Policy & Compliance
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January 09, 2025
New Mexico Justices Say Local Gov'ts Can't Restrict Abortion
New Mexico's highest court on Thursday struck down four local ordinances that restricted abortion access in the state, chastising the cities and counties behind them for running afoul of state laws on reproductive health and medical licensing.
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January 09, 2025
Stem Cell Therapy Co. Hit With $5.1M Deceptive Ad Judgment
A Georgia federal judge has ordered a stem cell therapy company and its co-founders to pay the state $5.1 million for falsely marketing its product as a cure-all miracle treatment for a slew of different medical conditions.
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January 08, 2025
UnitedHealth Wants $3.3B Amedisys Deal Challenge Tossed
UnitedHealth Group and Amedisys Inc. asked a Maryland federal court Wednesday to toss a challenge of their planned $3.3 billion merger, contending that federal and state enforcers are refusing to say what "local" home health and hospice service markets would be hurt by the deal.
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January 08, 2025
USTR Warns Of Risks Posed By Counterfeit Pharmacies
The Office of the U.S. Trade Representative on Wednesday released its latest list of overseas "notorious markets" selling illicit and counterfeit goods, pointing in particular to a boom in counterfeit online pharmacies selling knock-off medications that pose a risk both to public health and businesses' intellectual property interests.
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January 07, 2025
Alcohol Warnings Unlikely To Bring Same Fate Tobacco Faced
The U.S. surgeon general on Friday recommended that alcohol carry warnings about cancer risks, and attorneys say that while warning labels might be warranted, alcohol is unlikely to become the next tobacco.
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January 07, 2025
Feds Defend FCA Whistleblower Constitutionality At 11th Circ.
The federal government has called on the Eleventh Circuit to uphold the constitutionality of the False Claims Act's whistleblower provisions, saying a Florida district court ruling otherwise is an "outlier" that goes against U.S. Supreme Court precedent.
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January 07, 2025
FDA Off-Label Drug Guidance: 3 Things to Know
New guidance from the U.S. Food and Drug Administration walks back constraints the agency previously laid out on how drugmakers and other companies communicate with healthcare providers about off-label uses of approved treatments.
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January 07, 2025
PBMs And Health Insurers Back In Court In New Year
In the first week of the New Year, courts got busy dishing out a tough discovery decision to pharmacy benefit managers and hearing arguments over insurance denials from Humana and Blue Cross Blue Shield. Here, Law360 Healthcare Authority takes a look at some of the key decisions, arguments and lawsuits from the first week of 2025.
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January 07, 2025
Child Advocates Push For Mandatory Reporting Law Reform
An effort to reform mandatory reporting laws for suspected child abuse or neglect is gaining momentum amid concerns that too many families are being needlessly entangled in welfare investigations.
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January 07, 2025
6th Circ. Declines To Send Publix Questions To Ga. High Court
The Sixth Circuit won't certify a set of questions about Georgia state nuisance law to the state's Supreme Court, after ruling that Publix Super Markets Inc. hasn't shown the appeals court needs to step in before a bellwether trial in the national opioid multidistrict litigation.
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January 07, 2025
4th Circ. Revives Christian Vax Refuser's Religious Bias Suit
The Fourth Circuit reinstated Tuesday a lawsuit from a Christian nurse who claimed she was unlawfully fired for refusing to get vaccinated against COVID-19, ruling a trial court jumped the gun when it tossed her case.
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January 07, 2025
Biden Aide Klein On White House Gender Council's Legacy
As a member of the Biden administration, Jennifer Klein led the Gender Policy Council at the White House as federal abortion rights fell after the Dobbs decision and legal fights erupted over in vitro fertilization, putting her on the front lines of some of the nation's most politically charged debates.
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January 07, 2025
CFPB Adopts Rule To Take Medical Debt Off Credit Reports
The Consumer Financial Protection Bureau moved ahead Tuesday with plans to restrict the use of medical debt information in credit scoring and lending, finalizing a rule that it said will take an estimated $49 billion in unpaid medical bills off consumers' credit reports.
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January 06, 2025
Athira Inks $4M FCA Deal Over Ex-CEO's Research Fraud
Athira Pharma Inc. has agreed to pay $4 million to resolve allegations it used falsified academic research papers on neurological disorders like Alzheimer's to secure federal grants from the National Institute of Health, the U.S. Department of Justice announced Monday.
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January 06, 2025
Sheppard Mullin Hires University Of Calif. Health Counsel
Sheppard Mullin Richter & Hampton LLP announced Monday that it has hired two attorneys who previously served in-house at the University of California to bolster its healthcare industry practice group.
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January 03, 2025
Hospital Org Inks $135M Deal To End Ex-CFO's Fraud Claims
Community Health Network has agreed to pay $135 million to end federal healthcare fraud claims brought by its former chief financial officer, a deal reached two years after the Indiana healthcare system agreed to pay $345 million to settle False Claims Act allegations from the government in the qui tam action, the ex-CFO's counsel announced Thursday.
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January 03, 2025
DOJ Wants Oct. Amedisys Trial, UnitedHealth Wants Aug.
The U.S. Department of Justice sparred with UnitedHealth Group in a Maryland federal court filing Friday over when to hold a trial on the government challenge to the $3.3 billion purchase of home health and hospice services company Amedisys Inc.
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January 03, 2025
PBMs 'Wasting' Time in Opioid MDL Discovery Spat: Judge
An Ohio federal judge overseeing multidistrict opioid litigation on Friday denied pharmacy benefit managers a stay to appeal a discovery order and said he believed the PBMs were "wasting" the court's time.
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January 03, 2025
Insurers Ordered To Pay $165M For Deceptive Marketing
Insurance companies banned from selling policies in Massachusetts due to alleged deceptive marketing practices have been ordered to pay $165 million for selling the plans anyway and using similar false advertising in their pitches to consumers, a state judge has ruled.
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January 02, 2025
Issa Again Selected To Lead House IP Subcommittee
Rep. Darrell Issa, R-Calif., will again lead the House subcommittee overseeing intellectual property in the upcoming Congress, a role in which he has sponsored bills seeking to limit how many patents can be asserted in biosimilar cases and require disclosure of litigation funding.
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January 02, 2025
1st Private Co. Joins Insulin Price-Fixing MDL
A Florida-based car dealer is the first private company to join a multidistrict litigation accusing Novo Nordisk, Eli Lilly and Sanofi-Aventis of fixing the prices of insulin and other drugs to treat diabetes.
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January 02, 2025
Eli Lilly Slams Suit Alleging Shortage Of Weight-Loss Drug
Eli Lilly is seeking permission to join a legal fight over whether compounding pharmacies can keep making copycat versions of the company's lucrative weight-loss and diabetes drug, telling a federal court Wednesday that its interests aren't adequately represented by federal regulators.
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January 01, 2025
Healthcare and Life Science Deals Attys Expect In 2025
As the healthcare industry heads into 2025, deals attorneys are optimistic as they look to falling interest rates and a potentially more business-friendly administration set to enter the White House.
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January 01, 2025
Healthcare And Life Science Policies To Watch In 2025
Healthcare and life sciences attorneys will have their eyes on Washington, D.C., in the next few months. They will be keen to understand how a new presidential administration and a new Congress with razor-thin GOP control will approach a bevy of fraught issues.
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January 01, 2025
High-Stakes Healthcare Court Battles To Watch In 2025
With pivotal health law cases on the docket in 2025, attorneys will be watching how the incoming Trump administration proceeds in ongoing litigation over abortion care, the Affordable Care Act and the Medicare drug price negotiation program.
Expert Analysis
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Industry Must Elevate Native American Women Attys' Stories
The American Bar Association's recent research study into Native American women attorneys' experiences in the legal industry reveals the glacial pace of progress, and should inform efforts to amplify Native voices in the field, says Mary Smith, president of the ABA.
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White House Activity Is A Band-Aid For Regulating AI In Health
In the medium term, recent White House actions will have a greater impact on AI in the health care industry than Congress' sluggish efforts to regulate it, but ultimately legislation of AI's development and use in the health space will fall to Congress, say Wendell Bartnick and Vanessa Perumal at Reed Smith.
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Understanding Discovery Obligations In Era Of Generative AI
Excerpt from Practical Guidance
Attorneys and businesses must adapt to the unique discovery challenges presented by generative artificial intelligence, such as chatbot content and prompts, while upholding the principles of fairness, transparency and compliance with legal obligations in federal civil litigation, say attorneys at King & Spalding.
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How Mental Health Ruling Paves Road For Equal Coverage
The Tenth Circuit’s recent ruling in E.W. v. Health Net, which clarified the pleading requirements necessary to establish a Mental Health Parity and Addiction Equity Act violation, is a win for plaintiffs as it opens the door to those who have been denied coverage for behavioral health treatment to prove a mental health parity violation, says Mark DeBofsky at DeBofsky Law.
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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.