ACCESS + TEMPO creates a practical bridge among payment, regulatory oversight, real-world evidence, and technology-supported chronic care.

Provenance

First verified

2026-08-08

CMS ACCESS accepted-applicants source updated

2026-08-17

FDA TEMPO maintained participant table updated

2026-08-21

Revision state

Version 1.1 adds the exact FDA effectiveness limitation and explicit dual CMS/FDA source provenance, and corrects the stored fingerprint; the inference itself is unchanged.

Last verified

2026-09-03

Status

Current

Freshness

Current

Version

1.1

Fingerprint

8229a94ead00ee21

Change sensitivity

High

Evidence limits

This is a P4L inference from separate CMS and FDA sources. ACCESS status, TEMPO participation, clinical effectiveness, coverage, and scaled adoption remain distinct questions. FDA states that effectiveness for the participating intended uses has not yet been evaluated.

Primary sources

• https://www.cms.gov/priorities/innovation/innovation-models/access
• https://www.fda.gov/medical-devices/digital-health-center-excellence/participants-selected-tempo-digital-health-devices-pilot

Related signals

• SIG-2026-001 — FDA TEMPO selects Dexcom as first participant linked to CMS ACCESS
• SIG-2026-003 — CMS says more than 150 organizations accepted for ACCESS launch
• SIG-2026-004 — ACCESS operational model links outcome-aligned payment, care updates, and future structured data exchange
• SIG-2026-002 — FDA TEMPO participant-table observation — August 11, 2026
• SIG-2026-027 — FDA TEMPO maintained participant table lists four participants