Connected With Latham

Latham & Watkins
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Connected With Latham

In each episode of Connected With Latham, we discuss ideas, developments, and trends shaping the global economy.

  1. قبل ٥ أيام

    Drug Pricing: How Might the Trump Administration Transform FDA Enforcement Activities?

    FDA enforcement activities range from administrative actions like conducting establishment inspections and issuing warning letters to judicial enforcement through the Department of Justice, which can take the shape of civil or criminal actions. While we can expect the agency’s core activities to continue, its priorities may shift under the incoming Trump Administration. One point of emphasis might be increasing inspections at ex-US manufacturing sites, both to help ensure the quality of products sold into the United States from abroad, and to encourage US-based manufacturing. In this episode of Connected With Latham, Washington, D.C. partners Chris Schott, Jennifer Bragg, and Bill McConagha discuss important FDA enforcement trends, including the impact of First Amendment jurisprudence on the regulation of promotional statements, increasing reliance on tools like import alerts and warning letters to address alleged misconduct, and oversight of manufacturing facilities outside of the US — all in the context of how the incoming presidential administration may shape the FDA enforcement landscape. They also examine how the recent overturning of the Chevron doctrine may impact FDA’s regulatory and guidance activities.    Latham’s related webcast — "FDA Life Sciences Enforcement Updates: Recent Trends and a Look Ahead" — is available on-demand here.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York’s Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York’s Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

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  2. ٢٣ جمادى الأولى

    Drug Pricing: What’s In the New CMS Medicaid Final Rule?

    The Centers for Medicare & Medicaid Services (CMS) recently published its final rule to implement the Medicaid Services Investment and Accountability Act of 2019 (MSIAA). The final rule significantly deviates from the agency’s 2023 proposal, with CMS backing off from “follow the pill” best price stacking, subjecting certain vaccines to Medicaid rebates, and creating a “shame list” of high-cost Medicaid drugs, among other proposals. But the final rule still imposes new burdens on manufacturers, such as by expanding which type of utilization triggers a Medicaid rebate, and imposing aggressive compliance deadlines in connection with misclassifications. In this episode of Connected With Latham, Washington, D.C. partner Chris Schott and associate Danny Machado break down what CMS included — and omitted — from its final rule. They also speculate about the impact the Supreme Court’s overturning of the Chevron doctrine might have had on CMS’ regulatory decision-making, as well as why the final rule’s effective date is 60 days before the next presidential inauguration.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York’s Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York’s Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

    ٢٩ من الدقائق

  3. ١٥ ربيع الآخر

    Drug Pricing: Takeaways from the Chicago Medicaid Drug Rebate Program Summit

    Manufacturers, government officials, and other stakeholders recently convened in Chicago for the annual Medicaid Drug Rebate Program Summit. In this episode of Connected with Latham, Washington, D.C. associate Danny Machado interviews partner Chris Schott about takeaways from the conference, including thoughts on the new Medicaid regulation that CMS released just days before the conference.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York’s Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York’s Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

    ١٨ من الدقائق

  4. ١٦ ربيع الأول

    Drug Pricing: How The Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry

    Recent Supreme Court decisions, such as the opinions in Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce that overruled the long-standing Chevron doctrine, will likely impact how federal agencies interpret ambiguous statutes when regulating the pharmaceutical industry. And in Securities & Exchange Commission v. Jarkesy, the Court established a right to a jury trial for defendants facing civil monetary penalties in agency enforcement actions, which may affect how industry stakeholders respond to enforcement actions. In addition to these cases, which are not specifically focused on the pharmaceutical industry, ongoing manufacturer challenges to the Inflation Reduction Act’s negotiation provisions and to state 340B contract pharmacy laws will likely have a significant impact on the pharmaceutical industry. In this episode of Connected with Latham, Washington, D.C. partner Chris Schott and associate Danny Machado review recent and ongoing cases and explore how they could affect the pharmaceutical industry. Also tune in to the Latham webcast “The Demise of Chevron Deference and Its Impact on the Healthcare and Life Sciences Industries” for a deep dive into Loper Bright Enterprises v. Raimondo and Relentless Inc. v. Department of Commerce.    This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York’s Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York’s Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

    ٢٢ من الدقائق

  5. ١٦ صفر

    Pro Bono: Shabir Kabiri’s Remarkable Journey from Afghanistan to Asylum in the US

    In this episode of Connected with Latham, we explore the remarkable story of Shabir Kabiri, an Afghan refugee who secured asylum in the United States with the help of a Latham pro bono team. Shabir shares his harrowing journey, his time as a cadet at West Point, and the dangers he faced upon returning home. When Kabul fell to the Taliban in 2021, Shabir experienced the chaos and fear firsthand, as his former West Point roommate and a group of West Point classmates worked to orchestrate Shabir’s evacuation. New York partner Michèle Penzer and Director of Global Pro Bono Laura Atkinson-Hope discuss with Shabir the legal intricacies of his asylum case and the coordinated efforts of the Latham team to ensure his family’s safety.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York’s Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York’s Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

    ٣٤ من الدقائق

  6. ١٥ صفر

    Drug Pricing: How Are Payers Responding to the IRA?

    The US healthcare landscape is undergoing significant changes as the Centers for Medicare & Medicaid Services (CMS) continues to implement the Inflation Reduction Act (IRA). One key stakeholder group affected by the IRA drug price negotiations and Medicare Part D redesign are health insurance companies. In this episode of Connected with Latham, we delve into how these payers are responding to the IRA, including the new ability for Part D beneficiaries to spread their cost-sharing equally across the plan year. Amanda Forys from Magnolia Market Access joins Washington, D.C. partner Chris Schott and associate Danny Machado to discuss the findings of a recent survey on payer trends. Beyond discussing the broader effects of the IRA on the healthcare industry, the conversation also touches on possible Part D premium increases and how payers might be shifting new IRA obligations onto manufacturers.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York’s Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York’s Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

    ٢٩ من الدقائق

  7. ١٥ ذو الحجة

    Drug Pricing: Takeaways from the New Orleans Pricing and Contracting USA Conference

    Current developments grabbed much of the spotlight when key industry stakeholders met in New Orleans for the Pricing and Contracting USA Conference. In this episode of Connected With Latham, Washington, D.C. partner Chris Schott and associates Danny Machado and Elisabeth Crusey share their observations from the conference, concluding with four calls to action for pharmaceutical manufacturers.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York’s Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York’s Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

    ١٨ من الدقائق

  8. ٧ ذو الحجة

    Drug Pricing: A Look Behind the Curtain of the New ASP Reporting Website and Other Data Collection Portals

    The Centers for Medicare and Medicaid Services (CMS) recently updated its portal for Average Sales Price (ASP) reporting under Medicare Part B. Data collection portals are also essential for manufacturer compliance with the Inflation Reduction Act and for price reporting under the Medicaid Drug Rebate Program. The 340B program operates yet another online data portal. In addition to these federal programs, states are also implementing data collection interfaces. For example, the Texas Vendor Drug Program recently launched its electronic certification of information (eCOI) portal. Despite the significance of these portals, only a small number of users have access and can directly evaluate compliance obligations. In this episode of Connected with Latham, Washington, D.C. partner Chris Schott and associate Danny Machado discuss the details of the various data collection portals with Lynn Buhl and Sophie Sam of Riparian, a pharmaceutical consulting company that helps manufacturers navigate government pricing regulations, reporting, strategies, and program operations. Drawing on Lynn and Sophie’s direct experience with the various reporting portals, the podcast explores the challenges posed by the various certification requirements, explains why CMS’ update to the ASP Data Collection Module marks a good time for manufacturers to review their reasonable assumptions, and explores how implementation of the Inflation Reduction Act will further transform the price reporting landscape.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York’s Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York’s Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

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In each episode of Connected With Latham, we discuss ideas, developments, and trends shaping the global economy.

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    Latham & Watkins
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    Connected With Latham

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