Policy & Compliance
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April 22, 2025
'Fetal Personhood' Animates Neb. Aborted-Remains Debate
Nebraska lawmakers are sparring over a bill that would require healthcare facilities to bury or cremate fetal remains following an elective abortion. Supporters envision a "dignified" disposition. Opponents decry a requirement targeting providers while advancing the “fetal personhood” doctrine.
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April 22, 2025
Hogan Lovells Adds Ex-HHS Atty To Health Practice
Hogan Lovells on Tuesday announced the arrival of a former U.S. Department of Health and Human Services attorney to the firm's global regulatory and intellectual property practice group.
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April 22, 2025
Trump's Healthcare Order A Mixed Bag For Big Pharma
While Trump's executive order last week is more of a general road map than a clear plan for cutting prices, experts say it signals key policy priorities for the administration — including on a point of serious contention between drug companies and federal regulators.
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April 22, 2025
Pharma Co. Owner Cops To Selling $60M Of Sham HIV Drugs
An owner of a pharmaceutical company has pled guilty in Florida to participating in a $60 million nationwide scheme to illegally distribute misbranded and adulterated HIV drugs to patients.
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April 22, 2025
MoFo Adds Perkins Coie FDA Regulatory Leader In DC
Morrison Foerster LLP has hired a former Perkins Coie LLP leader who focuses his practice on a range of regulatory matters involving the U.S. Food and Drug Administration as its new head of food and regulatory, the firm announced Tuesday.
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April 22, 2025
Trump Deregulation Order Puts Target On Nurse Survey Rule
The Trump administration's push for mass deregulation is raising the hopes of nursing facilities that have spent years pushing back on a controversial rule limiting when a registered nurse must be present during facility safety inspections.
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April 22, 2025
State Legislatures Pull Back On Certificate-Of-Need Laws
Lawmakers in a handful of states are considering a fresh round of repeals and rollbacks to certificate-of-need laws, an often divisive tool designed to control healthcare costs by limiting duplication of services. That means more changes to a legal landscape that has evolved significantly since the advent of the statutes in the 1970s.
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April 22, 2025
Save Mart Reaches $20.5M Deal On Nonunion Retiree Benefits
California-based Save Mart Supermarkets will pay about $20.5 million to escape a suit from workers who alleged the company unlawfully revoked a monthly health reimbursement that it promised to nonunion retirees and their spouses for life, according to a proposed deal filed in federal court.
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April 22, 2025
Nossaman Health Atty Talks Staffing, Evolving Calif. Law
A former Procopio Health attorney has made the jump to Nossaman LLP at a time when California law around peer and judicial review processes for medical staff is evolving.
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April 21, 2025
Premera's Teen Trans Policy 'Textbook' Sex Bias, Judge Says
Premera Blue Cross discriminated based on sex against transgender teens at the center of a lawsuit alleging the insurer and health plan administrator illegally denied coverage for gender-affirming chest surgery, according to a Washington federal judge who also denied class certification because the teens' claims are not typical of class members.
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April 21, 2025
Harvard Sues Trump Admin Over $2B Funding Freeze
Harvard University on Monday hit the Trump administration with a suit in Massachusetts federal court, escalating a high-profile battle after the government slashed more than $2 billion in funding amid allegations the elite school has failed to properly address antisemitism on its campus.
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April 21, 2025
NJ Panel Revives Ex-Group Home Worker's Whistleblower Suit
A New Jersey appeals court reinstated a group home worker's lawsuit alleging she was fired for raising concerns about staffing levels and training, reasoning Monday that she met the pleading standards for the state's whistleblower law.
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April 21, 2025
Unions Demand Halt To DOGE's Info Access At DOL, HHS
A D.C. federal judge must block Elon Musk's Department of Government Efficiency from accessing sensitive systems in the U.S. Department of Labor and Department of Health and Human Services, unions argued in a preliminary injunction bid, saying the government's search for "waste, fraud and abuse" doesn't warrant access.
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April 21, 2025
HCA, Workers Eye Mediation in Wage Suit
HCA Healthcare Inc. asked a North Carolina federal court to press pause on a respiratory therapist's class and collective action accusing the company of manipulating workers' time sheets to pay them less overtime wages, saying the parties are planning to attend mediation in July.
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April 21, 2025
Justices Mull 5th Circ. Redo In ACA Preventive Care Fight
The U.S. Supreme Court on Monday appeared skeptical of a Fifth Circuit ruling that found members of a task force setting preventive services coverage requirements under the Affordable Care Act were unconstitutionally appointed, with multiple justices suggesting kicking the case back down to the circuit court for additional arguments.
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April 21, 2025
Justices Kick Flavored-Vape Dispute Back To 5th Circ.
After the U.S. Supreme Court affirmed the U.S. Food and Drug Administration's authority to reject an e-cigarette company's application to market flavored vapes, the high court on Monday granted summary disposition on one other pending case on the same subject, while denying certiorari to three others.
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April 19, 2025
Up Next At High Court: Preventive Healthcare, LGBTQ Books
The U.S. Supreme Court will hear arguments in five cases this week, including disputes over the constitutionality of a task force that sets preventive healthcare coverage requirements, a school district's introduction of LGBTQ-themed storybooks and whether parties can establish standing based on harms affecting third parties.
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April 18, 2025
Walgreens To Pay DOJ $300M Over Invalid Prescriptions
Walgreens revealed in a U.S. Securities and Exchange Commission filing Friday that it will pay upward of $300 million to resolve U.S. Department of Justice allegations that it knowingly filed millions of prescriptions for opioids and other drugs that didn't have a legitimate medical purpose or weren't valid.
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April 18, 2025
Lilly Blasts Compounders' 'Scattershot' Bid To Reverse FDA
Eli Lilly urged a Texas federal judge to deny a request from pharmacies that produce copycat doses of its popular weight loss drug to have the court reverse an FDA decision taking the drug off a national shortage list, saying the bid was filled with unreliable "scattershot" arguments.
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April 18, 2025
Mass General Inks $8.25M Deal To End Retirement Fee Suit
Boston-based healthcare system Mass General Brigham Inc. agreed to pay $8.25 million to settle a proposed class action alleging it unlawfully allowed its employee retirement plan to pay excessive administrative fees, according to a filing in Massachusetts federal court.
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April 17, 2025
Incyte Can Get Novartis' Privileged Info On Drug Royalty Deal
Novartis must produce certain privileged documents to Incyte concerning its understanding of their contract for royalty payments from sales of Incyte's blood cancer drug, unless Novartis agrees its former outside counsel, who negotiated the terms, won't testify about that topic at the upcoming contract breach trial, a New York federal judge said Thursday.
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April 17, 2025
RI Judge Wants To Know Who's Behind $11B Health Grant Cuts
A Rhode Island federal judge on Thursday pressed the Trump administration for details about the decision-makers behind the cancellation of billions in grants supporting state public health programs.
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April 17, 2025
Arkansas Bans PBMs From Owning Pharmacies
Pharmacy benefit managers operating in Arkansas will soon be prohibited from owning pharmacies in the state after Gov. Sarah Huckabee Sanders signed a bill that lawmakers say is meant to minimize conflicts of interest and safeguard patients.
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April 17, 2025
Tenet Asks Court To Enforce Dead Arbitrator's $546K Award
Tenet Healthcare Corp. has asked a Washington, D.C., federal judge to require the Service Employees International Union to follow an arbitrator's final order to pay $546,000 after making derogatory statements, despite the arbitrator dying before ruling on the union's post-judgment reconsideration motion.
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April 17, 2025
AFL-CIO, Unions Can Pursue Some DOGE Access Claims
The AFL-CIO, unions and advocacy groups may pursue allegations that Elon Musk's Department of Government Efficiency lacks the power to access data from the U.S. Department of Labor and other federal agencies, a D.C. federal judge ruled while tossing some claims under federal administrative and privacy law.
Expert Analysis
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Where Justices Stand On Chevron Doctrine Post-Argument
Following recent oral argument at the U.S. Supreme Court, at least four justices appear to be in favor of overturning the long-standing Chevron deference, and three justices seem ready to uphold it, which means the ultimate decision may rest on Chief Justice John Roberts' vote, say Wayne D'Angelo and Zachary Lee at Kelley Drye.
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Bracing For Calif.'s New Health Transaction Framework
As California's new cost and market impact review regulations' April 1 date for its updated notice and review process approaches, healthcare entities should ready themselves for dramatic changes to the state's regulatory landscape and prepare for potentially substantial transaction delays, say Jordan Grushkin and Matthew Goldman at Sheppard Mullin.
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Uncharted Waters Ahead For FCA Litigation In 2024
Following a year of significant court decisions, settlements, recoveries and proposed amendments, 2024 promises to be a lively year for False Claims Act actions and litigation, and one that will hopefully provide more clarity as FCA jurisprudence evolves, say attorneys at Crowell & Moring.
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OIG Report Has Clues For 2024 Healthcare Fraud Enforcement
A recent report from the Health Department's Office of the Inspector General reveals healthcare fraud and abuse enforcement trends that will continue in 2024, from increased telehealth oversight to enhanced policing of managed care, say attorneys at Sheppard Mullin.
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FOIA Exemption Questions On Redacted HHS Cannabis Letter
The U.S. Department of Health and Human Services' recent recommendation letter concerning the rescheduling of cannabis was heavily redacted, and based on an analysis on the applicability of Freedom of Information Act Exemption 5 to the letter, it's likely that we will see successful legal challenges to those redactions, say attorneys at Troutman Pepper.
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A Primer On New Calif. Health Transaction Reporting Rules
New California regulations regarding the reporting of certain transactions involving healthcare entities, which took effect on Jan. 1, address some industry feedback about overly broad requirements but still leave several areas of concern, says Andrew Demetriou at Husch Blackwell.
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In The CFPB Playbook: Rulemaking Rush Before Election Year
In this quarterly Consumer Financial Protection Bureau activity recap by former bureau personnel, attorneys at McGuireWoods explain the regulator's recent push to finalize new rules about data aggregators, digital payment apps and more before the election-year Congressional Review Act window opens.
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What The Law Firm Of The Future Will Look Like
As the legal landscape shifts, it’s become increasingly clear that the BigLaw business model must adapt in four key ways to remain viable, from fostering workplace flexibility to embracing technology, say Kevin Henderson and Eric Pacifici at SMB Law Group.
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4 PR Pointers When Your Case Is In The News
Media coverage of new lawsuits exploded last year, demonstrating why defense attorneys should devise a public relations plan that complements their legal strategy, incorporating several objectives to balance ethical obligations and advocacy, say Nathan Burchfiel at Pinkston and Ryan June at Castañeda + Heidelman.
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Digging Into The Debate On FDA's Proposed Lab Test Rule
A proposed 10-word amendment from the U.S. Food and Drug Administration represents a sea change in device regulation as it would summarily end decades of FDA enforcement discretion for laboratory developed tests, and the public comments offer some insight into the future of this long-running saga, say attorneys at Mintz.
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Law Firm Strategies For Successfully Navigating 2024 Trends
Though law firms face the dual challenge of external and internal pressures as they enter 2024, firms willing to pivot will be able to stand out by adapting to stakeholder needs and reimagining their infrastructure, says Shireen Hilal at Maior Consultants.
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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.