Shows
Citeline PodcastsScrip M&A Podcast: Will the FDA Staff Cuts Affect Biopharma M&A Activity?Scrip senior writer Joseph Haas discusses the potential impact of the recent FDA staff cuts with attorneys Andrew Goodman of Paul Hastings LLP and Alan Minsk of Arnall Golden Gregory, as well as Naya Therapeutics CEO Daniel Teper2025-05-0140 min
AGG Talks: Cross-Border BusinessHow Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. MarketIn this episode, Mike Burke, AGG Corporate partner and co-chair of the firm’s International practice, is joined by David Blank, AGG Healthcare partner, to discuss how foreign life sciences companies can proactively address healthcare compliance challenges when expanding into the U.S. market. Mike and David cover key fraud and abuse laws, including the False Claims Act, the Anti-Kickback Statute, Physician Self-Referral Law (Stark law), and the Civil Monetary Penalties Law, and highlight common mistakes companies make and the severe penalties for non-compliance. As regulatory issues can be incredibly costly and disruptive to a business, Mike and...2025-04-3027 min
FDA WatchBreaking Down Pharma in the Current Environment Shelly and Wayne chat with Dr. Michelle McMurry-Heath, Founder and CEO of BioTechquity Clinical, and Alan Minsk, Partner, Chair of the Food & Drug practice, and Co-Chair of the Life Sciences industry team at Arnall Golden Gregory LLP. You’ll hear their thoughts on the potential effects that FDA staffing cuts may have on drug and biologics approvals; how the current environment may affect investments in drug and biotech development; what companies can do to amid agency staffing shortages; how FDA can aim to include all demographics of patients in trials; and much more. In our headlines segment, She...2025-04-2146 min
AGG Talks: Home Health & HospiceAnti-Kickback Compliance for Hospice and Skilled Nursing ProvidersIn this episode, AGG Healthcare attorneys Bill Dombi and Jason Bring discuss recent OIG guidance on hospice and skilled nursing facility relationships, focusing on anti-kickback risks and fraud concerns. They cover key issues such as the importance of documenting fair market value for any services or space provided, being cautious of payments exceeding Medicaid room and board rates, and avoiding arrangements that appear to be made solely to secure referrals. Bill and Jason also touch on increased oversight and enforcement in the healthcare sector under a new presidential administration. 2025-04-0315 minAGG Talks: Cross-Border BusinessU.S. Healthcare Reimbursement Guidance for Foreign Life Sciences CompaniesIn this episode, Mike Burke, AGG Corporate partner and co-chair of the firm’s International practice, is joined by Andrew Tsui, AGG Healthcare Litigation partner, to explore the intricacies of reimbursement in the U.S. healthcare system. Mike and Andrew discuss challenges foreign life sciences companies face related to Medicare and Medicaid reimbursement, the regulatory hurdles involved, and common pitfalls to avoid. They also highlight the importance of understanding compliance requirements, enforcement mechanisms, and the role of federal agencies in shaping payment determinations. 2025-03-2031 minAGG Talks: Cross-Border BusinessU.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device ManufacturersAGG Corporate partner and co-chair of the firm’s International practice, Mike Burke, is joined by Gabe Scannapieco, AGG Litigation & Dispute Resolution partner, to discuss enforcement trends affecting foreign pharmaceutical and medical device manufacturers. Mike and Gabe explore the increasing regulatory scrutiny on overseas facilities, the role of U.S. agencies in compliance and inspections, and practical steps companies can take to mitigate legal and operational risks when entering the U.S. market. 2025-03-0626 minAGG Talks: Home Health & HospiceThe Impact of AI and Prior Authorizations on Home Health and HospiceIn this episode, AGG Healthcare attorneys Bill Dombi and Jason Bring discuss the role of managed care, artificial intelligence, and prior authorizations in home health and hospice. Bill and Jason examine a recent lawsuit filed against a major Medicare Advantage plan in the United States District Court for the District of Minnesota challenging the use of AI-driven claims reviews in Medicare Advantage coverage decisions. They also address concerns around prior authorization denials, their high reversal rates, and potential consequences for providers and patient care. 2025-03-0415 min
Behind the Screens: Conversations with Background Screening Pros hosted by Les RosenEpisode 17: Kevin Coy on Privacy Law, FCRA Compliance, and Navigating Legal Risks in Background ScreeningSend us a textHow do you stay ahead in a world where privacy laws are constantly shifting? How can businesses manage legal risks without slowing down growth?In this episode, I sit down with Kevin Coy, co-chair of the Privacy and Cybersecurity Practice at Arnall Golden Gregory LLP, to break down the legal challenges shaping background screening today. From navigating FCRA compliance and international privacy laws to understanding the impact of AI, Kevin shares practical insights from his extensive career. We explore his journey into privacy law, key lessons he’s learned, an...2025-02-2428 minAGG Talks: Home Health & HospiceHospice Special Focus Program: Pumping the BrakesIn this episode, AGG Healthcare attorneys Bill Dombi and Jason Bring discuss the hospice special focus program and CMS’ announcement that it will cease implementing the program in the face of litigation filed by providers and state associations. 2025-02-1814 minAGG Talks: Cross-Border BusinessVenture Capital Trends and Fundraising Strategies for Foreign Startups Expanding to the U.S.In this episode, Mike Burke, AGG Corporate partner and co-chair of the firm’s International practice, is joined by Paula Nagarajan, AGG Corporate partner, to discuss trends in the U.S. venture capital market and fundraising considerations for foreign startups expanding across borders. Mike and Paula highlight varying investment approaches and industry focuses in different geographic regions in the U.S., the importance of strong formation documents, and strategies for securing funding. They also highlight practical steps that founders can implement when pitching their company and building valuable industry relationships. 2025-02-1225 min
AGG Talks: Healthcare InsightsWhat Healthcare Companies Need to Know When the Government Comes KnockingIn this episode, AGG Healthcare Litigation co-chair Jason Bring is joined by AGG Healthcare Litigation and Government Investigations partner Kara Silverman to discuss best practices for healthcare companies facing a government investigation. Kara outlines what healthcare companies should do when confronted with subpoenas, search warrants, or unexpected visits from federal agents. Kara shares practical guidance on responding to investigations while protecting legal interests, the importance of working with experienced counsel, and how to navigate the complexities of regulatory scrutiny. 2025-02-1116 minAGG Talks: Cross-Border BusinessPreparing Employers for Immigration Policy Changes Under the Trump AdministrationIn this episode, Mike Burke, AGG Corporate partner and co-leader of the firm’s International practice, is joined by Teri Simmons, AGG Global Mobility chair, to discuss potential changes under the Trump administration to business immigration policies and the impact on foreign nationals working in the United States. Mike and Teri address critical compliance strategies for employers, risks posed by potential travel bans and temporary protected status revocations, and heightened scrutiny on work visas. They also provide guidance on how companies can prepare for audits and enforcement actions while minimizing business disruptions. 2025-01-0930 minAGG Talks: Healthcare InsightsNational MultiPlan Litigation: A Guide for Healthcare ProvidersIn this episode, AGG Healthcare attorneys Jason Bring and Matthew Lavin discuss the national MultiPlan litigation and its impact on healthcare providers. Jason and Matt break down the antitrust violations involving MultiPlan and major insurance companies, including allegations of price-fixing. They share insights into the litigation process, how providers can protect and preserve their claims, and the broader implications for healthcare policy and access to care. 2025-01-0618 minAGG Talks: Cross-Border BusinessShaping Georgia's Energy Landscape: Insights From Commissioner Tim EcholsIn this episode, Rebecca Davis and Caroline Magee, leaders of AGG's ESG team, are joined by Georgia Public Service Commissioner Tim Echols to discuss the role of energy in the future of Georgia’s economy, as well as what U.S. and international companies interested in doing business in Georgia should know. Together, they offer a look at the state's approach to renewable energy, data centers, EV infrastructure, and the integration of agriculture with solar innovation. 2024-12-2026 minAGG Talks: Cross-Border BusinessWhat Global Companies Need to Know About Navigating FDA Regulations and U.S. Market EntryIn this episode, Mike Burke, AGG Corporate partner and co-chair of the firm’s International Initiative, is joined by Alan Minsk, AGG Food & Drug chair, to unpack the intricacies of working with the Food and Drug Administration ("FDA"). Mike and Alan dive into common mistakes companies make when engaging with the agency and highlight the importance of preparation and strategic timing. They also discuss challenges concerning cross-border approvals, customs, and diverse regulatory systems worldwide. 2024-12-1224 min
America‘s Commercial Real Estate ShowLease Negotiation Battle Featuring Lawyer Members of the Atlanta Bar AssociationListen to two experienced real estate attorneys battle through key aspects of a commercial lease negotiation in front of a live audience receiving CE credit. This segment features Chris Troutman with Alston & Bird and Meghan Gordon with Arnall Golden Gregory LLP, and is moderated by show host and broker Michael Bull, CCIM.
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...2024-12-1135 minAGG Talks: Home Health & HospiceOIG Report Reveals Gaps in Hospice PRF Compliance: What Providers Need to KnowIn this episode, AGG Post-Acute & Long-Term Care co-chair Jason Bring is joined by AGG Healthcare partner Alex Foster to discuss a recent OIG report highlighting Provider Relief Fund compliance issues within the hospice industry. Jason and Alex break down the origins of provider relief funds during the COVID-19 pandemic, the common pitfalls identified in the OIG report, and the importance of maintaining proper documentation. As government scrutiny increases, they provide practical steps for providers to prepare for potential audits, such as strategies for navigating lost revenue reporting, tracking expenses, and engaging legal counsel to ensure compliance under privilege. 2024-12-0215 minAGG Talks: Cross-Border BusinessThe 2024 U.S. Election's Impact on ESG RegulationsIn this episode, Mike Burke, AGG Corporate partner and co-chair of the firm’s International practice, is joined by AGG Environmental co-chair Rebecca Davis and AGG Real Estate of counsel Caroline Magee to explore the future of environmental, social, and governance ("ESG") issues following the 2024 U.S. election. As the political and regulatory environment shifts, Mike, Rebecca, and Caroline discuss the challenges businesses face in navigating conflicting federal and state regulations. They also examine the potential impact of policy changes on environmental justice, infrastructure investments, and the electric vehicle ("EV") sector. With a focus on practical strategies, they offer in...2024-11-2127 min
The Pulse by Vital InciteThe $81 Billion Toll of Substance Use Disorders on the Workplace: Employer Strategies for Cost Effective Care and TreatmentSubstance use disorders related to alcohol and drug addiction are having a heavy emotional and financial toll on the workplace. It’s estimated that addiction costs employers upwards of $81 billion per year and employers struggle with how to provide the correct care. Finding in-network providers is challenging and health plans are paying a significant amount in out of network fees and “Shared Savings” that the carrier then takes.Tune into this episode of The Pulse as we examine the health plan impacts of substance abuse, including uncovering why so many facilities are not in network, what the carrie...2024-11-2049 minAGG Talks: Home Health & HospiceNavigating the Audit Maze: Insights From Northeast Georgia Health SystemIn this episode, AGG Post-Acute & Long-Term Care co-chair Jason Bring is joined by Kathy Barton and Natalie McNeal of Northeast Georgia Health System. Kathy and Natalie share insights on navigating the complexities of hospice audits, discuss their experiences with the appeal process, and offer practical strategies for success. They also delve into lessons learned, the importance of thorough documentation, and how to effectively prepare for administrative hearings. 2024-10-2833 minAGG Talks: Cross-Border BusinessMastering ITC Section 337 InvestigationsIn this episode, Mike Burke, AGG Corporate partner and co-chair of the firm’s International practice, is joined by Andrew Beverina, AGG Litigation & Dispute Resolution and Intellectual Property of counsel and former International Trade Commission attorney, to discuss the complexities of ITC Section 337 investigations. They explore strategies for companies facing import disputes, the nuances of the ITC's review process, and best practices for responding to investigations. Together, they highlight effective strategies for navigating intellectual property challenges in international trade. 2024-10-1728 minAGG Talks: Cross-Border BusinessThe Rise of Korean Investment in the Southeast U.S.In this episode, Mike Burke, AGG Corporate partner and co-chair of the firm’s International practice, is joined by AGG International Arbitration partner Lance Lee to discuss Korea's booming investment in the southeastern United States. Mike and Lance shed light on the decision-making process behind Korean companies' U.S. expansion and why states like Georgia are prime targets for overseas investors. They also discuss the challenges Korean businesses face in terms of regulations and workforce integration and the cultural nuances of managing cross-border operations. 2024-10-0224 minAGG Talks: Healthcare InsightsCharting the Future of Nursing Home StaffingIn this episode, AGG Healthcare attorneys Lisa Churvis and Alan Horowitz discuss critical aspects of nursing home staffing requirements. Lisa and Alan delve into the implications of recent legislative proposals and regulatory changes affecting the long-term care sector, exploring the economic impact on facilities and the challenges in meeting new standards. They also provide insights into the evolving landscape of healthcare policy and navigating the complexities of ensuring quality care while balancing operational realities in nursing homes. 2024-08-0645 min