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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
Webuild Escapes Suit Over $140M Award In Delaware
Italian construction giant Webuild has skirted a Chilean construction company's bid to enforce a $140 million arbitral award arising from a soured hospital construction project in the Chilean capital of Santiago, after a Delaware federal judge nixed the case on jurisdictional grounds.
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September 30, 2024
Claims Trimmed In Neb. Medical Pot Legalization Fight
A Nebraska state judge has dismissed two out of four claims in a lawsuit aiming to block voters from deciding on ballot measures that could legalize medical cannabis and establish a system regulating its manufacture and sale.
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September 30, 2024
Judge Wants More Info On Yale's Ties To Fertility Doctor
A Connecticut judge presiding over claims a fertility doctor used his own sperm to impregnate women in the 1980s asked two plaintiffs on Monday to back up their argument that Yale University and its affiliated hospital could be held liable, while the Ivy League entities sought to avert an evidence probe.
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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 30, 2024
Steward Health CEO Sues Senate Panel After Contempt Vote
The outgoing CEO of embattled Steward Health Care on Monday sued members of Congress who voted earlier this month to hold him in contempt for defying their subpoena to testify at a hearing into the downfall of the bankrupt hospital chain he heads.
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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
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.
Expert Analysis
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Vertex Suit Highlights Issues For Pharma Fertility Support
Vertex Pharmaceuticals' recent lawsuit challenging the U.S. Department of Health and Human Services' interpretation of the Anti-Kickback Statute is influenced by a number of reproductive rights and health equity issues that the Office of Inspector General should address more concretely, including in vitro fertilization and fertility preservation programs, says Mary Kohler at Kohler Health Law.
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Opinion
CMS' New 'Breakthrough' Device Policy Shows Little Promise
The Centers for Medicare & Medicaid Services’ recent procedural notice outlining a new Medicare coverage pathway for breakthrough medical devices will, at best, be a failed experiment and, at worst, result in Medicare beneficiaries denied access to innovative treatments, say attorneys at King & Spalding.
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Assessing Algorithmic Versus Generative AI Pricing Tools
A comparison of traditional algorithmic pricing models and those powered by generative artificial intelligence can help regulators and practitioners weigh the pros and cons of relying on large language models to price products or services, say Maxime Cohen at McGill University, and Tim Spittle and Jimmy Royer at Analysis Group.
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SBA Proposal Materially Alters Contractor Recertification
The Small Business Administration's new proposed rule on recertification affects eligibility for set-aside contracts, significantly alters the landscape for mergers and acquisitions in the government contracts industry, and could have other unintended downstream consequences, says Sam Finnerty at PilieroMazza.
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A Preview Of AI Priorities Under The Next President
For the first time in a presidential election, both of the leading candidates and their parties have been vocal about artificial intelligence policy, offering clues on the future of regulation as AI continues to advance and congressional action continues to stall, say attorneys at Mintz.
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How Companies Are Approaching Insider Trading Policies
An analysis of insider trading policies recently disclosed by 49 S&P 500 companies under a new U.S. Securities and Exchange Commission rule reveals that while specific provisions vary from company to company, certain common themes are emerging, say attorneys at Gibson Dunn.
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11 Patent Cases To Watch At Fed. Circ. And High Court
As we head into fall, there are 11 patent cases to monitor, touching on a range of issues that could affect patent strategy, such as biotech innovation, administrative rulemaking and patent eligibility, say Edward Lanquist and Wesley Barbee at Baker Donelson.
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Managing Community Health Needs Assessments: A Checklist
Excerpt from Practical Guidance
To guide nonprofit hospitals and health systems through their required community health needs assessment every three years, this checklist outlines the steps for 12 phases of the process.
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How Methods Are Evolving In Textualist Interpretations
Textualists at the U.S. Supreme Court are increasingly considering new methods such as corpus linguistics and surveys to evaluate what a statute's text communicates to an ordinary reader, while lower courts even mull large language models like ChatGPT as supplements, says Kevin Tobia at Georgetown Law.
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7th Circ. Rulings Offer Employee Vaccine Exemption Guidance
Dawn Solowey and Samantha Brooks at Seyfarth explain how two recent Seventh Circuit rulings in Passarella v. Aspirus and Bube v. Aspirus could affect litigation involving employee vaccine exemptions, and discuss employer best practices for handling accommodation requests that include both religious and secular concerns.
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Pa. Health Employers Must Prep For Noncompete Restrictions
Newly enacted legislation in Pennsylvania prohibits certain noncompete covenants for healthcare practitioners in the state beginning next year, creating compliance challenges that both employers and employees should be aware of, say attorneys at Buchanan Ingersoll.
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Opinion
Congress Must Do More To Bolster ERISA Protections
As the Employee Retirement Income Security Act turns 50 this month, we applaud Congress for championing a statute that protects worker and retiree rights, but further action is needed to ban arbitration clauses in plan provisions and codify regulations imperiled by the U.S. Supreme Court’s Chevron ruling, say Michelle Yau and Eleanor Frisch at Cohen Milstein.
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FTC Focus: What Access To Patent Settlements Would Mean
Settling parties should adopt a series of practice tips, including specifying rationales to support specific terms, as the Federal Trade Commission seeks to expand its access to settlements before the Patent Trial and Appeal Board, say Shannon McGowan and David Munkittrick at Proskauer.
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Why Attorneys Should Consider Community Leadership Roles
Volunteering and nonprofit board service are complementary to, but distinct from, traditional pro bono work, and taking on these community leadership roles can produce dividends for lawyers, their firms and the nonprofit causes they support, says Katie Beacham at Kilpatrick.
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Opinion
Agencies Should Reward Corporate Cyber Victim Cooperation
The increased regulatory scrutiny on corporate victims of cyberattacks — exemplified by the U.S. Securities and Exchange Commission's case against SolarWinds — should be replaced with a new model that provides adequate incentives for companies to come forward proactively and collaborate with law enforcement, say attorneys at McDermott.