Policy & Compliance

  • May 29, 2024

    Acting Boston US Atty Says Fraud Cases Still High Priority

    Prosecuting a range of fraud cases despite finite resources will remain a priority for Massachusetts acting U.S. Attorney Joshua Levy as he enters his second year in the job, he told reporters on Wednesday in a question and answer session at his office.

  • May 29, 2024

    Whistleblower Counsel Can't Get 'Exorbitant' $11.5M Fee

    A Boston federal judge slashed an "exorbitant" $11.5 million fee request made by counsel for a False Claims Act whistleblower in a case involving lab testing company Fresenius Medical Care, hammering the attorneys for inflated hourly rates, inflated time entries and a host of questionable billing practices.

  • May 28, 2024

    Staffing Rule Suit, Mayo COVID Claims And An Oathless Expert

    Nursing home trade groups sue over "nightmare" staffing rule, former Mayo Clinic workers get another shot at claims they were illegally fired over COVID-19 policy breaches, and an unsworn expert letter tanks a medical malpractice suit in Iowa. Law360 Healthcare Authority looks at those and other notable developments in healthcare litigation over the past week.

  • May 28, 2024

    Alaska Opioid Suit Moves Forward In Early Loss For PBMs

    An Alaska federal judge is allowing public nuisance claims to move forward against Express Scripts as pharmacy benefit managers are increasingly targeted in opioid litigation.

  • May 28, 2024

    More States Look To Rx Boards To Tackle Drug Prices

    State efforts to tackle high drug prices are gaining momentum through the creation of special boards that can evaluate — and sometimes cap — spending on the costliest prescription drugs, a trend likely to generate legal challenges from Big Pharma.

  • May 28, 2024

    5th Circ. Flips Cancer-Drug Maker's Defeat In Hair Loss MDL

    The Fifth Circuit has vacated a summary judgment ruling in favor of four women who say two drugmakers failed to warn consumers that their chemotherapy drug could cause hair loss, saying it was impossible for the companies to simultaneously comply with federal and state failure-to-warn laws.

  • May 28, 2024

    Healthcare Tech Co. To Pay $1.5M To End Class Wage Claims

    A healthcare software consulting company agreed to a $1.5 million deal resolving claims it violated Washington state wage law by requiring its software training staff to work up to 80 hours and seven days a week, according to a motion to approve the deal filed in federal court.

  • May 28, 2024

    The Most Likely Healthcare Targets In A Post-Chevron World

    Attorneys in the healthcare arena have a keen interest in a U.S. Supreme Court challenge to the Chevron deference doctrine, particularly in light of the sheer volume of guidance issued by the U.S. Department of Health and Human Services and its subsidiary agencies. With the high court now poised to decide Chevron’s fate, Law360 looks at health law that could be targeted in a post-Chevron world.

  • May 28, 2024

    Nursing Co. Strikes Deal To End EEOC Misgendering Probe

    A Washington nursing facility has reached a deal with the U.S. Equal Employment Opportunity Commission to settle a charge from a worker who said the business sat idle while co-workers repeatedly and intentionally referred to them by the wrong pronouns.

  • May 28, 2024

    Edwards Urges Full Fed. Circ. To Limit FDA Safe Harbor

    Edwards Lifesciences has petitioned the full Federal Circuit to narrow its interpretation of a U.S. Food and Drug Administration safe harbor that essentially allows patent infringement during drug development, arguing that if Congress wanted the statute to be interpreted broadly, "it would have said exactly that."

  • May 28, 2024

    Anesthesia 'Rollup' Decision May Hurry PE Regulator Suits

    A recent Texas court ruling in a Federal Trade Commission case focused on an anesthesiology practice's alleged "rollup" strategy could spur regulators to move faster against private equity owners of healthcare businesses.

  • May 28, 2024

    'Creative' Suits Aim To End Secret Arbitration At Ariz. Facilities

    Arizona's top law enforcement official is pursuing an unusual series of legal challenges that aim to strike down confidential arbitration agreements at long-term care facilities and shine a light on allegations of elder abuse or neglect.

  • May 23, 2024

    RFK Jr.'s Anti-Vax Suit Against Wash. AG Tossed

    A Washington federal judge has dismissed a lawsuit brought by Robert F. Kennedy Jr. on behalf of NBA legend John Stockton trying to shield doctors who make anti-vaccine statements, ruling claims that a medical board probe has chilled speech are speculative.

  • May 23, 2024

    NJ Justices Toss Direct Appeals Over Hospital Contract Bid

    The New Jersey Supreme Court ruled Thursday that an independent state-owned teaching hospital's conduct cannot be challenged directly in the state's intermediate appellate court because it isn't considered an administrative agency, affirming the dismissal of two protests over the hospital's selection of a pharmacy vendor.

  • May 23, 2024

    UBH Urges 9th Circ. To Take Up Petition In Health Claim Fight

    United Behavioral Health implored the Ninth Circuit to grant the insurance company's petition for appellate court intervention in a consolidated action alleging mismanagement of mental health and substance use disorder treatment claims, arguing a California federal court clearly erred by allowing further pleadings on a denial of benefits claim.

  • May 23, 2024

    Ambulance Co. Owner Accused Of $1M Pandemic Loan Fraud

    The owner of a California ambulance company who was charged last year with tax evasion and filing false returns has been further accused of fraudulently securing $1 million from federal pandemic relief loan programs, according to the U.S. Department of Justice.

  • May 23, 2024

    Cancer Society Strategist Starts 'New Adventure' With Venable

    Venable LLP has hired the former strategic director for the American Cancer Society's Cancer Action Network as a senior policy adviser for its legislative and government affairs practice group and its health policy team.

  • May 22, 2024

    Wash. Health System Wants $230M Worker Class Win Axed

    A Washington hospital system is seeking to derail a nearly $230 million judgement in favor of workers in a class wage case, contending the plaintiffs' key expert who testified at a state court trial recommended that jurors calculate damages based on a flawed equation that didn't account for differences in pay classifications.

  • May 22, 2024

    NC Panel Revives Retention Claim In Faulty Back Surgery Suit

    A North Carolina appeals court has revived a family's negligent retention claim against a clinic over a doctor who was ousted from the profession for unnecessary and faulty surgeries, finding the claim does not fall under the state's four-year statute of repose for medical malpractice claims.

  • May 22, 2024

    Anti-Abortion Activist Gets Two Years For DC Clinic Blockade

    An anti-abortion activist convicted of invading and blockading a Washington, D.C., reproductive health clinic was sentenced to two years of incarceration Wednesday, becoming the ninth defendant to get prison time in the D.C. federal court case.

  • May 21, 2024

    FTC Noncompete Ban Raises Stakes For Nonprofit Hospitals

    The Federal Trade Commission seems eager to apply its employee noncompete ban to healthcare, with a key target in mind: nonprofit healthcare providers that, in the agency's view, act more like for-profit businesses.

  • May 21, 2024

    Judge Shopping Row, Henrietta Lacks And SC Abortion Clock

    BigLaw lawyers get deeper into sanction spat, a case over profits from harvested cancer cells, and a Texas Supreme Court decision in a Fen-Phen malpractice suit. Law360 Healthcare Authority looks at those and other developments from the week in healthcare litigation.

  • May 21, 2024

    DC Circ. Says Drugmakers Can Limit Pharmacy Discounts

    The D.C. Circuit held Tuesday that a federal drug discount program does not bar manufacturers from restricting deliveries of discounted drugs to contract pharmacies, rejecting the U.S. Department of Health and Human Services' expansive interpretation of the 340B drug pricing program.

  • May 21, 2024

    Mich. Judge Doubts Abortion Laws Pass Constitutional Muster

    A Michigan state judge on Tuesday was skeptical state regulators could impose a waiting period and other requirements on people seeking abortions without violating a state constitutional amendment enshrining the right to abortion.

  • May 21, 2024

    NY High Court Upholds State Abortion Coverage Mandate

    New York's highest court on Tuesday upheld a state law requiring employee health plans to cover medically necessary abortions, finding a 2021 U.S. Supreme Court decision didn't change the state court's determination that an exemption process in the law was constitutional.

Expert Analysis

  • DOJ's Biopharma Settlement Raises Anti-Kickback Questions

    Author Photo

    In the aftermath of the U.S. Department of Justice's settlement with Ultragenyx over genetic testing programs, it may be prudent to reevaluate genetic tests through the lens of the Anti-Kickback Statute and reconsider whether it is proper for free testing programs to be treated like patient assistance programs, says Mary Kohler at Kohler Health Law.

  • Where Justices Stand On Chevron Doctrine Post-Argument

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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.