Issue 149

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 in FDA-regulated and pharma-focused digital health:

• Last week in Issue 148, I used one of the bonuses that Pear Therapeutics’ board awarded to executives as a way to gauge how happy the board was with the company’s overall performance. One reader pointed out that for Pear, the denominator I used was a “target bonus” and not a maximum bonus, which is what I assumed it was. While companies may differ on how they define “target” bonuses, this is often the number close to the midpoint in the defined bonus range. So, I perhaps wrongly concluded that Pear’s board gave its corporate performance an “A-” in 2021 because the bonus came in just under the target. However, if the target was already the midpoint, this reader suggested the board was sending executives the message that 2021 was more like a “C-” year.
• Speaking of Pear, the state of Minnesota is considering a bill that would award more than $8 million for a pilot that would likely benefit the company: “The commissioner of human services shall allocate $8,091,000 in round three of the federal opioid response grant program to be used to establish a pilot program to explore the effectiveness of using FDA authorized prescription digital therapeutics for the treatment of substance use disorders within the medical assistance program. …The clinic or practice site must be capable of incorporating in the pilot program a minimum of 1,000 patients enrolled in medical assistance who represent different demographics and who are receiving or are eligible to receive substance use disorder services, including treatment with medication or behavioral health services, or both.”
• Last week I reported that GAIA had terminated its clinical trial for Optimune because of enrollment problems stemming from the pandemic. The company wrote in to let me know it is set to kick off a new version of that trial with recruitment to begin this month. This one will not require any in-person, on-site visits but will rather be entirely online.
• The FDA granted Breakthrough Device Designation to Wysa for its “digital mental health conversational agent for patients 18 years and older with a diagnosis of chronic musculoskeletal pain (defined as pain lasting longer than three months) and depression and anxiety.”
• Blue Note Therapeutics inked a licensing deal with South Korea-based pharma and digital therapeutics company Bixink Therapeutics. Bixink’s first digital therapeutic is a CBT-based therapy for OCD called OCfree that it hopes to get through the FDA in 2025. Its deal with Blue Note includes licensing and commercializing Blue Note’s cancer-focused digital therapeutics, attune and DreAMLand, for the South Korean market.
• In related pharma partnerships for cancer-focused digital health: Elekta-owned Kaiku and Roche expanded on their years-long partnership this week. “We have already developed therapy and product-specific modules in cancer immunotherapy and other targeted therapies. Now we are excited to take our partnership further and to expand the reach of digital patient monitoring and management in terms of geography and across new therapies and cancer types for a growing number of patients.” It’s a little vague but there are a few more details in the announcement linked above.
• Speaking of vague on details: The FDA granted Nuvo a second 510(k) for its INVU wearable — a “maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), maternal heart rate (MHR) and Uterine Activity (UA).” The agency hasn’t published a summary document yet and the company hasn’t mentioned the new clearance, so we’ll have to hold tight to see how the IFU changes.
• One more thing: Not news but interesting to hear that CDRH Director Jeff Shuren told attendees at an event earlier this week that the FDA needs action from Congress before it can move forward on programs like Pre-Cert. “We can’t move to really more modern regulatory frameworks without changes in federal law. And we know that for these kinds of technologies – software as a medical device – the regulatory frameworks of today were designed yesterday, when Congress was not thinking of software-based devices…” Current regulatory pathways aren’t “fit for purpose for modern-day software-based technologies.” Article (sub. req.)

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Akili asks CMS for a HCPCS Level II code for EndeavorRx, while Pear asks for reimbursement like DME

According to recent updates to the agenda of CMS’ HCPCS meeting coming up in June, Akili applied for a new Level II HCPCS billing code for EndeavorRx, but CMS told it to just use the one it created when Pear ask last year. Here’s what Akili wanted its unique code for:

Like Pear’s three HCPCS applications for its PDTs back in December 2021 (Issue 130), Akili’s language is tailored to its product. No other digital therapeutic would fit into that category alongside EndeavorRx if CMS agreed to create a code using the words Akili suggested. As I wrote above, in response to Pear’s three 2021 requests, however, CMS created a catch-all Level II HCPCS billing code — A9291 — for “Prescription digital behavioral therapy, FDA cleared, per course of treatment.”

Similarly, CMS’ initial response to Akili is that it should use A9291 too. However, CMS will make a final determination following the meeting in June.

Did Akili really think CMS would create a unique code for its product after creating a catch-all category for Pear? Did the company just need it in writing that A9291 was the appropriate code to use? Was this more about continuing to raise awareness at CMS about digital therapeutics? Or did Akili already have this in the works before Pear got its answer, so it sent it in anyway?

Whatever the reason, Akili now has a go-ahead (at least preliminarily) that it can instruct providers and payers to use A9291 to bill and cover EndeavorRx through a plan’s medical benefit.

To be clear, this code doesn’t open up reimbursement from CMS, but it makes it easier for private payers to process billing for EndeavorRx as a medical benefit vs. the pharmacy benefit that Akili has mostly relied on to date.

Here’s a relevant section from Akili’s HCPCS application to CMS:

Can software be durable medical equipment?

Meanwhile, Pear Therapeutics’ asked CMS for a “Medicare Benefit Category and Payment Determination for reSET, reSET-O, and Somryst” now that the company has its Level II code, A9291, which went into effect on April Fool’s Day. According to the CMS application, Pear requested that its PDTs fall into the DME Medicare Benefit Category. In its preliminary determination, CMS rejected that request:

We’ll see if Pear manages to change CMS’ mind at the meeting in June, but that seems unlikely.

Remember: Establishing a new Medicare Benefit Category for prescription digital therapeutics would require an act of Congress. The Access to Prescription Digital Therapeutics bill floating around Congress right now aims to do that (Issue 140).

Clinical trial updates from Omada, Sanvello, Mayo, Woebot, and NightWare

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.

Mayo Clinic and Ellipsis Health study voice biomarkers for depression and anxiety in heart patients

Here’s a new and interesting 200-person trial that pairs up the Mayo Clinic with voice biomarker company Ellipsis Health:

Omada, Evidation, and Abbott study what adding a CGM does for Omada’s diabetes management program

It’s been a while since I’ve seen a new clinical trial from Omada Health:

Omada terminates Sutter Health and Palo Alto Medical Foundation study after low enrollment

Meanwhile, Omada officially shut down one of its clinical trials from last year presumably because of enrollment problems owing to the pandemic. The official line from the company: “Enrolling by invitation Terminated [Study terminated prematurely due to operational futility.]” It managed to enroll 27 of the hoped-for 250 participants.

Woebot is set to kick off next W-GenZD study on teen depression and anxiety

After finishing its first W-GenZD study last summer, Woebot is gearing up for a new clinical trial focused on teen depression and anxiety:

UnitedHealth-owned Sanvello posts first details on already completed mental health coaching trial

Here’s an odd one: Sanvello, which UnitedHealth Group acquired back when it was called Pacifica a few years back, just posted a clinical trial with 4,607 participants that actually already finished up (no results posted yet):

NightWare trial pits the digital therapeutic up against a sham to test efficacy in heart patients

Lots of details in the write-up for this 50-participant clinical trial: “Accordingly, the investigators are proposing a randomized, double-blind, placebo (i.e., sham intervention) controlled parallel pilot study that will provide the first clinical evidence for the efficacy of the NightWare digital therapeutic system to improve cardiovascular health outcomes in adults with PTSD-related nightmares.”

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