Limbic has been selected for the US Food and Drug Administration’s TEMPO pilot, which will evaluate its AI-led mental healthcare service for Medicare patients.

AI-led CBT for Medicare patients

The FDA’s Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot will allow Limbic to introduce Unpacked, a clinician-supervised service delivering cognitive behavioural therapy (CBT) to eligible Medicare beneficiaries with clinically significant depression or anxiety.

The service uses scheduled telephone conversations with an AI voice agent to deliver CBT, with licensed clinicians responsible for supervising each patient’s care.

Limbic said its selection makes it the first AI-led mental healthcare company to participate in the FDA pilot.

The company’s approach combines AI-led sessions with clinical oversight. AI agents conduct scheduled CBT sessions between clinician contacts, while clinicians review patient progress and session content and receive safety alerts.

Clinicians can adjust treatment or take over care when required. Where a patient is assessed as being at immediate risk, the company said clinicians will escalate the situation through established clinical protocols.

Ross Harper, co-founder and CEO of Limbic, said: “We’ve shown that AI can help close this gap, but only if deployed responsibly, with rigorous clinical evidence, clinician oversight, and accountability for patient outcomes.”

FDA and CMS to assess real-world outcomes

Limbic will collect data through the TEMPO pilot on patient outcomes, safety and use of the service. The data will contribute to the FDA’s assessment of how the technology performs in routine healthcare settings.

The announcement also links the programme with the Centers for Medicare & Medicaid Services’ ACCESS payment model, which is designed to support payment based on patient outcomes rather than the volume of services delivered.

Limbic said the combination could provide a route for its clinician-supervised AI model to be evaluated alongside new approaches to healthcare delivery and reimbursement.

The need for additional mental healthcare capacity is particularly relevant to older adults. Limbic cited US Department of Health and Human Services data showing that 73% of providers across Medicare and Medicaid are unable to accept new patients, mainly because their caseloads are full.

Unpacked is intended to provide access to CBT between clinician contacts, while maintaining clinical responsibility for each patient.

Patricia Taylor, licensed clinical psychologist and head of clinical operations at Limbic, said: “This is not AI replacing a therapist.”

Taylor added: “Unpacked is a clinical service, and a clinician remains responsible for every patient.”

The model therefore differs from fully automated mental health tools by placing licensed clinicians in charge of patient care while using AI to conduct scheduled therapeutic interactions.

Through TEMPO, regulators will have an opportunity to gather real-world evidence about the safety, outcomes and use of clinician-supervised AI mental healthcare. For Limbic, the pilot could provide evidence on whether an AI-supported CBT model can expand access to care while maintaining clinical oversight.

The selection comes as regulators and healthcare providers continue to assess how AI-enabled healthcare services can be incorporated into clinical practice while maintaining appropriate safeguards and accountability.