Issue 350

Welcome back to E&O: a paying subscribers-only weekly newsletter focused on three areas of health tech: FDA-regulated software devices, digital health as an employee benefit, and national virtual clinics.

 Exits & Outcomes Newsletter

• New York City-based Bevel, which offers an AI-based health companion app that focuses on sleep, exercise, and nutrition, quietly raised $10 million in new funding. Its previous backers included General Catalyst.
• Today is the first deadline to submit comments to the FDA prior to its meeting on how to regulate Generative AI in mental health devices. (Any comments submitted after today won’t be up for discussion during the meeting in November, but the agency will still review later ones that come in after this first deadline until the first week of December.) Shockingly few comments have been submitted so far — just nine as of this writing. (Hopefully, the agency has a backlog they just haven’t posted yet.) Companies like Limbic, Livio Labs, and Kindpath Health are among the very few to submit their thoughts to the agency. The Society for Digital Mental Health also sent in their comments.
• Also: The founder of North Shore Therapeutics, an early prescription digital therapeutics startup that I assumed had gone belly up, also submitted a comment to the FDA on Generative AI in mental health. According to the letter North Shore Therapeutics is (still) “developing NST-SPARK, a prescription digital therapeutic designed to address the negative symptoms of schizophrenia—an area of high unmet need with few effective treatment options.”

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Cigna clarifies its new national non-coverage policy for prescription digital therapeutics

Background: For years now proponents of prescription digital therapeutics have been eager for any sign of progress on the commercial payor front, so it was no surprise to see an outpouring of celebration this week on social media thanks to a brand new Medical Coverage Policy from Cigna that focuses on prescription digital therapeutics (sometimes styled as prescription digital therapy by Cigna). However, as is usually the case, the new national coverage policy document is more of a non-coverage policy document.

Cigna clarification: Since some of the chatter online has celebrated it as a new national coverage policy for just about all prescription digital therapeutics, I asked Cigna to clarify if that is the correct interpretation. In short: No.

No positive national coverage: Cigna told E&O that at the national level, this policy document was “specific” to the three prescription digital therapeutics named in it, which Cigna called out as not meeting its criteria to be considered medically necessary. Therefore, Cigna will not pay for them. Cigna wrote E&O in an email: “This policy provides guidelines for three PDTs that do not meet the required criteria and, therefore, are not covered because they are considered experimental, investigational, and unproven. Coverage for all other PDTs is determined by each health plan individually. Customers should review their specific benefit plan coverage guidelines to confirm which PDTs are covered.”

Individual plans might cover some PDTs? So, there is a chance that at the individual plan level Cigna may be working with plan sponsors to greenlight some PDTs on a case-by-case basis. That is an exciting developing for this reimbursement-starved segment of digital health, but it is far from a positive national coverage determination for nearly all PDTs.

Cigna only excluded 3 PDTs from possible coverage: For those of us who spend a lot of time reading these policy documents, it is notable that Cigna only called out three PDTs as being unproven. I’ve seen some that list out more than 20 and labeled them all unproven. That’s why some PDT proponents are so excited about this policy document — it’s leaving a door open.

Compare that to Anthem: For more context: Take this policy document from Anthem, which lists out more than two dozen mobile applications and describes why they are each unproven and not medically necessary. Anthem concludes: “Although some mobile-based software applications show promise, these products currently lack supporting studies from clinical trials that are strong enough to justify routine use. Therefore, they are not considered clinically appropriate at this time.” That’s much more representative of how these non-coverage documents are typically written by large commercial insurers. So, the fact that Cigna decided to list out a mere three PDTs as unproven (instead of 26 PDTs) might be taken to be a positive sign — by omission, anyway.

Which 3 PDTs did Cigna exclude? Curiously, the three PDTs that the Cigna policy explicitly excludes from payment each have a HCPCS code associated with their product: Neurosolutions’ IpsiHand, MotoNova’s Motus Hand and Foot, and AppliedVR’s RelieVRx.

No G Codes? RTM can’t be billed too? The Cigna policy document makes no mention of the new G Codes for digital mental health treatment devices, which apply to a handful of mental health-focused prescription digital therapeutics. While the Cigna document references Remote Therapeutic Monitoring, it doesn’t list out the RTM family codes. Instead it cautions providers: “Note: Remote therapeutic monitoring is considered an integral part of prescription digital therapeutics and is not separately reimbursable.” This is a curious statement. Cigna won’t pay providers for onboarding, education, set-up, or monitoring of a PDT? They’re just willing to pay for the device itself? Or will the service and device be bundled together — resulting in a higher price than the $129 E&O has reported some MACs are paying for the digital mental health treatment device supply code (G0552)? (This one is likely to remain mysterious until there is more proof that Cigna is actually paying for PDTs and not just not paying for three of them.)

Compare this to Highmark’s positive coverage: One health insurance company that has always been a pioneer when it comes to paying for digital health programs is Highmark. This medical coverage policy document from Highmark New York is an example of one that explicitly names four prescription digital therapeutics that the payer will pay for in certain cases — it’s not just a list of what it won’t pay for: “The following digital therapeutics have been approved by the Highmark New Technology Assessment Committee (NTAC) and, as such, are eligible when the above criteria are met:

• Luminopia One — Amblyopia – pediatric use
• RelieVRx — Chronic lower back pain
• Stanza — Fibromyalgia”

What to look for next from Cigna: Cigna’s new national non-coverage policy document implies that individual Cigna plans may begin covering some PDTs. Finding evidence of that along with explicitly named PDTs that are receiving Cigna coverage is the document PDT proponents should get excited about.

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