Policy & Compliance
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September 20, 2024
FTC Accuses Drug Middlemen Of Raising Insulin Prices
The Federal Trade Commission on Friday accused the three largest pharmacy benefits managers, Caremark Rx, Express Scripts and OptumRx, of artificially inflating insulin prices by relying on unfair rebate schemes that hurt competition.
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September 19, 2024
Ga. Appeals Court Says Hospital Must Get Certificate Of Need
The Georgia Court of Appeals for the second time has said that a Georgia hospital must obtain a new certificate of need from the state to convert its long-term care beds to short-stay acute care beds, following guidance issued by the state's justices earlier this year.
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September 19, 2024
Teamsters Unit Escapes Hospital Worker's Wage Suit
A Massachusetts federal judge tossed a hospital worker's claims that a Teamsters unit failed to properly represent her when she didn't receive as big a pay bump under a new collective bargaining agreement as expected, saying the union showed it did what it could to advocate for her.
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September 18, 2024
7th Circ. Questions Nixing $183M Eli Lilly Drug Rebate Verdict
A Seventh Circuit judge seemed unsure Wednesday whether to disturb a $183 million verdict against Eli Lilly in a false claims case targeting more than a decade of drug rebate miscalculations, questioning whether the company skipped checking legal guidance before calling its price reporting requirements unclear.
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September 18, 2024
Health AI Co. Says Texas AG 'Misrepresents' Compliance Deal
The Texas attorney general's Wednesday announcement of a compliance agreement with a healthcare-focused artificial intelligence company has sparked backlash from the company, which accused the state prosecutor of "dangerously" misrepresenting their agreement.
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September 18, 2024
Ex-Amgen Rep Wasn't Original Whistleblower, Judge Says
A Brooklyn federal judge tossed a former Amgen sales representative's whistleblower suit on Wednesday, saying many elements of his allegations of a kickback scheme had been disclosed in news reports and civil lawsuits prior to his filing.
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September 17, 2024
North Carolina Panel Orders Redo In Hospital Beds Battle
A Tar Heel State administrative court erred when it used the state health department's failure to hold a public hearing as a basis to yank the department's approval of the University of North Carolina's application to enhance its hospital's services, an appeals court ruled Tuesday, in a setback for Duke University's healthcare unit.
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September 17, 2024
Texas Fertility Clinic Hid 'Catastrophic' Lab Issue, Couples Say
Five couples accused a Houston fertility institute of hiding "catastrophic" laboratory issues that affected patients' embryos, saying in a lawsuit that the entity instead injected multiple hopeful mothers with "dead or dying" eggs.
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September 17, 2024
Henrietta Lacks' Family Still Seeks Justice For 'Immortal' Cells
Seven decades have passed since a doctor at a Baltimore hospital took, without permission, a sample of cells from a Black woman suffering from cervical cancer. While the durable strain of human cells known as "HeLa" has fueled a handful of lawsuits against drug companies accused of profiting from stolen genetic material, more are likely on the way.
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September 17, 2024
Brooklyn Feds Unveil Whistleblower Nonprosecution Plan
The Brooklyn U.S. Attorney's Office on Tuesday announced an initiative to reward corporate whistleblowers with nonprosecution deals amid a broader effort by federal prosecutors to encourage voluntary disclosure of criminal activity.
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September 17, 2024
Express Scripts Blasts 'Biased' FTC Drug Middlemen Report
The Federal Trade Commission defamed Express Scripts and violated its constitutional rights with an inaccurate report that ripped the role pharmacy benefit managers play as middlemen between drugmakers and insurers, according to a lawsuit lodged Tuesday in Missouri federal court.
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September 17, 2024
Blumenauer Pushes House Speaker To Put Pot Bill To Vote
U.S. Rep. Earl Blumenauer, D-Ore., on Monday urged House Speaker Mike Johnson to bring bipartisan cannabis legislation to a vote following revelations that Richard Nixon admitted privately that marijuana was "not particularly dangerous" while he publicly waged the war on drugs.
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September 16, 2024
5th Circ. Judge Chides High Court Calls in Abortion Pill Case
U.S. Circuit Judge James C. Ho on Monday threw shade at the U.S. Supreme Court and the Biden administration over what he described as side-switching on federal conscience laws for doctors.
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September 16, 2024
NC High Court Snapshot: Tax Fights And A Health Care Spat
Regulatory battles will take center stage when the North Carolina Supreme Court returns from summer break this week for a September argument lineup featuring appeals by Phillip Morris, Duke University's hospital and two Boost Mobile dealers.
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September 16, 2024
Nebraska Medical Cannabis Initiatives Will Be On Nov. Ballot
Initiatives to legalize medical marijuana in Nebraska will appear on the ballot come November, despite some evidence of fraud in the signature-collecting petition process, according to state election officials.
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September 13, 2024
The 2024 Regional Powerhouses
The law firms on Law360's list of 2024 Regional Powerhouses reflected the local peculiarities of their states while often representing clients in deals and cases that captured national attention.
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September 13, 2024
Doctor Charged In DOJ Fraud Suit Gets 6 Months Probation
One of the defendants accused in a healthcare fraud suit that ended in a mistrial in 2022 was sentenced Thursday to six months of probation after pleading guilty in June to one count of aiding and abetting the conversion of public money in connection with the alleged fraud.
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September 13, 2024
Neb. Court Allows Competing Abortion Measures On Ballot
Nebraska's top court agreed on Friday to let two competing — and sharply contested — abortion initiatives on the November ballot.
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September 13, 2024
Mass. Justices Say Benefits Don't Accrue Under Leave Law
Massachusetts' top court ruled Friday that the state's Paid Family and Medical Leave Act doesn't allow a group of state troopers to accrue certain benefits while on leave.
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September 12, 2024
ND Judge Finds 'Fundamental Right' To Abortion, Strikes Ban
Women in North Dakota have a "fundamental right" to abortion access pre-viability, a state judge ruled Thursday in a decision overturning a near-total state ban.
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September 11, 2024
Gender Care Hearing Centers On Ohio Bill Of Rights
Questions about potential conflicts between an Ohio gender care ban and a right to healthcare "freedom" enshrined in the state constitution dominated much of a Wednesday hearing in a state appellate court.
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September 10, 2024
Missouri High Court Puts Abortion Rights Back on Nov. Ballot
Missourians will have a chance to vote this year on a constitutional amendment enshrining the right to abortion access following a Tuesday ruling by the state's highest court.
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September 10, 2024
42 AGs Back Call For Social Media Warning Label Law
A bipartisan group of 42 attorneys general urged Congress on Tuesday to introduce warning labels on social media platforms in a bid to tackle risks posed to young people's mental health.
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September 10, 2024
2024's Top Rulings In Native American Law
The U.S. Supreme Court this year has handed down rulings with huge price tags attached — from millions in healthcare reimbursement funding required for tribes to lending Florida a win that will garner it a new revenue stream — that are expected to have large implications for Native American sovereignty. Here, Law360 takes a look at some of the biggest decisions in Native American law from the first half of 2024.
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September 10, 2024
Neb. Midwife Can't Sue For 'Hypothetical' Clients, Judge Rules
A Nebraska midwife who challenged state restrictions on the practice "barely" tried to establish grounds to sue the state over allegations that her would-be clients were being harmed, a federal judge ruled Monday, dismissing the case.
Expert Analysis
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Skirting Anti-Kickback Causation Standard Amid Circuit Split
Amid the federal circuit court split over the causation standard applicable to False Claims Act cases involving Anti-Kickback Statute violations, which the First Circuit will soon consider in U.S. v. Regeneron, litigators aiming to circumvent the heightened standard should contemplate certain strategies, say Matthew Modafferi and Terence Park at Frier Levitt.
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Gilead Ruling Signals That Innovating Can Lead To Liability
A California appeals court's ruling last month in Gilead Life Sciences v. Superior Court of San Francisco that a drug manufacturer can be held liable for delaying the introduction of an improved version of its medication raises concerns about the chilling effects that expansive product liability claims may have on innovation, says Gary Myers at the University of Missouri School of Law.
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Health Policy Legislative Landscape May Remain Frozen
With Congress again delaying the full resolution of fiscal year 2024 federal spending legislation, there is now an additional window in which Congress could work through several priority issues for healthcare stakeholders, though these issues are unlikely to be resolved in time, say attorneys at Faegre Drinker.
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Despite HHS Opinion, Gift Card Giveaways Require Caution
Though the U.S. Department of Health and Human Services' Office of Inspector General recently determined that a healthcare consulting firm's gift card plans do not violate the Anti-Kickback Statute, the opinion does not suggest blanket approval for providing gift cards in exchange for referrals, say Ragini Acharya and Matthew Deutsch at Husch Blackwell.
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DOJ's Biopharma Settlement Raises Anti-Kickback Questions
In the aftermath of the U.S. Department of Justice's settlement with Ultragenyx over genetic testing programs, it may be prudent to reevaluate genetic tests through the lens of the Anti-Kickback Statute and reconsider whether it is proper for free testing programs to be treated like patient assistance programs, says Mary Kohler at Kohler Health Law.
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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.