If you’ve been paying attention to healthcare reimbursement news, you’ve heard about the CMMI ACCESS model. You’ve probably heard it described as a breakthrough – the first time Medicare has created a direct payment pathway for technology-enabled chronic disease management. That description is accurate.
What’s less discussed is that there are four ways to participate, and the one most digital health companies assume they’ll use is also the one most of them can’t actually access without significant organizational restructuring.
I want to walk through all four pathways clearly, because the gap between “we’re excited about ACCESS” and “we’re structured to collect ACCESS payments” is where a lot of portfolio companies are going to get stuck in 2026.
What the ACCESS Model Actually Is
ACCESS – Advancing Chronic Care with Effective, Scalable Solutions – is a 10-year voluntary CMMI model that launches July 5, 2026. It tests a new payment approach called Outcome-Aligned Payments: participating organizations receive fixed quarterly payments for managing Medicare beneficiaries’ chronic conditions, but earn the full amount only if patients actually improve against measurable clinical targets.
The four clinical tracks are:
- Early CKM (hypertension, dyslipidemia, obesity, prediabetes): $360/patient year 1, $180 in follow-on years
- CKM (diabetes, chronic kidney disease, heart disease): $420/patient year 1, $210 follow-on
- Musculoskeletal (chronic MSK pain): $180/patient year 1, no follow-on period
- Behavioral Health (depression, anxiety): $180/patient year 1, $90 follow-on
Half of each payment is disbursed monthly as you go. The other half is withheld and released only after semi-annual reconciliation – and only if at least 50% of your aligned patients hit their clinical targets.
The economics are modest. Industry analysts at Capstone called the rates “quite low to motivate new entrants given the infrastructure required.” The model pencils out for companies with highly automated, tech-enabled workflows at scale. It doesn’t work for companies staffing their way to outcomes.
That said, the strategic value of being in Medicare directly – building the relationships, the compliance infrastructure, and the outcomes track record – goes well beyond the per-patient payments. This is a 10-year model. The companies that participate in Cohort 1 and Cohort 2 are building a durable Medicare presence that their competitors won’t have.
The 4 Pathways – Honestly Assessed
Pathway 1: Direct Participation as a Medicare Part B Enrolled Provider
This is the pathway that gets the most attention and applies to the fewest digital health companies.
To participate directly, your organization must be enrolled in Medicare Part B as a provider or supplier. You must designate a physician Clinical Director who is formally accountable for quality, safety, and clinical oversight. And you must have the compliance infrastructure to bill Medicare, manage HIPAA obligations, and meet FDA requirements for any devices you use in care delivery.
A pure software company can’t enroll. A company that licenses technology to clinicians can’t enroll. The entity that contracts with CMS must be a clinical care organization in Medicare’s eyes.
Who this works for today: established clinical organizations that are already Medicare-enrolled and want to wrap technology around their care delivery – physician practices, clinically-integrated home health companies, behavioral health providers with existing billing infrastructure. Some digital health companies have built this structure over years. Most haven’t.
Realistic assessment: If you’re reading this and you don’t already have Part B enrollment and a physician Clinical Director in place, Pathway 1 is a 2027+ conversation at the earliest.
Pathway 2: Captive Professional Entity (the Digital Health Restructuring Play)
This is the pathway most serious digital health companies should be evaluating right now – and the one that requires the most lead time.
The structure works like this: a digital health company creates or acquires an affiliated physician practice or medical group, enrolls that entity in Medicare Part B, and that entity participates in ACCESS as the official participant. The parent company provides the technology platform; the captive medical group provides the clinical operations and Medicare billing.
This is how Cadence Health – the remote patient monitoring company that publicly announced its intent to participate in ACCESS in March 2026 – has structured its business. It’s also the model that companies like Hims & Hers, Noom, and others have used to access direct clinical billing pathways in adjacent contexts.
The lift is real. You’re creating or acquiring a medical group, navigating corporate practice of medicine restrictions in each state you operate in, building Medicare billing infrastructure from scratch, and hiring or contracting a physician Clinical Director. None of that happens in a quarter.
The upside is also real. Direct participation means you own the Medicare relationship. You control your billing. You build outcomes data that belongs to you. You’re not dependent on a health system or physician group renewing a contract. And over a 10-year model, that independence compounds.
Who should pursue this: Companies with Series B+ funding, a clinical services component already embedded in the product (remote monitoring, telehealth, care management), and a board that’s willing to invest in organizational infrastructure before it generates revenue. If this describes your company, the time to start is now – because the organizational steps take 6-12 months minimum, and Cohort 2 starts January 1, 2027.
Pathway 3: The ACCESS Tools Directory (Visibility Without Revenue)
CMS is building an “ACCESS Tools Directory” – a clearinghouse of software and hardware tools that enrolled ACCESS Participants can browse and adopt. Vendors list themselves, self-certify that their products meet applicable federal and state requirements, and get discovered by participating clinical organizations.
This is not a payment pathway. You earn no Medicare payments by being in the directory. Your revenue comes from selling to or contracting with enrolled participants who choose your tool.
Think of it like being in an app store for ACCESS participants. It’s legitimate distribution. If you have a tool that would genuinely help a physician practice manage hypertension patients better, being in the directory is smart and costs nothing meaningful.
But I’d caution against a company framing their “ACCESS strategy” as “we’ll be in the vendor directory.” That’s not an ACCESS strategy – it’s a marketing tactic. The directory tells you where to sell; it doesn’t tell you how to collect.
Who this works for: Early-stage companies that aren’t ready to build clinical operations but want discovery and distribution to enrolled participants. Good first step. Not a destination.
Pathway 4: Contracting with an Enrolled Participant (the Fastest Path to Revenue)
This is the pathway that most digital health companies can actually execute in the next six months – and the one I think is most underappreciated in the current conversation.
Here’s how it works: instead of enrolling in Medicare yourself, you contract with an organization that is enrolled and participating in ACCESS. That could be a physician practice, a health system, an ACO, or a clinically-integrated digital health company with Part B status. You provide your technology, care management platform, or clinical workflow tools under a vendor agreement. They bill ACCESS; they pay you a share of the revenue by contract.
Headspace – the behavioral health app – is exploring something like this model, partnering with enrolled clinical organizations to get their tools used within the ACCESS framework without taking on Medicare enrollment themselves.
The tradeoffs are real. You’re dependent on your partner’s enrollment status, their compliance posture, and their willingness to negotiate a revenue share that reflects your contribution. You have no direct Medicare relationship and no direct billing authority. If the partnership doesn’t renew, your ACCESS revenue disappears.
But the speed and accessibility are genuinely valuable. If your company has a strong product in a qualifying clinical track, a contracting partnership with one or two enrolled participants can generate real Medicare revenue by Q3 2026 – without the 12-month organizational restructuring that Pathway 2 requires.
Who should pursue this: Companies that need near-term revenue from the ACCESS model, companies where the Pathway 2 restructuring isn’t feasible given their stage or structure, or companies that want to test the ACCESS commercial model before committing to full organizational changes. Pathway 4 can be a bridge to Pathway 2, not just an alternative.
The Decision Your Company Needs to Make This Quarter
Cohort 1 applications closed April 1, 2026. The companies in Cohort 1 – including Cadence Health and others who’ve moved quietly – have a six-month head start on building their Medicare outcomes track record.
Cohort 2 begins January 1, 2027. Applications are accepted on a rolling basis, but the organizational work needs to start now if you want to be operational by then.
Here’s the practical question for digital health companies and their investors: which pathway is actually achievable given your current structure, and what has to be true by October 2026 to get there?
If you’re a VC or PE firm with portfolio companies in metabolic health, behavioral health, chronic kidney disease, or cardiovascular prevention – this is the conversation to have with your CEOs this quarter. Not “are you excited about ACCESS” but “which pathway, and what does the roadmap look like.”
The gap between those two questions is where value gets created or left on the table.
Andy Strunk is the founder of Accretive Edge, a healthcare commercialization advisory firm. He works fractionally with PE and VC portfolios to close the gap between clinical traction and sustainable revenue growth. If you’re thinking through your company’s ACCESS strategy, I’d be happy to talk through it – reach me at astrunk@accretiveedge.com.
