FDA TEMPO selects Dexcom as first participant linked to CMS ACCESS

Why it matters

This creates an unusually direct bridge among regulatory flexibility, real-world evidence generation, Medicare payment, chronic-disease care, and digital-health adoption.

Decision implication

Digital-health companies should evaluate whether product evidence, use case, outcome measures, and care model can align with ACCESS/TEMPO-style pathways.

Who or what is affected

FDA
CMS Innovation Center
Dexcom
ACCESS participants
clinicians
Medicare beneficiaries

Evidence and sources

E5 — official federal source

https://www.fda.gov/news-events/press-announcements/fda-announces-first-participant-selected-tempo-digital-health-devices-pilot

P4L distinguishes the sourced event from the interpretation above. Participation, funding, proposed policy, or program inclusion does not by itself establish clinical effectiveness.

What P4L is watching next

Additional TEMPO participants
RWD requirements
implementation experience
ACCESS outcomes.

Related proof records

CLM-0003 — FDA's TEMPO participant table lists Cadence Solutions' HypertensionOS and Dexcom's Glucose Health Program.
CLM-0004 — ACCESS + TEMPO creates a practical bridge among payment, regulatory oversight, real-world evidence, and technology-supported chronic care.