Policy & Compliance

  • May 17, 2024

    Many Plans Already In Front Of 11th Circ. Trans Health Ruling

    The Eleventh Circuit's recent decision that a county health plan's coverage exclusion for gender transition surgery violated federal anti-discrimination law likely won't have a big impact on plans because they have already made adjustments for the U.S. Supreme Court ruling the appeals court applied, experts say.

  • May 16, 2024

    Ointment Scheme Conned Gov't Out Of Millions, Fla. Suit Says

    Two Florida brothers and one of their former employees are accused of running a years-long fraudulent scheme billing government healthcare programs and receiving millions of dollars after paying kickbacks to generate prescriptions for ointments that were not needed, according to a False Claims Act lawsuit.

  • May 16, 2024

    3rd Circ. Shuns Teva's 'Novel' Appeal On Israeli Investor Class

    The Third Circuit on Thursday turned away an appeal brought by Teva Pharmaceutical Industries Ltd., saying the class certification stage was not the right time to hear arguments over the "novel" question of the applicability of U.S. securities laws to Israeli-listed shares.

  • May 16, 2024

    FTC Deputy Director Rao On Healthcare Antitrust Agenda

    The reason behind the Federal Trade Commission's changed attitude toward antitrust in healthcare in recent years isn't simple, according to Rahul Rao, deputy director of the FTC's Bureau of Competition.

  • May 16, 2024

    EPA Doctor Not A Whistleblower For Slamming Lead Plan

    A former U.S. Environmental Protection Agency pediatrician and epidemiologist who publicly criticized the EPA's plan to reduce lead in drinking water as inadequate is not protected by federal whistleblower law, the Federal Circuit said Thursday.

  • May 16, 2024

    Fla. Seeks To Halt Biden's ACA Trans Discrimination Rule

    Florida urged a federal court to stop recently finalized regulations clarifying gender identity-based discrimination under the Affordable Care Act from taking effect, saying the new rules would force the state to abandon its health and safety laws or lose funding from the federal government.

  • May 15, 2024

    Feds Urge Prison For Convicted Baby Formula Fraudster

    Urging the judge to communicate the gravity of white collar crime, federal prosecutors in New York asked Wednesday that a Staten Island man get at least 2.25 years in prison after he pled guilty to forging baby formula prescriptions as part of a scheme to defraud insurers of $1.9 million.

  • May 15, 2024

    Anti-Trans Groups Fail To Block Wash. Youth Shelter Law

    A federal judge on Wednesday threw out a lawsuit filed by two anti-transgender groups challenging a Washington state law intended to ensure shelter for teens seeking gender-affirming care or reproductive health services, ruling that speculating on possible injury was not enough to clear a standing hurdle.

  • May 15, 2024

    AstraZeneca Sales Reps Win Early Cert. In Gender Bias Suit

    An Illinois federal judge on Tuesday granted a bid by workers to conditionally certify a collective in a lawsuit alleging AstraZeneca paid women less than men, giving the green light for notices to be sent out to female sales representatives who have worked at the pharmaceutical giant since late 2018.

  • May 14, 2024

    Hospitals Liable For Failing To Admit Killer, Pa. Justices Told

    The Pennsylvania Supreme Court was reminded Tuesday, during oral arguments over whether someone can be officially treated at a hospital without filling out an application, that the case before them concerned a man who killed his girlfriend after he was turned away despite claiming homicidal and suicidal impulses.

  • May 14, 2024

    Vein Tech Maker Faces Investor Suit Over DOJ Kickback Probe

    Vein disease device maker Inari Medical Inc. and three of its current and former executives face a proposed investor class action over claims that the company's share price fell after it disclosed an investigation into its compliance with federal anti-kickback laws.

  • May 14, 2024

    States Accuse EEOC Of 'Smuggling' Abortion Into PWFA Rule

    Louisiana and Mississippi have sued the U.S. Equal Employment Opportunity Commission seeking to invalidate regulations implementing the Pregnant Workers Fairness Act, claiming the agency's stance that employers must provide workers accommodations if they get an abortion flouts U.S. Supreme Court precedent and the PWFA itself.

  • May 14, 2024

    White House Targets Kidney Transplant Bias Amid Lawsuits

    A White House effort to reduce bias in the organ transplant system comes as some Black litigants are pressing legal claims against a national transplant network they say used a flawed, racially biased calculation to delay kidney transplants.

  • May 14, 2024

    Ariz. Justices Stay 1864 Abortion Ban To Allow For Appeal

    Enforcement of Arizona's 1864 anti-abortion law will remain on hold for at least 90 days as state Attorney General Kris Mayes evaluates whether to ask the U.S. Supreme Court to take up the case.

  • May 14, 2024

    Mich. AG Says Eli Lilly 'Cherry-Picking' Enforcement Data

    Michigan's attorney general has hit back against Eli Lilly's arguments that recent consumer protection law recoveries show her office is not being hampered in its investigations, as she seeks subpoenas in a probe of the pharmaceutical giant's pricing for an insulin drug.

  • May 14, 2024

    Holland & Knight Atty On 'Historic' Women's Health Moment

    Julia Hesse, a veteran healthcare attorney who recently joined Holland & Knight LLP, talks about her multifaceted practice, pressing public policy issues, and why menopause care can be the next big thing in women's healthcare.

  • May 14, 2024

    Huge Payouts Pressure Hospitals To Address Doc Sex Abuse

    A string of high-profile settlements and the conviction of a prominent urologist in New York are motivating more victims of sexual abuse to come forward and intensifying the legal scrutiny facing hospitals as they navigate a culture that grants doctors substantial authority.

  • 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.

Expert Analysis

  • Policy Misrepresentations Carry Insurance Rescission Risks

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    The Second Circuit's recent decision in Medical Mutual v. Gnik, finding that material misrepresentation in a clinic's insurance applications warranted policy rescission, is a clear example of the far-reaching effects that misrepresentations can have and provides a reminder that policyholders should employ relatively straightforward steps to decrease risks, say attorneys at Hunton.

  • The Pros And Cons Of NIST's Proposed March-In Framework

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    Recent comments for and against the National Institute of Standards and Technology’s proposed guidance on march-in rights — which permit the government to seize federally funded patents — highlight how the framework may promote competition, but could also pose a risk to contractors and universities, say Nick Lee and Paul Ragusa at Baker Botts.

  • 2 Recent Suits Show Resiliency Of Medicare Drug Price Law

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    Though pharmaceutical companies continue to file lawsuits challenging the Inflation Reduction Act, which enables the federal government to negotiate for lower prescription drug prices, recent decisions suggest that the reduced drug prices are likely here to stay, says Jose Vela Jr. at Clark Hill.

  • Defense Attys Must Prep For Imminent AI Crime Enforcement

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    Given recent statements by U.S. Department of Justice officials, white collar practitioners should expect to encounter artificial intelligence in federal criminal enforcement in the near term, even in pending cases, say Jarrod Schaeffer and Scott Glicksman at Abell Eskew.

  • Lessons For Nursing Facilities From DOJ Fraud Settlement

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    The U.S. Department of Justice's recent settlement with the owner of skilled nursing and assisted living facilities in Florida provides a cautionary tale of potential fraud risks, and lessons on how facilities can mitigate government enforcement actions, say Callan Stein and Rebecca Younker at Troutman Pepper.

  • HHS' Updated Tracking Tech Guidance Offers Little Clarity

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    The U.S. Department of Health and Human Services' Office for Civil Rights' updated guidance on the use of online tracking technologies appears more focused on legal issues raised in ongoing litigation with the American Hospital Association and less on practical guidance for covered entities, say attorneys at Sheppard Mullin.

  • Takeaways From The 2023 DOJ Fraud Section Report

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    Attorneys at Wiley discuss notable trends from the U.S. Department of Justice's recently reported Fraud Section activity last year and highlight areas of enforcement to watch for in the future, including healthcare fraud and Foreign Corrupt Practices Act violations.

  • NIST March-In Framework Is As Problematic As 2021 Proposal

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    While the National Institute of Standards and Technology's proposed march-in framework on when the government can seize patents has been regarded as a radical departure that will support lowering prescription drug costs, the language at the heart of it is identical to a failed 2021 notice of proposed rulemaking, says attorney Kelly Morron.

  • Spartan Arbitration Tactics Against Well-Funded Opponents

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    Like the ancient Spartans who held off a numerically superior Persian army at the Battle of Thermopylae, trial attorneys and clients faced with arbitration against an opponent with a bigger war chest can take a strategic approach to create a pass to victory, say Kostas Katsiris and Benjamin Argyle at Venable.

  • The Road Ahead For Florida's Drug Importation Program

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    Though the U.S. Food and Drug Administration approved Florida's drug importation program in January, a series of hurdles — including requisite buy-in from Canada — and potential legal challenges must be addressed before importation can begin, say attorneys at Ropes & Gray.

  • Assessing CDC's Revised Guideline On Opioid Prescriptions

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    Kenneth Weinstein, Nicholas Van Niel and Kate Uthe at Analysis Group look at newly available data to evaluate the impact that the Centers for Disease Control and Prevention's revised opioid monitoring guideline have had on prescription trends in recent years, highlighting both specific and overall decreases.

  • 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.