Issue 139

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’s going on in FDA-regulated digital health:

• New this week: Cognoa’s prescription-only digital diagnostic for autism spectrum disorder, Canvas Dx, is listed on Kaiser Permanente’s drug formulary as Tier 3 or “non-preferred”.
• The NIH’s National Advisory Council on Drug Abuse posted a potential funding opportunity that would help fund research to prove to payers that digital therapeutics for SUD are worth paying for: “However, despite FDA approval, adoption by providers and patients remains lower than hoped, partly due to a lack of payer reimbursement… There are two reasons for the poor adoption of digital therapeutics; the first is the lack of CPT codes for SUD digital health. The second is a lack of long-term efficacy and patient outcome data… To ensure that digital therapeutics that have been or are in the development process for SUD treatment are adopted, this funding opportunity concept aims to fund clinical trials that will generate data that is convincing for payers to support adoption.”
• The FDA has awarded a number of Breakthrough Device Designations in recent weeks, including Dexcom CGM for use in hospital settings; Cardiosense for an algorithm that identifies patients at risk of decompensated heart failure; and Nesos received another one (already has it for RA) but this time for postpartum depression (according to this Linkedin post).
• Click Therapeutics partnered up with Altoida, “an artificial intelligence (AI) company pioneering next-generation neurological disease diagnostics… to bring more sensitive measures of cognition into their digital therapeutics research.”
• Only one digital health-related FDA clearance this week: A third 510(k) for NightOwl, a digital health sleep apnea monitor, manufactured by Resmed-owned Ecostsense. The clearance listing points to this clinical trial, which may hint at what changed to require an additional 510(k), (but I couldn’t figure it out before deadline).
• One more thing… Speaking of sleep: Noticed that an interesting new clinical trial from NightWare looks to study the effect the DTx for nightmares has on heart health: “A pilot clinical trial to assess the effectiveness of the NightWare digital therapeutic intervention (vibration delivered via Apple Watch) vs sham (no vibration) for treating nightmares associated sleep disturbances and cardiovascular health in adults with PTSD-related nightmares.” More on the study lead’s bio page here.

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HCPCS code (not reimbursement) arrives for prescription digital behavior therapy on April 1

Remember: Back in December (Issue 130) I reported that Pear had applied to CMS for three HCPCS codes — one for each of its commercialized digital therapeutics: reSET, reSET-O, and Somryst. The news you know: Last week (while I was out) Pear announced that CMS had created a new Level II HCPCS code, A9291, for “Prescription digital behavioral therapy, FDA cleared, per course of treatment.” Three things to highlight about this development:

• Back in December, I dug into why Pear wanted HCPCS codes even though the AMA had already created CPT codes for remote therapeutic monitoring. (Re-read that issue here if that’s still unclear.)
• Pear asked CMS to create three HCPCS codes but CMS decided to create just one generic one for all prescription digital behavior therapy products.
• While CMS says the creation of this code will be helpful to non-Medicare payers looking to process billing for these products, the catch-all category will likely have an impact on how CMS prices PDTs in a future fee schedule (should such a day ever come to pass).

One HCPCS code to rule them (PDTs) all

The HCPCS code that CMS created — A9291 — puts all prescription digital behavior therapy into the “Miscellaneous Supplies and Equipment” category along with subcutaneous glucose monitor sensors, wigs, non-prescription drugs, artificial saliva and exercise equipment. Pear asked CMS to create three, tailored HCPCS codes that each read like a generic description for a niche product category, but hewed very closely to Pear’s three PDTs. For example, here’s Pear’s proposed description for a HCPCS code that reSET-O could use:

Speculation: In December I thought Pear’s request for these three codes was mostly a move to box-out competitors with PDTs in the market (or close to market), but the creation of a unified code for all prescription digital behavioral therapies across therapeutic areas will likely have a big impact on the price point that CMS may someday assign to PDTs in some future fee schedule. So maybe Pear was (also?) angling to preserve its pricing strategy.

Better Therapeutics, another prescription digital therapeutics company that SPAC’d onto the public markets last year, also celebrated the news of the new HCPCS code. Better indicated the code would be helpful when commercializing its first prescription digital therapeutic, BT-001, which aims to use cognitive behavioral therapy to treat the “behavioral root cause of type 2 diabetes”. (It expects to submit for a De Novo clearance in Q2 or Q3.)

If CMS does decide to assign a value to this HCPCS code in the future (and it decides that there is currently no comp for it in the existing fee schedule), then it will look to how private payers have priced any and all products paid for via the code.

But are treatments for diabetes, insomnia, substance use disorder, and opioid use disorder typically reimbursed at the same price points?

There’s the rub for higher-priced PDTs.

(I’m curious to hear any thoughts about this. Hit reply if you have any.)

To be clear, this new HCPCS code does not suggest that Medicare is any closer to paying for PDTs. CMS even made this distinction in its decision to create the code (emphasis is mine):

And while the new HCPCS code it goes into effect on April Fool’s Day (this year) — it’s really happening.

Clinical trial updates: MedRhythms, Bold Health, Better, Affect, Oui, Noom, and WW

This is a recurring feature of E&O Fridays that digs into new digital health-related clinical trials as well as updates to others E&O mentioned in previous issues.

MedRhythms is now recruiting 40 participants for its acute stroke DTx pilot study:

Here’s a description of MR-010:

Bold Health begins recruiting for Zemedy trial: Bold is now recruiting for its interventional trial for its Zemedy CBT program for people with IBS.

Better Therapeutics’ new 500-participant RCT for Phoenix PDT for T2D

Here’s a new trial from Better:

Affect Therapeutics posted a completed 79-person study on a meth use disorder PDT

No results yet:

Oui Therapeutics tweaked its study for its DTx for suicide ideation

Oui removed any mention of a “sham” control in its study posting. The trial aims “to assess the effectiveness of a digital intervention in reducing suicide attempts.” The company changed this part (original in brackets):

Noom for NASH: No results yet but Noom completed its trial focused on people with Nonalcoholic Steatohepatitis (NASH).

WW with CBT vs. WW without CBT: The company formerly known as Weight Watchers also completed a study but has yet to post results. This interventional trial included a WW-only arm and an arm that went through the WW program along with CBT training. WW is now recruiting for a similar trial that focuses on kids using its Kurbo weight loss program.

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