Policy & Compliance

  • September 04, 2024

    Glenmark Will Pay $25M To End Feds' Price-Fixing Suit

    Glenmark Pharmaceuticals USA will pay $25 million to resolve allegations that it violated the False Claims Act by conspiring to fix the price of a generic high cholesterol drug, federal prosecutors announced Wednesday.

  • September 04, 2024

    Arnold & Porter Adds Mintz Healthcare Enforcement Leader

    After setting up shop in Boston a little less than a year ago, Arnold & Porter Kaye Scholer LLP announced Tuesday that it was welcoming the co-chair of Mintz Levin Cohn Ferris Glovsky and Popeo PC's healthcare enforcement defense group.

  • September 03, 2024

    Teva Investors Get Go-Ahead To Resume Kickbacks Class Suit

    A shareholder's certified class action against pharmaceutical company Teva can resume after being paused for two years, as the company says it is working towards a settlement with the U.S. Department of Justice over related claims it used kickbacks to raise the price of its multiple sclerosis drug Copaxone, a Philadelphia federal judge has decided.

  • September 03, 2024

    5th Circ. Grills Feds On Congress' Intent In No Surprises Act

    A Fifth Circuit panel on Tuesday challenged the federal government over its interpretation of how it applies a formula to calculate qualifying payments under a law meant to protect Americans from surprise medical bills and questioned the arbitration process over the payments that a medical association said favors insurers. 

  • September 03, 2024

    Meet The Zuckerman Spaeder Attys In Drug Rebate Battle

    A pair of Zuckerman Spaeder LLP attorneys who once oversaw changes to the 340B drug discount program during the Obama administration have teamed up again to defend the program from what they call an attempt by the pharmaceutical industry to weaken its benefits.

  • September 03, 2024

    Justices Deny Oklahoma's Bid To Block HHS Funding Cut

    The U.S. Supreme Court on Tuesday denied Oklahoma's request to stop the U.S. Department of Health and Human Services from cutting funding over the state's refusal to refer family planning patients for abortion after the high court's Dobbs decision last year.

  • September 03, 2024

    2nd Circ. Won't Ax Dad's Removal Over Child's Mental Health

    The Second Circuit ruled Tuesday that a man who entered the U.S. illegally more than two decades ago can't cancel his removal on the grounds that it would cause his daughter hardship, ruling that any adverse impacts would be typical of family separation.

  • September 03, 2024

    Ohio AG Asks Appeals Court To Affirm Trans Care Restrictions

    Ohio lawmakers acted within their authority to regulate the practice of medicine when they passed a law this year that restricts gender-affirming care for minors and prohibits transgender girls from participating in girls sports, Ohio Attorney General Dave Yost told the state appeals court in a recent brief.

  • September 03, 2024

    Will Medicaid Incarceration Waivers Hit 'Cutting Room Floor'?

    A bipartisan push to get incarcerated individuals covered by Medicaid before they're released could drastically reduce healthcare disparities and provide health equity to underrepresented populations. But shifting political winds and an upcoming election could lead to budget cuts that put the program on the "cutting room floor."

  • September 03, 2024

    'Showdown' Looms As J&J Pursues Rebates In 340B Program

    Johnson & Johnson's plan to abandon upfront discounts and instead offer rebates for two popular medications under the 340B drug pricing law would fundamentally alter how the program has worked for decades. Federal enforcement efforts and other legal clashes are likely.

  • September 03, 2024

    Glenmark Hit With $50M Suit Over Potassium Pill Death

    A proposed class of buyers is suing Glenmark Pharmaceuticals Inc. for more than $50 million, alleging that the company's extended-release potassium chloride capsules are defective and instead deliver the potassium too fast, which resulted in the death of the lead plaintiff's mother.

  • August 30, 2024

    Vets, Attys Urge Supreme Court To Topple Feres Doctrine

    Veterans groups and lawmakers contend it's "high time" for the U.S. Supreme Court to scrap its 74-year-old doctrine prohibiting military service members and their families from suing the U.S. for negligence, arguing the vague rule has left soldiers with fewer rights than prisoners and noncitizens.

  • August 30, 2024

    Connecticut Judge Wants More Info In Doctors' Billing Row

    A Connecticut federal judge on Friday declined to immediately dismiss a medical staffing company's lawsuit against Harvard Pilgrim Health Care of Connecticut Inc. after the state's highest court answered three certified questions in the insurer's favor, asking for briefs after the insurer countered with a demand for a judgment.

  • August 30, 2024

    HHS Wins Escape From Low-Income Hospital Payment Fight

    A D.C. federal judge on Friday agreed to toss a lawsuit brought by a group of hospitals against the U.S. Department of Health and Human Services challenging its Medicare payment determinations for low-income patients, finding the hospitals didn't exhaust their administrative remedies. 

  • August 30, 2024

    Nebraska Expected To Vote On Medical Marijuana Legalization

    Medical marijuana advocates have met the requirements to put a legalization question before Nebraska voters on Election Day this November, the secretary of state announced Friday.

  • November 17, 2023

    HHS Seeks Exit From Low-Income Hospital Payment Rule Suit

    The U.S. Department of Health and Human Services asked a D.C. federal court Thursday to dismiss a lawsuit from a group of hospitals challenging Medicare payment determinations for low-income patients, the same day the court rejected the hospitals' request to continue pausing the case.

  • August 29, 2024

    Sutter Health Kickback Fight Likely Headed To Nov. Trial

    A California federal judge indicated Wednesday she's likely to send at least some claims in a whistleblower's kickback suit against Sutter Health and a surgical-practice group to a November trial, saying during a hearing there are disputes over the credibility of certain evidence and that's "the providence of the jury."

  • August 29, 2024

    Comer Tells PBMs To Correct Record On Role In Drug Pricing

    Rep. James Comer, R-Ky., chair of the House Oversight and Accountability Committee, is demanding that the heads of three major pharmacy benefit managers "correct the record" on their testimony made before his committee in July about their roles in drug pricing, including company claims that the PBMs don't steer customers to in-house pharmacies and that they allow non-affiliated pharmacies to negotiate contracts.

  • August 29, 2024

    Conn. ER Docs Ask To Drop Harvard Pilgrim Insurance Fight

    A staffing company covering six Connecticut emergency rooms has asked a federal judge to dismiss its lawsuit against Harvard Pilgrim Health Care of Connecticut Inc. after the state's highest court last week ruled in the insurer's favor on three certified questions of law regarding a surprise billing statute.

  • August 29, 2024

    HHS Withdraws Appeal In Hospital Web-Tracking Clash

    The Biden administration on Thursday abandoned its appeal of a federal court decision that knocked down new guidance restricting how hospitals can use web-tracking tools, handing the American Hospital Association a victory in a closely watched case.

  • August 29, 2024

    Full 11th Circ. Won't Rehear Ala. Trans Care Ban Challenge

    The Eleventh Circuit said it will not reconsider its ruling allowing Alabama to enact a ban on certain gender-affirming medical care for minors, knocking down a challenge brought by parents and those who received the treatment of the circuit's ruling, which found that the ban doesn't flout constitutional rights.

  • August 29, 2024

    GOP States Ask Justices To Undo Trans Patients' 4th Circ. Win

    A group of two dozen Republican attorneys general told the U.S. Supreme Court it should review a Fourth Circuit decision barring West Virginia and North Carolina from excluding coverage of gender-affirming medical care for transgender people, arguing states need the power to control controversial nascent treatments.

  • August 28, 2024

    CVS Can't Avoid Federal Claims In $200M FCA Suit

    A former CVS Health compliance director can pursue claims the company and its subsidiaries pocketed more than $200 million in overpayments, after an Illinois federal judge on Monday tossed several other claims from a qui tam suit alleging various schemes by CVS to take money from the government.

  • August 28, 2024

    9th Circ. Overturns Rule Mandating Sealing Of Health Records

    A Ninth Circuit panel found Wednesday that Hawaii state court rules mandating the automatic sealing of medical and health records in civil and criminal proceedings are unconstitutionally overbroad.

  • August 28, 2024

    Dr.'s Suit Blames Practice's Buyer For Chaos After Sale

    A North Carolina doctor struck back in a lawsuit blaming him for business challenges following the sale of his practice to another physician, alleging in counterclaims that the purchasing physician lied about his intentions for the practice and ultimately led it to ruin.

Expert Analysis

  • How To Navigate The FTC's New Private Equity Frontier

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    The Federal Trade Commission's recent district court complaint against an anesthesia firm and its private equity partner tests key bounds of the agency's stand-alone authority, and defense strategies can include challenges to both the geographic and the service market fronts, say attorneys at Baker McKenzie.

  • Newman Suspension Shows Need For Judicial Reform

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    The recent suspension of U.S. Circuit Judge Pauline Newman following her alleged refusal to participate in a disability inquiry reveals the need for judicial misconduct reforms to ensure that judges step down when they can no longer serve effectively, says Aliza Shatzman at The Legal Accountability Project.

  • An Overview Of Congress' Proposed Drug Shortage Solutions

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    Recently, Congress has seen a number of bipartisan bills that seek to prevent and respond to national drug shortages, though disagreements over the right vehicle and timeline have slowed progress, says Miranda Franco at Holland & Knight.

  • SEC's Life Sciences Actions Utilize Novel Tools And Theories

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    Recent enforcement actions show that the U.S. Securities and Exchange Commission is employing new forms of data analytics and noteworthy applications of insider trading laws in its scrutiny of fraud within the life sciences and health industries, say Edward Imperatore and Jina Choi at MoFo.

  • ESG Around The World: Japan

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    Japan is witnessing rapid developments in environmental, social and corporate governance policies by making efforts to adopt a soft law approach, which has been effective in encouraging companies to embrace ESG practices and address the diversity of boards of directors, say Akira Karasawa and Landry Guesdon at Iwata Godo.

  • How And Why Your Firm Should Implement Fixed-Fee Billing

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    Amid rising burnout in the legal industry and client efforts to curtail spending, pivoting to a fixed-fee billing model may improve client-attorney relationships and offer lawyers financial, logistical and stress relief — while still maintaining profit margins, say Kevin Henderson and Eric Pacifici at SMB Law Group.

  • Potential Broader Effects Of FDA's Lab-Developed Test Rule

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    Though it's unclear whether the U.S. Food and Drug Administration's proposed rule for regulating lab-developed tests will ever go into effect, it nonetheless functions as a threatened hammer that may make legislative efforts to regulate such tests more palatable, say attorneys at King & Spalding.

  • Judicial Independence Needs Defense Amid Political Threats

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    Amid recent and historic challenges to the judiciary from political forces, safeguarding judicial independence and maintaining the integrity of the legal system is increasingly urgent, says Robert Peck at the Center for Constitutional Litigation.

  • 2 New Ways FDA Is Changing Lab-Developed Test Regulation

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    The U.S. Food and Drug Administration's recently announced rulemaking and voluntary pilot program signal the agency's dedication to ramping up oversight of lab-developed tests, which have been largely unregulated by the FDA until now, say attorneys at Sidley.

  • How Law Firms Can Use Account-Based Marketing Strategies

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    Amid several evolving legal industry trends, account-based marketing can help law firms uncover additional revenue-generating opportunities with existing clients, with key considerations ranging from data analytics to relationship building, say Jennifer Ramsey at stage LLC and consultant Gina Sponzilli.

  • AGs' Distaste For Food Bill May Signal Other State Issues

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    States' recent opposition to a proposed federal law that would block them from regulating out-of-state agricultural production could affect issues beyond this narrow debate, such as the balance of state and federal regulatory power, reproductive rights post-Dobbs, and energy production and water use, say Christopher Allen and Stephen Cobb at Cozen O'Connor.

  • Strategic Succession Planning At Law Firms Is Crucial

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    Senior partners' reluctance to retire, the rise of the nonequity partner tier and generational differences in expectations are all contributing to an increasing number of departures from BigLaw, making it imperative for firms to encourage retirement among senior ranks and provide clearer leadership pathways to junior attorneys, says Laura Leopard at Leopard Solutions.

  • What An NCAA Drug Test Change Could Mean For Cannabis

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    If the NCAA follows through with its decision to remove cannabis from its banned list of substances, it will affect college athletes, athletic directors, public relations employees, and marketing departments at universities and colleges, and it will have a significant economic effect on the cannabis industry, say Stanley Jutkowitz and Sydney Jenkins at Seyfarth.