Policy & Compliance

  • 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.

  • May 21, 2024

    Counties Not 'Persons' In Texas Opioid MDL Appeal

    A Texas appeals panel found Tuesday that counties are not considered "persons" under the state's common law and therefore are not subject to the Texas Medical Liability Act's requirement that they serve expert reports to pharmacy defendants in the state's opioid multidistrict litigation.

  • May 21, 2024

    Custom Drug Makers Stay On DOJ Radar In Fla. Fraud Case

    Federal law enforcement's stake in a recent whistleblower lawsuit focused on expensive skin creams shows the agency's focus on pharmacies providing custom medications — long recognized as a lucrative avenue for Medicare fraudsters — hasn't waned.

  • May 21, 2024

    Experts Skeptical Of Federal Plan To Address Drug Shortages

    A recent federal proposal meant to ease drug shortages by giving hospitals a incentive to stockpile medications may do more harm than good in the effort to ensure drugs are consistently available.

  • May 21, 2024

    Ga. Says Feds Shouldn't Prevail In Medicaid Expansion Suit

    Georgia urged a federal judge on Monday not to rule in favor of the Biden administration in its suit attempting to keep its Medicaid program for low-income residents running until 2028, arguing the government has "no authority" to make it apply for a program extension when "illegal acts" delayed the program's launch.

Expert Analysis

  • Navigating ACA Reporting Nuances As Deadlines Loom

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    Stephanie Lowe at Liebert Cassidy walks employers through need-to-know elements of Affordable Care Act reporting, including two quickly approaching deadlines, the updated affordability threshold, strategies for choosing an affordability safe harbor, and common coding pitfalls.

  • Lessons From Rare Post-Verdict Healthcare Fraud Acquittal

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    A Maryland federal court recently overturned a jury verdict that found a doctor guilty of healthcare fraud related to billing levels for COVID-19 tests, providing defense attorneys with potential strategies for obtaining acquittals in similar prosecutions, says attorney Andrew Feldman.

  • ChristianaCare Settlement Reveals FCA Pitfalls For Hospitals

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    ChristianaCare's False Claims Act settlement in December is the first one based on a hospital allegedly providing private physicians with free services in the form of hospital-employed clinicians and provides important compliance lessons as the government ramps up scrutiny of compensation arrangements, say attorneys at Sheppard Mullin.

  • Patent Waiver For COVID Meds Would Harm US Biopharma

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    If the Biden administration backs the World Trade Organization in waiving patent rights on COVID-19 treatments, it would negatively affect the U.S. biopharmaceutical industry and help foreign competitors, without necessarily expanding global access to COVID-19 care, says clinical pathologist Wolfgang Klietmann.

  • New CMS Rule Will Change Nursing Facility Disclosures

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    A new rule from the Centers for Medicare & Medicaid Services significantly expands disclosure requirements for nursing facilities backed by private equity companies or real estate investment trusts, likely foreshadowing increased oversight that could include more targeted audits, say Janice Davis and Christopher Ronne at Morgan Lewis.

  • Skirting Anti-Kickback Causation Standard Amid Circuit Split

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    Amid the federal circuit court split over the causation standard applicable to False Claims Act cases involving Anti-Kickback Statute violations, which the First Circuit will soon consider in U.S. v. Regeneron, litigators aiming to circumvent the heightened standard should contemplate certain strategies, say Matthew Modafferi and Terence Park at Frier Levitt.

  • Gilead Ruling Signals That Innovating Can Lead To Liability

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    A California appeals court's ruling last month in Gilead Life Sciences v. Superior Court of San Francisco that a drug manufacturer can be held liable for delaying the introduction of an improved version of its medication raises concerns about the chilling effects that expansive product liability claims may have on innovation, says Gary Myers at the University of Missouri School of Law.

  • Health Policy Legislative Landscape May Remain Frozen

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    With Congress again delaying the full resolution of fiscal year 2024 federal spending legislation, there is now an additional window in which Congress could work through several priority issues for healthcare stakeholders, though these issues are unlikely to be resolved in time, say attorneys at Faegre Drinker.

  • Despite HHS Opinion, Gift Card Giveaways Require Caution

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    Though the U.S. Department of Health and Human Services' Office of Inspector General recently determined that a healthcare consulting firm's gift card plans do not violate the Anti-Kickback Statute, the opinion does not suggest blanket approval for providing gift cards in exchange for referrals, say Ragini Acharya and Matthew Deutsch at Husch Blackwell.

  • DOJ's Biopharma Settlement Raises Anti-Kickback Questions

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    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

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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.