Policy & Compliance
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April 10, 2024
4th Circ. Sides With CMS' Definition Of 'Line-Extension Drug'
The Fourth Circuit on Wednesday affirmed a summary judgment ruling in favor of the Centers for Medicare & Medicaid Services in a rule challenge by Vanda Pharmaceuticals, which took issue with the agency's criteria for what constitutes a line-extension drug.
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April 10, 2024
Pharmacy Gets Eli Lilly's Mounjaro Suit Tossed
A Florida federal judge has thrown out Eli Lilly & Co.'s suit accusing an online pharmacy of wrongly selling a compounded version of its drug Mounjaro, saying Eli Lilly was "using state law to enforce the terms of" federal law.
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April 10, 2024
Justices Asked To Ban FCA Suits Relying On Patent Reviews
Valeant Pharmaceuticals is going to the U.S. Supreme Court to argue that information cited in Patent Trial and Appeal Board reviews cannot later be used by whistleblowers in False Claims Act lawsuits.
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April 09, 2024
Sanofi Sees End To 4,000 Suits Over Zantac
The consequences of the demise of Roe rippled through state courts, big employers say they didn't get the generic-drug bargain they signed up for, and pharmaceutical giant Sanofi moved closer to resolving thousands of claims centering on the heartburn drug Zantac. Here, Law360 looks at the major healthcare litigation from the past week.
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April 09, 2024
Philips, Feds Enter Consent Decree Over Sleep Apnea Devices
Philips Respironics can't make sleep apnea breathing machines until it hires an independent monitor, undergoes inspections and meets its obligations under a plan to remediate patients affected by a 2021 recall of such devices, the U.S. Department of Justice and U.S. Food and Drug Administration announced Tuesday.
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April 09, 2024
3 Years In, 'No Surprises' Gets Mixed Reviews From Providers
It's been more than three years since President Joe Biden signed federal "surprise" medical billing legislation. But after a rocky roll-out and several successful legal challenges, some are giving the No Surprises Act mixed reviews, including its particularly contentious independent dispute resolution process.
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April 09, 2024
Calif. Healthcare Attys Working Late Thanks To New Regs
Attorneys working on healthcare deals in California are logging longer hours and getting less sleep as they grapple with new regulations that came into effect this month.
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April 09, 2024
Doctors 'On Notice': Liability And The Ariz. Abortion Decision
The Arizona Supreme Court on Tuesday dropped a dense statutory examination concluding that an abortion ban passed before Arizona became a state had not been supplanted by a modern statute allowing abortions until 15 weeks of pregnancy. Law360 looks at how the court addressed doctor liability.
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April 09, 2024
Court Axes Subpoena Of Ex-Wife In 1st Abortion Death Suit
The woman at the center of the nation's first abortion wrongful death suit since the landmark Dobbs decision need not produce info about how she allegedly obtained abortion-inducing drugs from two women, a Texas appeals court ruled Tuesday, saying doing so would violate the woman's Fifth Amendment right against self-incrimination.
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April 09, 2024
6th Circ. Ruling May Alter State Certificate Of Need Laws
A Sixth Circuit finding that part of Kentucky's certificate of need law is unconstitutional shows that circuit courts are still figuring out how medical spending control statutes fit with modern U.S. Supreme Court case law.
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April 09, 2024
Idaho Abortion Ban Tees Up Battle On 'Trafficking' Restrictions
As Idaho officials prepare to defend a near-total abortion ban at the U.S. Supreme Court this month, a state abortion "trafficking" statute is also heading for a federal court challenge that forecasts future constitutional battles over attempts to criminalize out-of-state travel.
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April 09, 2024
Tighter Limits On 'Junk' Insurance May Spur New Legal Fights
The Biden administration's new rule limiting short-term insurance plans isn't likely to end debates over how strictly to regulate health coverage that falls outside Affordable Care Act protections.
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April 09, 2024
White House, Senate Dems Want $1.3B To Fight COVID Fraud
The White House has been working with Senate Democrats on a $1.3 billion plan to expand the federal government's toolkit for going after pandemic fraudsters who took advantage of the influx of aid made available to different facets of the public during the COVID-19 pandemic.
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April 09, 2024
Life Sciences GCs On Tighter Regs, Outside Counsel Advice
General counsel at life sciences venture capital firms are navigating increased regulation in healthcare and looking to outside counsel to act as true advisers and problem-solvers as the healthcare industry becomes more complex.
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April 09, 2024
Health Equity Advocates Notch Win with Dental Coverage Rule
A new rule from the Department of Health and Human Services aimed at getting more adult dental care covered as an "essential" Affordable Care Act benefit promises to help close a critical healthcare equity gap.
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April 09, 2024
Ariz. High Court Restores Civil War-Era Abortion Ban
The Arizona Supreme Court on Tuesday revived the state's nearly 160-year-old abortion ban, concluding that a far more recent law that had allowed abortion through 15 weeks of pregnancy did not replace the older prohibition.
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April 09, 2024
Crowell & Moring Hires Senior Health Atty From Capitol Hill
Crowell & Moring LLP has hired a health care attorney from the U.S. House of Representatives who most recently served as a senior counsel in that body's Committee on Energy & Commerce, the firm announced Tuesday.
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April 08, 2024
Walmart Beats Investor Suit Over Opioid Probe Disclosures
Walmart beat back an investor class action on Monday alleging it failed to properly disclose that it was the subject of parallel criminal and civil investigations over its opioid sales, with a Delaware federal judge ruling that the suit's challenged statements were not false or misleading.
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April 08, 2024
Feds Say Philly Clinics Billed For 'Impossible' No. Of Visits
The head psychiatrist at a group of Philadelphia mental health clinics allegedly billed Medicaid for enough "med check" patient visits that he would have exceeded the hours in a day if he had taken the state-mandated minimum of 15 minutes per patient, according to a federal False Claims Act suit filed Monday.
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April 08, 2024
High Court Creating DEI Headwinds, Colo. AG Says
Colorado Attorney General Phil Weiser said Monday that the state's major losses last year in cases involving gay rights and prosecuting threatening speech were part of what he views as a trend at the U.S. Supreme Court of hampering efforts to increase diversity, equity and inclusion.
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April 08, 2024
La. Drug Caps Conflict With Federal Law, AbbVie Says
Drugmaker AbbVie is asking a Louisiana federal judge to grant its summary judgment motion and block new state-level pharmaceutical caps for the federal 340B drug discount program, calling the state's competing summary judgment motion arguments "legally and factually wrong."
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April 05, 2024
Ind. Can't Undo Abortion Law Injunction In Jewish Org's Case
An Indiana law banning most abortions in the state remains blocked for certain people with sincerely held religious beliefs, after a state appeals court largely upheld — in a sometimes sharply worded opinion — a preliminary injunction issued in a lawsuit brought by a Jewish reproductive rights group and other individual plaintiffs.
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April 05, 2024
Target, Major Employers Raise New Drug Price-Fixing Claims
Target Corp., Lowe's Cos. Inc. and American Airlines Inc. are among major employers that lodged new price-fixing claims in Pennsylvania federal court against dozens of pharmaceutical companies, accusing them of orchestrating illegal agreements to allocate customers and markets and fix the prices of hundreds of generic drugs for more than a decade.
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April 05, 2024
'Take The Win,' Judge Tells Texas In HHS Abortion Pill Suit
Texas' lawsuit challenging the Biden administration's guidance to require pharmacies to dispense abortion medication is moot following revised U.S. Department of Health and Human Services guidance clarifying that access to the drug isn't for abortion purposes, a federal judge ruled Friday, saying the state "should take the win."
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April 05, 2024
Abbott Settles TM Suit Over Gray Market Diabetes Test Strips
Abbott Laboratories told a New York federal judge Friday that the company has settled what remains of its trademark litigation campaign against makers of gray market diabetes test strips that has been going on since 2015.
Expert Analysis
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ESG Around The World: Mexico
ESG has yet to become part of the DNA of the Mexican business model, but huge strides are being made in that direction, as more stakeholders demand that companies adopt, at the least, a modicum of sustainability commitments and demonstrate how they will meet them, says Carlos Escoto at Galicia Abogados.
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The Case For Post-Bar Clerk Training Programs At Law Firms
In today's competitive legal hiring market, an intentionally designed training program for law school graduates awaiting bar admission can be an effective way of creating a pipeline of qualified candidates, says Brent Daub at Gilson Daub.
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10 Takeaways From New HHS Federal Compliance Guidelines
The U.S. Department of Health and Human Services' recently issued general compliance program guidance is the first of its kind that would apply across all health care stakeholders, and signals the agency’s first step to improve and update existing compliance guidance, says Melissa Wong at Holland & Knight.
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2 HHS Warnings Highlight Anti-Kickback Risks For Physicians
Two recent advisory opinions issued by the U.S. Department of Health and Human Services' Office of Inspector General involve different scenarios and rationales, but together they illustrate the OIG's focus on and disapproval of contractual joint ventures and other revenue-maximizing physician arrangements, say Robert Threlkeld and Elliott Coward at Morris Manning.
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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.