Issue 153

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:

• Apple announced a 510(k) clearance this week for a “Atrial Fibrillation History Feature.” Here’s how Apple explains it: “With watchOS 9, users who are diagnosed with AFib can turn on the FDA-cleared AFib History feature2 and access important information, including an estimate of how frequently a user’s heart rhythm shows signs of AFib, providing deeper insights into their condition. Users will also receive weekly notifications to understand frequency and view a detailed history in the Health app, including lifestyle factors that may influence AFib, like sleep, alcohol consumption, and exercise.” The FDA granted the software a 510(k) clearance on June 3rd — last Friday — but didn’t post it in its 510(k) database until the morning of Apple’s big WWDC event, which actually took place Monday afternoon. That led a number of tech sites to spot the clearance hours before the announcement.
• Considering they hired the founder of Mango Health a few years ago, this shouldn’t be a surprise: Apple also added a “medication experience” for Apple Watch and iPhone users. “Custom schedules can be created for each medication, whether it needs to be taken multiple times a day, once a week, or as needed, and users can set up reminders to help keep them on track. In the US, users can receive an alert if there are potential critical interactions with medications they have added to the Health app.”
• Pear Therapeutics spoke in favor of Akili’s application for a product-specific HCPCS code at the public HCPCS meeting this week. Remember: Pear’s attempt to secure three product-specific HCPCS codes for its PDTs led to CMS creating a generic HCPCS code for Prescription Digital Behavioral Therapy. Product-specific codes, of course, would allow companies to price their digital interventions at different rates. We’ll have to wait until the fall to hear what CMS thought of Akili and Pear’s latest request.
• Speaking of Akili, the soon-to-be public company deepened its bench by appointing Matt Franklin as its president and COO — a newly created post. Franklin was most recently the General Manager of the Precision Oncology business unit at Exact Sciences.
• Partnership news: Anthem, which is rebranding as “Elevance Health” (huh?) tapped Happify Health for at least two digital maternal health offerings. “Eligible members of Anthem’s affiliated health plans in select markets will have access to Happify Health’s online pregnancy community, where they can connect with mental health experts, obstetrics, and gynecology experts, dietitians, and other healthcare professionals, ask questions, and discuss their physical challenges, and develop meaningful connections with others dealing with similar health issues.” And: “Eligible members will also have access to Happify Health’s evidence-based digital therapeutics, including a new non-prescription digital therapeutic addressing mental health needs during pregnancy.”
• In other partnership news: Owkin inked an $80 million deal with Bristol Myers Squibb that could balloon into a $180 million deal if a number of future milestones are met. The deal includes a BMS contribution to Owkin’s Series B, but it also sees Owkin using its AI “capabilities to design potentially more precise and efficient clinical trials for Bristol Myers Squibb” with an initial focus on cardiovascular diseases.
• One more thing… In the US House of Representatives, the Access to Prescription Digital Therapeutics Act of 2022 — a bill that aims to create a new Medicare benefit category for prescription digital therapeutics now has five co-sponsors: Reps. McKinley (R-WV), Hern (R-OK), Matsui (D-CA), and two new ones this week — Reps. Butterfield (D-NC) and Trone (D-MD). Rep. Mike Thompson (D-CA) originally introduced it as its sponsor in the House. The Senate version of the bill has no new co-sponsors — only its original backers, Senator Shelley Moore Capito (R-WV) (sponsor) and Senator Jeanne Shaheen (D-NH) (co-sponsor) have signed on so far.

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AMA panel OKs new CPT codes for VR-mediated therapy, AI-powered AFib risk assessment, more

(CPT Explainer: If you’re not familiar with the CPT system, the AMA owns a copyright on CPT codes. It also convenes various medical specialty societies to come together throughout the year to decide which new codes are needed, which codes need to be updated, and which should be removed. This explainer on CPT codes is a good resource to understand their importance, the different types of classes of codes, and more.) Last month the AMA’s CPT Editorial Panel met and decided the fate of the Cat II and III codes that E&O first wrote about (at length) back in March (Issue 142) and again (briefly) in April (Issue 147). Read on for a rundown of which of the CPT codes were adopted and which were rejected or withdrawn along with any changes to their descriptions. But first a quick recap of two codes that were withdrawn prior to the meeting as reported by E&O previously:

• WITHDRAWN: E&O reported this in April, but this was probably the most relevant for this audience, so worth highlighting again: “Therapeutic Monitoring Services — Establish code 9X023 to the Remote Therapeutic Monitoring Services family to report device supply and recordings to monitor chronic conditions; and revise 98975, 98976, 98977, 989X6 by adding nervous system status”
• WITHDRAWN: Another one E&O already reported on as being withdrawn was a Category II code focused on monitoring medication adherence for opioid use disorder patients.

New developments and outcomes from the May meeting:

• REJECTED: The only AI-related CPT application that did not request Category III status was rejected: “AI Generated Oncologic Therapies — Establish code 9X021 to report the use of an analytic tool to assist in determining the appropriate treatment pathway for oncology patients”
• ACCEPTED: Even though it’s a Cat III, this is an interesting one as it’s a big milestone for digital pathology startups. “Cat III – Digital Pathology: Accepted addition of add-on codes X018TX030T to report additional clinical staff work and service requirements associated with digitizing glass microscope for primary diagnosis; and addition of a new heading in the Category III section and guidelines to define digital pathology digitization procedures”
• ACCEPTED: Another notable development was the acceptance of this Cat III for AFib algorithms. “Cat III – AI Analysis for Cardiac Function Services: Accepted addition of add-on codes X044T and child code X045T to report assistive algorithmic electrocardiogram risk assessment for cardiac dysfunction”
• ACCEPTED: “Cat III – Virtual Reality-Mediated Therapy: Accepted addition of code X050T to report virtual reality technology to assist therapy”
• ACCEPTED: “Cat III – Virtual Reality (VR) Procedural Dissociation Services: Accepted addition of codes X051T, X052T, X053T, X054T to report Virtual Reality (VR) procedural dissociation procedures; and addition of new Category III subheading with guidelines”
• ACCEPTED: “Cat III – Computer-based Musculoskeletal Assessment — Establish code X055T to report augmentative computer-based analysis of motion, posture, gait, and muscle function utilizing surface mechanomyography (sMMG); and addition of a new subheading and guidelines within the Category III section to describe Office-Based Measurement of Mechanomyography and Inertial Measurement Units”
• WITHDRAWN: “Cat III – AI Assisted Developmental Behavioral Assessment: Establish codes X056T, X057T, X058T, X059Tto report multi-modular neurodevelopmental and behavior assessment system with augmentative algorithmic analysis“

Clinical trial updates from Google, Pear, Wise, Mayo and Muse

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.

Wise Therapeutics whittles down its study to focus on social anxiety disorder instead of SAD and GAD

Wise Therapeutics initially aimed to enroll participants with either social anxiety disorder or generalized anxiety disorder for its ABM-01 digital therapeutic feasibility trial. This week Wise removed all mentions of GAD from its study description:

The study is currently recruiting participants.

New Pear Therapeutics feasibility study focuses on new feature for reSET-O

Pear is working with the Kaiser Foundation Research Institute and others to set-up a small 10-person feasibility study focused on a new feature for its flagship prescription digital therapeutic, reSET-O. The study compares the original reSET-O to a version Pear has codenamed Pear-002B:

Now recruiting: Mayo Clinic’s Muse-wearable meditation study focused on long COVID patients

Now recruiting: Myndlift and NYU study on digital therapy for ADHD

This one isn’t official yet, but E&O has learned that Myndlift is now recruiting for this study:

Google-owned BiliCam completes diagnostic app validation study

Years ago Google somewhat quietly acquired a small startup out of the University of Washington called Senosis. One of Senosis’ subsidiaries was a tiny LLC named BiliCam, which develops an app that uses a smartphone’s camera and an algorithm to diagnose jaundice in newborns. Well, BiliCam’s validation study is now complete, so I’m curious if an FDA submission is in the works?

(Almost nine years ago when my first kid was born his pediatrician used an app to track and assess his bilirubin levels. When I asked if they knew who developed the app, they admitted that they didn’t but they still figured the app must be accurate. It was on the AppStore after all! Should go without saying, but we have a different pediatrician now.)

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