Issue 362

Welcome back to E&O: a 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.

 How low can you go?

• • •

In this issue of E&O

• A quick look at the newly released (shockingly low) ACCESS Model payment amounts along with a few thoughts compiled from E&O readers. (Start by re-reading what Dr. Oz promised about those payments…)
• Big Health is back with nearly $24M in fresh funding from backers including CVS.
• But billing code utilization data shows that DMHT adoption in the first three quarters of 2025 was almost non-existent.

Shockingly low maximum annual rates for ACCESS Model

Well, the wait is over and the max annual rates for CMMI’s much-discussed outcomes-based chronic disease management program are out… and they are non-starters for most:

Source: CMMI’s ACCESS Model Model Payment Amounts and Performance Targets

Remember: The rates above are higher than what most would aspire to collect, because many potential ACCESS participants have already ruled out trying to convince the Medicare beneficiary to pay their 20 percent. If you waive those fees, the maximum annual rate per patient for behavioral health and MSK drops to $144 in year one. That’s the maximum — 50 percent of it is withheld until all of the outcome metrics are met too. Considering all of the requirements of the program, how do you get wearables into the hands of ACCESS patients if you are starting at $6 a month in guaranteed fees? Even if you are confident you’d double that for the full $144 eventually, that’s not enough to cover a $300 Oura that usually requires a $6 a month subscription. Whoop is even more expensive. Should we forget all those logos that CMMI showed us? (Both Oura and Whoop were on there.) E&O has reported extensively about the pricing of digital health companies that sell into employers. In those markets, it is not uncommon for a single online therapy session to be billed at a rate higher than $144. The two most successful MSK companies typically charge just under $1,000 a year per patient treated. Medicare has volume, yes, but at these rates does it matter? Even in the current fee-for-service Medicare market with RTM codes, a provider would expect reimbursement at around 10x the maximum annual rates CMMI outlined above. While I’ve asked around, I’ve yet to hear from a company that sees ACCESS as a revenue generating opportunity now that the payment amounts are public.

Two groups that might go for ACCESS anyway

CMS published the Outcome-Aligned Payments (OAPs) amounts just a few hours after announcing that 14 commercial insurance companies had pledged to set-up ACCESS Model-like infrastructure to create their own versions of the chronic condition management program for their own patient populations with a target launch date of January 1, 2028. UHG, CVS, Cigna, and Humana were among the names listed along with a long list of Blues. The ACCESS Model rollout has been carefully orchestrated. Despite Dr. Oz’s assurances above, CMS likely expected a lot of pushback from industry once the payment amounts came out, which explains why they waited so long to reveal them. It’s also notable that CMS announced the plans of the commercial payers mere hours before doing so. That move added another potential incentive for hesitant prospective ACCESS Model participants.

Group one: So, there may be some ACCESS participants who see the program as a likely loss leader that will set them up to participate in a multi-payer ACCESS program in the future where payment rates are higher on average than they will at the start, because commercial payers will likely pay more. These pioneers will have a rough go of it and the public will follow along with their progress. Remember: CMS said it would publish each participant’s results on an ongoing basis. I’m not sure who this group might include. Already established ACOs? CMS did create some incentives for them to jump in early. But which digital health companies or care groups can afford to burn two years on ACCESS with (likely) little to no revenue to show for it?

Group two: AI-first and other digital therapeutics companies with few humans in the loop. The more expensive digital health providers I mentioned above are typically tech-enabled virtual clinics, but their lower priced competitors usually keep their pricing low by offering a human-less digital therapeutic that hasn’t gone through the FDA. These companies are still typically 2x or 3x pricier than the OAP maximum rates that CMMI has dreamed up, but they are closer to the price range than their more expensive and, so far, more successful competitors. These companies would likely have to secure FDA clearance to participate in ACCESS, however, which is expensive and can lead to higher pricing. (See Big Health’s story below.) That’s what the FDA’s TEMPO pilot is trying to help solve to bring more of those companies under the FDA’s purview while they participate in ACCESS pre-clearance. I think we will see a mix of these two, but I’m more stumped on who specifically falls into Group 1. Lots of ideas for which companies might be Group 2. Am I missing any others? Who do you predict will participate in the ACCESS Model?

Big Health pulls a Lazarus and raises $23.7M

Big Health announced $23.7 million in new funding co-led by .406 Ventures and AlleyCorp, with contributions from CVS Health Ventures, Blue Venture Fund, Sandbox Clinical Ventures, Gilde Healthcare, and Supermoon Capital. In its funding announcement, Big pointed to its health system partners Henry Ford and Northwell as key to delivering its prescription digital therapeutics SleepioRx and DaylightRx at scale. Long time readers of E&O know that Big Health was out of runway in 2025. As E&O reported in September 2025: “The company ended May 2025 with just $6 million in cash and a monthly burn rate of about $1.3 million. That gave the company just a few months of runway — the middle of October is likely as long as Big can make it without new funds. E&O has learned that in June 2025, Big Health had a signed but non-binding term sheet co-led by two investors that would have secured $15 million for the company. It had a close date at the end of July.” In mid-September Big Health’s board resigned with the exception of the company’s CEO Yael Berman. Financially, Big was in dire straits: “Big Health’s 2024 revenue was half of what it was in 2023: Big Health brought in $10.6 million in revenue, down sharply from $21.6 million in 2023. As E&O reported a year ago, the company’s revenue only dipped slightly between 2022 ($22.6 million) and 2023. The significant decline in 2024 is, obviously, alarming. The company managed to narrow its losses, however: $19.3 million in 2024 vs. $33.7 million in 2023.” In light of the new funding, I talked to Berman about Big’s business moving forward. Here are a few excerpts from our call this week:

MACs and G0552 reimbursement: Berman said that all of the MACs have reimbursed for the supply code for Digital Mental Health Treatment devices (G0552), but on a case-by-case basis. While at least one MAC had previously listed a reimbursement rate around $120, currently none of them have a publicly listed price. Berman attributes that to the variety of digital therapeutic devices that fall under G0552. There are about nine DMHTs. (See the story below for some numbers around adoption of the DMHT G Codes so far.)

ACCESS Model: “We see ACCESS as complementary but not as a replacement to our core go-to-market strategy. So, we’re getting all of our products eligible to be used under ACCESS, and we have talked to our partners about that.” Berman noted that (at the time of our call) the payment rates were still undisclosed, and Big Health’s level of interest in ACCESS would be dependent on those numbers.

Employer channels and CVS relationship: Berman confirmed that CVS and Evernorth are both still distribution channels for Big Health’s wellness products, Sleepio and Daylight — the versions that are not FDA-cleared. CVS Health Ventures participation in the funding round is an indication that CVS sees other opportunities to distribute Big Health’s regulated products too.

AI: It is notable that Big Health managed to raise funding without a core focus on AI. Berman described her company’s AI strategy as “conservative” and said they company would use AI to personalize the patient experience, while keeping the core of the company’s digital therapeutics intact.

P.S. Based on E&O’s reporting last year, I was convinced Big Health was either set to be acquired or headed for bankruptcy — like most prescription digital therapeutics companies that preceded it. Curious to see how this next chapter unfolds for Big Health.

Prescribers billed Digital Mental Health Treatment (G0552) device supply code 291 times from Q1-Q3 2025

According to data provided to E&O by Komodo Health, a healthcare analytics AI company:

Source: Komodo Health, a healthcare analytics AI company

📈 Key Takeaway: This data shows that 280 unique patients received one of the digital therapeutics that qualify for billing under that DMHT supply code G0552 from January 2025 through September 2025. It also indicates that 11 of those patients either received a second prescription for a second course of treatment with one of the DMHTs, or they were prescribed two different DMHT devices during the period. Only 176 of those patients saw a provider at least once after they were prescribed a DMHT — as indicated by the number of unique patients who had providers bill G0553. While the tables above do not account for DMHT utilization in Q4 of last year, it is clear that adoption continued to be very low — almost nonexistent — for the first three quarters of 2025.

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