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
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.
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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.
Expert Analysis
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Class Actions At The Circuit Courts: September Lessons
In this month's review of class action appeals, Mitchell Engel at Shook Hardy identifies practice tips from four recent class certification rulings involving denial of Medicare reimbursements, automobile insurance disputes, veterans' rights and automobile defects.
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Proposed Legislation May Crack Down On Online Drug Ads
A bill recently proposed in Congress could serve as a sea change in how the U.S. Food and Drug Administration regulates drug-related speech, with significant trickle-down effects on various corners of not only the drug industry but also on consumers and providers themselves, say Dominick DiSabatino and Arushi Pandya at Sheppard Mullin.
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What To Expect From Calif. Bill Regulating PE In Healthcare
A California bill currently awaiting Gov. Gavin Newsom's approval, intended to increase oversight over private equity and hedge fund investments in healthcare, is emblematic of recent increased scrutiny of investments in the space, and may affect transactions and operations in California in a number of ways, say attorneys at Ropes & Gray.
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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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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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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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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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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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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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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.
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Strategies To Defend Against Healthcare Nuclear Verdicts
The healthcare industry is increasingly the target of megaclaims, particularly those alleging medical malpractice, but attorneys representing providers can use a few tools to push back on flimsy litigation and reduce the likelihood of a nuclear verdict, says LaMar Jost at Wheeler Trigg.
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What Drug Cos. Must Know About NY Price Transparency Law
Drug manufacturers must understand the contours of New York's recently implemented law requiring self-reporting of drug price increases, as well as best practices for compliance and challenges against similar laws in other states, say Elizabeth Bierut and Angie Garcia at Friedman Kaplan.
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Whistleblowers Must Note 5 Key Differences Of DOJ Program
The U.S. Department of Justice’s recently unveiled whistleblower awards program diverges in key ways from similar programs at other agencies, and individuals must weigh these differences and look first to programs with stronger, proven protections before blowing the whistle, say Stephen Kohn and Geoff Schweller at Kohn Kohn.