Policy & Compliance
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September 30, 2024
Ga.'s 'Heartbeat' Abortion Ban Struck Down Once Again
Georgia residents had their legal access to abortion temporarily restored Monday as the state's so-called heartbeat abortion ban was again struck down by a judge whose previous move to block the 2019 law had been reversed by the state's highest court.
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September 30, 2024
J&J Backs Off 340B Rebate Plan Following Feds' Objections
Johnson & Johnson abandoned its plan Monday to offer rebates rather than upfront discounts for two medications under the 340B drug pricing law, contending it had no choice after a federal agency threatened to impose excessive penalties.
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September 30, 2024
Physician Assistant Seeks Lenient Term In $10M Fraud Case
A North Carolina physician assistant is looking to spend just one year behind bars after a federal jury in Charlotte found him guilty of rubber-stamping bogus prescriptions for genetic testing, marking a far cry from prosecutors' requested nine-year prison sentence.
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September 27, 2024
Texas AG Wants Austin's Abortion Travel Fund Shut Down
Texas Attorney General Ken Paxton on Friday accused the city of Austin of illegally using taxpayer funds to cover travel costs for people traveling out of the Lone Star State to get abortions, claiming that the city is misappropriating the funds in violation of the state constitution.
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September 27, 2024
Kappos' Bayh-Dole Warning To Clients Draws Debate
An advocate for lowering drug prices squared off Friday against a former U.S. Patent and Trademark Office director about the potential risk of accepting government funds to develop drugs, as part of a discussion at New York University School of Law.
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September 27, 2024
Acadia To Pay $19.9M For Alleged Inpatient Billing Scheme
Acadia Healthcare will pay $19.85 million to settle allegations it billed false claims to the federal government for medically unnecessary behavioral health services provided to patients who weren't even eligible for treatment, the U.S. Department of Justice announced.
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September 27, 2024
Why Many Drugs Remain Pricey 40 Years After Hatch-Waxman
In the four decades since Congress passed the Hatch-Waxman Act in an effort to make generic drugs more available, the pharmaceutical industry has used patent thickets, "evergreening" and pay-for-delay tactics to block competition and keep prices of life-saving specialty drugs astronomical, several legal experts told Law360, while the industry argues other parties shoulder more of the blame.
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September 27, 2024
MetLife's 3rd Circ. Win Won't Stop ERISA Health Fee Suits
The Third Circuit's recent decision upholding MetLife's escape from a lawsuit accusing the company of pocketing $65 million in pharmacy rebates instead of using the funds to lower employee healthcare costs hands additional authority over to employers facing a new wave of class action litigation over excessive health fees, attorneys say.
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September 27, 2024
Medical Equipment Co., Founder Settle FCA Suit For $20M
A Florida-based medical equipment company and its founder will pay $20 million to settle claims under the federal False Claims Act that they improperly billed government healthcare plans for duplicated and unnecessary sales of devices meant to offer pain relief through electrical stimulation, Pennsylvania prosecutors said Friday.
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September 26, 2024
Virtua Discriminates Against Pregnant Patients, NJ Alleges
Virtua Health discriminates against pregnant patients by forcing them to undergo drug testing for inpatient admission to its hospitals — a policy that does not apply universally to other patients, New Jersey Attorney General Matthew J. Platkin alleged in a lawsuit filed Thursday in New Jersey state court.
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September 26, 2024
Winner Of $8.6M Suit Wants Mich. Justices' Take On Cap
The estate of a patient who won an $8.6 million medical malpractice verdict earlier this year is asking a Michigan federal court to certify a question to the state's Supreme Court to determine whether a statutory cap on noneconomic damages is constitutional.
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September 26, 2024
Senate Patent Bill Markups Delayed Until After Election
Congressional hearings scheduled for Thursday to mark up several bills related to patents, including measures dealing with patent eligibility, validity challenges and drug patents, have been postponed until after Election Day due to the Senate's adjournment.
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September 26, 2024
NY Lawmakers Beat ADA Suit Over Contentious Mask Ban
A New York federal judge threw out a challenge to Nassau County's ban on face masks worn by people trying to hide their identities in public, noting in an order Wednesday the plaintiffs lack standing since the ban doesn't apply to coverings worn to protect the wearer's health and safety.
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September 26, 2024
Healthcare Atty Rejoins Polsinelli After Foley Hoag Stint
Polsinelli PC announced on Wednesday that a doctor and former healthcare policy attorney who spent 11 years during a previous stint with the firm has returned to its Washington, D.C., office as a public policy shareholder.
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September 26, 2024
Behavioral Health Exec Pleads Guilty To Medical Billing Fraud
The chief executive of a behavioral health company on Thursday admitted to directing employees to bill Medicare and Medicaid for extra psychotherapy sessions that never took place.
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September 25, 2024
NY Judge Pauses Abortion 'Reversal' Case As AG Files Appeal
A New York federal judge has ruled that two more anti-abortion pregnancy centers are free to promote abortion pill "reversal" while a legal clash continues over whether the First Amendment protects their right to market the treatment, which is doubted by major medical groups.
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September 25, 2024
Generics Group Names Ex-BIO, PhRMA Exec As New CEO
The generic drug industry group the Association for Accessible Medicines on Wednesday announced it has appointed a new chief executive officer who brings over a decade of experience in the branded drug industry.
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September 25, 2024
DC Circ. Judges Ask If It's Too Late To Fast-Track Gastro Drug
A panel of D.C. Circuit judges grilled an attorney for Vanda Pharmaceuticals on Wednesday over claims Vanda's gastroparesis drug was improperly denied fast-track designation by the Food and Drug Administration, questioning why the company declined to complete animal toxicological studies even after the FDA paused the drug's human trials.
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September 25, 2024
Wash. Hospital System Misclassifies Workers, Nurse Says
A Washington-based hospital operator misclassified its workers as independent contractors and underpaid them for their overtime as a result, a registered nurse said in a proposed class and collective action in Washington federal court.
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September 25, 2024
AmerisourceBergen Can't Escape Workers' 401(k) Fee Suit
AmerisourceBergen Corp. can't escape a proposed class action alleging it allowed its employee 401(k) plan to be saddled with excessive recordkeeping costs, a Kentucky federal judge ruled, saying the workers' claims and calculations were detailed enough to move forward.
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September 24, 2024
Medical Aid-In-Dying Movement Faces Setback In NJ Fight
Advocates for state laws that allow physicians to prescribe lethal medication to terminally ill patients hit a roadblock when a New Jersey federal judge concluded the state can limit it to state residents. Previous challenges in two other states prompted changes to aid-in-dying statues.
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September 24, 2024
Novo Nordisk Tells Sens. Ozempic Costs Are Linked To PBMs
Novo Nordisk's CEO argued Tuesday that the high prices of the company's diabetes and weight loss drugs Ozempic and Wegovy primarily stem from the actions of pharmacy benefit managers, earning support from many members of a Senate committee and frustrating others who wanted more direct answers on the Danish drugmaker's own responsibilities.
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September 24, 2024
NY Diocese Targets Landmark Religion Ruling At High Court
A Roman Catholic diocese in New York and other religious ministries have launched a fresh attempt to get the U.S. Supreme Court to revisit a landmark ruling that restricts religious-freedom challenges to neutral, generally applicable laws.
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September 24, 2024
8th Circ. Grapples With Standing In Battle Over EEOC Regs
The Eighth Circuit appeared to be wrestling Tuesday with whether a group of red states had the right to sue over the U.S. Equal Employment Opportunity Commission's recently finalized pregnant worker regulations, as the states pushed for revival of their challenge to abortion-related components of the rule.
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September 24, 2024
State Courts Take Lead In Fraught Abortion Ballot Battles
A slew of abortion-rights ballot initiatives headed to voters this November are being challenged in state courts, keeping a politically charged issue in front of state judges at a time of historically low public trust in the judiciary.
Expert Analysis
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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.
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Giving The Gov't Drug Patent March-In Authority Is Bad Policy
The Biden administration's recent proposal to allow government seizure of certain taxpayer-funded drug patents is a terrible idea that would negate the benefits of government-funded research, to the detriment of patients and the wider economy, says Wayne Winegarden at Pacific Research Institute.
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How Clients May Use AI To Monitor Attorneys
Excerpt from Practical Guidance
Artificial intelligence tools will increasingly enable clients to monitor and evaluate their counsel’s activities, so attorneys must clearly define the terms of engagement and likewise take advantage of the efficiencies offered by AI, says Ronald Levine at Herrick Feinstein.