Issue 063.

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Digital health research from Brian Dolan.

Welcome to E&O.

Last week I wrote about Livongo’s first year as a public company, dug into some never-ran digital health programs from UHG, and posted a new database of prescription-only, digital therapeutics that are in the collective DTx pipeline. Here’s what’s happening this week:

• Rock Health and Natalist founder Halle Tecco posted a nostalgia-filled list of people who were working in digital health at the very beginning. I feel a little weird about being called a metaphorical grandfather of the industry at the age of 37, but, hey, I’ll take it. Lots of worthwhile people to follow on Twitter in this thread.
• Thanks for all the great feedback from subscribers on the Prescription DTx database, including ideas for new columns that will add more context (working on those now). I’ve since added a few companies’ pipelines that I missed, including products from Biofourmis and Woebot Health. There are now more than 90 products (at various stages of development) listed in the database. What are mini-database would you like to see?
• More PBM news this week as CVS added more digital health products to its version of a digital health formulary, its Point Solutions Management offering, including Big Health’s anxiety digital therapeutic, Daylight. The other four additions are all weight loss focused: Two offerings from Weight Watchers, Vida’s weight loss program, and Naturally Slim.
• I meant to include this last week: Rock Health and Dr. Ivor Horn are conducting a survey to assess diversity in the ranks of digital health startups’ leadership. There are a significant number of digital health founders on this list — click here to participate.
• The FDA issued a final guidance document on regulating devices that have multiple functions. This really just solidifies part of what the Cures Act instructed the FDA to do: Read it here.
• Another Cures Act solidification: The FDA published a final order related to a few more Class II device categories that will be exempt from 510(k). The list includes one category that may be relevant for some MSK-focused digital health companies: Interactive Rehabilitation Exercise Devices.
• One more thing… Last week I noted that Livongo was eyeing chronic kidney disease (CKD) as one of its next targets, and since then two heavyweights have announced CKD deals: Humana inked a two-state deal with Strive Health for kidney care disease coordination. And Baxter strengthened its existing partnership with Ayogo: “Ayogo is combining LifePlan—its unique behavior-based digital platform—with Baxter’s expertise in renal care to build mobile apps and digital solutions that bring personalized, relevant and timely support to patients with kidney failure.” Baxter also took an equity position in Ayogo as part of the deal.

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Lobbying activity and a new study suggest Livongo is ramping up focus on diabetes prevention

With a (maybe?) looming IPO from one of Livongo’s biggest competitors, Omada Health, Livongo seems to be ramping up its focus on its diabetes prevention program (DPP).

Livongo added DPP via its acquisition of Retrofit in early 2018, but its investor presentations and SEC documents focus on Livongo’s diabetes management program and don’t usually provide growth metrics related to DPP.

That may change soon.

Just look at its lobbyist spend. Livongo spent $110,000 lobbying the federal government during the first six months of the year, while it spent just $20,000 for all of 2019.

Last year Livongo’s lobbyists focused on “support for expansion of the Medicare Diabetes Prevention Program (DPP). Medicare reimbursement issues. Issues regarding privacy. Health information technology issues.”

This year Livongo lobbied on the same issues — including Medicare coverage of DPP — but also on the CARES (“Coronavirus Aid, Relief, and Economic Security”) Act. But it’s on track to spend more than 10 times as much on lobbying as last year.

(Medicare’s lack of coverage for digital diabetes prevention programs is a saga I covered in The Omada Health Report. Notably, Omada spent $215,000 exclusively on lobbying in 2017 to try to secure Medicare coverage of its DPP. Based on lobbyist records, Omada hasn’t spent any money on federal lobbying since then.)

In addition to the uptick in lobbying about DPP, Livongo also just published (https://www2.livongo.com/news/preventing-diabetes-through-a-consumer-directed-virtual-care-model) a new clinical study about its diabetes prevention program:

The company’s study pointed to food logging as the top predictor of weight loss, and, perhaps surprisingly:

One final piece of Livongo news that seems to indicate the company is considering its competitive positioning against Omada right now is an interview Livongo chairman and founder Glen Tullman gave to Forbes this week, entitled “When your company should IPO and other advice from unicorn Livongo’s founder.”

Tullman says: “A lot of companies go public and they think everything is going to be the same. And, in fact, a lot changes. You have now a quarterly report card that you get, and if that’s not up, you are dealing with a lot of press, and you’re dealing with customers who might be concerned. So, the management of the company gets more complicated.”

Hinge Health to hire 100+ PTs and docs for a virtual MSK clinic that better competes with Omada-Physera

Another company that seems to have Omada on the brain is Hinge Health.

The MSK-focused digital health startup seems to have answered Omada’s recent acquisition of Physera by revealing plans to hire 100 physical therapists and physicians to become a virtual MSK clinic by 2021.

Here’s how Hinge summed up the current digital MSK market:

That list tracks pretty well with my write-up of the MSK market from May.

Here are the new programs Hinge aims to offer by 2021:

“Prevention: tailored to each employer population, job-type specific, and covering 90% of job types in America

Acute/episodic: covering all joint & muscle groups with unlimited access to 1-on-1 virtual-sessions with our Physical Therapists

Surgical: covering pre/post-surgical rehab for the most common MSK surgeries”

Hinge notes in its announcement that it quadrupled its customer base in the past 12 months and now has nearly 200 enterprise customers. When I published the Hinge Health Report in April, the company had more than 100 customers. It had around 50 in mid-2019, which tracks with the company’s quadrupling claim above.

It is striking that Hinge Health is revealing this roadmap six months ahead of the hoped-for launch. I think moving into mental/behavioral health programs is a likely second vertical for Hinge once it is ready to move beyond MSK.

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: Rx-only Digital Therapeutics Pipeline of Pipelines (Subscribers-only Link)
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 063 of E&O.