Policy & Compliance
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January 13, 2025
Blue Cross Can't Skirt NC Hospital's Defamation Claims
A local hospital can pursue some of its defamation claims against Blue Cross and Blue Shield of North Carolina in a suit alleging the health insurer wrongly denied millions of dollars in reimbursements and falsely accused the facility of fraud, a federal judge ruled Monday.
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January 13, 2025
Duke Health Worker Agrees To Arbitrate Bias Suit, For Now
A former Duke University Health System Inc. radiology technologist who accused the healthcare network of firing her for being pregnant with her second child told a North Carolina federal judge Monday she is all right with her former employer's request to take the matter to arbitration.
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January 13, 2025
RFK Jr.'s Wash. Anti-Vax Suit Can't Get High Court Save
The U.S. Supreme Court on Monday rejected Robert F. Kennedy Jr.'s bid for an emergency order to temporarily block a state of Washington medical board investigation into alleged anti-vaccine statements made by retired doctors.
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January 13, 2025
Feds Say NC Medical Biz Owner Overbilled For Nutrient Drinks
A North Carolina businessman who ran a durable medical equipment business under multiple names overbilled the state's Medicaid program $1.85 million for special enteral nutritional formulas used to treat inherited metabolic disorders when he was actually just providing people common nutritional shakes like Ensure, the federal government said.
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January 13, 2025
Supreme Court Turns Away IP Safe Harbor Dispute
The U.S. Supreme Court on Monday said it won't consider whether the Federal Circuit has overexpanded a safe harbor for drug development, in litigation where Meril Life Sciences escaped allegations that it infringed Edwards Lifesciences' heart valve patents.
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January 10, 2025
Home Care Co. Must Pay $15M In DOL OT Suit
An Ohio federal judge granted the U.S. Department of Labor a win in its lawsuit accusing a third-party home care agency of failing to pay employees overtime and ordered the company to pay $15 million in unpaid wages and damages.
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January 10, 2025
Justices To Review ACA Preventive Care Fight
The U.S. Supreme Court agreed Friday to review a Fifth Circuit decision finding a task force setting coverage requirements on preventive care was unconstitutional, setting up a high-stakes battle over the Affordable Care Act that could affect individuals' insurance coverage for things like colon and breast cancer screenings.
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January 09, 2025
CFPB Hit With 2nd Suit Over Medical Debt Reporting Rule
The Consumer Financial Protection Bureau has been hit with a second lawsuit challenging its new rule that would wipe billions of dollars in medical debt off consumer credit reports, with ACA International filing a complaint in Texas federal court arguing healthcare markets are outside the agency's regulatory authority.
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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.
Expert Analysis
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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.
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Unpacking GAO's FY 2023 Bid Protest Report
The U.S. Government Accountability Office's recent bid protest report reflects an increase in sustained protests, illustrating that disappointed offerors may see little reason to refrain from seeking corrective action — but there is more to the story, say Aron Beezley and Patrick Quigley at Bradley Arant.
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White House AI Order Balances Innovation And Regulation
President Joe Biden’s recently issued executive order on artificial intelligence lays out a sprawling list of directives aimed at establishing standards for safety, security and privacy protection, and may help strike the balance between the freedom to innovate and the need to impose regulation in this rapidly evolving space, say Kristen Logan and Martin Zoltick at Rothwell Figg.
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Reading Between The Lines Of HHS' National Lab Opinion
The U.S. Department of Health and Human Services' Office of Inspector General recently rejected a national laboratory's request to pay a referring lab to process specimens, but the request might have been an attempt to exploit the OIG's advisory opinion process for a competitive advantage, says Mary Kohler at Kohler Health Law.
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A Closer Look At Proposed HHS Research Misconduct Rule
The U.S. Department of Health and Human Services' proposed updates to its policies on research misconduct codify many well-known best practices, but also contain some potential surprises for the research community and counsel, say attorneys at Hogan Lovells.