Working to Accelerate Medical Device and Diagnostic Reimbursement Timelines
Receiving authorization from the U.S. Food and Drug Administration (FDA) and securing nominal reimbursement coverage are two critical milestones that novel medical technologies must meet to scale market adoption and attract follow-on investment—but the process can take several years.
With innovative medical technologies likely to emerge from several of its active programs and small business awards, the Advanced Research Projects Agency for Health (ARPA-H) wants to understand better the typical pathways, exemplars, and specific challenges facing novel medical devices and diagnostics seeking reimbursement. This understanding will help inform how the agency could build on existing approaches in the public and private sectors and identify opportunities to deploy new capabilities to help accelerate reimbursement timelines and improve patient care.
The Investor Catalyst Hub is supporting this effort by issuing a network survey to gather feedback from medical technology developers, manufacturers, payors, healthcare providers, and other reimbursement stakeholders.
ARPA-H funds its programs for 2-5 years with a focus on the riskiest elements of technical development, so its funding recipients must have a commercially viable path beyond the agency’s funding to optimize taxpayer resources and deliver health impact. The agency’s goal is to reduce the median reimbursement approval gap for agency-funded efforts from nearly six years to two years through this effort.
There are existing mechanisms across the federal government that aim to shorten the reimbursement approval gap, like the FDA’s Total Project Life Cycle Advisory Program (TAP) and the Centers for Medicare & Medicaid Services (CMS)’ Transitional Coverage for Emerging Technologies (TCET). While ARPA-H coordinates with these partners on transition, the agency plays a different role from the FDA and CMS and is uniquely positioned to deploy resources to expedite reimbursement.
If you have valuable insights to share about ways to improve the reimbursement process, please complete the network survey by Friday, February 21, 2025. This survey does not focus on policy feedback.
If you’d like additional information before sharing your feedback, please register for an upcoming information session on Friday, January 17, 2025 at 1:30 p.m. ET. ARPA-H’s Project Accelerator Transition Innovation Office Scientific Operations Advisor, Arunan Skandarajah, Ph.D. will highlight the purpose and goals of the network survey and share important deadlines. Time will be reserved for Q&A.
Sign up here to stay updated on the progress of this network survey and to be notified when the final report is published.