Cleared is not covered: what payers ask of new medical technologies

FDA clearance or approval opens the door to the US market, but it does not decide whether anyone pays for a product. Payers ask different questions: is it better than what they already cover, for which patients, and at what cost? Many promising products stall at this second gate, often because the studies that satisfied the FDA do not answer what payers need to know.Hartmut Drommershausen, a DrPH student at the UNC Gillings School of Global Public Health who advises medical device manufacturers in the US and Europe on market access and reimbursement, walks through the three gates every new product passes: FDA, coverage, and coding and payment. Using public US cases, from continuous glucose monitors to ultrasound wound therapy, he focuses on what teams can build into their studies now, while the evidence plan can still change. In the days after the session, teams can book a short one-on-one conversation about their own product.Who should attend: faculty inventors, startup teams and innovation fellows working on medical devices, diagnostics or drug-device combination products. No prior knowledge of reimbursement is needed.

About the speaker:

Hartmut Drommershausen is a DrPH student at the UNC Gillings School of Global Public Health and the founder of healthcare SOLUTIONS Drommershausen, an independent market access practice based in Cologne, Germany, and Orlando, Florida. He previously led market access at Théa, Alcon, Glaukos, Medtronic and Smith & Nephew, and was part of the M&A team at Alcon. He now advises medical device manufacturers in the US and Europe on market access, pricing and reimbursement. His dissertation research looks at the gap between the evidence the FDA requires for Class II medical devices and the evidence CMS needs to cover and pay for them.