Tom Hughes is the Senior Principal Advisor in Healthcare Economics and Reimbursement at inc.com/">Regulatory and Clinical Research Institute, Inc. He holds a J.D. from William Mitchell College of Law, and an undergraduate degree from the University of Minnesota-Twin Cities. Top 3 Takeaways * The three legs of the reimbursement stool are coding, coverage, and payment. When figuring out reimbursement, it’s important to consider details like the site of care. Obtaining reimbursement requires showing evidence that your device is medically necessary. Show Notes * [1:20] Tom’s winding background. * [3:00] What is reimbursement? * [5:10] Tom’s process for introducing a company to reimbursement consulting. * [7:40] What happens if there isn’t a code for a new device? * [9:00] Evidence development. * [9:47] Reimbursement evidence vs. clinical trial evidence. * [11:10] How to demonstrate medical necessity. * [12:15] Where are startups weakest regarding reimbursement? * [14:00] The integration of regulatory and reimbursement. * [15:20] When to begin thinking about reimbursement. * [16:45] Payment vs. coding. * [19:30] Cash pay. * [20:50] Biggest reimbursement mistakes companies make. * [21:10] You should figure out what payor think. Selected Links * Overview of CPT coding * HCPCS codes Related Podcasts * 020 – Mary Beth Henderson * 017 – Ana Maiques * 013 – Ladan Jiracek, Manfred Franke, and Doug Clinton Disclaimer: We actively write about the themes in which we invest: artificial intelligence, robotics, virtual reality, and augmented reality. From time to time, we will write about companies that are in our portfolio. Content on this site including opinions on specific themes in technology, market estimates, and estimates and commentary regarding publicly traded or private companies is not intended for use in making investment decisions. We hold no obligation to update any of our projections. We express no warranties about any estimates or opinions we make.