Issue 061.

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Digital health research from Brian Dolan.

Welcome to E&O.

Last week I wrote about PPP loan applications, Orexo’s accelerated timeline, and a few curious clinical trial developments. Here’s what’s happening this week:

• I heard from a reader who clarified that the AMA letter I mentioned last week re: their request for coverage of self-measured blood pressure monitoring was specifically about extending coverage to the connected BP devices themselves — not the monitoring. I had it right, but I could have worded it better to stress that nuance.
• In other policy news, CMS Administrator Seema Verma wrote an article that hinted at what’s to come for telehealth and telemedicine coverage and accessibility post-pandemic. It reads as if: some telehealth will likely be restricted again (first-time visits for acute patients); payment will likely not stay at parity; CMS needs to protect taxpayer dollars from unscrupulous actors. Verma also shared some utilization numbers — 9 million Medicare beneficiaries had some kind of telehealth service between mid-March and mid-June.
• Meanwhile, a US House bill looks to add a 90-day extension to the current CMS coverage of telehealth. (That’s 90 days beyond the end of the pandemic, whenever the federal government declares it to be over.) More importantly, the bill would permanently remove the “rural health” and “federally qualified health center” provisions of CMS coverage for telehealth, which would allow for coverage of home-based telehealth. Read the bill.
• Belgium, where I spent my last two years of high school, is the latest European country to make progress on the digital therapeutics reimbursement front: The self-described mobile health application, moveUP, is fully-reimbursed now in Belgium for knee and hip replacement follow-up care. (If in a less-socially-distanced-future, any subscriber would like to talk digital health over a bottle of Cantillon, count me in.)
• Pear Therapeutics announced that it enrolled its first patient in its nine-week, Somryst clinical trial for chronic insomnia. Trial info here.
• Speaking of sleep: Verily looks to be ramping up its years-in-the-marking joint venture with Resmed to form a new company focused on sleep apnea. The NewCo is hiring a General Manager: “NewCo is a joint venture between Verily, an Alphabet Company, and ResMed. NewCo’s mission is to identify, enroll, and engage patients with breathing-related sleep disorders to improve outcomes. The General Manager of NewCo will be ultimately responsible for developing and growing NewCo into a viable business to realize its mission.”
• Following the official EU launch of a Propeller-Novartis combo product last week, here comes Teva… Teva Respiratory, a US affiliate of the pharmaco, announced the US launch of ProAir Digihaler Inhalation Powder, a “digital rescue inhaler indicated in patients four years or older for the treatment or prevention of bronchospasm who have reversible obstructive airway disease, and for prevention of exercise-induced bronchospasm (EIB). The device features built-in Bluetooth Wireless Technology sensors, which connect to a companion mobile app and provide inhaler event information.”
• Finally: The CMS Physician Fee Schedule for 2021 is late. I hear all eyes are on what CMS does with AI, or as CMS calls it “Augmented Intelligence” (huh?). Guessing the many pandemic policy changes made it difficult to get the fee schedule out on time?

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UnitedHealth confirms Optum acquired AbleTo, and UHG also quietly bought Pacifica Labs last year

CNBC’s Christina Farr reported in April that AbleTo was about to be snapped up by UnitedHealth’s Optum for about $470 million, but — up until two days ago, anyway — no official announcement materialized.

This week UnitedHealth briefly mentioned the deal in its Q2 earnings report:

On the earnings call, UnitedHealth Group’s CEO David Wichmann discussed digital behavioral health and the rise of remote care, but made no mention of the AbleTo acquisition that will support his company’s efforts in that area. Here’s what he said:

A quick P.S. — One piece of UnitedHealth’s portfolio that is related to AbleTo is its mental health offering, Sanvello. I’m not sure United has really hidden the fact that they own Sanvello, it’s well-marked on Sanvello’s website. At the same time, a fairly well-known startup, named Pacifica Labs, announced that it had rebranded as Sanvello back in June 2019 without mentioning an acquisition or UnitedHealth. Pacifica tweeted:

“It’s not just a rebrand” was right.

What actually happened was UnitedHealth acquired Pacifica and relaunched it as Sanvello. I’m curious to see how AbleTo and Sanvello complement each other now that they are both key pieces of UnitedHealth’s digital behavioral health offering.

Before Level2: A brief history of UnitedHealth’s ever-evolving digital diabetes programs

UnitedHealth’s other big news this week was the launch of a long-awaited digital diabetes program, called Level2. On the face of it, this is UnitedHealth’s attempt to compete with Livongo Health and Virta Health.

UnitedHealth also mentions real-time insights — a staple of Livongo’s marketing — and that some of Level2’s early users have gone into remission and no longer need medication for their Type 2 diabetes. That’s Virta Health’s positioning.

Level2 seems to stress incentives as a key piece of its program. If permitted in the participant’s state, they could earn financial incentives, like cash or gift cards for simple things like interacting with their coach, consistently wearing their CGM, or going for a walk.

Curiously, UHC describes Level2 as a “pilot” program. For now, it is available at no additional cost to “230,000 employer-sponsored, fully insured UnitedHealthcare members in 27 states and Washington, DC.” It plans to open Level2 up to some self-insured employers by year-end.

UnitedHealth has something of a long history with digital diabetes programs, however, most of its better-known dalliances over the years were more focused on diabetes prevention. Just as Omada Health was beginning to get a foothold in the market, UnitedHealth started down a similar path.

United built on its in-person diabetes prevention programs with the YMCA by building its own online DPP program, named Not Me, with a digital health startup named Jiff. Not Me was short for “Tell Diabetes Not Me” and it got started around 2013. Before that, Not Me was actually a TV documentary about diabetes prevention, and so the online version had some elements of Omada’s initial DPP program but the heart of Not Me was watching the 16 episodes of the TV show, which was a documentary about six people working their way through a diabetes prevention program. GE was the first employer to offer Not Me to its employees.

By mid-2014, UnitedHealth rebranded Not Me to LoseUWin, with the tagline: “When you lose, you win.”

Within two years, LoseUWin was replaced by Real Appeal, a more generically marketed weight loss program powered by a newer UnitedHealth acquisition, Audax Health. Audax was rebranded as Rally Health, which is still a part of UnitedHealth’s portfolio today.

Real Appeal’s homepage claims the program has had more than 700,000 participants over the years, and it makes no mention of diabetes or diabetes prevention.

Just as UnitedHealth’s fickle DPP lineup over the past seven years tracked with the rise of diabetes prevention in general (and Omada Health, specifically), its Level2 launch might be seen as a reaction to Livongo and Virta’s success in more recent years.

Bristol Myers Squibb’s MyHOPE digital therapeutic for Multiple Myeloma set for Q3 launch

Update: Be sure to read the last paragraph of this post for a response from BMS.

In November 2019, Bristol Myers Squibb completed its acquisition of Celgene. One Celgene digital health project, called MyHOPE for Multiple Myeloma, is among those still in the works.

BMS is hiring a few people to build out the team supporting MyHOPE, which the posts describe as “an active digital therapeutics program” where BMS is creating a “software as a medical device app/capability” for people in clinical trials for Multiple Myeloma.

MyHOPE has been active since 2019 when Celgene started it up. The job posts describe it as being in its “development phase”, but its first release is only months away:

Update: Following the publication of this issue of the E&O newsletter, a spokesperson from BMS emailed me and asked me to remove the timeline I found in the job posting. BMS described the Q3 2020 first release timeline as “inaccurate” information posted by a “third party vendor” (a recruiting firm). I asked for the correct timeline, but the company said that was “confidential” information.

It’s worth noting that I sourced this post from a combination of job postings. Some listed BMS as the hiring company, while the ones with more information, like the Q3 timeline, did not. Those blinded postings referred to a DTx for Multiple Myeloma in a New Jersey location. So, you understand the company line on this now. Suffice to say, I’m curious to see what the launch date turns out to be here.

Quick links: E&O research reports and databases

The links below aim to make it easier for paying subscribers to find the long-form research reports and databases on the E&O site:

Database: Digital Health PPP Loans (Open access)
The Proteus Digital Health Report (Subscribers-only Link)
The Hinge Health Report (Subscribers-only Link)
The Digital Health Enrollment Report (Subscribers-only Link)
The Omada Health Report (Subscribers-only Link)
The Google Health Report (Subscribers-only Link)
The Pear Therapeutics Report (Subscribers-only Link)
The AliveCor Report (Subscribers-only Link)
Apple’s Healthcare Work Experience (Subscribers-only Link)
Approximating Livongo’s S-1 (Subscribers-only Link)

That’s a wrap on Issue 061 of E&O.