Issue 104
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.
OK, here’s what’s happening this week in the world of pharma digital products and FDA-regulated digital health:
- The news you know: Cognoa secured De Novo clearance from the FDA for its autism spectrum disorder diagnostic, Canvas Dx. (E&O first uncovered the brand name back in February.) The FDA told me it took 213 days for Cognoa’s De Novo from when it received the submission until the clearance a few days ago. (I believe that’s about 7.6 times as long as it took the FDA to clear Apple’s ECG App via the De Novo pathway.) Canvas Dx creates a new product code: QPF or “Pediatric Autism Spectrum Disorder diagnosis aid.” More details here.
- Blue Note Therapeutics quietly launched another prescription digital therapeutic thanks to the COVID–19 waiver that the FDA created for digital therapeutics related to psychiatric disorders. E&O wrote about Blue Note’s quiet attune launch back in February, and Blue Note may have launched cerena around the same time — or shortly afterward. Cerena is a “digital therapeutic program to aid the physical health of people with cancer.” The program’s modules appear to focus on bone health, kidney health, food poisoning, sun exposure, and more.
- During a presentation this week, Orexo’s CEO Nikolaj Sorensen described the company’s DTC launch of its OTC alcohol use disorder digital therapeutic, vorvida, as having “mixed results” in Q1. He also revealed the company lowered the price point from $750 to $599, which seemed to help boost sales in April. (Sales in April exceeded total Q1 sales.) Presentation
- Decentralized clinical trials company Elektra Labs changed its name to HumanFirst and raised a $12 million Series A. The company works with 22 of the top 25 pharma companies by revenue. (I prefer the name Elektra, but I also named this newsletter and once came up with the name MobiHealthNews… so yea, based on this n=1 focus group, HumanFirst is probably better.)
- This might be old news but just noticed this week that Pear Therapeutics is running a study that uses a version of its insomnia digital therapeutic, Somryst, that is translated and adapted for a Spanish-speaking patient population. The study, which Pear is running with Columbia University’s social work department, is named Dormir Mejor.
- One more thing… During a recent digital therapeutics-focused webinar put together by Ipsos, MedRhythms’ president and founder Owen McCarthy briefly mentioned how his company overcomes the disadvantage of being unable to iterate its products as nimbly as direct-to-consumer, OTC health tech companies like Mymee, Happify, and Noom: “That is a big advantage. You don’t have to pour the foundation of the house before you know what the house is going to look like. In our case, we have some angst about that [because we are going the prescription route]. So, we have created a mechanism, which we call ‘product lab’ that is an under-IRB, clinical study that evaluates each protocol but more flexibly than we would in a large RCT — [so] we can test and iterate.”
Whoa, whoa… Hey there, stranger. Was this paying subscribers-only newsletter forwarded to you? Follow me over to E&O HQ for a minute.
Snatched from the jaws of victory: New 2022 CPT codes for digital therapeutics just got muddier
In early May, E&O reported that the American Medical Association’s CPT Editorial Meeting’s public agenda showed that it would consider new CPT codes (specifically for remote cognitive behavioral therapy services) that seemed to overlap with the Remote Therapeutic Monitoring (RTM) codes AMA first discussed at its October meeting and that E&O first reported on back in August 2020.
The original RTM codes were exciting because they were Category I codes and they seemed like they might potentially cover a broad swath of digital therapeutics, but these two newer codes from the May meeting for “Remote Cognitive Behavioral Therapy Services” are only Category III codes. (For a refresher on Cat I vs Cat III codes, check this out.)
This week the AMA’s CPT Editorial group revealed that these newer CPT codes for remote CBT services were accepted and will go into effect in January 2022.
Here’s the language from the AMA CPT Editorial Meeting’s May panel actions:
“Accepted addition of codes 0X47T to report a standardized online digital cognitive behavioral therapy program and 0X81T to report the management services performed by a physician or other qualified health care professional.”
I already dug into why these two codes might be a setback when I wrote about them in May:
“The seeming duplication of efforts is all the more puzzling if those RTM codes from October end up securing some kind of actual reimbursement from CMS while these Category III codes remain on the books to simply track utilization for some far-off, hoped-for CMS reimbursement.”
“In the near term, would that lead to a carve-out where digital therapeutics … that use CBT don’t get reimbursed but others do? (That sounds absurd, but remember, we’re talking about the US healthcare system here.)”
Maybe those broader RTM codes don’t end up securing reimbursement in the CMS fee schedule later this year and none of this matters all that much.
Still, I’m curious: who pushed for this CBT carve-out? Were they actively trying to hold back reimbursement for cognitive behavioral therapy-based digital therapeutics? Something else?
(Hit reply if you have any intel here — especially if you backed this coding carve-out. What am I missing?)
So, next up on this front is the 2022 CMS Physician Fee Schedule, which should come out in a few months. Will it include reimbursement for the Cat I RTM codes? If so, what will that mean for cognitive behavioral therapy-based DTx?
The other two items of interest from that May meeting were proposed Category III codes for “validated digital behavioral therapy for substance abuse” and “remote amblyopia treatment.”
The validated digital behavioral therapy for substance abuse codes appears to have been folded into the other CBT-related codes discussed above, while three Category III codes for remote amblyopia treatment were accepted and will go into effect in January 2022. (That’s good news for Novartis, which acquired Amblyotech, a company that offers remote amblyopia treatment, in April 2020.)
Clinical trial updates: Apple Respiratory Study, Pear Therapeutics, and Big Health
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 had mentioned in previous issues.
Pear RCT focused on Real-World Effectiveness of Somryst plus Fitbit devices compared to Fitbit devices alone
Yale is sponsoring a study in collaboration with Pear Therapeutics and Mayo Clinic that is testing out Pear’s insomnia DTx Somryst in combination with Fitbit devices:
“This will be a prospective multi-center controlled trial of 100 patients conducted to assess the real-world effectiveness of a mobile-delivered, prescription digital therapeutic (PDT) device delivering Cognitive Behavioral Therapy for Insomnia using a novel patient-centered data-sharing platform with linkage to Fitbit for 61 weeks.”
Pear Therapeutics’ new reSET-O (Pear-008) study kicked off in May
Another Pear study update: The company’s randomized, controlled, open-label, decentralized study on its DTx candidate PEAR-008, which the company has described as a new version of reSET-O, got started in May.
Boston University researchers testing Big Health’s Daylight for chronic MSK pain:
“The clinical trial calls for the recruitment and randomization of 80 individuals with chronic musculoskeletal pain and clinical levels of [generalized anxiety disorder] symptoms to either a dCBT program or a waitlist (Control) condition. The current research represents the first-step investigation of a treatment strategy with the potential to enhance care for patients with chronic pain by introducing a scalable, affordable, and system-friendly digital intervention (dCBT) that targets a prominent source of distress and associated disability in these patients. The investigators propose that by targeting GAD in chronic pain in a way that does not tax engagement in ongoing medical care provision, there is the potential to improve the uptake of effective care and to address both GAD and associated distress and disability.”
The Apple Respiratory Study in Seattle posted details
While the Apple Respiratory Study generated headlines a few months ago, it only made it into the clinical trials [dot] gov database this week. The study includes some interesting secondary outcome measures, which will be detected by the Apple Watch’s sensors, including handwashing, blood oxygen, heart rate, and more.
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