Policy & Compliance

  • May 14, 2024

    Convicted Fraudster Says Exchanges With Atty Are Privileged

    A convicted fraudster who had his sentence commuted by then-President Donald Trump — now charged with launching another scam shortly after leaving prison — is embroiled in a fight with New Jersey federal prosecutors over his attempt to assert attorney-client privilege for communications with an Israeli attorney who allegedly participated in the scheme.

  • May 14, 2024

    BigLaw Attys Fight Sanctions Over Alleged Judge Shopping

    Attorneys from Shook Hardy & Bacon LLP, Cooley LLP, Lightfoot Franklin & White LLC and prominent LGBTQ rights organizations did not engage in judge shopping when walking away from cases challenging an Alabama law banning certain medical procedures for transgender youth, the lawyers have told an Alabama federal court.

  • May 14, 2024

    Medicaid Work Mandates Resurface In Legal, Political Fights

    Work requirements can help solve the tricky politics of expanding Medicaid in some states. But the job mandates can also trigger regulatory and legal challenges that make them tough to carry out.

  • May 14, 2024

    Chinese Drug Co. Sanctioned After 'Tortuous' 3-Year Info Fight

    Chinese drug firm Zhejiang Huahai Pharmaceutical Co. Ltd. has been hit with sanctions after its chief executive officer failed to sit for a court-ordered deposition in sprawling multidistrict litigation taking place in New Jersey over generic drugs that U.S. authorities say were contaminated with carcinogens.

  • May 13, 2024

    USPTO Eyes Change To Patent Applicants' Disclaimer Practice

    The U.S. Patent and Trademark Office is looking to add a requirement for patent applicants filing so-called terminal disclaimers in order to overcome rejections by patent examiners over obviousness-type double patenting, a move that lawyers and a former USPTO official say could change the agency's approach considerably, especially for patents covering brand-name drugs.

  • May 13, 2024

    'Grinch' Is Not A Protected Class, HHS Tells 4th Circ.

    The U.S. Department of Health and Human Services has urged the Fourth Circuit to reject a chemist's discrimination, hostile work environment and retaliation claims, arguing that "Grinch" is not a protected class and federal law doesn't protect an individual "from not being well-liked in the workplace."

  • May 13, 2024

    Biogen Investors Seek Class Cert. In Alzheimer's Drug Suit

    A proposed class of Biogen shareholders urged a Massachusetts federal court to certify their now-revived class action alleging the drugmaker made misleading statements about a deficient Alzheimer's drug, arguing it can sufficiently lead the suit with Block & Leviton LLP as class counsel.

  • May 13, 2024

    11th Circ. Says Ga. County's Trans Health Ban Violates Title VII

    A split Eleventh Circuit panel upheld a win Monday for a transgender sheriff's deputy who challenged a Georgia county health plan's refusal to pay for gender-affirmation surgery, ruling the coverage exclusion violated federal anti-discrimination law.

  • May 13, 2024

    Nursing Home Says Buyer's Lease Silence Endangers Future

    An Ohio-based nursing home operator claimed Monday that its Pickaway County nursing home is in "imminent danger" because the company's owners are threatening the licensing and management of the nursing home by refusing to acknowledge terminated leases and not making the transition to a new lessee and operator.

  • May 13, 2024

    'Prolific' Asbestos Injury Firm Accused Of Fraud, Racketeering

    A "prolific" Illinois-based asbestos litigation law firm allegedly engaged in a yearslong scheme involving perjured testimony, suppressed evidence and baseless claims to extract as much money from as many companies as possible, according to one of the companies repeatedly targeted by the firm.

  • May 13, 2024

    Oil Co. Ends EEOC Disability Bias Suit Over Opioid Meds

    An oilfield equipment supplier will pay $35,000 to end a suit in Texas federal court by the U.S. Equal Employment Opportunity Commission accusing it of yanking a job offer from a welder because of his opioid use disorder medication, the EEOC said.

  • May 10, 2024

    Wash. Judge Doubles Hospital System's Penalty In Wage Case

    A Washington state judge has ordered a healthcare system to pay nearly $230 million to 33,000 workers, doubling the damages a jury awarded to the employees in April based on the company's "willful" violations of wage law.  

  • May 10, 2024

    Pharma Cos., FDA Debate 'Same Drug' In Orphan Drug Case

    Two pharmaceutical companies and the U.S. Food and Drug Administration faced off in D.C. federal court Friday over allegations that the federal agency wrongly approved a treatment that rivals Jazz Pharma's narcolepsy drug despite Jazz's exclusivity rights under the Orphan Drug Act.

  • May 10, 2024

    Okla. Tells Justices 10th Circ. Wrong On PBM Law

    Oklahoma's insurance department Friday asked the U.S. Supreme Court to take up its petition seeking review of a Tenth Circuit decision overturning portions of a state law regulating pharmacy benefit managers, arguing that high court intervention is needed to resolve disagreement among the circuits on federal preemption.

  • May 10, 2024

    UPMC Inks $38M Deal To End Neurosurgery FCA Suit

    The University of Pittsburgh Medical Center has agreed to pay $38 million to put an end to a False Claims Act suit brought by three medical workers from its neurological surgery department who said the medical center fraudulently billed federal healthcare programs.

  • May 10, 2024

    Texas Justices Limit Damages In Unwanted Pregnancy Case

    The Texas Supreme Court said Friday that a woman who sued her doctor for failing to perform a sterilization procedure can't collect damages for emotional and physical pain in connection with her wrongful pregnancy claim, holding that the birth of a healthy child isn't a compensable injury but "a life with inherent dignity and profound, immeasurable value."

  • May 10, 2024

    What To Know About Biden's ACA Nondiscrimination Rule

    Recently finalized regulations tackling what constitutes discrimination under the Affordable Care Act could have significant impacts on health plans that include greater liability for third-party plan administrators, attorneys say. Here are three things employers should know now that the final rule is on the books.

  • May 09, 2024

    Judge Clarifies Gilead Didn't Directly Infringe HIV Drug IP

    A Delaware federal judge on Thursday rejected Gilead Sciences' request to amend her judgment finding that two medications in its HIV prevention regimen, Truvada and Descovy, directly infringed the government's invalidated patents, but clarified her judgment to say that non-party patients or physicians committed the infringement.

  • May 09, 2024

    Doc Can't Escape Second Prednisone Overprescribing Suit

    A Pennsylvania federal judge won't strike claims for punitive damages and references to "outrageous" conduct from a complaint alleging that a doctor wrongly overprescribed medications including prednisone, saying the complaint plausibly alleged that he knowingly had a patient on a medication plan that harmed her.

  • May 09, 2024

    9th Circ. Says Judge Defied Order To Revive Opioid Case

    The Ninth Circuit on Thursday again revived a nearly 7-year-old case against a California doctor for allegedly selling opioid prescriptions and ordered that the case be reassigned, saying the presiding judge had defied the plain language of a previous order to reinstate the indictment.

  • May 09, 2024

    DOJ Task Force To Target Healthcare Monopoly, Collusion

    The U.S. Department of Justice's Antitrust Division sharpened its focus Thursday on healthcare platforms that combine doctors with insurers, data and more in what the administration's top competition official called the "alarming" accumulation of assets.

  • May 09, 2024

    La. Lawmakers OK Local Tax Break For Certain Eye Meds

    Louisiana would expand a local sales tax exemption to include prescriptions used to treat eye-related conditions under a bill that was unanimously passed by the state Senate and next goes to the governor.

  • May 09, 2024

    Ex-Celtic 'Big Baby' Gets 40 Mos. In Health Fraud Case

    Former Boston Celtics forward Glen "Big Baby" Davis was sentenced to 40 months in prison Thursday after being convicted for his role in a scheme to submit fraudulent invoices to an NBA healthcare plan.

  • May 08, 2024

    GW Hospital Bargained In Bad Faith, NLRB Dems Say In Redo

    A split National Labor Relations Board panel said Wednesday that George Washington University Hospital sabotaged union negotiations with unworkable proposals, reasserting precedent that employers bargain in bad faith by insisting on contract provisions that effectively nullify unions.

  • May 07, 2024

    MultiPlan, Insurance Cos. Accused Of Algorithmic Collusion

    A medical provider has lodged a proposed class action in Illinois federal court accusing MultiPlan and major insurance companies, including UnitedHealth, Aetna, Kaiser Permanente and Cigna, of using pricing tools to systematically underpay out-of-network providers.

Expert Analysis

  • 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.

  • 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.