Issue 221
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’s a quick rundown of things happening in FDA-regulated and pharma-focused digital health:
- Akili shared its Q4 results with investors this week. The company had 11,571 active paying EndeavorOTC users during Q4. It brought in $596,000 in revenue from EndeavorOTC during the quarter and $749,000 in revenue for the quarter overall. That’s up from $702,000 in Q3. The company brought in $1.7 million in total revenue for 2023 and $1.2 million of that was from EndeavorOTC. Just before Akili released these results its pharma partner in Japan, Shionogi, announced that it had submitted the Japanese version of Akili’s EndeavorRx to Japan’s FDA equivalent. More here.
- Icon, a global CRO, acquired HumanFirst, which helps pharma companies use digital health technology and digital biomarkers in clinical trials. Icon is a public company, but it didn’t share any financial details about the transaction.
- Supersapiens, one of the consumer-focused companies that had developed a wellness program around CGMs, announced it was canceling all of its memberships amid a “strategic restructuring”. According to a crowdfunding pitch that the company posted at the end of last year, it brought in about $2 million in revenue from its 15,000 users in Europe in 2022. It estimated $3 million in 2023 revenues. It just announced it was coming to the USA with a diabetes-focused program last month, but reports indicate the company had trouble with regulators. Read more here.
- Little scoop: Xealth, which helps clinicians distribute digital health programs to patients, raised about $3.4 million, according to an SEC filing.
- Another little scoop: The FDA cleared a new model of Hinge Health’s Enso device. The original iteration of Enso, named Cur, secured its first 510(k) back in 2016. The agency hasn’t posted a summary document yet on this new clearance, so no details on what’s new. More on Enso here.
- Empatica launched a new version of its FDA-cleared epilepsy wearable, now named EpiMonitor: “EpiMonitor has been FDA-cleared for use in adult and children populations aged 6 and up, and is the only wearable solution with regulatory approval for seizure detection available to purchase in the US. It is the successor to Embrace2, which enjoyed global acclaim as the leading wearable for seizure detection for years, and the first ever to be available to patients.”
- In Germany’s national formulary of reimbursed prescription digital therapeutics (DiGA), Kaia slashed the price of its lower back pain digital therapeutic from €489.39 to €221.49.
- Also in Germany: Mindable Health lowered the price of its DiGA for panic disorder from €576.00 to €245.50.
- Finally, after reading my write-up about Dario’s acquisition of Twill a few weeks ago, a few readers wrote in with reactions. One said that the total acquisition price would end up being closer to $40 million — not the $30 million I calculated from the government filings.
Was this forwarded to you? Increasingly, E&O is a covered benefit from many forward-looking digital health-focused employers. Why not yours? Consider a Business or Enterprise subscription today. Click this link to become a paying subscriber (there are personal plans available too).
HCPCS and CPT final decisions and outcomes
Here’s a quick round-up of recent decisions made by CMS’ HCPCS committee and the AMA’s CPT Editorial Panel, which met last month.
HCPCS final decision: Tyto rejected despite support from Elevance
Tyto tried to convince the HCPCS committee that its TytoHome device and software,which it describes as “the first all-in-one telemedicine solution, able to perform full-body, remote physical examinations” should be separately payable from the physician services that Medicare already pays for remote care. CMS ultimately decided that Tyto needs to pursue its case for a billing code elsewhere:
“Based on the information provided in the application and after consideration of the comments we received, we believe this request should be considered under the Potentially Misvalued Codes Initiative, which examines concerns regarding valuation of existing Current Procedural Terminology (CPT) codes.”
As a refresher, Tyto enlisted help from its key partner Elevance to bolster its case to CMS. Here’s a snippet of CMS’ summary of Tyto’s case:
“They stated, that Elevance Health, formerly Anthem Healthcare, seeks designation of a new HCPCS Level II S code for TytoHome to assist Elevance in the expansion of its remote physical examination program. Issuance of an S code would allow Elevance to streamline billing and reimbursement process, improve transparency, and reduce errors and rejections.”
HCPCS final decision: Natural Cycles gets a tweak to its new code’s language
Natural Cycles managed to get most of what it wanted from the HCPCS committee. CMS was willing to change the wording of its newly created code for Natural Cycles, but it insisted on keeping the payment on a monthly cycle instead of an annual one, which better aligns with Natural Cycle’s annual subscription business model. The new code, however, no specifically mentions “contraception” after Natural Cycles asked for that: HCPCS Level II code A9293,
“Fertility cycle (contraception & conception) tracking software application, fda cleared, per month, includes accessories (e.g., thermometer)”
HCPCS final decision: Axena Health gets a tweak to its new code’s language for Leva Pelvic Health System
Like Natural Cycles, Axena managed to convince CMS to tweak the wording of its new billing code so it better described Leva, but CMS still insisted on referring to the device as a “biofeedback” device, which Axena had hoped to remove from the description. Here’s the new code: Establish a new HCPCS Level II code S9002, “Intra-vaginal motion sensor system, provides biofeedback for pelvic floor muscle rehabilitation device” to describe Leva Pelvic Health System.
Moving on to the CPT meeting…
CPT meeting summary: Only Cat III codes for AliveCor made it through, other code change applications related to digital health were rejected or withdrawn
Rejected: Online Digital Evaluation and Management – New and Established Patients
As predicted, a code change application for online digital evaluation of new and established patients did receive a vote at the recent AMA CPT Editorial Panel meeting last month — but it was rejected. This was the text:
“Online Digital Evaluation and Management – New and Established Patients: Establish codes 98XX1, 98XX2, 98XX3, 994X0, 994X1, 994X2 to report online digital evaluation and management services for new patients.”
As I’ve written previously: Similar codes to the above exist today but for established patients only. This tweak would have been particularly meaningful to text-based virtual care companies because it adds new patients. CMS has historically interpreted these codes to refer to messages only and not in-person or video communications. Two category three codes that I’ve been tracking were accepted and are set to go into effect next year.
Accepted: Cat III codes that will likely help companies like AliveCor
These codes look particularly relevant for AliveCor, which has established partnerships with drug companies to use its devices for similar use cases, so I wouldn’t be surprised if they are behind them:
“Cat III-AI-based QT Interval Monitoring – Establish code XX19T to report QT interval monitoring during drug administration and assessment for QT prolongation.” and “Cat III-Algorithm-based Electrocardiogram – Establish codes XX20T, XX21T, XX22T to report algorithm-based electrocardiogram.”
As E&O reported a month ago: Applications for tweaks to the Remote Therapeutic Monitoring codes related to Digital Cognitive Behavioral Monitoring and Remote Monitoring were both withdrawn before the meeting.
Trials: Apple, Click Therapeutics, Bold Health
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.
Revised Enrollment (again and again and again): Is Apple messing with me? Once again Apple’s Heartline study, which originally anticipated 150,000 then said 24,000 then said it had enrolled 34,244 last year then claimed to have enrolled 45,472 last month is back at 34,244 again.
Maybe last month’s update was a mistake? Once again Apple and Janssen revised their high-profile Heartline study’s enrollment total. Since it was done recruiting a year ago when it said it had enrolled 34,244 participants — I figured that was that. The study changed the enrolled number to 45,472 last month before changing it back to 34,244 in recent days. Still a far cry from the originally hoped-for 150,000.
“The primary objectives of this study are to identify and diagnose Atrial Fibrillation (AF), evaluate improvement in cardiovascular (CV) outcomes, improve direct oral anti-coagulant (DOAC) adherence and persistence, and better characterize participants and identify predictors of disease.”
Done recruiting: Apple’s study with the University of Colorado (Denver) on fall prevention
Apple is working with study sponsor UC Denver as a collaborator — along with the National Institute on Aging — on a fall prevention study. It just finished recruiting 197 participants, just three shy of the expected 200 participants:
“In addition to the usual care arm, the Intervention arm will receive a physical therapy and pharmacy consultation in the ED. PTs will perform a fall risk assessment and provide recommendations on the safety of discharge. Pharmacists will perform medication review, recommend cessation or tapering of medication that increase fall risk using motivational interviewing (MTM) techniques. The participants will also receive Apple Watch training and an Apple Watch to perform tasks that test their memory and mobility during their ED visit and during our home visits at 1,3, 6, and 12 month after enrollment.”
Now recruiting: Click Therapeutics study to stop scratching in psoriasis and atopic dermatitis
Click is undertaking this study on its own:
“CT-100 is a platform that provides interactive, software based therapeutic components that may be used as part of a treatment in future software-based prescription digital therapeutics. One class of CT-100 components are Digital Neuro-activation and Modulation (DiNaMo TM) components. …The purpose of the proposed study is to evaluate initial effects of the DiNaMo component on measures of undesired behavior intensity and related outcomes in a variety of conditions, such as atopic dermatitis and psoriasis.”
Done recruiting: Click and Boehringer Ingelheim study on schizophrenia digital therapeutic
Click and BI managed to recruit 53 participants — three more than anticipated — for this study:
“An exploratory, double-arm, 4-week study to explore the feasibility and acceptability of abbreviated treatment with CT-156 for people with Schizophrenia.”
Done recruiting: Bold Health and UPenn’s study on the digital therapeutic Zemedy for IBS
This study is no longer recruiting, but no update on the number of actual participants so far. Researchers anticipated about 300. More:
“The purpose of this research is to assess if a new digital app version of a self-help intervention for Irritable Bowel Syndrome (IBS), is an acceptable and effective treatment for improving the overall quality of life in patients with IBS.”
Links to E&O’s reports, databases, newsletters
Click below for dedicated pages for each of those categories:
- Read through the long-form E&O research reports here.
- Search and sort the E&O databases here.
- Skim more than 300 past issues of E&O newsletters here.
