Issue 181

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 are two recent happenings in FDA-regulated and pharma-focused digital health…

• The FDA cleared non-profit Tidepool’s automated insulin dosing app, named Tidepool Loop, which intended for the management of type 1 diabetes. Tidepool originally submitted the app via the 510(k) process in December 2021. The clearance makes the app available to users six-years-old and older. Tidepool might be best known as one of the handful of organizations that secured a spot in the FDA’s Pre-Cert program.
• Pear’s lobbyists at work? The Minnesota state legislature is considering a bill that would add prescription digital therapeutics to the list of covered services in its Medicaid program. Read the language of the bill here.

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Highmark isn’t going to pay for every FDA-cleared prescription digital therapeutic

Remember: Back in October Highmark, a health insurance company with about 6 million members in Delaware, New York, West Virginia and Pennsylvania, posted a medical policy that indicated it would start paying for FDA-cleared, prescription digital therapeutics. The medical policy listed nine prescription digital therapeutics that had been cleared by the FDA at the time of the policy’s creation. I caught up with Highmark’s Senior Medical Director Matt Fickie M.D. this week to clear up a few questions I had about the policy. Turns out, there’s a lot more nuance here than it seemed at first. Here’s a summary with highlights from our conversation:

Did Highmark’s work with Freespira inspire this medical policy? I asked Fickie if Highmark’s years-long collaboration with pioneering digital therapeutics company Freespira inspired the creation of this medical policy. He confirmed that some of the same people who worked on Freespira’s clinical studies were involved in this policy’s creation, but noted that Freespira was in a slightly different category because it does not require a prescription like the digital therapeutics covered by this policy.

Actually, HCPCS code A9291 was the triggering event: I should have guessed this, but the triggering event for this medical policy was the creation of the A9291 HCPCS code. Fickie said Highmark began working on this medical policy in April 2022 shortly after CMS created the new billing code. Highmark — like many other health insurance companies, I’m sure — was worried about a flood of billing claims from digital health companies that thought this new HCPCS code might apply to them. This new FDA-cleared PDT medical policy was partly intended to nip that in the bud.

More details on the multi-specialty panel that created the policy: Fickie explained that the multi-specialty panel of experts that developed the medical policy included people from the various functions of the health insurance company. So, the group included experts in areas including new technology assessment, reimbursement policy, medical policy, pharmacy policy, and contracting. The group also included clinicians with general medicine and behavioral health backgrounds. (These next two sections are probably the most important.)

FDA clearance is just Highmark’s starting point: Fickie explained that Highmark chose to use FDA clearance as an initial requirement because there are too many digital health-focused evidentiary standards floating around. At his last count, his team had found about 70 frameworks. Requiring FDA clearance is just the starting point for this reimbursement process, however. Highmark will do its own review of clinical utility. It’s not solely relying on the FDA to assess clinical utility because the FDA is more focused on safety.

Will Highmark pay for all FDA-cleared prescription digital therapeutics? No. This is not blanket coverage for the FDA-cleared prescription digital therapeutics listed in the medical policy. It also doesn’t mean FDA clearance is the only bar for Highmark — it’s just its starting point. The FDA-cleared prescription digital therapeutics listed in Highmark’s first iteration of the medical policy are examples of the types of devices relevant to the medical policy. If your PDT is not yet FDA-cleared, then Highmark likely won’t discuss reimbursement under this medical policy with you. The next iteration of the medical policy will likely show which companies and products specifically gained reimbursement.

Highmark’s process for assessing PDTs: Highmark is currently in the process of conducting new technology assessments for each of the prescription digital therapeutics that have sought reimbursement from the payer. (So, that means Pear is likely undergoing three separate ones for its three PDTs). If they pass that assessment, they are referred to the contracting team at Highmark where they’ll be doing some credentialing work. (This is new ground for Highmark — how do you credential a digital therapeutics company? Fickie said their evolving standard will include things like how data is shared and stored along with other indicators of a company’s ability to operate as a healthcare company and not just a tech company.) Then it moves on to contracting where they will discuss appropriate billing codes to use and frequency.

Hints at Highmark’s strategy for selecting PDTs to cover: Fickie was quick to point out that although this medical policy appears to be a boon for prescription digital therapeutics makers, Highmark developed the policy because it believes it will serve its members. Highmark didn’t create the policy to help the companies. Fickie hinted that the PDTs focused on unmet medical needs in niche and intractable areas of medicine are likely to gain reimbursement under the policy. (Speculation: This comment made me think that most if not all on the initial list of PDTs mentioned in the medical policy are likely to gain reimbursement.) Highmark’s focus here is to cover niche PDTs that might help 10 percent of their members. It’s a “precision strategy” to find “smaller pockets of opportunity”.

Is Highmark likely to pay for more than one PDT focused on treating the same condition? I asked Fickie if Highmark is likely to pay for more than one PDT for a given medical condition and pointed out that this scenario is actually a real one today: There are now two FDA-cleared PDTs focused on irritable bowel syndrome (Mahana and metaMe’s Regulora). Fickie said that Highmark is likely to pick winners in those cases because multiple options might be difficult to administer.

Did Highmark consider PDTs as being better suited for the pharmacy benefits? While the HCPCS code triggered this medical policy, which, of course, covers paying for procedures via the medical benefit, Fickie said in some cases these FDA-cleared, prescription digital therapeutics will be handled by the pharmacy team instead. (I’m curious to see if any within the initial batch of PDTs that Highmark is assessing end up going that route right away.)

Clinical trials: Mahana, Akili, Roche, Dopavision

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

Mahana Therapeutics reveals few details of Mahana Tinnitus in new clinical trial post

Mahana, which already has a prescription digital therapeutic for treating IBS through the FDA and on the market, is set to begin a clinical trial for a digital therapeutic that uses cognitive behavioral therapy to treat tinnitus. More on the study of the six-week program:

Mahana expects to finish up its study on its irritable bowel syndrome (IBS) digital therapeutic for young adults by month’s end

This study was supposed to be finished at the end of last year, but Mahana now expects to be completely done by the end of January. Like the study above, Mahana gives away precious little in its study posts. The title of this study may tell you more than anything else in the listing:

The University of Michigan studies Akili’s EndeavorRx as a potential preventive tool for depression

Here’s a small 30-person study that might help Akili build its evidence base around depression in kids 9 to 17 years old:

Roche studies how digital health tools impact outcomes and utilization in people taking anti-cancer meds

Roche does not disclose any details about which digital health tools it is using in this randomized 440-participant (anticipated) study, but figured it was worth flagging:

Dopavision tweaks its MyopiaX study’s design, masking, anticipated enrollment, and more

German company Dopavision made some big changes to its clinical trial for MyopiaX, a digital treatment that aims to slow the progression of myopia in children and adolescents. The original trial was double-masked and was supposed to run for two years. It’s also set to finish up next June now instead of March 2025. Here’s the current plan:

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