Issue 121

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 going on this week in FDA-regulated and pharma-related digital health:

• Pear Therapeutics announced a value-based agreement for reSET and reSET-O with PBM Prime Therapeutics this week, but E&O readers knew about this one back in June — just a few weeks after the ink was dry on the contract. This is a big deal for the company: Prime is owned by 10 Blues plans, including Florida Blue, BCBS of Alabama, Capital Blue, and BCBS Minnesota. The PBM serves 23 additional Blues too as well as big employers like Hormel, Boeing, and General Dynamics.
• One soundbite that jumped out for me at this week’s DTx East event came from Ryan Lawton, Chief Architect, Blue Shield of California: “One challenge, even in the prescription digital therapeutics space, is that while they have shown efficacy they haven’t quite figured out yet how not to contribute more to medical spend. This idea of replacement therapy is an idea that still needs a tremendous amount of focus.”
• Akili announced the topline results of its Phase 2 study of SDT-001 (the Japanese version of the PDT branded as EndeavorRx in the US), which it is commercializing via its partner Shionogi. From the release: “The SDT-001 treatment group showed larger improvements across the clinical endpoints compared to both the TAU and the Sham groups. In the total population, the improvements seen over Sham did not meet statistical significance, but post hoc analysis applying the propensity score suggested that SDT-001 improvements over TAU were statistically significant.”
• MedRhythms inked a partnership with Universal Music Group, which landed them in Rolling Stone. The company’s prescription digital therapeutics use music as part of stroke rehab, for example, and: “Research supports that preferred music content increases adherence to treatment and improves therapeutic outcomes, which is why providing patients with music they enjoy is a critical component of the system and why the company’s partnership with UMG is meaningful and important.”
• In its comments about the proposed Physician Fee Schedule for 2022, Smith+Nephew asked CMS to bump up reimbursement for MSK devices via the forthcoming Remote Therapeutic Monitoring CPT code. S+N really swung for the fences here: “In particular, we are concerned that CPT code 989X3 is not properly valued with a proposed 2022 APC payment rate of $38.18. This does not take into account the cost of the $600 monthly fee for the 3D virtual exercise rehabilitation device unit for musculoskeletal physical therapy. HOPDs will not be able to provide this service, billed once monthly, to their patients recovering from total joint arthroplasty unless the APC rate is appropriate. Therefore, we urge CMS to assign CPT code 989X3 service to APC 1545 (New Technology – Level 8) with a payment rate of $650.50. This would cover the monthly cost of this providing this technology to beneficiaries undergoing virtual rehabilitation from total joint replacement.”
• Health Advances has a worthwhile write-up of the FDA’s recent publication of a database that attempts to capture all FDA-cleared AI-enabled devices.
• Just this evening the FDA posted a paper on how medical device companies should share cybersecurity vulnerabilities with their patients. (This will make for some fun weekend reading.)
• One more thing… If you’d like to have your say about how medical device regulators around the world should think about AI and medical devices, well, good news: The International Medical Device Regulators Forum (IMDRF) Artificial Intelligence Medical Devices (AIMD) Working Group is currently soliciting feedback on terms and definitions related to “machine learning-enabled medical devices”. More here.

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AMA’s CPT Editorial Panel met this week: Here are three proposed codes they didn’t advance

While the American Medical Association’s CPT Editorial Panel meeting took place this week, the outcome from the meeting won’t be publicly known for a few weeks. A last-minute update to the meeting’s agenda, however, (which is typical for these meetings), showed that the group decided not to debate a handful of proposed CPT codes at the meeting. Three codes that the AMA group decided to withdraw just before the meeting this week:

• Digital Behavioral Therapy Management: “Establish code 99XX0 in the Evaluation and Management section to report digital behavioral therapy management using an online cognitive behavioral program.”
• Cat III – Digital Pain Management Therapy: “Establish code 0X99T to report augmented reality mobile application for rehabilitative pain control.”
• Cat III – Automated Cognitive Health Assessment: “Establish code 0X93T to report automated cognitive health assessment.”

Trial updates: BMS, Neuroglee, MedRhythms, Apple, Remedee

Here’s E&O’s weekly roundup of changes and additions to clinical trials focused on FDA-regulated digital health devices and other pharma-related digital health.

Neuroglee Therapeutics to test its mild cognitive impairment digital therapy

Neuroglee is set to study the effectiveness and safety of its digital intervention for patients with mild cognitive impairment (MCI). It will also recruit cognitively normal participants to receive the same intervention:

Remedee’s RCT for wearable and app that treats fibromyalgia

Remedee hopes to enroll 170 participants in its RCT, which will include a group that gets access to its offering immediately and one that will be in a waitlist control group.

Small update: MedRhythms expects its 40-participant MR-010 study for stroke rehab to kick off this month instead of July 2021 as originally planned.

Pack Health and BMS study health coaching for patients after CAR T cell therapy

Apple whittles down its primary outcomes measure in its heart failure study

In the original iteration of Apple’s Measuring Cardiopulmonary Fitness in Ambulatory Heart Failure Patients Through the Use of Apple Watch Features (TRUE-HF) study with Toronto’s University Health Network, the primary outcome measure from the Apple Watch was:

However, in an update this week the study collaborators whittled that down to just:

Links to E&O’s reports, databases, newsletters

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