Policy & Compliance
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September 03, 2024
5th Circ. Grills Feds On Congress' Intent In No Surprises Act
A Fifth Circuit panel on Tuesday challenged the federal government over its interpretation of how it applies a formula to calculate qualifying payments under a law meant to protect Americans from surprise medical bills and questioned the arbitration process over the payments that a medical association said favors insurers.
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September 03, 2024
Meet The Zuckerman Spaeder Attys In Drug Rebate Battle
A pair of Zuckerman Spaeder LLP attorneys who once oversaw changes to the 340B drug discount program during the Obama administration have teamed up again to defend the program from what they call an attempt by the pharmaceutical industry to weaken its benefits.
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September 03, 2024
Justices Deny Oklahoma's Bid To Block HHS Funding Cut
The U.S. Supreme Court on Tuesday denied Oklahoma's request to stop the U.S. Department of Health and Human Services from cutting funding over the state's refusal to refer family planning patients for abortion after the high court's Dobbs decision last year.
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September 03, 2024
2nd Circ. Won't Ax Dad's Removal Over Child's Mental Health
The Second Circuit ruled Tuesday that a man who entered the U.S. illegally more than two decades ago can't cancel his removal on the grounds that it would cause his daughter hardship, ruling that any adverse impacts would be typical of family separation.
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September 03, 2024
Ohio AG Asks Appeals Court To Affirm Trans Care Restrictions
Ohio lawmakers acted within their authority to regulate the practice of medicine when they passed a law this year that restricts gender-affirming care for minors and prohibits transgender girls from participating in girls sports, Ohio Attorney General Dave Yost told the state appeals court in a recent brief.
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September 03, 2024
Will Medicaid Incarceration Waivers Hit 'Cutting Room Floor'?
A bipartisan push to get incarcerated individuals covered by Medicaid before they're released could drastically reduce healthcare disparities and provide health equity to underrepresented populations. But shifting political winds and an upcoming election could lead to budget cuts that put the program on the "cutting room floor."
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September 03, 2024
'Showdown' Looms As J&J Pursues Rebates In 340B Program
Johnson & Johnson's plan to abandon upfront discounts and instead offer rebates for two popular medications under the 340B drug pricing law would fundamentally alter how the program has worked for decades. Federal enforcement efforts and other legal clashes are likely.
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September 03, 2024
Glenmark Hit With $50M Suit Over Potassium Pill Death
A proposed class of buyers is suing Glenmark Pharmaceuticals Inc. for more than $50 million, alleging that the company's extended-release potassium chloride capsules are defective and instead deliver the potassium too fast, which resulted in the death of the lead plaintiff's mother.
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August 30, 2024
Vets, Attys Urge Supreme Court To Topple Feres Doctrine
Veterans groups and lawmakers contend it's "high time" for the U.S. Supreme Court to scrap its 74-year-old doctrine prohibiting military service members and their families from suing the U.S. for negligence, arguing the vague rule has left soldiers with fewer rights than prisoners and noncitizens.
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August 30, 2024
Connecticut Judge Wants More Info In Doctors' Billing Row
A Connecticut federal judge on Friday declined to immediately dismiss a medical staffing company's lawsuit against Harvard Pilgrim Health Care of Connecticut Inc. after the state's highest court answered three certified questions in the insurer's favor, asking for briefs after the insurer countered with a demand for a judgment.
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August 30, 2024
HHS Wins Escape From Low-Income Hospital Payment Fight
A D.C. federal judge on Friday agreed to toss a lawsuit brought by a group of hospitals against the U.S. Department of Health and Human Services challenging its Medicare payment determinations for low-income patients, finding the hospitals didn't exhaust their administrative remedies.
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August 30, 2024
Nebraska Expected To Vote On Medical Marijuana Legalization
Medical marijuana advocates have met the requirements to put a legalization question before Nebraska voters on Election Day this November, the secretary of state announced Friday.
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November 17, 2023
HHS Seeks Exit From Low-Income Hospital Payment Rule Suit
The U.S. Department of Health and Human Services asked a D.C. federal court Thursday to dismiss a lawsuit from a group of hospitals challenging Medicare payment determinations for low-income patients, the same day the court rejected the hospitals' request to continue pausing the case.
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August 29, 2024
Sutter Health Kickback Fight Likely Headed To Nov. Trial
A California federal judge indicated Wednesday she's likely to send at least some claims in a whistleblower's kickback suit against Sutter Health and a surgical-practice group to a November trial, saying during a hearing there are disputes over the credibility of certain evidence and that's "the providence of the jury."
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August 29, 2024
Comer Tells PBMs To Correct Record On Role In Drug Pricing
Rep. James Comer, R-Ky., chair of the House Oversight and Accountability Committee, is demanding that the heads of three major pharmacy benefit managers "correct the record" on their testimony made before his committee in July about their roles in drug pricing, including company claims that the PBMs don't steer customers to in-house pharmacies and that they allow non-affiliated pharmacies to negotiate contracts.
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August 29, 2024
Conn. ER Docs Ask To Drop Harvard Pilgrim Insurance Fight
A staffing company covering six Connecticut emergency rooms has asked a federal judge to dismiss its lawsuit against Harvard Pilgrim Health Care of Connecticut Inc. after the state's highest court last week ruled in the insurer's favor on three certified questions of law regarding a surprise billing statute.
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August 29, 2024
HHS Withdraws Appeal In Hospital Web-Tracking Clash
The Biden administration on Thursday abandoned its appeal of a federal court decision that knocked down new guidance restricting how hospitals can use web-tracking tools, handing the American Hospital Association a victory in a closely watched case.
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August 29, 2024
Full 11th Circ. Won't Rehear Ala. Trans Care Ban Challenge
The Eleventh Circuit said it will not reconsider its ruling allowing Alabama to enact a ban on certain gender-affirming medical care for minors, knocking down a challenge brought by parents and those who received the treatment of the circuit's ruling, which found that the ban doesn't flout constitutional rights.
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August 29, 2024
GOP States Ask Justices To Undo Trans Patients' 4th Circ. Win
A group of two dozen Republican attorneys general told the U.S. Supreme Court it should review a Fourth Circuit decision barring West Virginia and North Carolina from excluding coverage of gender-affirming medical care for transgender people, arguing states need the power to control controversial nascent treatments.
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August 28, 2024
CVS Can't Avoid Federal Claims In $200M FCA Suit
A former CVS Health compliance director can pursue claims the company and its subsidiaries pocketed more than $200 million in overpayments, after an Illinois federal judge on Monday tossed several other claims from a qui tam suit alleging various schemes by CVS to take money from the government.
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August 28, 2024
9th Circ. Overturns Rule Mandating Sealing Of Health Records
A Ninth Circuit panel found Wednesday that Hawaii state court rules mandating the automatic sealing of medical and health records in civil and criminal proceedings are unconstitutionally overbroad.
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August 28, 2024
Dr.'s Suit Blames Practice's Buyer For Chaos After Sale
A North Carolina doctor struck back in a lawsuit blaming him for business challenges following the sale of his practice to another physician, alleging in counterclaims that the purchasing physician lied about his intentions for the practice and ultimately led it to ruin.
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August 28, 2024
Jazz, Hikma Must Face Bulk Of Xyrem Antitrust Suit
Jazz Pharmaceuticals and Hikma Pharmaceuticals appear bound for trial against most solo insurer and class action antitrust claims over alleged efforts to block generic competitors to Jazz's Xyrem narcolepsy drug, under a newly unsealed California federal court order largely rejecting competing motions for summary judgment.
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August 28, 2024
Mont. Hospital Pays $11M In FCA Case For Doc's Fake Billing
Nonprofit healthcare center St. Peter's Health will pay nearly $11 million to settle alleged False Claims Act violations stemming from conduct by a former oncology doctor who submitted fraudulent claims to government programs for up-coded cancer treatment services and who double-billed office visits to boost his own salary, according to the U.S. Attorney's Office for the District of Montana.
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August 27, 2024
Justices Told Gender Care Ban Defies Decades-Old Precedent
A group of transgender adolescents on Tuesday urged the U.S. Supreme Court to overturn a Sixth Circuit decision allowing Tennessee to enforce a state ban on certain medical procedures that they say treats individuals differently based on their assigned sex at birth.
Expert Analysis
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Attorneys Have An Ethical Duty To Protect The Judiciary
The tenor of public disagreement and debate has become increasingly hostile against judges, and though the legislative branch is trying to ameliorate this safety gap, lawyers have a moral imperative and professional requirement to stand with judges in defusing attacks against them and their rulings, says Deborah Winokur at Cozen O'Connor.
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Cross-Market Implications In FTC's Anesthesia Complaint
The Federal Trade Commission's recent complaint against a private equity firm's acquisition of anesthesiology practices highlights the controversial issue of cross-market harm in health care provider mergers, and could provide important insights into how a court may view such theories of harm, say Christopher Lau and Dina Older Aguilar at Cornerstone Research.
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AI Can Help Lawyers Overcome The Programming Barrier
Legal professionals without programming expertise can use generative artificial intelligence to harness the power of automation and other technology solutions to streamline their work, without the steep learning curve traditionally associated with coding, says George Zalepa at Greenberg Traurig.
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Preparing Law Students For A New, AI-Assisted Legal World
As artificial intelligence rapidly transforms the legal landscape, law schools must integrate technology and curricula that address AI’s innate challenges — from ethics to data security — to help students stay ahead of the curve, say Daniel Garrie at Law & Forensics, Ryan Abbott at JAMS and Karen Silverman at Cantellus Group.
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ESG Around The World: South Korea
Numerous ESG trends have materialized in South Korea in the past three years, with impacts ranging from greenwashing prevention and carbon neutrality measures to workplace harassment and board diversity initiatives, say Chang Wook Min and Hyun Chan Jung at Jipyong.
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General Counsel Need Data Literacy To Keep Up With AI
With the rise of accessible and powerful generative artificial intelligence solutions, it is imperative for general counsel to understand the use and application of data for myriad important activities, from evaluating the e-discovery process to monitoring compliance analytics and more, says Colin Levy at Malbek.
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A Look At Healthcare Timelines Set By Biden's AI Order
President Joe Biden's artificial intelligence executive order establishes standards for using AI in the healthcare industry, including a number of staggered deadlines that should help coordinate a more unified federal approach to AI governance, say attorneys at Holland & Knight.
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A Look At Successful Bid Protests In FY 2023
Attorneys at Sheppard Mullin look beyond the statistics in the U.S. Government Accountability Office’s recent annual report on bid protests, sharing their insights about nine categories of sustained protests, gained from reading every fiscal year 2023 decision in which the protester had a positive result.
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Navigating Discovery Of Generative AI Information
As generative artificial intelligence tools become increasingly ubiquitous, companies must make sure to preserve generative AI data when there is reasonable expectation of litigation, and to include transcripts in litigation hold notices, as they may be relevant to discovery requests, say Nick Peterson and Corey Hauser at Wiley.
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FDA's Lab-Developed Test Rule May Bring Historic Challenges
If finalized, the U.S. Food and Drug Administration's proposed rule for regulating laboratory-developed tests will provoke some of the most interesting legal challenges that the agency has faced in decades, with outcomes that will likely reverberate across the agency's product centers, says Stacy Amin at MoFo.
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Finding Focus: Strategies For Attorneys With ADHD
Given the prevalence of ADHD among attorneys, it is imperative that the legal community gain a better understanding of how ADHD affects well-being, and that resources and strategies exist for attorneys with this disability to manage their symptoms and achieve success, say Casey Dixon at Dixon Life Coaching and Krista Larson at Stinson.
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AI Use May Trigger False Claims Act's Public Disclosure Bar
The likely use of publicly available artificial intelligence tools to detect government fraud by combing through large data sets will raise complex questions about a False Claims Act provision that prohibits the filing of claims based on previously disclosed information, say Nick Peterson and Spencer Brooks at Wiley Rein.
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Beware Privacy Risks In Training AI Models With Health Data
Because data used to train artificial intelligence models may be protected by the Health Insurance Portability and Accountability Act or other regulations, users of these models should conduct proper diligence to avoid costly compliance failures, say Neha Matta and Barbara Bennett at Frost Brown.