Policy & Compliance

  • October 04, 2024

    NC Physician Assistant Sentenced To 6 Years For $10M Fraud

    A North Carolina federal court handed down a 72-month prison sentence to a physician assistant after a federal jury in Charlotte found him guilty of rubber-stamping bogus prescriptions for genetic testing to the tune of more than $10 million.

  • October 04, 2024

    4 Benefits Appellate Arguments To Watch In October

    The Fourth Circuit will consider a drugmaker's challenge to a West Virginia state law restricting access to the abortion drug mifepristone and Ohio pension funds are seeking to revive an investor class action at the Second Circuit, while the First and Ninth Circuits will take up executive compensation disputes. Here are four appellate arguments in October involving employee benefits that attorneys may want to keep on their radar.

  • October 04, 2024

    Healthcare Co. Inks Deal In DOL Equal Pay Investigation

    A healthcare diagnostics company has agreed to pay nearly $60,000 to the U.S. Department of Labor to end an agency probe over concerns that a New Jersey manufacturing facility undercompensated female employees compared to their male colleagues.

  • October 03, 2024

    Texas Transgender Health Rule Suit Paused For Gov't Appeal

    A Texas federal judge said he'd stay a lawsuit from Texas and Montana challenging new federal protections for transgender healthcare while the Biden administration appeals the court's July order freezing the new rule.

  • October 03, 2024

    12 Lawyers Who Are The Future Of The Supreme Court Bar

    One attorney hasn't lost a single U.S. Supreme Court case she's argued, or even a single justice's vote. One attorney is perhaps "the preeminent SCOTUS advocate." And one may soon become U.S. solicitor general, despite acknowledging there are "judges out there who don't like me." All three are among a dozen lawyers in the vanguard of the Supreme Court bar's next generation, poised to follow in the footsteps of the bar's current icons.

  • October 03, 2024

    Texas Takes Aim At Insulin Manufacturers For Price-Gouging

    Texas sued several major insulin manufacturers and pharmacy benefit managers in Texas state court on Thursday, accusing the companies of running quid pro quo deals to bump insulin prices by as much as 1,000% and violating Texas laws around deceptive trade practices.

  • October 03, 2024

    Ex-US House Energy Committee Atty Joins Foley In DC

    Foley & Lardner LLP has announced that a former senior counsel to the U.S. House Committee on Energy and Commerce joined the firm's Washington, D.C., office as counsel in its public policy and government relations practice group.

  • October 02, 2024

    ​​​​​​​Lab Co. Settles Bogus Testing Claims With Feds For $27M

    Precision Diagnostics Toxicology Lab, one of the nation's largest drug testing laboratories, has agreed to pay $27 million to resolve allegations that it billed Medicare and other federal healthcare programs for medically unnecessary tests, federal prosecutors announced Wednesday.

  • October 02, 2024

    Pfizer Didn't Warn Of Tumor Risks In Depo-Provera, Suit Says

    Pfizer Inc. faces a product liability and negligence suit filed Tuesday in California federal court alleging it distributed the hormonal contraceptive drug Depo-Provera without adequately warning patients and doctors about the risk of brain tumors associated with its use, a danger that has been widely published in scientific journals for years.

  • October 02, 2024

    Colo. Judge Sees No Injuries In Health Data Breach Class Suit

    A Colorado federal judge has dismissed a proposed class action alleging a software company waited nearly three months to tell data breach victims about hackers accessing personal and medical information for more than 250,000 people, concluding the plaintiffs' allegations weren't enough to give them standing.

  • October 02, 2024

    Abortion Clinic To Get Early Discovery In Patient Spying Case

    A Massachusetts federal judge said Wednesday that an abortion clinic should get expedited discovery into its claims that a neighboring "pregnancy resource center" illegally infiltrated its patient communications in an attempt to derail appointments.

  • October 01, 2024

    CFPB Warns On Collecting 'Invalid,' Unverified Medical Debt

    The Consumer Financial Protection Bureau on Tuesday cautioned debt collectors about significant potential compliance risks when working in the medical debt market, issuing guidance that identified a number of practices as illegal and capable of triggering "strict liability" under federal law.

  • October 01, 2024

    Judge Backs Louisiana 340B Law In Loss For Pharma Lobby

    A Louisiana federal court has issued a sweeping loss to Big Pharma's top lobbying group and two pharmaceutical companies that argued a state law improperly expands the scope of the federal drug discount program.

  • October 01, 2024

    Ga. County Urges Full 11th Circ. To Nix Trans Deputy's Win

    A Georgia county told the Eleventh Circuit on Monday that a health plan coverage exclusion for gender-affirming surgery is comparable to other exclusions in coverage and does not violate federal anti-discrimination laws.

  • October 01, 2024

    9th Circ. Revives FCA Claims Against Dermatology Practice

    A Ninth Circuit panel on Monday revived the claims of a former employee who accused a Nevada dermatology practice of retaliation under the False Claims Act and other wrongdoing, reversing the practice's early win and sending the case back for trial.

  • October 01, 2024

    Novel FCA Decision Amplifies Voices Of Whistleblower Critics

    A Florida federal judge's characterization of whistleblowers as self-appointed "special prosecutors" when they file lawsuits on the federal government's behalf amplifies the voices of critics questioning the constitutionality of a key enforcement tool for fighting fraud, while threatening to create a circuit split.

  • October 01, 2024

    11th Circ. Hearsay Ruling May Open Door To Top Court Review

    An Eleventh Circuit decision to allow co-conspirator statements under a hearsay rule exclusion in a $400 million health insurance fraud case could stretch the scope of federal fraud law and might draw the attention of the U.S. Supreme Court.

  • October 01, 2024

    Biotech Investors Reach $32.5M Deal Over Failed COVID Test

    A class of Talis Biomedical Corp. investors accusing the company of inflating their stock price in the run-up to its IPO and then failing to launch a COVID-19 diagnostic test asked a California federal judge on Monday to preliminarily approve their $32.5 million settlement, citing Talis' shrinking cash reserves and imminent plans to file for bankruptcy.

  • October 01, 2024

    Gov't Looks To High Court To Preserve Free Preventive Care

    The federal government has taken a fight over the Affordable Care Act's requirements for cost-free preventive care to the U.S. Supreme Court.

  • October 01, 2024

    Doctors Were 'Bamboozled' By $160M Health Fraud, Jury Told

    A Houston man accused of defrauding the government out of $160 million by submitting false claims for diabetes medication is only guilty of creating a competitive business model, his attorney said Tuesday, telling a Texas federal jury it was "ridiculous" to say doctors across the country were "bamboozled" by an alleged scheme.

  • October 01, 2024

    FDA Chief Talks Shortages, Food Labels, Reorganization

    Pharmaceutical supply chain challenges. A major agency reorganization. Rare disease research. These issues were top of mind for U.S. Food and Drug Administration Commissioner Robert Califf in a recent "fireside chat" with the Alliance for a Stronger FDA, a group of trade associations, pharmaceutical companies, health-focused nonprofits and other stakeholders.

  • October 01, 2024

    Nostrum Labs Hits Ch. 11 A Year After Medicaid Settlement

    Nostrum Laboratories, a New Jersey drugmaker that paid millions to settle allegations that it underpaid Medicaid drug rebates for its bladder infection drug after it hiked the price more than 400%, filed for Chapter 11 protection with nearly $68.3 million in debt.

  • October 01, 2024

    'Unsworn' Actors Sink Qui Tam Provision, Fla. Judge Rules

    A Florida federal judge on Monday ruled that the provision of the False Claims Act allowing whistleblowers to bring suits on behalf of the federal government is unconstitutional, dismissing a closely watched Medicare Advantage fraud case and potentially upending a key federal enforcement tool.

  • September 30, 2024

    Calif. Sues Eureka Hospital For Denying Emergency Abortion

    California on Monday sued Providence of St. Joseph Hospital in Eureka for denying an emergency abortion to a woman it diagnosed with a serious pregnancy complication and sending her off to a small community hospital with a bucket and towels.

  • September 30, 2024

    Takeda End Payors, Direct Buyers Win Antitrust Class Cert.

    A New York federal judge Monday adopted a magistrate judge's recommendation to certify two classes of direct purchasers and end payors in consolidated antitrust actions accusing Takeda Pharmaceuticals Co. of unlawfully inflating the price of its diabetes treatment Actos by delaying entry of generic alternatives.

Expert Analysis

  • Where Justices Stand On Chevron Doctrine Post-Argument

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    Following recent oral argument at the U.S. Supreme Court, at least four justices appear to be in favor of overturning the long-standing Chevron deference, and three justices seem ready to uphold it, which means the ultimate decision may rest on Chief Justice John Roberts' vote, say Wayne D'Angelo and Zachary Lee at Kelley Drye.

  • Bracing For Calif.'s New Health Transaction Framework

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    As California's new cost and market impact review regulations' April 1 date for its updated notice and review process approaches, healthcare entities should ready themselves for dramatic changes to the state's regulatory landscape and prepare for potentially substantial transaction delays, say Jordan Grushkin and Matthew Goldman at Sheppard Mullin.

  • Uncharted Waters Ahead For FCA Litigation In 2024

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    Following a year of significant court decisions, settlements, recoveries and proposed amendments, 2024 promises to be a lively year for False Claims Act actions and litigation, and one that will hopefully provide more clarity as FCA jurisprudence evolves, say attorneys at Crowell & Moring.

  • OIG Report Has Clues For 2024 Healthcare Fraud Enforcement

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    A recent report from the Health Department's Office of the Inspector General reveals healthcare fraud and abuse enforcement trends that will continue in 2024, from increased telehealth oversight to enhanced policing of managed care, say attorneys at Sheppard Mullin.

  • FOIA Exemption Questions On Redacted HHS Cannabis Letter

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    The U.S. Department of Health and Human Services' recent recommendation letter concerning the rescheduling of cannabis was heavily redacted, and based on an analysis on the applicability of Freedom of Information Act Exemption 5 to the letter, it's likely that we will see successful legal challenges to those redactions, say attorneys at Troutman Pepper.

  • A Primer On New Calif. Health Transaction Reporting Rules

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    New California regulations regarding the reporting of certain transactions involving healthcare entities, which took effect on Jan. 1, address some industry feedback about overly broad requirements but still leave several areas of concern, says Andrew Demetriou at Husch Blackwell.

  • In The CFPB Playbook: Rulemaking Rush Before Election Year

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    In this quarterly Consumer Financial Protection Bureau activity recap by former bureau personnel, attorneys at McGuireWoods explain the regulator's recent push to finalize new rules about data aggregators, digital payment apps and more before the election-year Congressional Review Act window opens.

  • What The Law Firm Of The Future Will Look Like

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    As the legal landscape shifts, it’s become increasingly clear that the BigLaw business model must adapt in four key ways to remain viable, from fostering workplace flexibility to embracing technology, say Kevin Henderson and Eric Pacifici at SMB Law Group.

  • 4 PR Pointers When Your Case Is In The News

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    Media coverage of new lawsuits exploded last year, demonstrating why defense attorneys should devise a public relations plan that complements their legal strategy, incorporating several objectives to balance ethical obligations and advocacy, say Nathan Burchfiel at Pinkston and Ryan June at Castañeda + Heidelman.

  • Digging Into The Debate On FDA's Proposed Lab Test Rule

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    A proposed 10-word amendment from the U.S. Food and Drug Administration represents a sea change in device regulation as it would summarily end decades of FDA enforcement discretion for laboratory developed tests, and the public comments offer some insight into the future of this long-running saga, say attorneys at Mintz.

  • Law Firm Strategies For Successfully Navigating 2024 Trends

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    Though law firms face the dual challenge of external and internal pressures as they enter 2024, firms willing to pivot will be able to stand out by adapting to stakeholder needs and reimagining their infrastructure, says Shireen Hilal at Maior Consultants.

  • AI In Health Law: The Top Guest Articles Of 2023

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    As the use of artificial intelligence accelerated this year, Expert Analysis writers examined AI's significant impact on the healthcare sector, ranging from key compliance considerations for companies utilizing AI tools to regulators' efforts to keep up with rapidly evolving technologies.

  • The Most-Read Legal Industry Law360 Guest Articles Of 2023

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    A range of legal industry topics drew readers' attention in Law360's Expert Analysis section this year, from associate retention strategies to ethical billing practices.