Issue 190
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New billing code applications for digital cognitive behavioral therapy, PDTs (but just EndeavorRx, really), AI tweaks, coaching reimbursement and more
In May the American Medical Association’s CPT Editorial Meeting will once again convene to review a sizeable list of billing code submissions, which are formally known as Code Change Applications (or CCAs), including a few that are relevant to digital health companies. (And for a refresher on how CPT billing codes work along with the differences between Category I codes and Category III codes, read this explainer.)
The May 2023 crop of code change applications includes ones focused on prescription digital therapeutics, digital cognitive behavioral therapy, psychotherapy services, and more granular classification of AI-based procedures. These meetings are off-the-record and the companies behind the billing code applications are typically not revealed, but it seems likely to me that Akili is behind at least one of them. Why? Because one of the applications describes Akili’s EndeavorRx rather precisely:
“Cat III – Prescription Digital Therapeutics – Establish codes X178T, X179T to report treatment of inattentive or combined-type attention deficit hyperactivity disorder using digital therapeutic software.”
A Category III submission is the beginning of a long road for reimbursement. This move (and not pursuing a Cat I code) suggests that in the near term, Akili is just hoping for a specific code it can use with commercial payors. I’m also surprised by the generic name of this application — “prescription digital therapeutics” is a big category and this code would only apply to one product? Two other digital health-related code applications that caught my eye were also a bit puzzling:
“Digital Cognitive Behavioral Therapy – Establish codes 90X10, 90X11, 90X12 to report digital cognitive behavioral therapy.” and “Psychotherapy Duration Codes – Establish codes 90X13, 90X14, 90X15 to report psychotherapy duration services.”
You can tell by the proposed code numbers that these were written by the same applicant, but it’s not clear to me how they are related. Is the second set of codes supposed to be for “remote” services? And is there really a need for another Category 1 code that is focused on digital cognitive behavioral therapy? The Digital CBT code application’s wording doesn’t give me much to go on, but it made me wonder if this was submitted by Big Health.
I’ve yet to report on this, but back in September Big Health wrote CMS a letter that argued the current digital CBT billing codes are insufficient and there should be one that pays for the therapy itself.
In the company’s words:
“CMS could accomplish this by creating separate HCPCS codes that would account for services comprising the furnishing of digital CBT therapeutic devices and build on CMS’ work to adopt CPT code 989X6 (87 FR 46026), which describes CBT remote therapeutic monitoring devices (that are designed for monitoring CBT but not the actual CBT therapy itself).”
Maybe I’m reading too much into the mere dozen-word description from the code application above, but it seems to be asking for the same thing Big Health asked CMS for in its letter. However, when I asked Big Health to confirm whether it was behind this CPT application, the company told me it was not.
Another potentially important application is seeking to move health coaching services out of Category III and into Category I, which likely would mean reimbursement. The code description doesn’t specifically mention “remote” or “digital” but I suspect it would apply to those services too (maybe?).
“Cat III to Cat I – Health and Well-being Coaching Services — Establish codes 99X05 – 99X09 to report health and well-being coaching services; and delete Category III codes 0591T, 0592T, 0593T.”
The new batch of code applications also includes some tweaks to how CMS and the AMA’s Editorial Panel will categorize AI-based software devices in the future.
“Appendix S AI Taxonomy Revisions – Revise Appendix S-AI Taxonomy to include new examples recently included in the CPT code set that are assistive and augmentative services.”
And this very curious comment about asking about AI in all future code change applications for digital health-based services:
“CCA Revisions Related to Digital Medicine/AI – Request to add questions regarding AI to the CPT Code Change Application.”
Trial updates: Lumos Labs, Akili, MedRhythms, 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 mentioned in previous issues.
New: Akili fast-follower Lumos Labs has a new study on its game-based therapy for adults with ADHD
Here’s the new study from Lumos Labs, makers of the Lumosity brain training game, that appears to be a competitor to Akili’s EndeavorRx for adults:
“The objective of this study is to assess the safety and effectiveness of an at-home, game-based digital therapy for treating adult patients with Attention-Deficit/Hyperactivity Disorder (ADHD).”
Delayed: Akili’s COVID survivor cognitive training trial
Akili pushed back both its primary completion and study completion dates for its cognitive training in survivors of COVID-19 trial — by one year. The study is now expected to finish completely by 2025. The clinical trial, which is sponsored by Vanderbilt University Medical Center, is not yet recruiting. More:
“Study Aim: To evaluate the feasibility of conducting a randomized trial evaluating the effectiveness of a digital app-based intervention (AKL-T01) to improve 4-week cognition (post-intervention) in cognitively impaired survivors of Covid-19.”
Done recruiting: Big Health’s effectiveness study on Sleepio for insomnia patients
Big Health managed to recruit a total of 336 participants for its latest Sleepio trial. This study may lead to one of Big Health’s FDA submissions. The company has said it was weighing a submission focused on a depression claim, but it also appears poised to submit applications related to insomnia and anxiety too.
Tweaked: MedRhythms and its partners at Boston University and University of New England raised the age maximum for participants in its Parkinson’s Disease trial
MedRhythms’ trial focused on its digital music therapeutic previously tried recruiting participants aged 40-80. It is currently still recruiting and just upped the maximum age to 85 years old. More:
“In this pilot, we will utilize a breakthrough digital therapeutic that delivers music-adaptive RAS to alleviate PD-specific problems by regulating stepping patterns. Using music as a substrate for cue delivery, this digital therapeutic leverages gait benefits from RAS along with enjoyment of music listening, thus making it a viable and engaging modality that will yield habits of regular walking.”
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