policy
Kennedy hints at breakthrough coverage announcement
Just a few days after CMS proposed repealing a coverage pathway available to FDA breakthrough devices used by hospitals, health Secretary Robert F. Kennedy Jr. told lawmakers the administration had other plans in the offing.
During a hearing of the House Ways & Means Committee, Rep. Blake Moore (R-Utah), co-sponsor of a bill that would offer temporary coverage to breakthrough devices after they receive marketing authorization, asked Kennedy about the administration’s plans to do anything similar with rulemaking. Kennedy responded that an announcement was forthcoming.
The FDA designates investigational medical devices as breakthroughs when it deems that they may provide for more effective treatment or diagnosis of medical conditions and that meet another criteria, such as being especially novel. These products then receive expedited review and communication from the agency. Concerns with paying for breakthrough devices without further review include that designations often come before there's significant clinical evidence about a device and that FDA does not assess whether devices are cost effective.
Moore said his bill, the Ensuring Patient Access to Critical Breakthrough Products Act, was the “brainchild of Trump’s first administration,” which created a temporary coverage pathway for breakthrough devices after approval. The Biden Administration promptly repealed the rule.
“If a treatment can meet the FDA's burden of proof of safe and effective and other requirements for breakthrough designation, there's no reason Medicare shouldn't be able to provide temporary medical coverage while CMS completes its review for permanent coverage,” said Moore.
Kennedy went on to say he agreed with the policy idea, particularly if “it’s a temporary payment that can be revoked.” He added: “As you know with many medical devices, we find problems with them later.”
This tidbit, along with much more analysis, was included in my colleagues' excellent coverage of Kennedy’s testimony last week.
Artificial intelligence
Odd results in a mental health chatbot RCT
Newly published results of a study appear to show great promise for a chatbot in helping people with their mental health. But digging beneath the surface, there are unusual results which raise questions about the quality of the work.
Researchers in Israel randomized nearly 1,000 university students reporting psychological distress to three groups: One received a chatbot that delivers psychological support from a startup called Kai; one was assigned to 12 weeks of face-to-face group therapy; and one was placed on a waitlist. The AI app swept the field with participants showing improvements in measures of anxiety, well-being, and life satisfaction. Improvements in depression in the AI group did not meet the bar for statistical significance compared to those who received group therapy.
A randomized control trial of a mental health chatbot? I love to see it. On its surface, the study design looks pretty good, especially the use of an active therapy control that helps account for placebo effects.
The biggest issue said John Torous, director of digital psychiatry at Beth Israel Deaconess Medical Center, is that the face-to-face therapy group saw anxiety worsen during treatment period of the study. “Any treatment will beat something that makes people worse,” he told me.
Methodological sticklers would also prefer that the Kai app be compared to some kind of sham app or digital control. Apps are very engaging and can have a treatment effect even when they don’t have any therapeutic content. If you want to prove your app has a treatment effect, it’s better to compare it to another app.
Lead author Anat Shoshani, a professor at Reichman University, declined to comment. Kai CEO Alex Frankel pointed to another study of the company’s technology in the United States.
Policy
ACCESS takes and questions
I've been having some interesting conversations about the Medicare innovation center's ACCESS Model since I wrote about the experiment in tech-enabled care last week. If your health system or practice is thinking about how to partner with participants — or would never consider it — I want to hear from you.
Among the many thoughtful articles written about the model, I appreciated this nice analysis from Kevin O'Leary at Health Tech Nerds, which found that of the 68 companies CMS indicated had expressed interest in participating after the initial announcement, just 22 are currently on the approved list. He says this divide is emblematic of a "staring contest" between CMMI and digital health companies, many of which find the model's current payment rates "unworkable."
Much has been made of the lack of prominent chronic disease players like Omada, Sword Health, Hinge Health, and so on. O'Leary points out in particular that the venture-backed digital health community doesn't seem interested.
The companies I've spoken to that embraced ACCESS did so because the model plays to their strengths or encourages them to lean into automation they were going to develop anyway. On the other hand, for venture-backed companies with different plans and limited funding, it would be a lot for them to steer the ship in a new direction with an uncertain promise. Given CMS extended the deadline to apply for the first cohort to May 15, it'll be interesting to see who else jumps in.
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