Policy & Compliance

  • May 31, 2024

    Final Defendant Gets 2 Years In Prison For DC Clinic Blockade

    An anti-abortion activist was sentenced to two years incarceration in D.C. federal court Friday, the final defendant to be sentenced among nine others charged in a 2020 blockade at a reproductive health clinic.

  • May 31, 2024

    Judge Doubts Okla. Can Stop Title X Cut Over Abortion Stance

    A Tenth Circuit judge appeared skeptical Friday that Oklahoma could prevent federal officials from stripping $4.5 million in funding over the state's refusal to provide abortion referrals, suggesting the state's claim of anti-abortion discrimination is better suited to an attack on Title X writ large.

  • May 31, 2024

    Judge Wonders If Wash. Social Media Ban Blocks Free Speech

    A Washington appellate judge on Friday questioned the constitutionality of a state law barring injured workers from posting video of their state workers' compensation medical exams on social media, saying it could be cutting off someone's only way of communicating with the outside world.

  • May 31, 2024

    15 States Sue To Block Biden's ACA Trans Discrimination Rule

    The Biden administration was hit with a lawsuit on Friday over its rule clarifying the application of the Affordable Care Act's nondiscrimination protections to gender identity, with a group of 15 states claiming the guidance is an effort "to enshrine sweeping gender-identity mandates without congressional consent."

  • May 31, 2024

    Texas Supreme Court Rejects Challenge To Abortion Ban

    The Texas Supreme Court unanimously rejected a petition Friday that challenged the state's near-total ban on abortion, ruling the law's narrow exceptions for pregnant women in life-threatening emergencies are broad enough to withstand a constitutional challenge.

  • May 30, 2024

    Physician, Health Cos. Spar Over Docs In Fla. Qui Tam Suit

    A doctor and several healthcare businesses accused each other of withholding evidence in a Florida federal False Claims Act lawsuit, with the doctor saying several key Zoom meeting records were destroyed, although the businesses have alleged the doctor refused to provide a financial agreement she made with a cohort.

  • May 30, 2024

    Ozempic Maker Says Texas Pharmacy Selling Knockoff Drug

    The manufacturer behind the Ozempic weight loss drug has asked a federal court to prohibit a Houston-area pharmacy from selling compounded, non-FDA-approved medications that claim to contain the drug's key ingredient.

  • May 30, 2024

    Sen. Warren Pushes CMS On 'Medical Loss Ratio' Data

    Sen. Elizabeth Warren, D-Mass., is urging the Centers for Medicare & Medicaid Services to collect more data to determine whether private healthcare insurers in Medicare Advantage that employ vertical integration are evading a statutory requirement that they spend the bulk of their earnings on medical claims.

  • May 30, 2024

    Dental Co., Ex-Worker Agree To Arbitrate OT Spat

    A New York federal judge granted a former dental assistant's request to arbitrate her claims accusing a dental company of failing to pay hourly workers all their overtime wages owed or on a weekly basis as state law mandates for manual laborers.

  • May 29, 2024

    FDA Sued Over Controversial Lab Test Rule

    A clinical lab trade group that has been highly critical of the U.S. Food and Drug Administration's new final rule on laboratory-developed tests filed a lawsuit late Wednesday, saying the agency doesn't have the authority to regulate the tests as medical devices.

  • 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.

Expert Analysis

  • Valeant Ruling May Pave Way For Patent-Based FCA Suits

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    The Ninth Circuit’s recent ruling in Silbersher v. Valeant marks a significant development in False Claims Act jurisprudence, opens new avenues for litigation and potentially raises the stakes for patent applicants who intend to do business with the government, say Joshua Robbins and Rick Taché at Buchalter.

  • Suits Against Insulin Pricing Are Driven By Rebate Addiction

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    A growing wave of lawsuits filed by states, cities and counties against insulin manufacturers and pharmacy benefit managers improperly allocate the blame for rising insulin costs, when in actuality the plaintiffs are partially responsible, says Dan Leonard at Granite Capitol Consulting.

  • When Physician Retirement Arrangements May Be Legal

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    A recent advisory opinion from the Office of Inspector General regarding physician retirement arrangements sheds light on key considerations and mitigating factors that may be useful when attempting to balance healthcare operational needs with statutory conformity, says Magda Rodriguez at Day Pitney.

  • ESG Around The World: Gulf Cooperation Council

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    The Gulf Cooperation Council is in the early stages of ESG policy implementation, but recent commitments by both states and corporations — including increases in sustainable finance transactions, environmental commitments, female representation on boards and human rights enforcement — show continuing progress toward broader ESG goals, say attorneys at Cleary.

  • 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.