Issue 174
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 this week in FDA-regulated and pharma-focused digital health…
- Israel-based ChroniSense Medical’s Polso Watch quietly secured a 510(k) clearance for its pulse oximetry sensor. The wearable, which is not yet commercially available, is designed to sense much more than that though. More here.
- Turkey-based H2o Therapeutics announced that it had secured FDA clearance for its prescription mobile app, Parky, which monitors symptoms of Parkinson’s Disease like tremors and dyskinesia via the Apple Watch.
- Meanwhile, Empatica received a new FDA clearance for its platform, which is now “cleared for continuous data collection to monitor blood oxygen saturation (SpO2) during rest, peripheral skin temperature, activity associated with movement during sleep, and Electrodermal Activity (EDA).”
- Abbott is ramping up hiring for its Lingo biowearables team. Remember: Lingo is the new concept for a direct-to-consumer CGM-like, peel-and-stick sensor that Abbott announced at the big CES event in January. Someday it might track ketones, lactate, glucose, and alcohol.
- Meanwhile, a latecomer Congressman added his named to a letter in support of Apple, which is facing a possible Apple Watch import ban if AliveCor wins its patent infringement suit against the company. Representative J. Luis Correa (D-CA) added his name to the letter, which doesn’t weigh in on the merits of the case itself but asks that the ITC not ban the importation of the Apple Watch citing the device’s benefits to public health.
- Switzerland’s government appears poised to accept FDA market authorizations from the US as acceptable for market entry there too. It will no longer require US companies to also seek out a CE Mark for medical devices.
- One more thing… Japan’s pioneering prescription digital therapeutic company CureApp secured reimbursement in Japan for its hypertension app in recent months. The country’s medical device regulator also recently posted an English language version of a document that shares some details about the device’s market authorization.
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Cognoa and AppliedVR ask CMS to create new Level II HCPCS codes for their digital products
Pear Therapeutics (Issue 139)and Akili (Issue 168) both previously asked CMS to create individual HCPCS codes for each of their prescription digital therapeutics, but ultimately failed to convince them to create product-specific codes and ended up with a catch-all code that probably includes most PDTs. As I reported back in Issue 173, recently AppliedVR and Cognoa made similar attempts to convince CMS to set up unique codes for their offerings, which they argue are distinct from Pear’s and Akili’s.
This week both companies argued their cases in a public forum (a Zoom webinar) and fielded questions from CMS about the need for these two new billing codes. Let’s start with a quick refresher on where things stood before this week’s meeting followed by a quick summary of what went down on the Zoom.
AppliedVR asked CMS to create a new Level II HCPCS code for its FDA-cleared, prescription digital therapeutic RelieVRx, which uses immersive virtual reality to treat chronic low back pain. Here’s part of AppliedVR’s argument:
“According to the applicant, clinical trial evidence demonstrates that the durable VR hardware is required to deliver significantly greater reductions in pain intensity and pain interference compared to software-only or application-only methods. RelieVRx is self-administered, unsupervised in the patient’s home while the patient is in a seated position. The therapy is not delivered as part of a clinician service. The device is returned upon completion of the 56-day course of treatment and is available for reuse. The device has an expected useful life of 3 years or greater, is suitable for repeated use, and does not include non-medical software or allow nonmedical use. According to the applicant, there are no existing HCPCS Level II codes available for immersive VR for pain or other therapeutic indications used in the home.”
CMS punted on a decision — even a preliminary one — so far:
“In an effort to better understand the request to use a virtual reality device to treat chronic back pain, CMS is interested in additional information or more explanation of how the immersive nature of this device creates an outcome for the patient that would not have the same effect were the software to instead be used on a non-virtual reality device such as a computer, tablet, or phone.” “CMS has no preliminary recommendation with regard to this product as we continue to consider its clinical distinction relative to other products. In the meantime, classification, coverage, and payment for RelieVRx will be made on an individual claim-by-claim basis by the MACs.”
New this week: Takeaways from the CMS-AppliedVR discussion
In its preliminary non-decision CMS clearly asked AppliedVR to explain the importance of the immersive nature of this device and specifically asked why the same effect couldn’t be achieved via similar software running on a non-VR device like a computer, tablet, or smartphone. AppliedVR’s stable of presenters included well-known VR in healthcare academics and researchers like Stanford’s Beth Darnall, PhD and Walter Greenleaf PhD as well as Cedar Sinai’s Dr. Brennan Spiegel.
They focused on RelieVRx’s clinical study results and the general mechanisms of action at play when using immersive virtual reality to deliver therapies. Still, it was striking that at the end of the presentations, the first question that one of the committee members from CMS asked AppliedVR was if it had any data on whether its VR-based therapeutic would work just as well as an app. AppliedVR’s flagship study put it head-to-head with an audio-only version of its therapeutic content, which the company argues was a good proxy for how AppliedVR fares against telehealth services. (That was also the study the FDA used to grant the product’s breakthrough device status.)
Here’s Darnall:
“The question is whether the proprietary software has tested delivery via other devices other than the virtual reality headset. The answer is ‘no, that is not the case.’ Treatment such as cognitive behavioral therapy is typically delivered in-person, sometimes over Zoom, etc. This is the actual problem that we’re overcoming with the RelieVRx device is that we don’t have the ability to scale those types of treatments. With the virtual reality headsets we have the ability to do that. What’s unique about the VR headset is, of course, the presence, the immersion. It imparts a completely distinct, deeper clinical effect than if somebody just received audio or 2D display of information, such as information received over the internet.”
One of CMS’s follow-ups to that was to ask:
“Just to clarify again: you haven’t taken your software and tested on an app or videogame or anything like that to see if there was any significant distinction with your treatment, correct?”
AppliedVR admitted that they do not have a head-to-head study that they can point to but they claimed that if you look at the effect sizes from the RelieVRx studies and compare them to those achieved by other modalities in separate studies, RelieVRx delivered superior clinical outcomes. CMS responded one more time:
“OK, yea, because it would be great to see a comparison for RelieVRx to show that your product is superior in the VR headset versus on an app instead of just using an audio type testing. That would have been nice to see.”
At this point AppliedVR’s advisor Spiegel responded:
“I would just add that this software doesn’t really run on anything but a VR headset. I don’t think it is possible to achieve that since, literally, the programming on Unity is not compatible with an iPhone.”
Spiegel and Darnall built on that a bit and dug back into the importance of the immersive effect of VR before CMS asked once again:
“So, you said the virtual reality with it being immersive is important, which I get. I am not demeaning that in any way. Then why did you use a study that only uses audio only?”
AppliedVR gave a similar response to what it said before, and it seemed like this could have looped forever. Good reminder about how difficult it is to plan a clinical trial pipeline for a digital therapeutic. It seems like every gatekeeper along this go-to-market has different and unpredictable preferences about comparators in digital health studies. Has anyone ever set up a study specifically designed to appease the CMS HCPCS committee a few years down the road?
Moving on to Cognoa’s HCPCS petition for Canvas DX
As a refresher, here’s the background on this one leading up to the events of this week: Cognoa asked CMS to create a new Level II HCPCS code for its prescription digital diagnostic Canvas Dx, which is a diagnostic aid for Autism Spectrum Disorder.
Here’s part of the company’s argument:
“The applicant believes a unique HCPCS Level II code to describe Canvas Dx is necessary because most payors have pushed Canvas Dx to be adjudicated under the medical benefit given that any observed healthcare cost offsets for ASD resulting from earlier diagnosis of ASD are typically observed under the medical benefit. Digital diagnostic devices have a different and unique use and cost profile that warrants different coding from therapeutics. Whereas therapeutics are typically prescribed for the ongoing or episodic treatment of chronic conditions, diagnostic digital devices like Canvas Dx are ordered at a singular point in time to aid a health care provider in assessing the presence or absence of a condition. For both private and public payors, the ability to accurately monitor the cost of, and evaluate holistically, each of the two distinct categories of emerging digital solutions will be of critical importance as the digital health field expands exponentially in the coming years. Assessing the cost of a ‘one and done’ digital diagnostic device compared to ongoing spend for digital therapeutics would be extremely challenging under a single digital therapeutic umbrella code.”
If you read Issue 173, then you know that CMS’ preliminary recommendation was a bit of a blow to Cognoa:
“Our understanding is that the Canvas Dx would generally be used in a procedure reported with a HCPCS Level I (CPT) code. We have not identified a specific need for this product to be separately paid, since we believe that a particular payer may elect to pay for the service in which this product is used. For instance, Medicare would typically reflect the costs of the product in the payment for the procedure, if it is used, and as such it would not be separately payable.”
While AppliedVR was asked to better explain its device’s unique mechanism of action, Cognoa had to overcome a preliminary “no”.
New this week: Takeaways from the CMS-Cognoa discussion
Cognoa tapped Foley Hoag attorney Haider Andazola as one of its reps for the HCPCS public meeting. Andaloza aimed to make the case that Canvas Dx would not be a good candidate for a CPT code and that it needed a HCPCS code instead. I missed some of his opening remarks, so the company shared a summary of his prepared remarks with me via email.
Here is a snippet from them:
“My remarks focus on emphasizing the similarities between Cognoa’s request at issue here and CMS’s decision on a similar request in the December 2021 HCPCS Public Meeting establishing HCPCS code A9291. There, CMS ultimately recognized that a prescription digital therapeutic is dispensed to a patient directly by a specialty pharmacy and that specialty pharmacies do not use CPT codes to bill payers for technologies covered under the patient’s medical benefit. Likewise here, CanvasDx is dispensed directly to a patient by a specialty pharmacy for use in the home. The lack of a HCPCS code to describe a prescription digital diagnostic limits payers’ ability to cover and process claims for CanvasDx. … CanvasDx is self-administered by the caregiver/patient in their home wholly separate from a clinical encounter, and the physician does not incur a cost for use of the technology that they would separately bill for under a CPT code. Thus, the use case of CanvasDx is clearly distinguishable from other diagnostic tools described by CPT codes, which explains why payers are exploring separately paying for CanvasDx under the medical benefit.”
One of the CMS panel’s first questions to Cognoa was whether Canvas Dx was “used just for clarification purposes” or whether it was used in conjunction with other diagnostic tools?
Cognoa’s CEO Sharief Taraman, MD responded that Canvas Dx is an “aid” to diagnosis and not an independent diagnostic, as classified by the FDA. CMS then asked if it was better described as a “screener” and Cognoa’s team replied “no” — Canvas Dx delivers much more actionable information than a screener.
CMS asked a few other questions that probed just how much of a diagnostic Canvas Dx really is as well as a question about whether psychologists are excluded from using it because it is prescription-only. (Cognoa argued that the Rx-only decision was the FDA’s, and noted that only some states allow psychologists to write prescriptions. Cognoa also didn’t understand how this was relevant to the HCPCS discussion.)
One of the final questions from CMS was about how payers are currently coding for use of Canvas Dx. Cognoa CEO Dr. Taraman repied:
“[They aren’t] because we don’t have a HCPCS code for it to be billed under the medical benefit. We have attempted but we received feedback from the payers that it needs its own code. The codes we have looked at don’t apply to the device.”
Any predictions as to whether either or both of these moved CMS to a “yes”?
Clinical trial updates: Pear, Woebot, Johns Hopkins, and Oviva
This is a recurring feature of E&O Fridays that digs into new digital health-related clinical trials as well as updates to others that E&O mentioned in previous issues.
Study start: Pear’s slightly modified reSET-O study started up in November
Small update here to note that Pear’s tweaked reSET-O study started up in early November. More:
“The purpose of this study is to develop and evaluate the acceptability of a novel feature for use with the prescription digital therapeutic reSET-O. This feature aims to improve the quality of treatment for opioid use disorder (OUD) patients starting buprenorphine initiation at home by providing new digital content and withdrawal symptom assessment to support them during this process. This study will evaluate the acceptability of this new feature and assess success of at-home buprenorphine initiation.”
Now recruiting: Woebot’s digital therapeutic for postpartum depression study: More:
“This randomized, double-blind, controlled trial evaluates the efficacy and safety of 8 weeks of treatment of two digital therapeutics in a population of women with mild to moderate postpartum depression. Patients will be referred by an obstetrician, pediatrician, or other healthcare professional, or by other digital and site based recruitment methods and, if interested, will complete the pre-screening process. Those confirmed as eligible will be scheduled to attend a screening/baseline onsite visit. Eligible participants will be randomized to one of the two groups and will receive instructions on downloading and using the smartphone application to which they were randomized. Participants will use the app as instructed and will attend telehealth visits to complete assessments for the primary and safety endpoints at Weeks 4 and 8 (EOT).”
Now recruiting: Woebot and Stanford’s digital therapeutic Phase II study for substance use disorder
Interestingly, this study still labels the intervention as not being regulated by the FDA:
“This study aims to validate W-SUDs as a digitally-delivered substance use disorder program through a fully-powered randomized control trial that will test the comparative efficacy of the mobile-app based substance use disorder program (W-SUDs) to reduce substance use relative to a psychoeducation control condition, which has no cognitive behavioral therapy and the content is not delivered through a conversational user interface.”
Delayed: Johns Hopkins’ Apple-supported Corrie AFib management program study
Johns Hopkins pushed back the start of its Apple Watch-powered Corrie study from November 2022 to January 2023. It won’t fully finish up until April 2024 now:
“The overall objective of this proposal is to evaluate the feasibility of a comprehensive digital atrial fibrillation (AFib) management tool that will empower patients to a) take an active role in learning about AFib management options, starting and adhering to evidence-based therapies and lifestyle changes and b) to guide the patients during AFib episodes which are associated with anxiety and impairment in quality of life. Researchers plan to evaluate the feasibility and preliminary efficacy of this novel digital toolkit in improving quality of life and decreasing AFib burden in a pilot randomized clinical trial (RCT).”
New: Oviva’s Type II diabetes remission study via low calorie diet in the UK
Here’s an interesting new digital health study out of the UK:
“The goal of this 12-month interventional study is to analyse the clinical outcome benefits, scalability and cost-effectiveness of a digital Low-Calorie digital Type 2 diabetes mellitus (T2DM) remission program compared to usual National Health System (NHS) care.”
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