Issue 158
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 going on in FDA-regulated and pharma-focused digital health:
- The FDA finally posted the summary document for Apple’s most recent 510(k) for its AFib History feature that runs on the Apple Watch. Read through brief discussions of the software device’s clinical studies here. And here are the full indications for use: “The Atrial Fibrillation (AFib) History Feature is an over-the-counter software-only mobile medical application intended for users 22 years of age and over who have a diagnosis of atrial fibrillation (AFib). The feature opportunistically analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of AFib and provides the user with a retrospective estimate of AFib burden (a measure of the amount of time spent in AFib during past Apple Watch wear). The feature also tracks and trends estimated AFib burden over time, and includes lifestyle data visualizations to enable users to understand the impact of certain aspects of their lifestyle on their AFib. It is not intended to provide individual irregular rhythm notifications or to replace traditional methods of diagnosis, treatment, or monitoring of AFib. The feature is intended for use with the Apple Watch and the Health app on iPhone.”
- The agency also granted 510(k) clearance to Canadian sleep company Cerebra Medical’s home sleep devices and software. “Cerebra Sleep System… a lab quality in-home polysomnography (PSG) that is fully self-applied by the patient, without the presence of a technician. The Cerebra Sleep System has been designed from the ground up for in-home use and offers a truly scalable solution for bringing PSG testing to the home environment. The intuitive tablet interface and detailed instructional videos are key to high study success rates while the ability to wirelessly transfer study results for scoring and review drive operational efficiencies.”
- Correction: Last week (Issue 157) I described Akili’s EndeavorRx as intended for use by “teens” but the company is only FDA-cleared for kids 8 through 12 years old so far. The version for teens is still in the works. E&O regrets the error (and much else).
- Speaking of Akili, the company’s SPAC sponsor filed a listing application with Nasdaq at the end of June that begins the process of transforming the public SPAC company into a publicly traded entity named Akili with the trading symbol “AKLI”. So, that final SPAC step is imminent. Akili also announced its board of directors along with results from a trial that used its prescription digital therapeutic AKL-T01 to treat people with Lupus.
- OK, one more Akili item… The US federal government’s Agency for Healthcare Research and Quality (AHRQ) put out a request for “supplemental evidence and data” on ADHD diagnosis and treatment options. One of the questions they are looking to study: “What are the comparative safety and effectiveness of pharmacologic and/or nonpharmacologic treatments of ADHD in improving outcomes associated with ADHD? How do these outcomes vary by presentation (inattentive, hyperactive/impulsive, and combined) or other comorbid conditions? What is the risk of diversion of pharmacologic treatment?” Akili’s EndeavorRx is listed below as an example of a non-pharmacological treatment.
- I teased this re-brand last week, but Happify Health is now known as “Twill”. The rebrand likely helps Happify shed its original branding as a DTC wellness app company as it evolves into more of a healthcare company.
- Heads up: No, OxfordVR did not get FDA clearance for its digital therapeutic gameChange (not yet, anyway). There seems to be some confusion about this and maybe an inaccurate press report or two, but OxfordVR did secure Breakthrough Designation from the FDA three weeks ago. That’s not a market authorization though.
- One more thing… The news you know: A smartphone-based home lab test called Minuteful Kidney from Healthy [dot] io snagged an FDA 510(k). “The Minuteful Kidney test app and kit allow people to test themselves at home for signs of CKD and receive immediate clinical results. Through colorimetric analysis, computer vision, and AI we use the smartphone camera to deliver an FDA-cleared, clinical-grade medical test. The app walks the user through a simple test, making it as easy as snapping a photo.”
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CMS proposed changes to the Remote Therapeutic Monitoring billing codes
In the proposed Physician Fee Schedule for 2023, CMS proposed a few tweaks to the Remote Therapeutic Monitoring Services billing codes that E&O has tracked for the past few years. CMS also suggested a plan for pricing the new remote cognitive behavioral therapy (CBT) billing code. Here’s a quick summary of this article so you can skip ahead or skip it altogether and read about clinical trial updates in the next article (yes, this gets pretty wonky, pretty fast):
- CMS proposed to eliminate two of the remote therapeutic CPT codes and replace them with four temporary G (HCPCS) codes
- CMS proposed not to create a generic device supply code for Remote Therapeutic Monitoring
- CMS proposed that regional Medicare Administrative Contractors (MACs) should determine pricing for its new remote CBT billing code
- CMS came to that decision based on feedback from the industry, including companies like Pear Therapeutics, Big Health, and Orexo, which the American Psychiatric Association interviewed
CMS wants to delete two CPT codes and replace them with four G codes
CMS said that it has heard concerns from the industry about CPT codes 98980 and 98981. As written, the codes may end up being underused or too burdensome to use since they require clinical staff to have oversight from physicians or other billing practitioners. CMS proposes to replace the two CPT codes with four new HCPCS codes that aim to resolve those issues.
Here are two relevant snippets from the CMS proposal:
“The commenters also expressed concern about another issue with the RTM coding that also relates to the clinical labor in the direct PE for the two treatment management codes. The commenters acknowledged that the clinical labor involved in these codes, that is, the portion of these services performed by clinical staff incident to the services of the billing clinician, requires direct supervision by the billing practitioner. The commenters stated that direct supervision of clinical staff performing these activities was burdensome, and suggested that physicians and nonphysician practitioners who can bill for ‘incident to’ services would be unlikely to use the codes if direct supervision were required. The commenters suggested that we designate CPT codes 98980 and 98981 as care management services or alternatively, that we develop HCPCS G codes that would allow the ‘incident to’ clinical labor portions of the services to be furnished under general supervision of the billing physician or nonphysician practitioner…”
“…Conversations continue to revolve around the two concerns detailed above related to the clinical labor in the direct PE for the two RTM treatment management codes, CPT codes 98980 and 98981. Thus, for CY 2023 we are proposing to create four new HCPCS G codes with one pair of codes aimed at increasing patient access to remote therapeutic monitoring services and the second pair aimed at reducing physician and NPP supervisory burden.”
CMS decided to wait on creating a generic device supply code
Since the original set of RTM codes only included supply codes for devices related to respiratory and musculoskeletal interventions, commenters asked CMS to create a generic supply code that other companies outside of these two conditions could use. CMS said it wanted to collect more info before creating a generic device code though:
“…We also considered requests from interested parties to develop a generic device code for RTM. We have decided to wait to develop a generic RTM device code and instead will seek comment to inform any new coding relating to devices. Thus, we are seeking comment about RTM devices that are used to deliver services that meet the “reasonable and necessary” standard under section 1862(a)(1)(A) of the Act. We seek information related to the types of data collected using RTM devices, how the data that are collected solve specific health conditions and what those health conditions are, the costs associated with RTM devices that are available to collect RTM data, how long the typical episode of care by condition type might last, and the potential number of beneficiaries for whom an RTM device might be used by the health condition type.”
Pricing for the new remote cognitive behavioral therapy code to be set by MACs
While there is no generic device code for remote therapeutic monitoring companies outside of respiratory and MSK interventions, a new code for cognitive behavioral therapy (989X6) seems poised to open up the RTM codes to a broader number of digital health companies. CMS proposed, however, not to set the pricing for that code at the federal level. Instead, it pushed that decision down to the regional Medicare Administrative Contractors (MACs).
(I would guess that move was a win for those digital therapeutics companies who have been pushing not to be lumped together into generic billing code descriptions that treat all prescription digital therapeutics the same.)
The relevant passage from CMS:
“During the RUC review of CPT code 989X6, specialty societies indicated that the technologies for this service are still evolving. As a result, there were no invoices for devices specific to the cognitive behavioral therapy monitoring services described by the code that could be shared. In response, the RUC recommended that CPT code 989X6 be contractor priced. Given the anticipatory nature of this code, we agree with the RUC recommendation that this new code should be contractor priced until we learn more about the devices being used to furnish the service.”
Big Health, Pear, Orexo, and others helped CMS come to that decision
Since CMS mentioned the RUC’s recommendation, I dug into the proceedings from the RUC’s meeting back in January. (They only just released them in time with the Proposed Fee Schedule.)
One of the key documents that convinced the RUC to recommend that CMS punt the pricing of the CBT code to the MACs (this is just ridiculous alphabet soup, right here, isn’t it?) was research done by the American Psychology/Psychiatry Association (ok, APA). The APA asked a number of digital health companies about their pricing and their take on the proposed remote CBT code. The APA concluded in their letter to the RUC:
“The resource costs associated with CBT products vary under current distribution models depending on how these products are accessed and used by patients… During the interviews, it became apparent that CBT products might fit better as separately payable supplies or in a different benefit category… Based on the information gathered, APAPsychology and APA-Psychiatry recommend [MAC] Pricing for CPT 989X6, which will accommodate the wide variability in practice patterns and pricing.”
I wanted to include a few comments from the individual companies too since the APA did in its letter’s attachments.
Here’s what Pear wrote about the forthcoming CBT code (hint: it’s probably not going to encourage prescribers to use it):
“Pear’s current products are not sold or distributed in a way where the physician practice is incurring a charge.”
Here’s part of what Big Health wrote:
“The coding structure does not fully or clearly describe the CBT products offered by Big Health… The resource costs associated with the BigHealth products vary under current distribution models depending on how these products are accessed and used by patients. The Big Health products might fit better as separately payable supplies associated with a healthcare practitioner service or in different benefit category.”
And here’s what Orexo wrote:
“Orexo’s digital therapies build on the artificial intelligence (AI) software broca and simulates interaction between the patient and an empathetic physician or therapist. CPT Code 989X6 would include devices that offer ‘tracking’ for clinician monitoring purposes and ‘therapeutic’ devices. There is, therefore, no single payment amount that would appropriately capture the cost associated with use of the divergent set of devices that fit within the language of the code descriptor.”
The APA also received responses from Sanvello, Headspace Health, and Calm — along with a few others. Surprisingly, many well-known digital health companies with a CBT-powered intervention were not on their outreach list.
In any case, all of the above is part of the proposed Fee Schedule for 2023, so be sure to submit comments by early September.
Clinical trial updates from Click, Wise, Group K, Calm, Sidekick, and MoodRing
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.
Group K’s observational study for a liver labs diagnostic app
Here’s a brand new observation study of a smartphone-based, point-of-care diagnostic testing platform from Group K that focuses on various liver function biomarkers, including bilirubin:
“This is an observational study exploring the performance of a novel point-of-care diagnostic testing platform designed to quantitate the presence of liver function biomarkers such as bilirubin. Blood samples will be collected from participants to further development and validation of the testing platform to support FDA review. The diagnostic device is intended to provide rapid in-office test results using a finger stick of blood, a reaction test device, and a smartphone app.”
Sidekick Health study on digital therapeutic for people with breast cancer
Sidekick continues to rollout clinical studies for its digital therapeutics. This one does not appear to have a pharma partner attached:
“Sidekick Health has developed an interactive digital therapeutic program (SK-421) specifically designed for reducing side effects in breast cancer patients. The study will be a single center pilot study with an intervention group and a comparison group recruiting 66 breast cancer patients prescribed to surgery, chemotherapy, radiation and/or hormonal therapy according to standard breast cancer treatment. The 14-week pilot study will determine whether the interactive digital therapeutic program, supporting lifestyle changes, can positively impact management of side effects, quality of life, physical activity and fitness and medication adherence in this patient population. Patients will be randomized to receive either the standard of care (SoC) treatment alone or SoC with the addition of the digital therapeutic program.”
Click Therapeutics swaps out sham for care as usual in DiNaMo study
I wrote about this one a few weeks back, but Click just swapped out its planned sham comparator for care as usual. The company also noted that this study is not just focused on people with cognitive impairment because of Multiple Sclerosis, but also because of breast cancer or lung cancer too. More:
“CT-100 is a platform that provides an interactive, software based therapeutic component that may be used as part of a multimodal treatment in supplementary or standalone prescription or nonprescription software-based digital therapeutics (PDT/DTx), being developed by Click Therapeutics, Inc.”
Wise Therapeutics tweaks its inclusion criteria age range for social anxiety disorder digital therapeutic
Wise tightened its inclusion criteria for its study on a social anxiety disorder digital therapeutic from an age range of 18-65 to 22-65.
“Participants with Social Anxiety Disorder (SAD) will use a digital therapeutic for 30 days, and will complete assessments measuring a broad range of anxiety and mood-related symptoms, with a focus on SAD symptoms, and metrics of functional impairment during this time. After the treatment period, participants will be followed at 6 month and 12 month after the completion of the study.”
Calm study aims to develop an app for people with cancer
Calm just published details on a study it already completed (no results yet) that has a number of aims, but one of them is to develop a mediation app designed for people with cancer:
“Specific Aim 2: DESIGN a meditation app prototype tailored to cancer patients/survivors unique needs including content related to cancer-related experiences, emotions, symptoms, physical and psychological needs, cancer-specific symptom self monitoring, social support and sense of belonging within the app and through Facebook.”
Now recruiting: Calm app study that aims to test the effects of using Calm for its impact on stress, anxiety, and sleep in pregnant women.
MoodRing App study to see if the self-tracking app reduces healthcare utilization
The company behind the MoodRing app is exploring a number of things in this study including whether its mood tracking app for teens results in lower healthcare utilization. More on the six-month, 450-person study:
“The MoodRing intervention is a mobile application for adolescents, parents, and an accompanying web-based clinician portal which enables adolescents to monitor their mood through the use of passively collected smartphone data. This randomized controlled trial will evaluate whether MoodRing as compared to usual care improves the quality of depression management.”
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