription drug costs across the country is being hashed out in the courts. Here are three cases to watch that could have lasting effects on the program's future.

  • October 26, 2026

    Novo Can't Get 'Deceptive' Lilly GLP-1 Ads Blocked Amid Suit

    A New Jersey federal judge on Monday refused to issue an injunction blocking Eli Lilly & Co. from running ads allegedly comparing its GLP-1 drug to Novo Nordisk Inc.'s using "outdated" clinical trials and "false superiority messages," ruling that Novo Nordisk hasn't shown it would be irreparably harmed.

  • October 26, 2026

    Feds Say States Lack Standing To Sue Over HHS Vax Overhaul

    The Trump administration is again asking a California federal judge to toss a coalition of states' lawsuit challenging its decision to cut vaccine recommendations for children, arguing that the states cannot show harm that gives them standing to sue.

  • October 26, 2026

    Nomi Says HHS Shirked COVID Care Reimbursement Promise

    Utah-based Nomi Health Inc. sued the U.S. government on Friday, claiming that it failed to provide more than $200 million in promised payments for testing and vaccination services provided to uninsured Americans during the COVID-19 pandemic.

Expert Analysis

  • Defending Hospital Antisteering Clauses From DOJ Scrutiny

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    The Trump administration has recently made clear that pursuing antitrust challenges to antisteering provisions in hospital-insurer contracts is a priority — but a review of similar cases against hospital systems and important precedent from the U.S. Supreme Court illuminates some potential defenses in such cases, says Derek Moore at Rule Garza.

  • What Expanded CMS Authority Means For Health Compliance

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    A recent delegation gives the Centers for Medicare & Medicaid Services independent authority to impose permissive exclusions, creating a more active federal enforcement system with heightened risks for healthcare organizations, says Jose Vela at Clark Hill.

  • DOJ Directive Gives Contractors A Fraud Risk Road Map

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    For government contractors, the 10 factors described in the U.S. Department of Justice's recent corporate fraud enforcement directive function as a de facto scoring rubric for internal audits that mirrors what prosecutors will prioritize, say attorneys at Spencer Fane.

  • A Nuanced Reading Of DOL's Mental Health Parity Guidance

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    Though a recent U.S. Department of Labor bulletin may suggest that agency enforcement pressure on group health plans with respect to mental health parity is easing, the takeaways are more complex, and plan sponsors should not relax compliance efforts, say attorneys at Proskauer.

  • Where DOJ's Fraud Directive May Actually Affect Enforcement

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    The U.S. Department of Justice’s recent directive outlining corporate fraud enforcement priorities is mostly a management document instead of a policy, but one part may actually undermine the directive's goals by leading to worse outcomes for organizational defendants and less corporate self-disclosure, says Zachary Warren at Williams & Connolly.

  • Importer Risk Rises As AI Enters Trade Fraud Enforcement

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    The Trump administration's new data-driven and artificial intelligence-enabled push against tariff evasion raises the stakes for companies with global supply chains, making it crucial that they consider strengthening response protocols, documentation and internal reporting mechanisms, say attorneys at Cooley.

  • What CMS Audit Rule Means For Medicare Advantage Plans

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    Despite ongoing legal challenges, the Centers for Medicare & Medicaid Services is moving forward with implementation of its risk adjustment data validation audits, raising statistical concerns around overpayments indicated by variance in unbalanced samples, say Stephen Fink, Brad Rice and Igor Karagodsky at Analysis Group.

  • What To Know As State 'Neural Data' Privacy Laws Emerge

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    Attorneys at Goodwin discuss new state laws aimed at regulating consumer data generated from nervous system activity, explain why neurotechnology is attracting state and federal legislators’ attention, and highlight the compliance obligations that industry players should address now.

  • Health Plan Takeaways After 2nd Circ. No Surprises Act Ruling

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    While the Second Circuit's recent ruling in East Coast Advanced Plastic Surgery v. Cigna gives health plans breathing room in finding that healthcare providers cannot enforce out-of-network billing dispute resolution awards in court, sponsors should not assume that declining to pay awards will go unaddressed by regulators, say attorneys at Thompson Hine.

  • Contact Lens Rule's Evolution Steers FTC Guidance Program

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    The history of the Federal Trade Commission's Contact Lens Rule illustrates the goals of the FTC's recently announced guidance program, which aims to strengthen consumer protection and safeguard competition, say attorneys at Wilson Sonsini.

  • Abbott FCA Deal Shows Enforcement Adequacy Quandaries

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    Abbott Laboratories’ recent False Claims Act resolution illustrates several tricky questions that both prosecutors and defense counsel must address when weighing whether a civil enforcement action alone adequately addresses allegedly wrongful conduct, says James Koukios at MoFo.

  • New DNA Screening Standard Has No Clear Playbook

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    Although the government has not yet released promised guidance intended to support its new standards for screening mail-order DNA, companies should not read this as a reprieve from the Oct. 13 compliance deadline because the delay shifts enforcement risk to statutes that need no new authority, including false statements, the False Claims Act and fraud, says Ashwin Ram at Buchalter.

  • Texas Medicaid Fraud Decision Leaves 2 Open Questions

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    The Texas Supreme Court's decision in Laboratory Corp. of America Holdings v. Texas and NPT Associates, holding that the Texas Medicaid Fraud Prevention Act's omissions provision requires proof of materiality, creates ambiguity about the materiality requirement and about how Texas courts will treat federal precedent going forward, say attorneys at Sidley.