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 <<First Name>>, here's your digest for the week 

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DeciBio Weekly Digital Health Digest
Volume 7 — March 3, 2020
Happy Super Tuesday! If you're in a Super Tuesday state and haven't yet voted, we hope you find the time to do so.

Apple details upcoming Heartline study, set to be one of the largest digital health trials in history. Why 5G matters for healthcare and how Verizon is making strategic plays to dominate the space. Teladoc shatters Q4 targets as the telehealth industry continues picking up favorable tailwinds. 

Here's your roundup for the week:
Recent Headlines
Market Activity
Apple, J&J’s new Medicare study to address criticisms of Apple Heart Study
TLDR: While Apple’s seminal Heart Study produced positive results leading to the first FDA-cleared, over-the-counter ECG, the study has received criticism for over-representing low-risk (i.e., young) patients. For this new study, Apple will team up with J&J and real-world data and clinical trial management provider Evidation Health to track a minimum of 150K Medicare-enrolled seniors to see if use of the Apple Watch ECG alongside the Heartline app lowers risk of stroke compared to standalone use of the app.

So what? The Heartline study, open to the ~40M Americans enrolled in Medicare, will be one of the largest randomized digital health trials in history. The study builds upon the Heart Study, aiming to demonstrate that irregular rhythm notifications paired with an educational app with a data tracking dashboard can improve clinical outcomes (lowered risk of stroke, earlier diagnosis of AFib). The study has high stakes for all three partners — Apple stands to expand private Medicare reimbursement (Devoted Health began covering it last fall) and gain broader adoption; J&J will secure troves of digital biomarker and outcomes data to feed its cardiovascular drug R&D franchise; and Evidation will further refine its solution while earning greater visibility and reputation as a leader in RWD and digital trial solutions.
The 5G Revolution — Verizon’s strategic push into healthcare
TLDR: “5G”, the latest generation of mobile broadband technology, is expected to bring a quantum leap in digital connectivity, speed, and security. Verizon has been quick to recognize and operationalize 5G’s opportunities in healthcare, establishing the first 5G-enabled hospital in Palo Alto, the first 5G-enabled health innovation lab at Emory, and inking a partnership with Walmart to bring 5G to Walmart’s primary care, pharmacy, and retail operations.

So what? 5G is expected to contribute $4.5 trillion to the healthcare economy in 2035 (1.25X current U.S. healthcare spending). More specifically, 5G is equipped to enable “massive internet of things” (MIoT) and “mission critical services” applications, allowing exponential increases in the scale / scope of supported computing, performance quality, and security of remote patient monitoring, telehealth communications, real-time clinical analytics, and massive data computing and exchange. See the latest article in Fortune for 5G’s implications for autonomous driving and other non-healthcare applications.
Telemedicine to leverage 2019 momentum to drive further adoption in 2020 and beyond:
TLDR: Teladoc reported that 2019 revenues ($553.3M, up 32% YoY), visits (4.1M, up 57% YoY), and paid U.S. membership base (36.7M, up 61% YoY) beat company projections. The company has issued high-level guidance of 20-30% growth for these KPIs, with 2020 revenues expected to grow 26-28%, total visits 33-43%, and paid U.S. membership 17-23%. The company also noted expected declines in per-member per-month earnings due to onboarding of large health plans. 

In 2019, the AMA added 6 new “e-visit” codes to the 2020 CPT Codes, 9 codes for enabling virtual multidisciplinary care teams, and 2 codes for self-reported patient blood pressure monitoring. In a similar trend, CMS expanded reimbursement for telehealth services “incident to” the “general supervision” of the billing physician (i.e., allowing auxiliary members of the care team in remote locations to reimburse for telehealth services), and added 20 minutes per month of reimbursable RPM care. Telehealth advocates are now targeting proposed COVID-19 emergency legislation, requesting that the Congress push CMS to waive remaining restrictions on Medicare reimbursement for telehealth.  


So what? Telehealth appears to be reaching an inflection point, with noteworthy M&A activity, new major entrants, favorable regulatory and reimbursement trends, and growing consumer utilization (now on-par with wearable devices; see below). 
Source: Rock Health "Digital Health Consumer Adoption Report (2019)
Insulet trial paused, commercialization timeline delayed due to software glitch
TLDR: Insulet, profiled in last week’s digest for inking partnerships with Abbott and Dexcom to create a closed-loop “artificial pancreas”, has put pens down on its ongoing pivotal trial after identifying a “software anomaly” that could result in the system using an incorrect blood glucose value to inform insulin delivery dosage. The company expects commercialization to be pushed back from late 2020 to early 2021.  

So what? While the news caused Insulet’s stock to drop 4%, Insulet’s medical director and SVP, Trang Ly, highlighted that, “[Insulet’s] significant investment in mobile and cloud technology...enables [its] engineers to monitor enormous amounts of information in real-time from the Omnipod Horizon clinical trials. This information allowed [Insulet] to quickly identify, investigate, and decide to correct the issue.” Although Ly claims patient feedback has remained overwhelmingly positive, Insulet’s misstep should serve as a warning to other device and software providers that such oversight might damage already-reticent adoption of digital health technologies by patients, providers, and payors.
Funding and M&A
Headlines curated weekly by DeciBio's digital health team
Chris Lew
Senior Associate
Fanny Anderson
Associate
Tina Wang
Senior Analyst
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