Policy & Compliance
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January 22, 2025
Logistics Cos. Say Workers' Tobacco Fee Suit Filed Too Late
A pair of logistics companies are asking a Connecticut federal court to throw out a proposed class action alleging they violated federal law by not fully reimbursing employees who paid an additional tobacco-use fee on their healthcare, saying all the claims in the suit are barred by statutes of limitation.
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January 21, 2025
The Legal And Practical Questions Around Trump's WHO Exit
President Donald Trump’s first-day order setting in motion the United States’ withdrawal from the World Health Organization could leave the nation less prepared for global health threats and trigger legal clashes over the president’s authority to act unilaterally.
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January 21, 2025
4th Circ. Won't Undo Doctor's Conviction For Reusing Devices
A former North Carolina ear, nose and throat doctor staring down 25 years in prison for healthcare fraud lost an appeal Tuesday seeking to overturn her conviction, with the Fourth Circuit finding that the lower court did not commit any reversible error that would favor a shot at redemption.
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January 21, 2025
What To Know About Trump's Medicare Drug Price Order
In his first day in office, President Donald Trump rescinded a Biden directive for health officials to create new drug-pricing models for Medicare and Medicaid recipients. Here's what you need to know about the status of the pricing plans and what comes next.
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January 21, 2025
Minn. Agency Beats Worker's COVID Testing Policy Suit
A Minnesota state agency defeated a Catholic employee's lawsuit claiming it unlawfully refused to grant him a religious exemption from its COVID-19 vaccination and testing policies, with a federal judge ruling Tuesday that the worker had failed to show the agency knew about his religious objections.
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January 21, 2025
Outgoing HHS Official On The Thorny Issues Of Child Welfare
In an interview with Law360 Healthcare Authority, the now-former head of HHS' Administration on Children, Youth, and Families stresses the importance of preventive services and weighs in on the promise and perils of mandated reporting laws.
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January 21, 2025
DACA Health Coverage, Gilead IP Deal And PBM Insulin Case
Several state attorneys general are looking to defend immigrants' Affordable Care Act coverage, while a group of pharmacy benefit managers failed to oust the FTC's Democratic members from a case alleging collusion to inflate insulin prices. Law360 Healthcare Authority looks at the cases and decisions that shaped the industry over the last week.
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January 21, 2025
With Circuits Split, Mass. Judge Backs Tough Fraud Standard
An influential judge with a history of shaping False Claims Act litigation weighed in decisively on a debate that has split circuit judges and may eventually reach the Supreme Court. Attorneys across the country are evaluating the impact.
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January 17, 2025
Law360 Names Practice Groups Of The Year
Law360 would like to congratulate the winners of its Practice Groups of the Year awards for 2024, which honor the attorney teams behind litigation wins and significant transaction work that resonated throughout the legal industry this past year.
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January 17, 2025
Law360 Names Firms Of The Year
Eight law firms have earned spots as Law360's Firms of the Year, with 54 Practice Group of the Year awards among them, steering some of the largest deals of 2024 and securing high-profile litigation wins, including at the U.S. Supreme Court.
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January 17, 2025
Unified Care Services To Pay $18M To Settle PPP Case
Skilled nursing chain Unified Care Services LLC and its owner have agreed to shell out $18 million to put to rest a whistleblower suit alleging the California-based company and its affiliates knowingly included false information on Paycheck Protection Program loan applications, according to an announcement made Friday.
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January 17, 2025
Walgreens Knowingly Filled Invalid Prescriptions, Feds Say
The U.S. Department of Justice has accused Walgreens of knowingly filling millions of prescriptions for opioids and other controlled substances that did not have a legitimate medical purpose or were not valid, intervening in cases brought by four whistleblowers in Illinois federal court.
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January 17, 2025
Bayer, J&J Minimized Drug Reaction Data, 3rd Circ. Told
A doctor urged the Third Circuit on Friday to revive his whistleblower suit against Bayer Corp. and Johnson & Johnson, arguing that the drugmakers' regulatory approval applications played down the side effects of the antibiotics Cipro and Levaquin.
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January 17, 2025
MultiPlan Wants Antitrust Claims Over Pricing Tools Tossed
MultiPlan and several major insurance companies urged an Illinois federal court to toss claims that they schemed to fix reimbursement rates, saying the pricing tools at issue do not hurt the healthcare providers that are bringing the case.
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January 17, 2025
Trade Group Sues To Stop Federal Mental Health Parity Regs
A benefits-focused employer trade group sued the U.S. Department of Labor and other federal agencies in D.C. federal court Friday, seeking to block recently finalized mental health parity regulations the group alleges are unconstitutional and violate administrative procedure laws.
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January 17, 2025
4 Battles Over Gender-Affirming Care To Watch In 2025
The U.S. Supreme Court will rule on the federal government's challenge to Tennessee's ban on gender-affirming care for minors, and the Eleventh Circuit is considering a bid to upend federal rules extending the Affordable Care Act's nondiscrimination protections to transgender patients. Here, Law360 looks at four cases that could have ramifications for benefits law in 2025.
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January 17, 2025
1st Circ. Revives Biotech Worker's COVID-19 Vax Challenge
The First Circuit on Thursday resuscitated religious discrimination claims brought by a former pharmaceutical company employee who alleged her employer's COVID-19 vaccination mandate during the pandemic was in conflict with her sincerely held religious beliefs.
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January 16, 2025
Texas Judge Says 3 States Can Pursue Mifepristone Suit
A Texas federal judge said Thursday that Idaho, Missouri and Kansas can continue to challenge federal approvals for the abortion medication mifepristone in Texas federal court after private plaintiffs dropped their claims.
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January 16, 2025
NC Gov. Boosts Abortion Safeguards Amid 'Alarming Attacks'
North Carolina's newly minted Gov. Josh Stein on Thursday in one of his first official acts rolled out an executive order that shores up abortion protections in the Tar Heel state, joining the ranks of other Democratic politicians seeking to cement progressive priorities ahead of a second Trump administration.
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January 16, 2025
Initial Green Light Given to UnitedHealth's Deal In TCPA Suit
A Washington federal judge gave a $2.5 million settlement between UnitedHealthcare and a class of Telephone Consumer Protection Act claimants preliminary approval, signing off on a deal that class counsel says would net each class member over $90, if all applied.
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January 16, 2025
Merck Defends 3rd Circ. Win In Mumps Vaccine Antitrust Case
Merck urged the Third Circuit not to reconsider a ruling that immunized the company from antitrust claims over submissions it made to federal regulators for its mumps vaccine, arguing the appeals court was right to find the submissions were protected.
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January 16, 2025
Chamber Slams Opioid Judge's PBM Audit Privilege Ruling
The Sixth Circuit must step in to prevent a pharmacy benefit manager from being forced to turn over internal compliance audit documents, the U.S. Chamber of Commerce has said, arguing a lower court's decision threatens to undermine the existence of in-house counsel's attorney-client privilege.
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January 15, 2025
Gilead, Feds Resolve HIV Drug Patent Dispute Amid Appeal
Gilead Sciences and the federal government have agreed to dismiss all claims and counterclaims in a yearslong intellectual property and contract battle over HIV prevention drugs Truvada and Descovy, according to stipulations of voluntary dismissal filed Wednesday in both the Federal Circuit and Delaware federal court.
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January 15, 2025
FTC Won't Disqualify Commissioners From PBM Insulin Case
The Federal Trade Commission denied bids from Caremark Rx, Express Scripts and OptumRx that sought to bar the commission's Democratic members from participating in a case accusing the pharmacy benefit managers of inflating insulin prices.
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January 15, 2025
Ruling On Fla. Gender Law Animus Is Flawed, 11th Circ. Told
Florida urged an Eleventh Circuit panel on Wednesday to overturn an order declaring the state's ban on certain types of medical treatment for gender dysphoria unconstitutional, arguing the lower court wrongly used the condition as a proxy for transgender individuals in ruling that the prohibition was proof of discriminatory animus.
Expert Analysis
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AI In Health Law: The Top Guest Articles Of 2023
As the use of artificial intelligence accelerated this year, Expert Analysis writers examined AI's significant impact on the healthcare sector, ranging from key compliance considerations for companies utilizing AI tools to regulators' efforts to keep up with rapidly evolving technologies.
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The Most-Read Legal Industry Law360 Guest Articles Of 2023
A range of legal industry topics drew readers' attention in Law360's Expert Analysis section this year, from associate retention strategies to ethical billing practices.
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Inside Higher Education's New FCA Liability Challenges
As the educational sector expands its use of government funding, schools are at increased risk under the False Claims Act, but recent settlements offer valuable lessons about new theories of liability they may face and specific procedures to reduce their exposure, say James Zelenay and Jeremy Ochsenbein at Gibson Dunn.
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AI Executive Order's Life Science, Healthcare Industry Effects
The recent White House executive order to manage risks associated with artificial intelligence includes provisions specific to healthcare and life sciences that merit special attention, including transparency, human oversight of AI output, and real world performance monitoring, say attorneys at Ropes & Gray.
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HHS Advisory Highlights Free Product Inducement Risks
A recent U.S. Department of Health and Human Services advisory opinion highlights concerns that valuable free products and other inducements may influence patients and providers to choose one manufacturer’s product over another, notwithstanding that such free healthcare products may be a benefit, say attorneys at Morgan Lewis.
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Attorneys' Busiest Times Can Be Business Opportunities
Attorneys who resolve to grow their revenue and client base in 2024 should be careful not to abandon their goals when they get too busy with client work, because these periods of zero bandwidth can actually be a catalyst for future growth, says Amy Drysdale at Alchemy Consulting.
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In The World Of Legal Ethics, 10 Trends To Note From 2023
Lucian Pera at Adams and Reese and Trisha Rich at Holland & Knight identify the top legal ethics trends from 2023 — including issues related to hot documents, artificial intelligence and cybersecurity — that lawyers should be aware of to put their best foot forward.
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How Attorneys Can Be More Efficient This Holiday Season
Attorneys should consider a few key tips to speed up their work during the holidays so they can join the festivities — from streamlining the document review process to creating similar folder structures, says Bennett Rawicki at Hilgers Graben.
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Top 10 Whistleblowing And Retaliation Events Of 2023
The U.S. Securities and Exchange Commission and federal and state courts made 2023 another groundbreaking year for whistleblower litigation and retaliation developments, including the SEC’s massive whistleblower awards, which are likely to continue into 2024 and further incentivize individuals to submit tips, say attorneys at Proskauer.
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Children's Book Writing Makes Me A Better Lawyer
Becoming a children's book author has opened doors to incredible new experiences of which I barely dared to dream, but the process has also changed my life by serving as a reminder that strong writing, networking and public speaking skills are hugely beneficial to a legal career, says Shaunna Bailey at Sheppard Mullin.
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The State Of CFPB Focus On Credit Reporting Of Medical Debt
An increase in credit reporting complaints and the Consumer Financial Protection Bureau's recent annual report on the Fair Debt Collection Practices Act — which focuses on medical debt in credit reporting — are both evidence of the fact that the bureau will continue to prioritize oversight of credit reporting of medical debt, says Kristen Watson at Burr & Forman.
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FDA's Recent Litigation Records Are Strong, But Imperfect
The U.S. Food and Drug Administration has notched its share of litigation wins in recent years thanks to a number of key advantages, but the FDA has been less successful in certain highly visible arenas, Jonathan Berman and Colleen Heisey at Jones Day.
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5 Steps For Healthcare Companies After Biden's AI Order
Rather than simply monitoring for the issuance of agency guidelines on artificial intelligence in the wake of President Joe Biden's October executive order, health and life sciences companies should take action now and begin building internal operational and technical infrastructures designed to govern the use of AI, says Joy Sharp at Faegre Drinker.