Issue 224
Welcome back to E&O: SaMD, a paying subscribers-only weekly newsletter focused on the world of digital pharma products, prescription digital therapeutics and other FDA-regulated digital health.
E&O: Software as a Medical Device
Here are a few quick things happening in FDA-regulated and pharma-focused digital health:
- Germany’s national formulary for reimbursed prescription digital therapeutics (DiGA) permanently listed Kranus Lutera, a 12-week digital therapeutic program for men with bladder emptying disorders. The digital therapeutic is priced at €670.49.
- The DiGA formulary also changed the status of one its preliminarily listed digital health programs to a permanent listing: Vitadio’s Type 2 diabetes offering. Vitadio was first added to the DiGA formulary back in April 2022. More: “Vitadio uses a multimodal therapy approach to provide individualized support for lifestyle changes and self-management. The application guides users through the program with the help of daily tasks and automated messages. The tasks develop depending on the users’ decisions and progress in the program and focus on establishing a routine in the area of self-management. Users follow an interactive course that covers topics such as motivation, nutrition, physical activity, sleep hygiene, psychological well-being and social aspects of living with diabetes.” It costs €499.80 for 90 days of access.
- Owlet tapped Wheel to provide prescribers for its direct-to-consumer but prescription-only BabySat offering. “Wheel clinicians will provide caregivers with timely prescriptions for BabySat, Owlet’s FDA-cleared pulse oximeter, tailored for infants with pre-existing medical conditions.”
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AMA considers various changes to RPM/RTM codes as well as the creation of many new Cat III codes for AI-powered clinical decision support
Next month the American Medical Association’s CPT Editorial Panel will once again convene to review a sizable 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 2024 crop of code change applications includes a number of big changes to both the remote physiological monitoring and remote therapeutic monitoring code sets as well as a handful of requests to add Category III codes for various AI-powered clinical decision software.
Finally, not specifically digital health-related but certainly relevant: there is one application that calls for the creation of billing codes to pay providers for their time when requesting prior authorization from payers. Huh.
RPM and RTM change requests
This applicant is calling for the creation of six new codes and revisions to nine existing codes. The agenda for the meeting doesn’t typically include too many specifics on the individual applications, but this one has a fairly long (if not entirely revealing) summary of the requested changes:
“Revise the Digitally Stored Data Services/Remote Physiologic Monitoring guidelines; add a remote physiologic monitoring device supply code (99XX4) for 2 to 15 calendar days; revise code 99454 to include 16-30 calendar days; revise the Remote Physiologic Monitoring Treatment Management services guidelines; add a new code (99XX5) for remote physiologic monitoring treatment management services; revise code 99457 to include 11-20 minutes; revise code 99458 to each additional 10 minutes; revise the Remote Therapeutic Monitoring Services guidelines; revise codes 98975, 98976, 98977, 98978; add remote treatment monitoring device supply codes (98XX4, 98XX5, 98XX6) to report respiratory, musculoskeletal and cognitive behavioral therapy for 2-15 calendar days; revise the Remote Therapeutic Monitoring Treatment Management services guidelines; add a new Remote therapeutic monitoring treatment management services code (98XX7); revise 98980 to include 11-20 minutes of service; and revise the time component for code 98981.”
Requested tweaks to some existing telemedicine services codes
Here’s another requested change to a set of telemedicine-related CPT codes that appear to focus on making billing for audio and/or video telemedicine clearer:
“Modifier 95 Reporting Instructions – Remove the Telemedicine symbol from Office or Other Outpatient E/M codes 99202-99215; revise the Online Digital Evaluation and Management Services guidelines to direct users to codes 9X075-9X081 (approved for 2025) for synchronous audio video office visits and to codes 9X083-9X091 (approved for 2025) for synchronous audio-only office visits; and revise Appendix P CPT Codes That May Be Used For Synchronous Real-Time Interactive Audio-Video Telemedicine Services with the removal of codes 99202- 99215.”
Unusually large number of Category III CPT code creation requests
Next month’s meeting has a ton of requests for new Cat III codes — mostly for AI-assisted clinical decision support software. Here are just a few examples:
- Cat III-Continuous External Electrocardiographic Monitoring – Establish codes XX51T-XX54T to report continuous external ECG recording/monitoring.
- Cat III-AI-assisted Heart Failure Detection – Establish code XX68T to report noninvasive detection of heart failure derived from augmentative software analysis of an echocardiogram.
- Cat III-AI-Assisted Brain Mapping – Establish codes XX66T, XX67T to report AI-enabled connectomic mapping and analysis of brain networks and function using MRI.
Trials: MedRhythms-Alexion. Proteus lives on. New Akili OTC RCT. Verily smartwatch study finishes. Apple/Johns Hopkins tweak Corrie. Woebot terminates another study early.
This is a recurring feature of E&O SaMD that digs into new digital health-related clinical trials as well as updates to others mentioned in previous issues.
New: MedRhythms and Alexion team up for undisclosed digital therapeutic focused on people with Neuromyelitis optica spectrum disorder (NMOSD)
As far as I can tell, this trial points to an unannounced collaboration between MedRhythms and Alexion Pharmaceuticals for a digital therapeutic that isn’t even listed on MedRhythms’ pipeline page. Not yet recruiting. More:
“The purpose of this proof of concept study is to assess the acceptability and safety of MR-C-014 in persons with Neuromyelitis optica spectrum disorder (NMOSD) who have a gait deficit.”
New and now recruiting: Akili RCT on EndeavorOTC in college population
Akili is now recruiting for an RCT focused on its flagship OTC ADHD digital therapeutic at two colleges in New York and Vermont. More:
“The objective of this study is to evaluate the impact of a digital therapeutic (EndeavorOTC, also known as AKL-T01A) on clinical symptoms of executive and cognitive functioning in a real-world sample of university students. This study aims to answer whether EndeavorOTC represents a useful intervention for targeting broad cognitive and emotional health among university students.”
Delayed: Vanderbilt’s study of Akili’s Endeavor on COVID cognitive issues
Vanderbilt has delayed its study’s end date by a year — from January 2024 to January 2025. 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.”
New study suggests that Otsuka continues to develop its Proteus ingestible sensor and wearable patch assets
Proteus Digital Health’s assets live on at Otsuka. This study is focused on the technology’s detection accuracy and detection latency. More:
“This is an open-label study to determine the accuracy of ingestible event marker (IEM) detection and detection latency of the D-Tect patch by completing a series of patch applications and IEM ingestions in the clinic.”
Study from Eko tests equipping parents with its smart stethoscope for monitoring infants’ ECGs More:
“This proof-of-concept study will enroll infants, defined as individuals <1 year of age. It will assess the feasibility and effectiveness of a physician and parent/caregiver in using the Eko DUO and CORE 500 to capture ECGs in patients <10 kg in a clinic and home setting.”
Complete: Verily’s smartwatch study on physical capacity in COPD and Parkinson’s patients
Verily finished up this study back in November and managed to recruit 154 out of an anticipated 200 participants. More:
“The aim of this study is to investigate whether a smartwatch can measure the physical capacity of patients with Parkinson’s Disease and COPD in the physiotherapy practice and at home.”
Terminated: Woebot ended its study at Scripps on feasibility of a digital therapeutic for post-partum stress, anxiety, depression
After recruiting 281 of the 450 anticipated participants in its trial, Woebot made the decision to terminate this trial. The reason it gave was simple an “internal company decision.” Woebot told E&O last year that it ended a number of studies focused on prescription digital therapeutics under development because it was pivoting away from that business model. That is likely what was going on here too. More:
“To evaluate the feasibility and acceptability of W-PPMA among a diverse group of postpartum mothers.”
Tweaked: Study update suggests that Johns Hopkins, Apple, and AHA pivot Corrie heart rehab offering from virtual-only to hybrid care
Maybe a small tweak but I thought it was worth noting: Corrie, a digital health cardiac rehab program developed by Johns Hopkins researchers with help from Apple and the AHA, is now stressing that it is a “hybrid” program and no longer just a “virtual” one. See the brief description below for the added “hybrid” designation… More:
“In this randomized clinical trial, the researchers are investigating whether a multi-component virtual/hybrid cardiac rehabilitation program will improve functional status, cholesterol level, overall cardiovascular health, individual risk factors, quality of life and mental health for patients who have recently been diagnosed with myocardial infarction, received a coronary stent, underwent heart surgery or catheter-based valve replacement, as compared to usual care.”
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