FDA Initiates TEMPO Pilot with Dexcom for Digital Health Devices

The U.S. Food and Drug Administration (FDA) has recently made a significant move toward enhancing chronic disease management by selecting Dexcom, Inc. as the inaugural participant in its Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot program. Announced on July 22, 2026, this pilot is not just a key milestone for the FDA, but it also signifies a collaborative effort with the Centers for Medicare & Medicaid Services (CMS) and its Innovation Center. The primary aim is to generate real-world evidence supporting the integration of digital health devices into Medicare-covered care, particularly for those suffering from chronic diseases.

The TEMPO pilot initiative aligns with the ACCESS Model by advancing the use of technology to improve health outcomes for millions of Americans with chronic conditions. As stated by Dr. Michelle Tarver, Director of the Center for Devices and Radiological Health, "For the millions of Americans living with chronic conditions, access to the right technology at the right time can be life-changing." This pilot aims to collect real-world data (RWD) that will substantiate the effectiveness of new technologies within real-world settings, crucial for regulatory assessment and future reimbursement pathways under Medicare.

At the core of the TEMPO pilot is the Dexcom Glucose Health Program, which is designed to monitor glucose levels and provide tailored guidance to both patients and healthcare providers. This program will be evaluated during the pilot to determine its effectiveness in improving metabolic and nutritional status, which is vital for addressing conditions such as prediabetes and type 2 diabetes. The expected results are not only to improve glycemic control but also to enhance patient engagement through real-time data and insights drawn from artificial intelligence (AI), enabling informed decision-making.

With the FDA and CMS working together on this initiative, contractors specializing in digital health technologies, healthcare data analytics, and evidence generation can expect emerging procurement opportunities. Vendors engaged in supporting chronic disease management solutions will find potential contracts arising from the need for innovative healthcare delivery models. As highlighted by CMS Deputy Administrator Abe Sutton, the pilot represents a step towards modernizing how technology is integrated into Medicare, ensuring a clear payment pathway that rewards improvements in patient health outcomes.

Participants in the TEMPO pilot will be tasked with collecting, monitoring, and reporting real-world data relevant to their devices' intended uses for improving patient outcomes. This initiative will not only help evaluate the performance of digital health technologies but will also contribute to a burgeoning sector focused on integrating these innovations into comprehensive healthcare services. Contractors interested in these developments should prepare for increasing competition and collaboration in the healthcare technology field, particularly as the FDA plans to select up to ten participants within each of the four ACCESS model clinical use areas.

Furthermore, engagement in this pilot could position vendors favorably for future federal procurements related to healthcare modernization and Medicare service enhancements. This evolving landscape underscores the importance of staying attuned to federal procurement trends surrounding digital health initiatives and exploring ways to leverage these opportunities effectively.