Issue 209
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:
- As I predicted in last week’s PDT newsletter, Akili has withdrawn its CPT code change application from the AMA’s upcoming CPT Editorial Panel meeting. Officially, the applicant behind this submission is undisclosed, but it seems obvious from the very specific language here that it was Akili. Here’s the language of the now withdrawn code application: “Cat III – Remote Therapeutic Intervention for Algorithmically Adjusted Treatment of ADHD – Establish codes X225T, X226T, X227T to report prescription digital therapeutic (PDT) providing sensory stimuli and simultaneous motor challenges for neural attentional control.”
- Akili launches Android version of EndeavorOTC: In other Akili news, the company launched an Android version of its OTC digital therapeutic for adults with ADHD. “EndeavorOTC, the mobile video game treatment clinically proven to improve attention and focus in adults with ADHD, is now available on Google Play for popular Android devices, including most Samsung Galaxy and Google Pixel models. Out of the estimated 11 million adults living with ADHD in the United States, approximately 40 percent are Android users so we believe this release represents a crucial step in offering an accessible non-drug treatment option to adults with ADHD, particularly amid the continued stimulant medication shortage and ongoing mental health crisis.”
- MedRhythms tapped Curavit Clinical Research as its virtual contract research organization for a study of MR-001, MedRhythms’ neurorehabilitation system designed to improve walking and ambulation in adults with chronic stroke walking impairments. “The goal of the study is to further characterize the long-term economic and clinical benefits of MR-001 beyond what has been established in a multi-center, randomized clinical trial. This will also include evaluating patient engagement and therapeutic response durability.”
- The FDA granted a 510(k) clearance to Hoth Intelligence for OrionXR. No summary document yet from the agency but Hoth had previously described its offering like this: “Hoth Intelligence is developing hardware and software that reconstructs a CT or MRI scan to create a patient-specific 3D object. This can then be loaded into a virtual reality headset that allows clinicians to ‘see through and into’ patients to assist in performing tasks such as inserting catheters with greater accuracy.” More background
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CMS to Congress: We see potential of prescription digital therapeutics.
This week on Capitol Hill, the Health subcommittee of Energy & Commerce held a hearing to discuss 25 bills with representatives from CMS. One of those two dozen bills was the Access to Prescription Digital Therapeutics Act, which aims to create a new Medicare benefit category for PDTs. If you didn’t have time to tune into the live-streamed session, read on.
All of the members’ questions about prescription digital therapeutics were directed at Dr. Dora Hughes, MD, MPH, Acting Director, Center for Clinical Standards and Quality and Acting Chief Medical Officer at CMS.
More than once during the hearing, Dr. Hughes acknowledged the “potential” of prescription digital therapeutics.
She also repeatedly pointed to CMS’ list of questions about digital therapeutics in its recent Proposed Physician Fee Schedule as evidence that CMS was working on it.
Read on for a few excerpts representative of the type of exchanges that Dr. Hughes had with members of Congress who brought up PDTs during the hours-long session.
Rep. Bill Johnson (R-OH) asked Dr. Hughes a couple of specific questions related to the Access to Prescription Digital Therapeutics bill, but first he discussed the mental health access gap in the US.
Here are the two questions he asked next:
Rep. Johnson:
“What is CMS doing to ensure that PDTs are being viewed as an important tool and are incorporated into those efforts [to improve access to mental health care]? What is your approach to coverage and reimbursement for innovative health technologies like digital therapeutics?”
Dr. Hughes:
“Thank you for that important question. As you know CMS has prioritized behavioral health as an issue that we have and will continue to focus on more intensively in the days ahead. With respect to PDTs, as you note they do have potential to really address some of the access issues and provide our beneficiaries the care that they need. We have been exploring this issue. We asked questions through our recent proposed payment rule. We are looking to see the comments and the evidence that we receive back and hope that we can work with you on expanding access to PDTs.”
Dr. Hughes returned to a version of the prepared response she gave above on the few occasions a member brought up PDTs.
About an hour later, Rep. Doris Matsui (D-CA) made a point of highlighting the Access to PDTs bill and then said:
“I hope my colleagues will join me in pushing for this critical bipartisan bill in a markup bill soon.”
(I wonder if this was the main goal of highlighting the bill in the hearing? Get more co-sponsors or backers to get it folded into a bigger package of legislation and into markup?)
Rep. Matsui then asked Dr. Hughes:
“How might digital therapeutics help bridge the gap for mental health services among Medicare beneficiaries, especially among underserved populations?”
An excerpt from Dr. Hughes’ answer:
“We recognize the potential for PDTs to address some of the access and care needs of our beneficiaries. We are mindful that the FDA has approved at least a couple of applications. We have asked questions in our recent Proposed Payment Rule. We are reviewing those comments and we hope to have more information shortly.”
Trials: Big Health, GAIA, Koko, and 2Morrow
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: GAIA’s study on a digital therapeutic for psoriasis
“This clinical trial with 348 patients with psoriasis aims to investigate the effectiveness of a self-guided online program for patients with psoriasis.” More
Now recruiting: GAIA’s study on a digital therapeutic for burnout, named reviga
“In this single-blinded randomized controlled clinical trial 290 patients with stress or burnout will be investigated regarding the effectiveness of a digital therapeutic for improvement of stress level, the unguided online intervention reviga.” More
Now recruiting: 2Morrow’s study on its digital therapeutic for chronic pain
“This study will evaluate the existing 2Morrow Chronic Pain Self-Management Program, in the form of a mobile app, as a digital therapeutic for improving patients’ pain self management and function who suffer from chronic pain. Specifically, the investigators will conduct a 2-arm randomized control feasibility study to evaluate: 1) the feasibility of using the mobile app and an optional activity tracker, 2) the feasibility of conducting a 2-arm trial, and 3) estimate the effect size for planning for a larger efficacy trial based on our primary outcomes. The intervention arm will test a mobile app that aims to help people reduce pain interference who have chronic pain, as well as mental health issues with depression and anxiety. Participants in the intervention arm will also have the option to sense health data with a tracker that integrates with the app, which will inform the feasibility of this feature.” More
Now recruiting: Koko Lab’s study on its online program for treating insomnia, Full Sleep
“The purpose of this study is to investigate improvements in sleep by comparing two 6-week digital programs, either online or app-based, that deliver Cognitive Behavioral Therapy for Insomnia (CBT-I), the ‘gold standard’ treatment for insomnia, with or without a bedside device to help track sleep.” More
Done recruiting: Big Health’s study on Daylight for treating generalized anxiety disorder The company and its partner Boston University managed to recruit 351 participants — nearly as many as the 374 anticipated:
“This study aims to examine the effectiveness of app-based digital CBT for anxiety compared to psychoeducation in individuals with a diagnosis of Generalized Anxiety Disorder. The primary outcomes are anxiety symptom reduction and remission after 10 weeks.” More
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