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.

After a number of subscribers asked me to look into it, I spent a good amount of time this week learning about the Health Assurance Acquisition Corp. SPAC that Livongo founders Glen Tullman and Hemant Taneja put together with other ex-Livongan execs and investors from General Catalyst. Let me know if you have any thoughts on the direction they will go in by hitting reply.

 E&O Fridays.

This week I had a fun 10-minute slot for a rapid-fire-side-chat as a part of HITLAB’s one-day virtual event recapping the week of JPMorgan. HITLAB posted this hilarious screenshot of me from my interview with Debra Bass from NuvoCares. (If you know a good Zoom presentation skills coach, please send them my way. Clearly, I need professional help.) Here’s what’s happening this week in the world of pharma digital products and FDA-regulated digital health:

• Fellow ampersanded company, Hims & Hers went public yesterday via a SPAC merger. Its CEO talked to TechCrunch about international expansion and more.
• Boston Scientific acquired wearable cardiac monitoring company Preventice for $925 million upfront and another potential $300 million in milestone payments. I wrote about Merck GHI Fund’s roll-up strategy for Preventice just a few weeks ago, and I actually tweeted that this acquisition was happening 52 days ago when I noticed an anti-trust government filing posted by the FTC the first week of December.
• Another big digital health deal this week was Philips’ acquisition of CapsuleTech for $635 million. Capsule used to be a part of Qualcomm Life. Philips already acquired another former Qualcomm Life asset, 2net, from Francisco Partners. Francisco sold the third piece of Qualcomm Life, an employee fitness offering, called Motion, to UnitedHealth. Depending on what 2net and Motion went for — Francisco may have gotten close to a 10x return on its Qualcomm Life acquisition. (That’s assuming it didn’t invest anything more into the assets since acquiring them from Qualcomm.)
• London-based Ampersand Health made available a digital therapeutic in the UK for people with inflammatory arthropathies, including rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. My Arthritis DTx uses techniques from cognitive behavioral therapy and acceptance and commitment therapy as well as mindfulness.
• Renovia, which develops digital therapeutics for female pelvic floor disorders, announced that it completed patient enrollment (350 people) for its all-virtual randomized controlled trial one month ahead of schedule.
• The Digital Therapeutics Alliance announced it was working with BeMedTech (sort of the AdvaMed of Belgium) to help it figure out regulation and reimbursement of digital therapeutics in that country.
• Calm’s co-founder and co-CEO says the company’s app has been downloaded 100 million times as of this week.
• JMIR published results from a 100-person observational study that tested Akili Interactive’s EVO Monitor: “These findings suggest that EVO Monitor, an unsupervised, video game–based digital program integrated with adaptive mechanics, is a clinically valuable approach to measuring cognitive performance in patients with multiple sclerosis.”
• One more thing… I missed this last week. Amalgam Rx, which was founded by the same team that created Welldoc, acquired a clinical decision support (CDS) company, Avhana Health, which has “deep integrations” with EHRs: “Amalgam Rx will expand Avhana’s CDS tools to multiple therapeutic areas and combine them with other digital solutions to simplify doctors’ workflows.”

Did someone forward this newsletter to you? This link is for you then.

Five new “remote therapeutic monitoring” CPT codes set to join existing RPM codes

(This may get a little wonky, so I’ll try to keep it short. As always, talk to an expert on this front, but I wanted to point something out if your team wasn’t aware yet.)

As I reported back in August 2020 in Issue 064, in October the AMA Editorial Meeting was set to consider nine digital health-related codes — updates to existing ones and new ones. As expected, most of those were withdrawn in the end or rejected outright.

However, a few of them have been combined into a new group of CPT codes that will likely become important to a broader spectrum of digital health companies than previous ones.

(First: 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.)

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).

What’s notable about the moves made this past October at the AMA’s Editorial meeting is that this new group of codes, (which originally looked to be an effort to modify the language of 99091 to maybe include non-physiologic data in RPM?) emerged with the names “Remote Therapeutic Monitoring Services” and “Remote Therapeutic Monitoring Treatment Management Services.”

That one word — “therapeutic” — may open up these codes to a greater number of digital health companies. After all, describing a digital health service as “therapeutic” is much broader than having to prove it captures a “physiologic” signal.

For a hint as to what these codes may include, a few other proposed codes for “Remote Patient Status Monitoring,” “Remote Respiratory Status Monitoring Services,” and “Remote Physical Therapy Services” were all folded into these five new Remote Therapeutic Monitoring codes.

Like the existing RPM codes, the new RTM CPT codes correspond to three kinds of services. Here are the notes related to the new codes from the October AMA meeting:

What’s odd is that there are five of these therapeutic codes vs. four of the old physiologic ones. For the physiologic codes, two of them were related to time spent on the services, so I’d imagine two of the therapeutic ones will also correspond to time spent. Does that mean two of the therapeutic codes will correspond to “device supply”? It’s not clear why there’s a need for that.

Since all of the above happened in October, it’s likely these codes have already been assigned dollar values by the RUC, the group of physicians that decide what new and updated CPT coded services are worth. Then CMS needs to decide if they will add them to their proposal for the 2022 Physician Fee Schedule, which is likely the next time we can learn anything new about them.

If nothing else, these new CPT codes will help track utilization of more digital health services beyond those that included a body-generated physiologic data signal. Higher utilization could help drive future reimbursement of the codes by CMS.

The AMA keeps a tight lid on new CPT codes so it’s pretty much impossible to get anyone who knows anything to explain these to me, but it’s safe to say this is progress for more potential digital health reimbursement — at least on the fee-for-service front.

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