FDA Selects Dexcom for TEMPO Pilot, Skipping Premarket Review
The FDA has chosen Dexcom as its first participant in the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot program. This initiative allows digital health manufacturers to offer their devices to Medicare patients prior to formal FDA approval, provided they collect and share real-world data on device performance.
DEXCOM’S OFFER:
The Dexcom Glucose Health Program focuses on two clinical areas within the CMS ACCESS model: monitoring metabolic and nutritional status and providing tailored guidance and AI insights for behavioral changes. The program aims to assist in prediabetes and type 2 diabetes screening, potentially improving glycaemic control in those with prediabetes.
TEMPO AND ACCESS:
The TEMPO pilot operates alongside the CMS ACCESS payment model, which encourages outcome-aligned payments for healthcare organizations managing chronic conditions like hypertension, diabetes, chronic musculoskeletal pain, and depression.
A SIDE DOOR WITH CONDITIONS:
While praised as a potential game-changer for digital health, some legal experts have questioned the TEMPO arrangement, characterizing it as a "side door" that may permit commercial use of products without full FDA scrutiny. Concerns remain about oversight and data privacy within this new framework.