Limbic joins FDA TEMPO pilot to test phone-based voice AI CBT with Medicare ACCESS enrollees

# What happened Limbic was selected to participate in the FDA's TEMPO pilot to test its Unpacked voice AI therapy within the Centers for Medicare & Medicaid Services' ACCESS model. TEMPO (Technology-Enabled Meaningful Patient Outcomes) lets the FDA gather real-world data on devices not yet cleared when they are used under ACCESS, a 10-year outcomes-based chronic care payment model.

# What Unpacked does

# Why TEMPO + ACCESS matters for Limbic Under TEMPO, Limbic will collect real-world data on outcomes, safety and patterns of use among Medicare ACCESS enrollees with clinically significant depression or anxiety. That evidence is intended to support a later FDA authorization application if Limbic chooses to pursue one. ACCESS's payment model emphasizes outcomes at scale and has relatively low per-member rates, which Limbic says encourages using technology to expand care efficiently.

# Accessibility and payment details Limbic is waiving copays for ACCESS Medicare participants. The voice format addresses gaps where app- or internet-based digital health tools exclude patients who lack devices or connectivity. Limbic reports prior internal findings that voice delivery of the same protocols can improve therapeutic alliance compared with text delivery.

# Clinical governance and regulatory preparation To participate in ACCESS, Limbic created its own medical group to act as a licensed Medicare provider and to hold clinical governance so it can accept risk for outcomes. For TEMPO selection, Limbic submitted over 100 pages of documentation including nine peer-reviewed clinical studies as well as details on data protection and quality assurance. The company also notes prior regulatory progress: Limbic's mental health product was the first in the U.K. certified as a Class IIa medical device.

# Scale and deployment so far Limbic says its tools have been deployed across a dozen U.S. states and in the U.K., supporting about 850,000 patients. Participation in ACCESS could expose the service to up to 34 million Medicare beneficiaries who are eligible for the model.

# in practice Unpacked's AI-led sessions expand clinician bandwidth by handling routine interactions while keeping clinicians in the loop for oversight and escalation. Clinician review, real-time safety alerts and the ability for clinicians to take over care are core safeguards described by the company.

# What this will produce TEMPO participation will generate real-world evidence on effectiveness, safety and usage patterns in an older Medicare population that has historically been under-represented in therapy. That evidence can inform future regulatory filings and broader deployment decisions.

# Bottom line Limbic's selection for the FDA TEMPO pilot embeds a voice-first, clinician-supervised AI CBT service into CMS' ACCESS model to test how the approach performs for Medicare beneficiaries. The company is collecting structured clinical and operational data to support potential future FDA authorization while offering a telephone-accessible therapy option with waived copays for ACCESS participants.