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Ropes & Gray LLP
Ropes & Gray attorneys provide timely analysis on legal developments, court decisions and changes in legislation and regulations.
Episodes
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Jan 30, 2024 • 11min
Insights from OIG’s Strategic Plan for Oversight of Managed Care (Part II)
Following the first discussion surrounding the Strategic Plan for Oversight of Managed Care for Medicare and Medicaid and its impact on the first two phases of the managed care life cycle: plan establishment and enrollment and associated enforcement and regulatory actions, Ropes & Gray litigation & enforcement partner Andrew O’Connor provides an overview of the final two stages of the managed care life cycle: payment and services to people. He discusses ongoing enforcement trends in light of the Strategic Plan and note a market shift among plans, providers, and vendors, to a more proactive approach to monitoring and oversight.

Jan 26, 2024 • 20min
The Data Day: Protecting Your Company and Your Data in the Wake of a Cyber Incident
Tune in to Ropes & Gray's podcast series, The Data Day, brought to you by the firm’s data, privacy & cybersecurity practice. This series focuses on the day-to-day effects that data has on all of our lives as well as other exciting and interesting legal and regulatory developments in the world of data, and features a range of guests, including clients, regulators and colleagues. On this special episode, in honor of World Data Privacy Day coming up on January 28, hosts Fran Faircloth, a partner in Ropes & Gray's Washington, D.C. office, and Edward Machin, counsel in the London office, discuss the most important steps they advise clients to take to protect their business and their data from a cybersecurity attack.

Jan 25, 2024 • 31min
Non-binding Guidance: U.S. Life Sciences Regulatory and Compliance Outlook 2024 (Part III): Advertising and Promotion
Join Ropes & Gray’s life sciences attorneys for a podcast series exploring regulatory, compliance, and enforcement changes emanating from Washington, D.C. and the potential impact on life sciences companies in 2024. In this third episode, life sciences regulatory and compliance partners Kellie Combs and Josh Oyster discuss key developments and trends related to medical product advertising and promotion. They cover the latest enforcement trends, revisit FDA’s most recent guidance on the communication of off-label scientific information, and also discuss the implications of a long-awaited First Circuit decision.

Jan 24, 2024 • 20min
Talkin’ Trade: Third-Party Subpoenas in ITC Section 337 Proceedings
Many litigations require discovery not just from the parties to the dispute, but from other entities—and Section 337 investigations at the U.S. International Trade Commission are no different. But there are many unique aspects of third-party subpoena practice at the ITC. On this episode of Ropes & Gray's ITC-focused podcast series, Talkin' Trade, IP litigators Matt Rizzolo, Matt Shapiro, Rachael Bacha, and Brendan McLaughlin discuss the ins and outs of obtaining, enforcing, and responding to third-party subpoenas under the tight timelines of Section 337 proceedings.

Jan 24, 2024 • 39min
There Has to Be a Better Way?: What’s Wrong With Doing the Right Thing?
It’s a common phrase in the compliance world: “do the right thing.” But what is “the right thing?” Are there risks to moralizing organizational decision-making? And what happens when two seemingly “right” actions are—or may be—in conflict? On this episode of the Better Way? podcast, co-hosts Hui Chen and Zach Coseglia, along with the Lab’s Dr. Caitlin Handron, explore how culture, context, and individual perspectives impact our understanding of what it means to “do the right thing.”

Jan 22, 2024 • 33min
Non-binding Guidance: U.S. Life Sciences Outlook 2024 (Part II): Product Development and Pricing
Join Ropes & Gray’s life sciences and health care attorneys for a podcast series exploring regulatory, compliance, and enforcement changes emanating from Washington, D.C. and the potential impact on life sciences companies in 2024. In this second episode, we focus on key issues to watch related to product development, approval, and drug pricing in 2024. These include FDA activities aimed at expediting the development of drugs to treat rare diseases, changes to FDA’s accelerated approval program, clinical trial diversity initiatives, actions to support use of real-world evidence, and developments in drug pricing and market access as CMS works to implement the Medicare Price Negotiation Program and prepares for the Medicare Part D redesign.

Jan 22, 2024 • 23min
Revisiting Pooled Employer Plans (“PEPs”): A Cost-Effective, Low-Risk Solution for Providing Retirement Plan Coverage (Part I)
In part one of this two-part podcast series, David Kirchner and Elliot Saavedra of the Ropes & Gray benefits consulting group, revisit one of the biggest advances in retirement plan design in recent memory: pooled employer plans (“PEPs”). Based on their findings from a survey they conducted of several of the leading providers in this space and their experiences with this new, innovative approach to employer-sponsored retirement plans, they take a fresh look at PEPs and how the market has evolved over the last three years. Stay tuned for part two, where they will dive deeper into the responsibilities that employers should be mindful of when considering, evaluating and monitoring PEPs, as well as recent regulatory changes impacting PEPs

Jan 17, 2024 • 28min
Non-binding Guidance: U.S. Life Sciences Regulatory and Compliance Outlook 2024 (Part I): FDA Enforcement and Litigation
Join Ropes & Gray’s life sciences attorneys for a podcast series exploring regulatory, compliance, and enforcement changes emanating from Washington, D.C. and the potential impact on life sciences companies in 2024. In this first episode, we focus on key issues to watch related to FDA enforcement and litigation in 2024. These include potential litigation over FDA’s planned final rule to regulate laboratory-developed tests (“LDTs”), the Supreme Court's review of FDA’s approval of mifepristone for medication abortion, litigation related to FDA discouraging the use of ivermectin in humans during the pandemic, and the potential effects of organizational changes in FDA’s Office of Regulatory Affairs (“ORA”) on inspections and enforcement.

Jan 16, 2024 • 10min
Insights from OIG’s Strategic Plan for Oversight of Managed Care (Part I)
On part one of this two-part podcast installment, Ropes & Gray litigation & enforcement partner Andrew O’Connor discusses the Strategic Plan for Oversight of Managed Care for Medicare and Medicaid issued in August by the Department of Health & Human Services (“HHS”) Office of Inspector General (“OIG”). Part one’s discussion focuses on the first two phases of the managed care life cycle: plan establishment and enrollment and associated enforcement and regulatory actions, and OIG’s compliance priorities for Medicare Advantage (“MA”) plans and how the Strategic Plan implicates regulatory and enforcement developments in the managed care space more broadly.

Jan 11, 2024 • 25min
A Word for Our Sponsors: A Conversation with Vikrant Raina of BV Investment Partners
On this episode of Ropes & Gray’s podcast series, A Word for Our Sponsors, hosts Paul Van Houten and Deb Lussier, the co-leaders of the sponsor solutions practice, chat with Vikrant Raina, CEO and managing partner at BV Investment Partners, about BV’s successful first continuation fund.


