Issue 234

Welcome back to E&O: SaMD, a paying subscribers-only weekly newsletter focused on the world of digital pharma products, prescription digital therapeutics and other FDA-regulated digital health.

 E&O: Software as a Medical Device

• Starting in July 2024, Mahana Therapeutics’ IBS-focused prescription digital therapeutic was priced and listed in the catalog that the US Department of Veterans Affairs uses for procurement. (Correction: The original wording of this blurb mistakenly used the term “secured reimbursement” which is not the same thing as a listing in the MedSurg catalog.) The list price for Mahana IBS in the VA catalog is $195.01 per 90 days of treatment, which isn’t too far off from its out-of-pocket price on its own website — $199.
• Over in Germany, the country’s nationwide formulary for reimbursed digital health programs (DiGA), the government changed its price for Bayoocare’s tinnitus-focused app from €449 to €260.
• It seems like the recent AMA CPT Editorial Panel meeting may have accepted some or all of the proposed changes to the Remote Monitoring codes that I reported on back in July. Those included: “Revise the Digitally Stored Data Services/Remote Physiologic Monitoring guidelines; add a remote physiologic monitoring device supply code (99XX4) for 2 to 15 calendar days; revise code 99454; revise the Remote Physiologic Monitoring Treatment Management services guidelines; add a new code (99XX5) for remote physiologic monitoring treatment management services to include 10 minutes of service; Revise codes 99457, 99458; Revise the Remote Therapeutic Monitoring Services guidelines; revise codes 98975, 98976, 98977, 98978; add remote treatment monitoring device supply codes (98XX4, 98XX5, 98XX6) to report respiratory, musculoskeletal and cognitive behavioral therapy for 2-15 calendar days; revise the Remote Therapeutic Monitoring Treatment Management services guidelines; add a new Remote therapeutic monitoring treatment management services code (98XX7) to include 10 minutes of service; revise codes 98980, 98981.” More on the actual changes next month.

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Ancient history: How Proteus Digital Health priced its smart pills for Tennessee’s Medicaid program

Sword Health’s recent claim that it was pioneering outcomes-based pricing in digital health reminded me about a deal that (now bankrupt) Proteus Digital Health inked before the pandemic. (If you’re not familiar with Proteus, re-read this report E&O wrote a few years ago.) A 2019 agreement the company signed with Tennessee’s Medicaid program focused on medication compliance among patients with Hepatitis C. TennCare agreed to pay Proteus for each patient “cured” with a premium price paid for curing patients in the “harder to reach” bucket. Tennessee defined a harder to reach member as one who ticked the box on at least three of these:

• active alcohol or substance abuse
• hospitalization within past 2 years for a behavioral health-related comorbidity
• previous evidence of nonadherence to medications
• previous unsuccessful treatment of Hepatitis C due to medication noncompliance
• unstable housing conditions in the last 3 months
• currently employed (guessing this one was supposed to be unemployed?)

Proteus program with Tennessee Medicaid was officially a pilot program that could not include more than 250 members without prior approval to add more. Only 75 percent of the pilot participants could fall into the harder to reach bucket. Here were the pricing terms of the contract:

• $3,250 per cured hard to reach member
• $2,000 per cured general member
• $0.90 per pill

Round-up of FDA clearances and links to summary documents: Apple, Astellas, Big Health, Deepwell and more

Here’s a round-up of recent FDA 510(k)s, de novos, and listings along with links to the summary documents where available. The agency has been pretty slow to post those documents in recent months, but it seems to be back on top of them now. Read on for more on recent SaMD market authorizations…

Apple’s De Novo clearance for its OTC hearing aid feature: Apple’s “Hearing Aid Feature HAF” received a De Novo from the agency that was almost a year in the making. Apple first submitted the De Novo application in December 2023. It submitted a Predetermined Change Control Plan (PCCP) in July 2024 before receiving the De Novo in September — perfectly timed with its big conference. More on the De Novo clearance here.

No new info on Apple’s sleep apnea 510(k) — yet. More on Big Health’s Daylight 510(k) for treating Generalized Anxiety Disorder: As I noted in a past issue, it was a bit odd that Big Health used an insomnia-focused device for its predicate for Daylight. The FDA’s clearance summary document gets into that: “Daylight and the predicate Somryst have the same Intended Use as computerized behavioral therapy devices for psychiatric disorders. There are slight differences in indications for use in that Daylight is indicated for treatment of symptoms of generalized anxiety disorder, but this does not constitute a new intended use. Daylight has similar technological characteristics to Somryst, including software architecture and delivery of digital cognitive behavioral therapy through a mobile application.”

How Big Health’s Sleepio differs from Somryst: Big Health also used Somryst as its predicate for Sleepio, both digital treatments for insomnia. There is a difference between the two offerings though, which I learned by reading the summary document about the clearance: “There are slight differences in indications for use in that Sleepio is considered appropriate for transitional adolescents (18-21) as well as adults (22+) but this does not constitute a new intended use.”

Amalgam Rx’s new iSage Rx 510(k) adds support for basal insulin+GLP-1s: Earlier this summer, Amalgam Rx secured a new 510(k), which the summary document makes clear is an update that includes support for GLP-1s. “Added ‘Support for the Titration of combinations of basal insulin and GLP-1 receptor agonists’ as a new intended use.”

Luminopia’s 510(k) from August was clearance to add new Samsung VR headset: Luminopia received a new 510(k) for its amblyopia digital treatment last month and now we know why. It added support for a Samsung Gear HMD (head mounted display) VR headset. “The proposed modification is the addition of one additional head-mounted display (HMD) model to the list of compatible HMDs in the Directions For Use for the Luminopia SaMD.”

Deepwell DTx’s OTC clearance for its breathing system focused on blood pressure: A reader recently asked me if Deepwell’s recent 510(k) was likely to position their digital therapy as a Digital Mental Health Treatment device under the proposed Physician Fee Schedule for 2025. The FDA clearance document for the company’s first 510(k), while interesting, seems to indicate — no. “A Breathing System (ABS) is intended for use as a relaxation treatment for the reduction of stress by leading the user through interactively guided and monitored breathing exercises. The device is indicated for use only as an adjunctive treatment for high blood pressure, together with other pharmacological and/or non-pharmacological interventions.”

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