ARTICLE SUMMARY:
FDA’s device center is now represented on key billing code and payment committees as part of CDRH’s efforts to ensure more companies are actively preparing for reimbursement challenges alongside their regulatory work. We spoke to CDRH Deputy Director Doug Kelly about his push to bridge gaps and find a common language between medtech regulatory and reimbursement silos in the context of the center’s evolving TAP pilot.
FDA has been deepening its level of engagement in medtech reimbursement matters and Doug Kelly, MD, is at the center of that action.
One notable recent development: the CDRH deputy director of science has signed on to fill newly established (nonvoting) FDA liaison roles on two of the most influential groups in the US reimbursement system: the CPT Editorial Panel, which establishes the codes that underlie most healthcare billing, and the RVS Update Committee (RUC), which assigns resources to physician activities that serve as the basis for Medicare payment rates. Kelly has already attended several CPT panel meetings in this capacity, and he plans to represent FDA for the first time at a RUC meeting this fall. (See box, “The Basics on CPT and RUC.”) 
“We're there to look at what CPT does, help them with their process, and help them understand FDA’s process,” Kelly told Market Pathways in a recent interview. In addition, he can bring back from the panels lessons learned and relationships gained to inform the advice FDA gives to device companies. This is particularly relevant in the context of CDRH’s TPLC Advisory Program pilot, in which select device companies are encouraged to look to FDA not simply as a regulatory gatekeeper but as an advisor to help clear post-FDA market access hurdles, including reimbursement. (See “FDA as Consultant and Confidante? Talking TAP With CDRH’s AJ Baumel,” Market Pathways, December 7, 2023.)
