Policy & Compliance
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September 08, 2025
Lowe's Workers Drop Suit Claiming Unlawful Insurance Fees
Ex-Lowe's employees have dropped a proposed class action alleging the home improvement retailer violated federal law by overcharging tobacco-using employees for health insurance, according to a notice filed in North Carolina federal court.
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September 08, 2025
FibroGen To Pay SEC $1.25M Over Drug Mistatements
Biopharmaceutical company FibroGen Inc. has agreed to pay a $1.25 million penalty to the U.S. Securities and Exchange Commission to resolve claims that its former chief medical officer fudged results for its primary drug, Roxadustat, which treats anemia in kidney disease patients.
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September 05, 2025
Judge Doubts DOE Stance On Ending Mental Health Grants
A Seattle federal judge hinted on Friday that 16 states have valid claims against the U.S. Department of Education for arbitrarily discontinuing mental health funding for public schools, expressing frustration with the federal government's argument that it could terminate grant funding the same way it could fire a landscaper under contract.
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September 05, 2025
Merck Shakes Off Some Claims From Cholesterol Drugs Suit
A New Jersey federal judge has partly granted a request from Merck & Co. to dismiss claims brought by Humana over an alleged anticompetitive scheme to control distribution of cholesterol drugs Zetia and Vytorin, tossing several proposed theories of monopolization but allowing unjust enrichment claims and state law antitrust claims to survive.
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September 05, 2025
HCA Healthcare Can't Halt Discovery In 401(k) Forfeiture Suit
A Tennessee federal judge denied HCA Healthcare's bid Friday to stop discovery while the court considers its motion to toss a worker's suit claiming it illegally used forfeited 401(k) funds to cover its own contribution costs, finding the alleged novelty of her claims can't block case information collection.
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September 05, 2025
Vein Tech Maker Wants Suit Over DOJ Kickback Probe Tossed
Vein disease device maker Inari Medical Inc. and its former top brass have asked a New York federal judge to toss a proposed investor class action over claims the company's share price fell after it disclosed an investigation into its compliance with federal anti-kickback laws, arguing the suit fails to allege any specific kickbacks or false statements.
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September 05, 2025
FDA Explains Rejection Of MDMA Therapy For Treating PTSD
The U.S. Food and Drug Administration rejected a historic new drug application to treat post-traumatic stress disorder with the psychedelic MDMA due to concerns with the drug's safety and effectiveness and with the design of the clinical trials behind the bid, according to an agency letter made public Thursday.
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September 05, 2025
Ga. Ban On Trans Prisoner Healthcare Paused, Class Certified
A Georgia federal judge has reached what he described as a "straightforward" decision to temporarily pause the state's law banning the use of state resources for hormone replacement therapies for transgender state prisoners, and is considering granting the plaintiffs' request for permanent injunctive relief.
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September 05, 2025
6th Circ. Finds Boss' Pregnancy Remark Supports Bias Claim
A split Sixth Circuit panel revived part of a lawsuit from a woman who alleges a Michigan hospital system laid her off because she was pregnant, finding that evidence that the worker's supervisor was concerned about the pregnancy's effects on department productivity supports pregnancy discrimination claims.
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September 05, 2025
Brown Univ. Prof Says Top Court Ruling Bolsters Habeas Bid
A Lebanese nephrologist who teaches at Brown University under an H-1B visa argued last week that the U.S. Supreme Court's ruling this summer in Kennedy v. Braidwood Management, a case focusing on whether members of a U.S. government task force were constitutionally appointed, bolsters her argument that the U.S. Customs and Border Protection officers who deported her lacked the authority to do so.
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September 05, 2025
Mass. Justices Mull Privacy Issues In Era Of Online Records
Massachusetts' highest court heard arguments Friday in a pair of cases asking the justices to balance the public's right to access court documents against the privacy interests of potential medical malpractice victims and people charged with but later cleared of crimes.
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September 05, 2025
Workers Say Tenet Misspent Forfeitures In Mega 401(k) Plan
A Tenet Healthcare ex-employee alleged in a proposed class action Friday in Texas federal court that the healthcare company misspent nearly $28.6 million in forfeitures from an employee 401(k) plan by using the assets to reduce employer-side contribution obligations to other workers' accounts.
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September 04, 2025
Feds Seek Stay On Court Order Releasing Foreign Aid Billions
The Trump administration urged the D.C. Circuit on Thursday to stay a federal judge's order that it release billions in frozen foreign aid pending its appeal, saying the disbursement will likely be "impossible" to recover according to the international aid organization plaintiffs' "own description of their financial condition."
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September 04, 2025
Split 3rd Circ. Rejects Janssen, Bristol Myers Pricing Appeal
A split Third Circuit panel Thursday shot down another challenge to the Medicare drug pricing negotiation, this time rejecting a consolidated appeal from Bristol Myers Squibb and Janssen and upholding a lower court's finding that the program is indeed voluntary and therefore constitutional.
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September 04, 2025
Feds Stand By $10M Medicare Fraud Conviction At 4th Circ.
The Fourth Circuit should uphold the six-year sentence of a physician assistant who was found guilty of Medicare fraud after prosecutors said he rubber-stamped bogus prescriptions for genetic testing worth about $10 million, the government told the court.
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September 04, 2025
4th Circ. Affirms Gardasil's Vaccine Table Inclusion
A unanimous Fourth Circuit panel affirmed Thursday that adding the human papillomavirus vaccine Gardasil to the Vaccine Act's injury table did not violate the U.S. Constitution, rejecting three plaintiffs' arguments that the Secretary of Health and Human Services lacks the authority to make additions to the table without an act of Congress.
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September 04, 2025
Admonished For 'Entitlement,' Pillsbury Atty Ducks Sanction
A Nevada federal judge opted against sanctions for Pillsbury Winthrop Shaw Pittman LLP partner Mark Krotoski, and instead issued a formal admonishment on the "entitlement" behind "misleading arguments and representations" about the reason an expert witness was unavailable during a wage-fixing and wire fraud trial.
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September 04, 2025
Why The Harvard Funding Case Is 'Clear As Mud' On Appeal
A sweeping Harvard University victory in a suit challenging President Donald Trump's block on $2.2 billion in grant funding tees up a high-stakes appeal that experts say may turn on a wonky jurisdictional issue on which the U.S. Supreme Court seems to lack any sort of consensus.
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September 04, 2025
Aetna, Optum's $8.3M ERISA Health Fee Deal Gets Final OK
A North Carolina federal judge granted final approval to an $8.3 million class action settlement to end an employee health plan participant's allegations that Aetna conspired with OptumHealth Care Solutions to pass on administrative fees disguised as medical expenses, according to an order docketed Thursday.
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September 04, 2025
DOJ Moves To End Challenge To RFK Jr.'s Vaccine Directive
The Justice Department is seeking a quick exit from a suit challenging Robert F. Kennedy Jr.'s directive recommending against the COVID-19 vaccine for pregnant women and children, telling a Massachusetts federal court Thursday that the three women and coalition of medical associations behind the suit can't demonstrate a link between the directive and any potential injuries.
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September 04, 2025
RFK Renews Attacks On CDC At Fiery Capitol Hill Appearance
U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. faced intense questioning from lawmakers on Capitol Hill on Thursday, with a handful of Republicans joining Democratic senators in voicing alarm over recent turmoil in vaccine policy and in leadership at the Centers for Disease Control and Prevention.
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September 04, 2025
Top NIH Scientists Allege Retaliation For Defending Vaccines
Two prominent infectious disease scientists have filed whistleblower complaints with the U.S. Office of Special Counsel, claiming illegal retaliation by the Trump administration for challenging administrative actions, including those they believed undermined vaccine efficacy and endangered public safety.
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September 04, 2025
Tenn. Behavioral Healthcare Co. Owes OT, Worker Claims
A Tennessee behavioral healthcare provider failed to pay its employees for work they performed off the clock and automatically deducted unpaid time for meal breaks they didn't take, a technician said in a proposed collective action in federal court.
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September 03, 2025
9th Circ. Affirms Toss Of Satanists' Idaho Abortion Ban Suit
The Ninth Circuit refused to revive the Satanic Temple's lawsuit that challenged Idaho's laws criminalizing abortion, ruling in a published amended opinion Tuesday that the religious association of more than 1.5 million Satanists lacked standing to sue, both based on its members and as an organization.
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September 03, 2025
Judge Backs Harvard In Suit Over Trump's $2B Fund Freeze
The Trump administration illegally froze more than $2 billion in grants earmarked for Harvard University when it failed to offer an explanation as to how cutting the funds addressed the government's stated goal of ending antisemitism on campus, a Massachusetts federal judge ruled Wednesday.
Expert Analysis
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How States Are Regulating Health Insurers' AI Usage
The absence of a federal artificial intelligence framework positions states as key regulators of health insurers’ AI use, making it important for payors and service providers to understand the range of state AI legislation being passed in California and elsewhere, and consider implementing an AI-focused compliance infrastructure, say attorneys at Ropes & Gray.
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HHS Plan To Cut Immigrant Benefits Spurs Provider Questions
A recent notice from the U.S. Department of Health and Human Services identifying new federal public benefit programs for which nonqualified aliens are not eligible may have a major impact on entities that participate in these programs — but many questions remain unanswered, say attorneys at Foley.
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Noncompete Forecast Shows Tough Weather For Employers
Several new state noncompete laws signal rough conditions for employers, particularly in the healthcare sector, so employers must account for employees' geographic circumstances as they cannot rely solely on choice-of-law clauses, say lawyers at McDermott.
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Previewing State Efforts To Regulate Mental Health Chatbots
New York, Nevada and Utah have all recently enacted laws regulating the use of artificial intelligence to deliver mental health services, offering early insights into how other states may regulate this area, say attorneys at Goodwin.
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How DOJ's New Data Security Rules Leave HIPAA In The Dust
The U.S. Department of Justice's recently effective data security requirements carry profound implications for how healthcare providers collect, store, share and use data — and approach vendor oversight — that go far beyond the Health Insurance Portability and Accountability Act, say attorneys at Nelson Mullins.
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Texas Med Spas Must Prepare For 2 New State Laws
Two new laws in Texas — regulating elective intravenous therapy and reforming healthcare noncompetes — mark a pivotal shift in the regulatory framework for medical spas in the state, which must proactively adapt their operations and contractual practices, says Brad Cook at Munsch Hardt.
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DOJ-HHS Collab Crystallizes Focus On Health Enforcement
The recently announced partnership between the U.S. Department of Justice and U.S. Department of Health and Human Services to combat False Claims Act violations, following a multiyear trend of high-dollar DOJ recoveries, signals a long-term enforcement horizon with major implications for healthcare entities and whistleblowers, say attorneys at RJO.
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How The Healthline Privacy Settlement Redefines Ad Tech Use
The Healthline settlement is the first time California has drawn a clear line in the sand around how website tracking must function in practice, so if your site uses tracking technologies, especially around sensitive content like health or finance, regulators are inspecting your website's back end, not just its banner, say attorneys at Baker Donelson.
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How Sweeping Budget Bill Shakes Up Health Industry
With the recently passed One Big Beautiful Bill Act marking one of the most significant overhauls of federal health policy since the passage of the Affordable Care Act, providers, managed care organizations and life sciences companies must now shift focus from policy review to implementation planning, say advisers at Holland & Knight.
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New DOJ Penalty Policy Could Spell Trouble For Cos.
In light of the U.S. Department of Justice’s recently published guidance making victim relief a core condition of coordinated resolution crediting, companies facing parallel investigations must carefully calibrate their negotiation strategies to minimize the risk of duplicative penalties, say attorneys at Debevoise.
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A Look At Key 5th Circ. White Collar Rulings So Far This Year
In the first half of 2025, the Fifth Circuit has decided numerous cases of particular import to white collar practitioners, which collectively underscore the critical importance of meticulous recordbuilding, procedural compliance and strategic litigation choices at every stage of a case, says Joe Magliolo at Jackson Walker.
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What US Medicine Onshoring Means For Indian Life Sciences
Despite the Trump administration's latest moves to onshore essential medicine manufacturing, India will likely remain an indispensable component of the U.S. drug supply chain, but Indian manufacturers should prepare for stricter compliance checks, says Jashaswi Ghosh at Holon Law Partners.
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FCA Working Group Reboot Signals EHR Compliance Risk
The revival of the False Claims Act working group is an aggressive expansion of enforcement efforts by the Justice Department and the U.S. Department of Health and Human Services targeted toward technology-enabled fraud involving electronic health records and other data, say attorneys at ArentFox Schiff.