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Health
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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
4th Circ. Judge Startled By 'Really Odd' $9M Wage Suit Win
A Fourth Circuit panel on Friday grappled with the degree of control nurses have over their work and if they automatically become employees by signing a noncompete, as it considered a medical staffing company's bid to overturn a $9 million misclassification suit judgment following a bench trial.
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September 27, 2024
Fed. Circ. Won't Revive $5.9M CMS Contingency Fee Suit
The Federal Circuit on Friday refused to revive a contractor's $5.9 million dispute over a Medicare recovery audit task order, saying the Centers for Medicare and Medicaid Services reasonably terminated the deal and didn't owe the company any more money.
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September 27, 2024
Ga. Hospital Patients Ask Judge to Revive Facebook Data Suit
A proposed class of patients claiming Piedmont Healthcare Inc. unlawfully shared their confidential health data with Facebook urged a federal judge to rethink his late-August decision tossing their suit, saying the judge failed to consider their claims the health system criminally violated HIPAA's privacy rule.
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September 27, 2024
Mich. Justices Take Up Another Auto Reform Coverage Case
The Michigan Supreme Court agreed Friday to review a crash coverage dispute concerning whether changes to the state no-fault act's medical care reimbursement rates apply to post-reform treatment, weighing in on a case where the injury occurred after the June 2019 statutory amendment but before the July 2021 effective date.
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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
Ault Disruptive To Dissolve After Failing To Ink SPAC Deal
Blank check company Ault Disruptive Technologies Corp. said on Friday that it plans to dissolve and liquidate because it will not be able to complete an initial business combination before Dec. 20.
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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
HHS Flags Ransomware Rise In New Deal With Wash. Provider
A Washington state-based healthcare provider has agreed to pay $250,000 and boost its data security to resolve the U.S. Department of Health and Human Service's enforcement action over a 2017 ransomware attack, amid what the agency said has been a steep rise in reports of such cyberattacks over the past six years.
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September 26, 2024
Senate Bill Calls For Stronger Healthcare Cyber Standards
Democratic lawmakers introduced legislation Thursday aiming to better protect patient health information and avoid cyberattacks by strengthening cybersecurity standards, months after a highly publicized data breach earlier this year of a UnitedHealth unit that lacked basic security measures like two-factor authentication.
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September 26, 2024
Healthcare REIT Defeats Investor Suit For Good
An Alabama federal judge on Thursday permanently tossed an investor suit against a healthcare-focused real estate investment trust, Medical Properties Trust Inc., that alleged the trust hid the poor performance of four acute care hospitals it owns in Pennsylvania, saying the plaintiff's asserted theory in the suit "is somewhat Jekyll and Hyde."
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September 26, 2024
New Report Urges Feds To Take Larger Role In Pot Policy
The rise of state-sanctioned cannabis markets amid the absence of federal regulation has prioritized policies intended to launch marijuana sales over those focused on public health, according to a government-sponsored report made public Thursday.
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September 26, 2024
Split 2nd Circ. Backs 8 Years For Conn. COVID Money Scam
In a published opinion Thursday, a split panel of the Second Circuit upheld a Connecticut man's eight-year prison sentence for stealing federal COVID-19 relief funds from the city of West Haven through a conspiracy with a state representative, finding that the punishment was not "substantively unreasonable."
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September 26, 2024
Obesity Drug Developer Leads 2 Upsized IPOs Totaling $310M
Obesity-focused drug developer BioAge Labs Inc. gained in debut trading Thursday after raising $198 million through an upsized initial public offering, leading one of two new listings that netted a combined $310 million under the guidance of four law firms.
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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
Colo. Justices Pause Discovery In Hospital Lien Suit
The Colorado Supreme Court on Wednesday stayed discovery in a class action against hospital company Centura Health, as it decides whether to take up the plaintiff's challenge to a Denver judge's second attempt at deciding what documents the plaintiff must produce.
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September 26, 2024
Ex-University Head Says COVID Isolation Death Suit Is Late
Former Seton Hall University President Joseph E. Nyre has asked a New Jersey federal judge to toss gross negligence and fraudulent concealment claims brought by the estate of a student who died from epilepsy in mandatory isolation in her dorm room after testing positive for COVID-19, arguing both claims are time-barred.
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September 26, 2024
Pa. Justices Say COVID Closures Aren't Covered Losses
Pennsylvania's Supreme Court shut the door Thursday on COVID-19 pandemic loss insurance coverage for businesses closed by government mandate, ruling that requisite physical loss or damage required tangible alteration to property, reversing a lower court decision that stated loss of use was sufficient.
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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.
Expert Analysis
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Think Like A Lawyer: Dance The Legal Standard Two-Step
From rookie brief writers to Chief Justice John Roberts, lawyers should master the legal standard two-step — framing the governing standard at the outset, and clarifying why they meet that standard — which has benefits for both the drafter and reader, says Luke Andrews at Poole Huffman.
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Recent Settlement Shows 'China Initiative' Has Life After Death
Though the U.S. Department of Justice shuttered its controversial China Initiative two years ago, its recent False Claims Act settlement with the Cleveland Clinic Foundation demonstrates that prosecutors are more than willing to civilly pursue research institutions whose employees were previously targeted, say attorneys at Benesch.
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DOJ Innovasis Settlement Offers Lessons On Self-Disclosure
The recent $12 million settlement with Innovasis and two of its executives demonstrates the U.S. Department of Justice's continued prioritization of Anti-Kickback Statute enforcement amid the growing circuit split over causation, and illustrates important nuances surrounding self-disclosure, say Denise Barnes and Scott Gallisdorfer at Bass Berry.
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How Orange Book Antitrust Scrutiny Is Intensifying
Pharmaceutical patent holders should be reviewing Orange Book listing practices, as the Federal Trade Commission takes a more aggressive antitrust approach with actions such as the Teva listing probe, and the U.S. Food and Drug Administration calls attention to potentially improper listings, say attorneys at McDermott.
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Weight-Loss Drugs May Spur Next Major Mass Tort
With lawsuits concerning Ozempic and similar weight-loss drugs potentially becoming the next major mass tort in the U.S., companies should consider key defense strategies ranging from alternate dispute resolution to enhanced drug safety, say Dino Haloulos and Jarif Khan at Foley & Mansfield.
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Bid Protest Spotlight: Standing, Prejudice, Conflicts
In this month's bid protest roundup, Caitlin Crujido at MoFo examines three recent decisions from the U.S. Government Accountability Office concerning whether a would-be protestor was an interested party with standing, whether an agency adequately investigated potential procurement violations and whether a proposed firewall sufficiently addressed an impaired objectivity organizational conflict of interest.
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Opinion
The FTC Needs To Challenge The Novo-Catalent Deal
Novo's acquisition of Catalent threatens to substantially lessen competition in the manufacturing and marketing of GLP-1 diabetes and obesity drugs, and the Federal Trade Commission should challenge it under a vertical theory of harm, as it aligns with last year's merger guidelines and the Fifth Circuit decision in Illumina, says attorney David Balto.
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Series
Being A Luthier Makes Me A Better Lawyer
When I’m not working as an appellate lawyer, I spend my spare time building guitars — a craft known as luthiery — which has helped to enhance the discipline, patience and resilience needed to write better briefs, says Rob Carty at Nichols Brar.
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FDA's Multifaceted Role On Display In MDMA Therapy Scrutiny
Ongoing deliberations at the U.S. Food and Drug Administration regarding MDMA-assisted therapy for post-traumatic stress disorder serves as a window into the intricate balance of scientific innovation and patient safety oversight, and offers crucial insights into regulatory nuances, say Kimberly Chew at Husch Blackwell and Kevin Lanzo at Pharmaka Clinical Consulting.
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Lead Like 'Ted Lasso' By Embracing Cognitive Diversity
The Apple TV+ series “Ted Lasso” aptly illustrates how embracing cognitive diversity can be a winning strategy for teams, providing a useful lesson for law firms, which can benefit significantly from fresh, diverse perspectives and collaborative problem-solving, says Paul Manuele at PR Manuele Consulting.
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Analyzing FDA Draft Guidance On Clinical Trial Diversity
In light of the U.S. Food and Drug Administration's draft guidance on clinical trial diversity action plans, there are several important considerations for sponsors and clinical researchers to keep in mind to prevent delay in a drug or device application, say attorneys at Crowell & Moring.
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What's New In The AI Healthcare Regulatory Space
Attorneys at Hogan Lovells review the current legal and regulatory landscape for artificial intelligence applications in healthcare, touching on policies around safety, transparency, nondiscrimination and reimbursement, and what to expect in the future.
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The Good, The Bad And The Ugly Of Healthcare's PE Boom
While an influx of capital may provide access to new resources and innovative technologies, the private equity model's method of funding may be fundamentally at odds with patient-first healthcare, and in recent years that inherent tension has gotten ugly, say Eva Gunasekera and Jaclyn Tayabji at Tycko & Zavareei.
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3 Policyholder Tips After Calif. Ruling Denying D&O Coverage
A California decision from June, Practice Fusion v. Freedom Specialty Insurance, denying a company's claim seeking reimbursement under a directors and officers insurance policy for its settlement with the Justice Department, highlights the importance of coordinating coverage for all operational risks and the danger of broad exclusionary policy language, says Geoffrey Fehling at Hunton.
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Opinion
Now More Than Ever, Lawyers Must Exhibit Professionalism
As society becomes increasingly fractured and workplace incivility is on the rise, attorneys must champion professionalism and lead by example, demonstrating how lawyers can respectfully disagree without being disagreeable, says Edward Casmere at Norton Rose.