2026-08-27 — CMS is planning a formal launch event for the ACCESS behavioral-health payment model

• STAT’s Health Tech newsletter reported 08-27 that CMS is planning a launch event for ACCESS, the 10-year outcomes-based-payment demonstration whose behavioral-health track already includes Headspace, SonderMind, Concert Health, Mindoula, and April Health/Wysa. ⚠️ The full STAT+ piece is paywalled — WebFetch and a jina.ai reader proxy both returned only the headline and byline (Mario Aguilar), not the article body, so no detail on the event’s date, format, or whether the BH track features in it. Flagged as a real but thin signal — worth a follow-up read via a STAT+ subscription rather than treated as fully verified. (STAT Health Tech, 08-27, paywalled)

2026-08-24 — FDA adds Limbic and SonderMind as the first behavioral-health TEMPO participants, filling the gap this thread flagged open

• The FDA quietly filled the behavioral-health gap in its TEMPO digital-health pilot on 2026-08-24, adding Limbic and SonderMind as the program’s first two behavioral-health participants — resolving the exact open item this thread logged on 08-17 (“Behavioural health is one of four named CMS focus areas with no participant yet”). Limbic’s “Unpacked” is a clinician-supervised AI voice agent that delivers scheduled 20-minute cognitive-behavioral-therapy phone sessions to Medicare beneficiaries with clinically significant depression or anxiety, with licensed clinicians reviewing session content, receiving real-time safety alerts, and able to take over care at their discretion; SonderMind’s is a smartphone anxiety/depression app positioned as an adjunct to therapy or medication, with stated contraindications for suicidality, mania, psychosis, and PTSD. Both can now be marketed to Medicare’s 34 million beneficiaries without prior FDA marketing authorization in exchange for feeding real-world performance data back to regulators, and both connect directly to CMS’s Outcome-Aligned-Payments ACCESS model this thread already tracks — SonderMind was already a named BH-track ACCESS applicant. TEMPO now has four total participants across two of its four focus areas (Cadence and Dexcom on the cardio-metabolic side). This is out of both sweep windows (event predates 2026-09-02 15:00 ET by over a week) but was never caught by this map and directly resolves a stated open watch item, discovered via STAT News’s 2026-09-03 coverage of the pilot’s mechanics. (FDA TEMPO participants page, MedTech Dive, 08-24, Fierce Healthcare, STAT News, 09-03)

2026-08-17 — Second rolling cohort opens; a parallel FDA pathway appears

• CMS’s ACCESS model opened its next participant cohort today, the second rolling start of a 10-year program. The CMS Innovation Center’s model page names 2026-08-17 as a scheduled rolling start, with the next on October 1. A rolling administrative start generates no announcement of its own, so what is confirmed is CMS’s pre-stated schedule standing unrevised — logged as a hit on that basis and no stronger. (CMS Innovation Center)
• A same-day page refresh adds mild corroboration: CMS’s accepted-applicants page now carries a “last updated: August 17, 2026” stamp and lists roughly 280 accepted organizations, up from the 150+ cited earlier — consistent with a cohort actually opening, though still administrative rather than announced. (CMS accepted applicants)
• Separately, the FDA named Cadence as the second participant in its TEMPO pilot, which is coordinated with CMS innovation models and exempts digital health devices from premarket authorisation while they collect real-world data through Medicare. Dexcom was first, 07-23. Behavioural health is one of four named CMS focus areas with no participant yet. ✏️ Superseded 2026-08-24 — Limbic and SonderMind became the first behavioral-health TEMPO participants that day; see the 2026-08-24 entry above (recorded 09-03, ten days late). Worth tracking alongside ACCESS as a second federal route by which behavioural-health technology reaches Medicare beneficiaries. (MedTech Dive)

2026-07-23 — The BH track surfaces

• CMS’s ACCESS Model behavioral-health track surfaced — the 10-year Outcome-Aligned-Payments demonstration launched 07-05; ~85 of 150+ accepted applicants chose the BH track, including Headspace, SonderMind, Concert Health, Mindoula Health, and April Health by Wysa — tying outcomes-based payment directly to multiple watchlist entities at once. (Fierce Healthcare)

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