Issue 126
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 happening in the world of FDA-regulated and pharma-focused digital health:
- The FDA issued its list of final and draft guidances that it expects to get to in 2022. The lineup has a few focused on SaMD, including: Clinical Decision Support Software (final), Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (draft), and Content of Premarket Submissions for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) (draft).
- Yesterday the agency also published a draft guidance, Content of Premarket Submissions for Device Software Functions, and is now seeking public comments.
- Digital Medicine Society (DiME) has brought together Abbvie, Janssen, Novartis, Pfizer and UCB in a pre-competitive collab to develop nocturnal scratch as a digital endpoint for atopic dermatitis. While sponsors are collecting digital endpoints more and more, “the industry has yet to see a new medical product approved on the basis of a digital endpoint,” according to DiME. This collab hopes to change that.
- One more thing… In what is perhaps the most successful social media marketing move by a prescription digital therapeutics company, Germany’s Newsenselab called out Facebook (now Meta) for debuting a new logo that looks a lot like the one they use for their migraine DTx, m-sense. Their tweet has so far garnered more than 53,000 likes and 11,000 retweets.
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Apple quietly secures a new 510(k) for its irregular heart rhythm notification app
The FDA granted Apple a new 510(k) clearance for its irregular heart rhythm notification software. Details on what changes led to the new clearance will likely emerge later this month. This feature was one of the two De Novos that Apple announced from the stage at its WWDC in 2018. Since then the irregular heart rhythm notification (IHRN) feature for the Apple Watch has had an IFU that read like so:
“Photoplethysmograph analysis software for over-the-counter use. A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a diagnosis.”
One subtle difference between the software that received the De Novo in 2018 and this recent 510(k) is that the name of the 2018 device was named “Irregular Rhythm Notification Feature” while the new one is called “IRNF App”.
This recent 510(k) took 73 days from the date FDA received the submission until the official clearance. The FDA granted Apple’s De Novos back in 2018 at a far quicker pace. One of Apple’s original De Novos only took 28 days.
CMS says Remote Therapeutic Monitoring codes will be “sometimes therapy” codes
After receiving more than 2,900 comments from the industry that mentioned the Remote Therapeutic Monitoring codes section of the 2022 Physician Fee schedule, CMS didn’t make too many changes to the way it said it would treat the RTM codes in its proposed feed schedule. Here are the two paragraphs from the final Fee Schedule document that explain how CMS will treat the RTM codes in 2022:
“After considering the comments, we are finalizing our proposed adoption of the RTM codes and our proposed valuations for the services. We heard commenters express concern about billing the new RTM codes. Comments covered the range of possible outcomes – from accepting the CPT codes to revising or developing new codes. Our decision to finalize the proposed RTM codes and our proposed valuations for the services strikes a balance between supporting beneficiary access to care that these services describe and allowing for non-E/M billing practitioners to furnish and bill for these services. We acknowledge the major themes that emerged in the comments from stakeholders about broadening the base of practitioners that could furnish the RTM and RPM services, as well as maximizing the efficiency with which these services could be furnished.”
“In the interest of coding efficiency for these services, we hope to continue to engage in dialogue with stakeholders, including the AMA CPT, in the immediate future on how best to refine the coding for the RTM services to address some of the specific concerns raised by stakeholders. We note that as general medicine codes, these codes can be billed by physicians and other qualified health care professionals. We also note that the five RTM codes will be designated as ‘sometimes therapy’ codes, which means that the services can be billed outside a therapy plan of care by a physician and certain NPPs, but only when appropriate. While therapists’ services must always be provided under therapy plans of care, RTM services that relate to devices specific to therapy services, such as the ARIA Physical Therapy device (CPT code 98977), should always be furnished under a therapy plan of care. We are also clarifying that the two device codes, CPT codes 98976 and 98977, are not subject to the de minimis standard that establishes the threshold for the statutorily required payment adjustment that applies to therapy services provided in whole or in part by therapy assistants. However, the initial set-up and patient education services represented by CPT code 98975 is subject to the de minimis policy.”
AMA reveals a few DTx-related CPT code rejections and accepted revisions for 2023
While CMS made its final decisions on how it will treat Remote Therapeutic Monitoring codes in 2022, the AMA’s Editorial Panel posted the results from the committee’s recent meeting. I mentioned these proposed codes back in Issue 112 and 113, but I included a quick rundown of nine proposed codes that caught my eye back then along with whether the AMA panel ended up accepting or rejecting them (or whether they were withdrawn prior to the meeting) along with more info on one of the accepted ones below.
- WITHDRAWN: Digital Behavioral Therapy Management – “Establish code 99XX0 in the Evaluation and Management section to report digital behavioral therapy management using an online cognitive behavioral program”
- REJECTED: Cat III – Digital Behavioral Health Interventions – “Establish code 0X98T to report digital behavioral health interventions via a multiple function digital device”
- ACCEPTED (more below): Cognitive Behavioral Therapy Monitoring – “Establish code 989X6 to report remote therapeutic monitoring to monitor cognitive behavioral therapy; and delete codes 0X47T, 0X81T”
- WITHDRAWN: Cat III – Digital Pain Management Therapy – “Establish code 0X99T to report augmented reality mobile application for rehabilitative pain control”
- WITHDRAWN: Cat III – Automated Cognitive Health Assessment – “Establish code 0X93T to report automated cognitive health assessment”
- ACCEPTED: Cat III – Health and Well-Being Coaching Guideline Revision – “Revise the introductory guidelines language for Health and Well-Being Coaching”
- ACCEPTED: Cat III – Remote Therapeutic Activity Measurement – “Establish codes 0X06T, 0X07T to report remote therapeutic dynamic activities”
- WITHDRAWN: Cat III – Virtual Reality (VR) Procedural Disassociation and Distraction – “Establish codes 0X08T, 0X09T to report virtual reality procedural disassociation and distraction”
- ACCEPTED: Taxonomy of Artificial Intelligence (AI) for Medical Services and Procedures: “Establish an Appendix that will improve the terminology and understanding of AI as it relates to the CPT code set”
CBT Monitoring Code — For the accepted code for Cognitive Behavioral Therapy Monitoring, the AMA panel explained their action like so:
“Accepted addition of code 989X6 to report remote therapeutic monitoring device supply to monitor cognitive behavioral therapy; revision of the Remote Therapeutic Monitoring Services guidelines and the Remote Therapeutic Monitoring Treatment Management Services guidelines to clarify reporting of cognitive behavioral therapy; and deletion of codes 0X47T, 0X81T”
What that reveals that maybe wasn’t obvious before is that this is a supply code. It reads as if the code will pay for the software needed to deliver CBT, which would be a big development. Given the price points E&O has tracked for various prescription digital therapeutics in the market today, I’m curious to see how many dollars this supply code will carry.
Clinical trial updates from Biogen and Akili
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.
Biogen’s two new Konectom studies for Neuromuscular Disorders
Biogen posted some details on two new studies that will leverage the company’s new Konectom digital clinical trial platform. The first one is an observational study focused on MS that aims for 500 participants:
“The purpose of the study is to explore association patterns between digital outcome assessments from Konectom and MRI measures of brain tissue damage.”
Biogen shared a lot more detail on its second Konectom study:
“The primary objective of the study is to explore the convergent validity of smartphone-based Konectom DOAs against in-clinic standard assessments.”
“The secondary objectives of this study are to evaluate the test-retest reliability of smartphone-based Konectom Digital Outcome Assessments (DOAs); to determine the relationship between Konectom upper limb DOAs and conventional upper limb assessments in clinical environments; to determine the relationship between Konectom lower limb DOAs and status of ambulation in clinical environments; to evaluate group differences in smartphone-based Konectom DOAs [self-administered at home and in-clinic] between person with spinal muscular atrophy (PwSMA) or person with amyotrophic lateral sclerosis (PwALS) and healthy subjects (HS); to evaluate the variability of Konectom DOAs self-administered in everyday environment in HS and PwSMA or PwALS; to compare Konectom DOAs between in-clinic supervised administration versus self-assessments in everyday environment in HS, PwSMA and PwALS groups; to evaluate the relationship of Konectom DOAs against patient-reported outcomes (PROs) in PwSMA or PwALS and to evaluate the clinical safety of Konectom in PwSMA and PwALS.”
Akili tweaked the inclusion/exclusion criteria for their adolescents-focused ADHD study
There’s a more interesting Akili study below, but for the company’s big adolescent ADHD study, the company changed its inclusion and exclusion criteria. The study will no longer exclude teens who are regular users of psychoactive drugs but has since added an inclusion criterion that reads:
“Stably on or off psychoactive medications for ≥4 weeks prior to study enrollment and throughout the 4-week study.”
Children’s National Research Institute is testing Akili’s EndeavorRx with children with sickle cell
Here’s more on the small 20-person study:
“Children with sickle cell disease (SCD) exhibit significantly reduced cognitive functioning (often difficulties with attention) compared to peers and siblings without SCD. EndeavorRx (Akili Interactive Labs: Boston, MA) is an FDA-approved home-based, electronic attentional-control training program designed to treat attention problems in youth. Users access EndeavorRx on a tablet device for 25-30 minutes each day, 5 days per week, for 4 weeks. The program involves training in a game-like environment that repeatedly challenges attentional-control abilities and adapts to user performance, becoming more difficult over time as performance improves. This pilot study is examining the feasibility, acceptability, and preliminary efficacy of EndeavorRx in a sample of 20 children with SCD ages 8-16 who are being treated with chronic blood transfusion therapy.”
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