Episode 125 – Drug Pricing and Market Access: The RAPID Pathway

The Centers for Medicare & Medicaid Services (CMS) proposed the Regulatory Alignment for Predictable and Immediate Device (RAPID) pathway to coordinate FDA device approval and Medicare coverage decisions under one coordinated process from the start — aiming to shrink a historically five-year gap to as few as 60-90 days. In this episode of Connected With Latham, Washington, D.C. partners Chris Schott and Nate Beaton, along with associate Danny Machado, break down how RAPID works, how it differs from prior coverage initiatives, and what device manufacturers should consider as the pathway takes shape.   Also check out our bi-weekly Drug Pricing Digest on the website or subscribe to receive future editions in your inbox.   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