Issue 110
Digital health research from Brian Dolan

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 this week in the world of pharma digital products and FDA-regulated digital health:

• Carrot Inc. officially announced its new FDA clearance for its smoking cessation device, the Pivot Breath Sensor. Last week (Issue 109) I mentioned this clearance but the details were sparse pre-announcement. The company says the clearance is for an expanded use claim. “Goes beyond measuring the impact of smoking cessation: The sensor has now been proven to increase a person’s motivation to quit.” While Carrot doesn’t call attention to it in its press release, the new clearance also adds language to make clear that the device is not intended to be used with other combustible, inhaled products. Its original clearance did not include the word “combustible” in this exclusion.
• The news you know: You probably already read about the Apple supplier who announced this week that its wearable sensor stack now includes noninvasive glucose-sensing, which likely points to near-term future Apple Watch capabilities. It’s surreal that an Apple supplier would dare to tout features so publicly. Makes me wonder if Apple declined to adopt them for some reason. “Rockley’s sensor module and associated reference designs for consumer products integrate hardware and application firmware to enable wearable devices to monitor multiple biomarkers, including core body temperature, blood pressure, body hydration, alcohol, lactate, and glucose trends, among others.”
• Not too many clinical trial updates this week so I’ll include two brief ones here. The VA just posted details about a trial focused on PE Coach, its mobile app companion to treatment for PTSD. “Preliminary results suggest that Veteran patients prefer to receive therapy with PE Coach and Veterans complete more recovery-oriented homework when they do. This study will randomize 124 Veterans with PTSD to treatment with or without PE Coach. The project will evaluate the effect of the app on PTSD-related functioning, quality of life, and PTSD symptoms. The investigators will test whether the app improves functioning and symptoms, increases homework, and reduces drop out.” More here.
• And a tiny update on Woebot’s RCT — it’s expected 268 enrollees now instead of 288. Here’s a refresher on Woebot’s intervention: “A Conversational Agent (CA) instantaneously available 24 hours per day, 7 days per week, ‘checks in’ with users. Using conversational tones, it encourages mood tracking and delivers general psychoeducation as well as tailored empathy, cognitive behavior therapy (CBT)-based behavior change tools, and behavioral pattern insight. Woebot’s app-based platform and user-centered design philosophy make it an optimal modality for Substance Use Disorders (SUD) treatment delivery. It offers immediate, evidence-based tailored support in the patient’s peak moment of craving.”
• One more thing… Thanks to everyone who sent in notes, questions, intel, and tips on Noom for E&O’s forthcoming report. Keep ’em coming — I’m trying to wrap the research phase up soon and the Noom investor deck you still have from 2015 is probably the missing piece of the puzzle… send it my way!

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CMS proposes remote therapeutic monitoring reimbursement: Here are the dollar amounts

Well, we are getting close to a conclusion on this story, which E&O has been tracking since August 2020 (Issue 064) back when the AMA CPT Editorial Meeting was set to discuss a bunch of new digital health-related codes that ended up producing a new set of codes for non-physiologic remote monitoring under the label of “remote therapeutic monitoring services” or RTM.

The big news this week: The Centers for Medicare and Medicaid Services (CMS) has published its proposed Physician Fee Schedule for 2022 and it includes reimbursement for these five RTM codes on parity to the existing RPM codes.

(But first: I’ve included this paragraph in a few prior issues, but if you’re not familiar with the CPT system, the AMA owns a copyright on CPT codes. It also convenes various medical specialty societies to come together throughout the year to decide which new codes are needed, which codes need to be updated, and which should be removed. This explainer on CPT codes is a good resource to understand their importance, the different types of classes of codes, and more.)

Background on RPM: You probably have heard about these four CPT codes for “Remote Physiologic Monitoring Treatment Management Services” (99453, 99454, 99457, and 99458). These have been around for a few years now and CMS even reimburses for services billed using them. One of the key things about these RPM codes is that they only apply to the capture and monitoring of “physiologic” data, which is generally understood to mean a signal that is generated by the human body (think: blood glucose levels, ECG, blood pressure, and so on). The fully revealed descriptions of the five RTM codes are also new this week. Prior to the fee schedule document, it wasn’t precisely clear what each of the codes included — and why there were two supply codes. Here’s a quick rundown of each along with the amount of reimbursement that CMS has proposed for each:

• 989X1 (Remote therapeutic monitoring (e.g., respiratory system status, musculoskeletal system status, therapy adherence, therapy response); initial set-up and patient education on use of equipment), $22.50
• 989X2 (Remote therapeutic monitoring (e.g., respiratory system status, musculoskeletal system status, therapy adherence, therapy response); device(s) supply with scheduled (e.g., daily) recording(s) and/or programmed alert(s) transmission to monitor respiratory system, each 30 days) $45.00
• 989X3 (Remote therapeutic monitoring (e.g., respiratory system status, musculoskeletal system status, therapy adherence, therapy response); device(s) supply with scheduled (e.g., daily) recording(s) and/or programmed alert(s) transmission to monitor musculoskeletal system, each 30 days) $45.00
• 989X4 Remote therapeutic monitoring treatment, physician/other qualified health care professional time in a calendar month requiring at least one interactive communication with the patient/caregiver during the calendar month; first 20 minutes $30.56 (facility) and $51.38 (non-facility)
• 989X5 Remote therapeutic monitoring treatment, physician/other qualified health care professional time in a calendar month requiring at least one interactive communication with the patient/caregiver during the calendar month; each additional 20 minutes $30.56 (facility) and $41.31 (non-facility)

Two codes specific to MSK and respiratory remote therapeutic devices: One of the questions I’ve had is why there were two supply codes, and it turns out that each of them is narrowly tailored. I bolded the text above, but 989X2 is a supply code for respiratory remote therapeutic monitoring and 989X3 is a supply code for musculoskeletal therapeutic monitoring. (These devices must meet the FDA’s definition of a medical device to qualify for this reimbursement.) This makes some sense in hindsight because, at the very beginning of this process, the RTM codes were formed in part by combining code applications specific to respiratory and MSK (Issue 085). The question now is whether this means every subcategory of remote therapeutic monitoring will now have to lobby for their own supply codes? Sure looks like it.

Three codes for all remote therapeutic monitoring: While the two supply codes are specific, the three other codes apply to the broad category of remote therapeutic monitoring. They list out MSK, respiratory, therapy adherence, and therapy response as examples of the category, but the descriptions are open-ended and include non-physiologic remote monitoring writ large.

Which healthcare professionals can use these billing codes? Remember, this is the proposed fee schedule — not the final. One of the issues CMS asks the industry for help with is which healthcare professionals (are likely to and) should be able to bill for these services. I won’t get into the weeds here because it is a little over my head, but the proposed fee schedule points out that some of these remote therapeutic services are most likely to be managed by physical therapists and nurses. However, as written, the RTM codes would not pay PTs or nurses for these services — only physicians and a few other medical professionals. Resolving that is one area CMS is looking for comments from the industry.

What’s next: Comments are due by mid-September and then we’ll see how the final fee schedule looks. This marks the opening of a new front for fee-for-service reimbursement of remote monitoring beyond the strictly defined physiologic remote monitoring programs of the past few years. What do you think of the proposed reimbursement for these RTM codes?

Orexo books $46K in DTx revs in H1, cites social media targeting policy changes as new marketing challenge

Swedish pharmaceutical company Orexo reported results for the first half of the year, and revenues from its fledgling digital therapeutics business have so far reached about $46,000. About three-quarters of that revenue came in during the second quarter while the rest trickled in at the beginning of the year. Orexo is currently marketing two digital therapeutics: vorvida for alcohol use disorder and deprexis for depression. Orexo’s partner GAIA developed both programs.

Sales of vorvida contributed almost all of the H1 revenues from the digital therapeutics business with deprexis contributing a negligible amount. Both digital therapeutics are currently available on Orexo’s website direct-to-consumer without a prescription.

Social media targeting promotions stymied: Move to patient communities marketing

The most interesting piece of information in Orexo’s halftime update was related to its social media marketing campaign, which was off to a great start before the company had to pull the plug: “During the start of the quarter, we adjusted our marketing activities and targeted social media promotion, which led to some increase in sales. However, new guidelines from the social media platforms, effective in April, made targeted promotion of products associated with substance use disorder and mental health more difficult due to ethical and stigma concerns. This has limited our ability to expand these efforts and we’re now developing new cost-efficient promotional concepts to reach people suffering from alcohol misuse or depression. One of these new concepts is our partnership with Sober Grid announced this week enabling us to better reach our target groups.” Sober Grid is a patient community for people in addiction recovery that counds 300,000 users worldwide. Orexo says the agreement makes Sober Grid a new sales channel for vorvida and deprexis. Marketing campaigns via Sober Grid are set to begin in Q3.

Orexo inks deal with Trinity Health North Dakota

Orexo provided free access to vorvida and deprexis to patients at Trinity Health facilities in North Dakota during the pandemic. The program led to a commercial agreement:

Orexo said it also has commercial agreements in place with a clinic in NYC and one in St. Louis. The company also announced a deal with an unnamed, self-insured “large tech company” back in Q1. Orexo says that deal is now in the implementation phase. More in its H1 report here.

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