Issue 166

Welcome back to E&O Fridays, a paying subscribers-only weekly newsletter focused on the world of digital pharma products and FDA-regulated digital health.

 E&O Fridays.

Here’s what’s going on this week in FDA-regulated and pharma-focused digital health…

• Earlier this month, the FDA and its counterparts in Canada suggested to The International Medical Device Regulators Forum (IMDRF) that the group’s work on Software as a Medical Device (SaMD) regulations from 2013-2017 could use a few updates. Here are the areas the FDA said the international group should update: “Goal: To refine the previously published SaMD documents to improve international alignment and ensure ongoing consistency, predictability, and transparency by considering improvements to existing documents related to: The granularity of the risk categorization matrix (N12); The location of where the software may be running (N10); Other improvements as identified by survey results.” In addition to suggestions about updating existing frameworks, the FDA also pointed out areas where the consortium could create new ones: “Harmonized SaMD labeling; Harmonized guidance for post-market SaMD activities; Alignment and coordination with other IMDRF WGs and technical documents (e.g. AI, Cybersecurity).”
• The FDA cleared Neuro-Eye Diagnostic Systems’ smartphone app-based vision test, EyeQTester, via a recent 510(k). The FDA-cleared test is classified as a Digital Amsler Grid app so it likely won an indication for use focused on diagnosing or detecting age-related macular degeneration or other eye diseases. While the summary document from the FDA is not yet public, details on the company’s clinical trial, which the FDA reviewed as part of the clearance process, are available here.
• News you know: This week Evernorth added a handful of digital health programs to its “digital health formulary”. The new additions include Big Health’s Sleepio (insomnia) and Daylight (anxiety); Quit Genius’ alcohol use disorder and opioid use disorder programs; HealthBeacon’s Injectable Care Management System for inflammatory conditions. Evernorth also started pilots with Jasper Health (oncology), Zerigo (psoriasis and eczema), Hinge Health (women’s pelvic health), and Lid Sync (medication treatment adherence).
• One more thing… Medical device company Masimo, which develops non-invasive patient monitoring devices, has filed a lawsuit against Pear Therapeutics that alleges trademark infringement. Masimo claims that Pear’s “reSET” and “reSET-O” brands are infringing on its own set of products that use the brand name “SET”.

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New study suggests Big Health will submit Sleepio to the FDA for 510(k) OK as insomnia treatment

This week Big Health posted a clinical trial for its flagship digital therapeutic Sleepio that suggests the company has finally decided to submit Sleepio to the FDA for a 510(k) clearance. Sleepio generally matches the description of the intervention in the study but the researchers don’t use the Sleepio name in the study description at all.

First, some background: While Big Health has convinced PBMs to pay for its digital therapeutics through the pharmacy benefits channel and Sleepio and Daylight have been used in more clinical trials than the average digital therapeutic, Big Health has managed to steer clear of seeking out FDA clearances for either product. (Big’s traction serves as a strong counterpoint to the go-to-market strategy of many prescription digital therapeutics companies.)

As a result, Big Health has historically tacked on caveats to its marketing materials that make clear it is not making treatment claims about insomnia, general anxiety disorder, or major depressive disorder.

More recently, however, Big has marketed its digital therapeutics with more specific treatment claims for those disorders while citing the FDA’s COVID pandemic enforcement discretion for Psychiatric Digital Health Devices. Big Health can either pursue FDA market authorization now so that it can continue to make these claims once the Public Health Emergency is officially over, or it could decide to stop making those treatment claims and go back to the same positioning it used prior to the pandemic.

Back to the study: So, this week Big Health posted details of a new study that it is sponsoring and conducting with collaborator UCSF. It’s name is “Clinical Effectiveness of Digital CBT-I for the Treatment of Insomnia Disorder: A Randomized Controlled Trial” or “Digital CBT-I for Insomnia Disorder” aka “CrEDIT” for short. The CrEDIT study looks to be a step towards an FDA submission for Sleepio:

The (anticipated) 332-participant study is set to begin next month and should finish in October 2023.

Unlike Big Health’s previous studies (where it was the sponsor or named collaborator), for the CrEDIT study, the researchers ticked the box that indicated Sleepio is regulated by the FDA but not yet cleared.

I can’t find a previous study that answered the question that way: They all listed Sleepio as a device that was not regulated by the FDA.

Much ado about nothing? The counter-argument here might be that Big Health is acknowledging its recent dealings with the FDA because of the PHE enforcement discretion policy. So, maybe that’s why it ticked those FDA-regulated boxes?

However, Big has posted other clinical trials during the pandemic, and this new study remains the first to describe Sleepio as an as-yet-uncleared, FDA-regulated medical device.

Updates on AMA’s new CPT billing code meeting from earlier this month: More withdrawals

The American Medical Association’s Editorial Panel met earlier this month to decide the fate of a new crop of CPT billing codes, which included about a half dozen related to digital health services. (E&O wrote up the initial line-up back in July in Issue 159.)

While the panel’s actions won’t be released for another few weeks, a recent update the event’s agenda showed that the applicants behind a number of the digital health billing codes withdrew the application just before the meeting started. This is the common practice when the chances of getting a positive vote are slim or the application might be strengthened by combining forces with other applicants. Anyway, it does tell us which of the codes I wrote about in Issue 159 won’t be heading to CMS any time soon.

Here’s the update:

These codes did go to a vote, but we don’t know the outcome yet

The two new Remote Therapeutic Monitoring (RTM) code applicants that I mentioned in July did go to a vote during the meeting, so we don’t know either way yet if these made it through. As I wrote in July:

The other digital health-related codes that went to a vote at the meeting were:

• Virtual Reality (VR) Facilitated MotorCognitive Training — Establish code X092T to report semi-immersive VR motor-cognitive training
• Cat III – Psychedelic Drug Monitoring Services — Establish codes X088T, X089T, X090T, X091T for reporting psychedelic drug monitoring services; and create a new subheading “Continuous Therapeutic Monitoring, Assessment and Intervention for Psychedelic Medication” with guidelines
• AI-Assisted Oncologic Treatment — Establish code X093T to report augmentative intelligence identification of personalized oncologic treatment

Withdrawn pre-meeting: Remote Uroflowmetry Testing, AI-powered Motion Analysis, Telemedicine Modifier for Text-based check-ins These code applicants did not go to a vote because they were withdrawn prior to the official start of the AMA Editorial Panel meeting at the beginning of the month:

• Remote Uroflowmetry Testing — Establish codes 9X040, 9X041 to report remote multi-day comprehensive uroflowmetry
• Full Body Markerless Motion Analysis with AI Processing — Establish code 9X039 to report full body computer-based markerless 3D kinematic and kinetic motion capture with assistive AI processing; and delete code 0693T
• Finally, this isn’t a request for a new code but rather a modifier to make it clear via the billing record when a telemedicine session was via text message instead of video call or audio call. Telemedicine Modifier: Establish a modifier to identify when a text message is the form of communication during virtual check-in visits

We should know more in the coming weeks.

Clinical trial updates: Three Pear studies, Blue Note terminates study, and Apple-Janssen pushed back

This is a recurring feature of E&O Fridays that digs into new digital health-related clinical trials as well as updates to others E&O mentioned in previous issues.

Pear finishes recruitment for its game-based variant of reSET-O codenamed PEAR-008

Pear has completed recruitment for the study, which initially anticipated 130 participants. Researchers managed to recruit 52:

Meanwhile, Pear’s real-world chronic insomnia study for Somryst has enrolled more than 1,500 participants

Pear’s study aimed to bring in 1,500 participants but managed to enroll 1,590 instead. Brief description below and more details here:

Finally, Pear’s study with Yale and Mayo on a Fitbit-Somryst combo offering has moved its finish date from this October to next June

Well, there were a surprising number of updates Pear’s various studies this week. Here’s the third and final one: Its Fitbit-Somryst study has been delayed as noted in the headline above:

Terminated: Blue Note Therapeutics’ study comparing the effectiveness of two of its digital therapeutics for people with cancer, attune and cerena

Blue Note hoped to enroll up to 551 people with stage I-III breast cancer or stage I-III NSCLC, but the company terminated the study after only enrolling 31 participants. More:

Otsuka and Click Therapeutics’ comparative trial of two digital therapeutics for major depressive disorder (MDD) has finished recruiting

The companies originally hoped to enroll about 360 participants but did not update that figure with an actual number of enrollees yet. More on the study here:

The Akili effect? Mentia DTx updates its study’s description to reveal its cognitive therapeutic is a video game

In a collaborative study with the NIH’s National Institute on Aging (NIA), Mentia DTx just revealed that its digital therapeutic for Alzheimer’s disease (and its related dementias) is a videogame. The study is now enrolling by invitation. Previously, this study’s description just referred to the intervention as a “technology-based program”. The company changed that one word so it now reads like so:

Pushed back: Apple and J&J study exploring the Apple Watch for atrial fibrillation detection, medication adherence, and stroke prevention just got pushed back another month

I don’t typically mention if a study is delayed by a single month, but the Apple-Janssen Heartline study has a lot of eyes on it, so I figured I’d mention it. Previously, this study was set to finish up at the end of September 2025, but it now looks to finish up at the end of October 2025. More details:

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