192 Cleared Devices, Barely Any Revenue: Can FDA's TEMPO Pilot Fix Digital Therapeutics' Business Model?
The FDA-CMS pilot lets prescribers administer DTx products before clearance, with real-world data feeding both the clearance decision and Medicare coverage. Early DMHT billing shows demand — 446 patients in Q3 2025, up from 99 in Q1.
Digital therapeutics has never had a clearance problem — it has a payment problem. There were 192 FDA-cleared DTx devices as of December 2024, yet the category's most famous company went bankrupt and others abandoned the prescription model entirely. The FDA's TEMPO pilot, run in coordination with CMS, is the most serious attempt yet to fix the underlying economics.
TEMPO — Technology-Enabled Meaningful Patient Outcomes — lets prescribers within CMS's ACCESS model administer digital therapeutics before FDA clearance, with real-world data from that use feeding the eventual clearance decision. Announced in December 2025 with statements of interest collected from January 2026, the pilot named Dexcom as its first participant in July.
The reimbursement scaffolding is forming
Medicare began paying for digital mental health treatment (DMHT) devices in 2025 through new billing codes; seven DMHT devices are currently Medicare-eligible. Utilization grew from 99 patients across 184 visits in Q1 2025 to 446 patients across 897 visits through Q3 — genuine growth on a very small base.
The pilot is pitched as a middle ground between unregulated app-store wellness products and full FDA clearance, testing whether outcome-linked payment can rescue a category with strong evidence and weak economics. After Pear's bankruptcy and Akili's retreat from the prescription model, TEMPO may be less a pilot than a last, best experiment.
Reporting: Healthcare Brew; FDA TEMPO announcements.
Source
Original reporting: Healthcare Brew ↗