The Food and Drug Administration (FDA) is tapping Limbic, the maker of an AI-led behavioral health tool, as an early participant in its TEMPO pilot.
The Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot allows the agency to select devices not yet FDA-cleared to participate in the new chronic care Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model. Limbic is among three other companies selected thus far and is the first in the cohort to use an AI-led mental health solution.
In Limbic's new offering, Unpacked, a voice AI agent delivers 20-minute CBT therapy sessions through scheduled phone conversations, with clinician oversight. Those eligible are Medicare beneficiaries with clinically significant depression or anxiety participating in ACCESS.
Through TEMPO, Limbic will gather real-world data on outcomes, safety and how patients use the service, which will help with eventual FDA authorization when it decides to seek it. Participation offers Limbic a way to reach an unprecedented number of patients: 34 million Medicare beneficiaries.
“Existing regulatory frameworks were not written for generative AI in healthcare—they predate that technology,” Ross Harper, co-founder and CEO of Limbic, told Fierce Healthcare. “To unlock value across healthcare with LLMs, but to do so responsibly and safely, the FDA has been looking to partner with selected companies like Limbic and apply something called enforcement discretion.”
CMS’ ACCESS is a newer outcomes-based payment model, in which several behavioral and digital health companies are participating. Because Unpacked is a clinical service, a clinician remains responsible for each patient. Clinicians review each patient’s progress and session content and get real-time safety alerts. They can adjust or take over as needed. The point of the AI-led approach is to expand clinician bandwidth and scale care.
“We are able to massively increase the number of patients that we can support, because we are less scale-limited by clinician supply, but we still keep clinicians in the loop because they are critically important,” Harper said.
The idea behind a voice AI agent is accessibility. “We’re finding some fantastic things with voice. Huge advantages,” Harper said. A lot of digital health is exclusionary, meaning if a patient doesn’t have a mobile app or reliable internet, they can’t use that product. Unpacked is accessible even via a landline or flip phone. Limbic is also waiving all copays for ACCESS Medicare participants.
AI lends itself well to ACCESS participation because the model’s rates are pretty low, Harper said, so companies need to be really innovative with how they scale services. “Almost baked into the payment rate of CMS ACCESS is the idea of using new technologies to drive outcomes at lower costs,” Harper noted. A recent Limbic study found that the same protocols delivered via a voice agent compared to via text actually lead to gains in therapeutic alliance.
Limbic's default voice AI agent is female, though users can change it according to their preference. The company prioritized a voice that is compassionate, engaging and understandable. What sets it apart from other AI tools, per Harper, is that Limbic openly works with regulators to meet the highest care delivery standards. Other AI tools purporting to offer therapy run the risk of regulatory scrutiny. And a number of states are introducing measures meant to curb autonomous AI therapy.
To date, Limbic has been deployed in a dozen U.S. states and in the U.K., supporting 850,000 patients. In the U.S., it supports providers and payers with clinical AI tools like intake, triage, scheduling and in-treatment support. Many patients served have already been Medicare enrollees, which influenced the company’s decision to join ACCESS, and is notable because seniors are under-represented as therapy recipients.
Limbic was the first mental health AI product certified as a Class IIa medical device in the U.K., where it has Limbic Care, a clinical AI companion offering on-demand conversational support and guided CBT interventions.
To participate in ACCESS, Limbic set up its own medical group to become a licensed Medicare provider. It staffs clinicians “to have full care governance for a patient, which means we can then take risk on the outcome,” Harper said. To be selected for TEMPO, Limbic submitted over 100 pages of documentation, including nine peer-reviewed clinical studies and details on its data protection protocols and quality assurance protocols, Harper said.
While CMS ACCESS is a 10-year program, Harper is hopeful that outcomes-based models will stick around, especially given the provider shortages facing the U.S.
“What this is is the very first example of what I hope will be many, where payers are paying for outcomes delivered, not services rendered,” Harper said. “Ten years is too short, and I expect major payers in other segments will adopt a similar model.”