Issue 212
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 are a few quick bullets on things happening in FDA-regulated and pharma-focused digital health:
- Sidekick Health acquired Germany-based aidhere, which is the developer of zanadio, a weight loss digital therapeutic that is permanently listed in Germany’s national digital health formulary (DiGA). While the companies didn’t share any financial details of the transaction, they did share some metrics about zanadio: “zanadio has fulfilled over 50,000 prescriptions and is recognized within Germany’s regulated nationwide DiGA (Digitale Gesundheitsanwendungen) formulary for prescribable digital apps. Achieving long-term behavioral change and significant weight loss of 8% in patients at the end of 12 months, and with over 10,000 doctors prescribing it, zanadio is fully reimbursed for patients with a BMI from 30 to 40 kg/m². As a permanently approved DiGA, zanadio is reimbursed by all statutory health insurers in Germany.”
- MedRhythms announced that it commercially launched its first prescription digital therapeutic, InTandem this week. InTandem’s indication for use statement: “InTandem is indicated to improve walking and ambulation in adult chronic stroke patients. InTandem is intended to be used in the home for the physical rehabilitation of ambulatory adults with chronic stroke walking impairments.” Here’s the just-launched InTandemRx website too.
- This week Better Therapeutics also announced the commercial availability of its first prescription digital therapeutic, AspyreRx, which uses cognitive behavioral therapy for people with Type 2 diabetes. “During the initial launch phase, as the Company works on securing insurance coverage, eligible patients can access AspyreRx on a cash-pay basis for a limited time.”
- The FDA said it added 171 new AI or machine learning-enabled medical devices to its round-up of cleared AI devices here.
- The news you know: The FDA announced that it would create a new “Digital Health Advisory Committee to help the agency explore the complex, scientific and technical issues related to digital health technologies (DHTs), such as artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software.” More info here if you want to apply.
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AMA set to tweak remote therapeutic monitoring codes in January 2025. (Plus other CPT code change application results.)
The AMA posted the CPT coding decisions from its September 2023 meeting, and the relevant news for this newsletter’s readers is that the AMA agreed to tweak the wording of the remote therapeutic monitoring CPT codes to make clear that “digital” cognitive behavioral therapy is included in the codes.
Based on a previous description of the code change application, the AMA seems to have also agreed to revise the Qualified Nonphysician Health Care Professional Online Digital Assessment and Management Service subheading of the codes to make clear which provider types can use the codes. The changes go into effect in January 2025.
Here’s the official (though vague) description of what changed from the AMA:
“Digital Cognitive Behavioral Therapy: Accepted revision of codes 98975, 98976, 98977, 98978 to include digital therapeutic intervention; and revision of the Remote Therapeutic Monitoring Services and the Remote Therapeutic Monitoring Treatment Management Services guidelines.” Effective date: January 2025.
As I speculated a few months ago, it is likely that Big Health and their partner at the APA crafted the code change application above. The APA has indicated that they’d like the following provider types to bill using the codes:
“APA representatives have met with leaders from the Centers for Medicare & Medicaid Services to propose a coding and reimbursement model for digital therapeutics. APA is working to create a system that would allow psychologists, physicians, and other eligible providers to bill private or government insurance organizations for using these apps with patients.”
As I’ve already reported, this code change application that almost certainly came from Akili was withdrawn:
Withdrawn: “Cat III – Remote Therapeutic Intervention for Algorithmically Adjusted Treatment of ADHD.”
The AMA does not publicly explain the reason for rejections, but one of the code change applications that was rejected was a revision of the RPM code 99454 to specify each calendar month instead of a 30-day period.
Rejected: “Remote Physiologic Monitoring – Revise 99454”
Here’s a curious one. Redefining what “in-person” and “face-to-face” means for virtual care was postponed.
Postponed: “In person-Face to Face Definitions” The original application included much more information:
“In person-Face to Face Definitions — Revise the Instructions for Use of the CPT Codebook in the Introduction of the code set to clarify that for purposes of CPT coding, ‘face-to-face’ encompasses both in-person and synchronous audio-video communication; revision of guidelines throughout the code set to clarify when face-to-face, in-person, synchronous audio-video, or synchronous audio-only communication is appropriate; revision of codes 99495-99498, 90875, 90876, 96116, 96121, 96125, and 97161-97172 with the removal of the term ‘face-to-face’; revision of 98960-98962 with the addition of the phrase ‘or synchronous audio-only’; and revision of 0362T, and 0373T with the removal of ‘face-to-face’ and the addition of ‘in person’.”
Trials: Big Health, Mahana Therapeutics, GAIA, MedRhythms, AppliedVR
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.
Now recruiting: Big Health’s STAND depression study for teens and adults
Big Health’s Major Depressive Disorder study for teens and adults is now recruiting. Anticipating 248 participants. More:
“This study aims to examine the efficacy of a self-guided digital therapeutic app for depression compared to a control app in individuals aged 13 and older with a diagnosis of Major Depressive Disorder. The primary outcomes are patient- and clinician-reported depression symptom severity after 5 weeks.”
Done recruiting: Big Health’s RISE study on depression
Big managed to recruit 61 participants for this study. More:
“This study aims to examine the effectiveness of app-based digital CBT in individuals with a diagnosis of Major Depressive Disorder. The primary outcomes are depression symptom reduction and engagement with fulfilling activities after 5 weeks.”
Completed: Mahana Therapeutics’ Tinnitus pilot study
Since E&O first reported on this digital therapeutic for tinnitus from Mahana, the company has scrubbed mentions of it from its website. The pilot study is now complete. More:
“The main objective of this prospective, open-label, non-significant risk study is to assess the efficacy and safety of Mahana Tinnitus together with care as usual in approximately 250 adults with symptoms of tinnitus.”
Done recruiting: MedRhythms’ Amped-PD study at Boston University More:
“The experimental intervention, ‘Amped-PD’, is a 6-week, user-managed community-based walking program that utilizes music-adaptive RAS that progressively increases walking intensities. This study will examine if Amped-PD (Experimental Intervention) is more effective than a standard-of-care walking program (Active-Control Intervention) in improving physical activity based on moderate intensity walking, and in improving motor deficits related to quality of walking in individuals with mild-to-moderate PD. This study will also examine whether the resultant habits formed from each intervention matter in relation to training-related changes in physical activity..”
Completed: AppliedVR’s RelieVRx study at MGH More on this 10-person study:
“The goal of this study is to pilot test a skills-based virtual reality (VR) for acute orthopedic injury. It will measure the feasibility, signals of improvement, exploratory pain mechanisms, and user experience of an established skills-based program (RelieveVRx) for acute orthopedic injury.”
New: GAIA’s study on a new digital therapeutic for Multiple Sclerosis More:
“The trial aims to evaluate the effectiveness of a novel digital health application (levidex), which was designed to increase quality of life in persons with multiple sclerosis (MS). Therefore, 470 people with MS will be recruited and randomized to two groups: (1) an intervention group that will receive access to levidex in addition to treatment as usual (TAU) (n = 235) and (2) a control group receiving an overview of relevant brochures from the Deutsche Multiple Sklerose Gesellschaft (German Multiple Sclerosis Society) on the topic of lifestyle in MS in addition to TAU (n = 235).The primary outcome measure is the total score on the Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HALEMS), collected 6 months post-randomization.”
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