ACCESS: The Ten-Year Window for Digital Health Investment That Everyone Missed While Arguing About Drug Pricing

Disclaimer: The views and opinions expressed in this essay are solely my own and do not reflect the views, opinions, or positions of my employer or any affiliated organizations.

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Abstract

CMS announced the ACCESS model (Advancing Chronic Care with Effective, Scalable Solutions) on December 1, 2024, creating a ten-year payment pathway for technology-enabled chronic disease management in Original Medicare. The model launches July 1, 2026 and represents the most significant Medicare payment innovation for digital health since the program’s inception. This essay examines the structure, mechanics, and investment implications of ACCESS based on the limited public information available, explores the parallel FDA TEMPO pilot for device enforcement discretion, and analyzes opportunities across the digital health stack from infrastructure to point solutions. Key findings: ACCESS targets conditions affecting two-thirds of Medicare FFS beneficiaries (approximately 26 million people), introduces outcome-aligned payments that waive patient cost-sharing, and creates the first sustainable reimbursement model for prescription digital therapeutics and remote monitoring solutions that have struggled under traditional fee-for-service. The model arrives as commercial RPM coverage contracts, suggesting federal payment may become the primary revenue source for chronic care technology companies over the next decade.

Table of Contents

What CMS Actually Built and Why It Matters

The Payment Mechanics We Know and the Huge Questions That Remain

The TEMPO Pilot: FDA’s Companion Bet on Uncleared Devices

The Market Sizing Exercise Everyone Should Be Doing

Infrastructure Plays: Plumbing Before Applications

Point Solution Positioning: Who Wins in Each Track

The Primary Care Integration Problem That Could Sink Everything

Business Model Implications and Unit Economics

Investment Thesis by Company Stage and Type

What Gets Built Between Now and July 2026

What CMS Actually Built and Why It Matters

Let me start with what this is not. ACCESS is not about drug pricing, not about outcomes-based pharma rebates, not part of IRA implementation. It’s a pure digital health play focused on chronic disease management using technology as the primary care delivery mechanism. CMS dropped this December 1st with surprisingly little fanfare given it’s basically creating a new $10B+ market category over ten years.

The model targets four clinical tracks covering conditions that hit roughly two-thirds of Medicare fee-for-service beneficiaries. That’s about 26 million people if you do the math on current FFS enrollment. Track one is early cardio-kidney-metabolic stuff like hypertension, high cholesterol, prediabetes, and obesity with central adiposity markers. Track two is more advanced CKM including diabetes, CKD stages 3a and 3b, and atherosclerotic cardiovascular disease. Track three is chronic musculoskeletal pain lasting more than three months. Track four is behavioral health covering depression and anxiety.

The tracks are smart groupings because they cluster conditions that get managed with similar intervention types and care delivery models. Someone participating in the eCKM track needs to handle all qualifying conditions in that track for any given patient, which forces integrated care rather than siloed point solutions. This is basically CMS saying we’re done with the fragmented approach where you’ve got seven different vendors each monitoring one thing with no coordination.

Payment structure is what they’re calling Outcome-Aligned Payments which is a fancy way of saying you get recurring revenue tied to actually moving clinical outcomes rather than billing for specific activities. So instead of billing for RPM codes or CCM codes or whatever alphabet soup of billing codes you’re currently wrestling with, you get paid to manage the condition and full payment depends on hitting outcome targets across your patient population. CMS hasn’t released the actual dollar amounts yet which is driving everyone nuts from a business planning standpoint, but the structure is you get paid per enrolled patient per time period and the payment is higher initially then drops to a maintenance rate once patients hit control.

The outcome targets are based on clinical guidelines and measure things like blood pressure reduction of 10 mmHg for hypertension, A1C control for diabetes, patient-reported outcome measures for depression and anxiety, pain scores for MSK. The key design choice is CMS will pay based on the overall share of your enrolled population that meets targets rather than individual patient success. So if you enroll 100 hypertension patients and 75 of them hit their BP targets, you get full payment even though 25 didn’t make it. This is actually pretty generous compared to some of the outcome-based models we’ve seen and recognizes that not everyone responds to interventions.

Patient cost-sharing gets waived which is huge. Traditional Medicare requires copays and deductibles for most Part B services but ACCESS participants can waive all of that. This removes a massive enrollment friction point and probably increases participation rates by 30-50% based on what we’ve seen in other programs when you eliminate out-of-pocket costs. CMS is offering the patient incentive safe harbor for this which gives regulatory cover under anti-kickback statute.

The other piece that’s interesting is the referring provider co-management payment. PCPs or other clinicians who refer patients into ACCESS programs can bill a new code for reviewing progress updates and coordinating care like adjusting meds or updating problem lists. The service is billable approximately every four months with no beneficiary cost-sharing. CMS has not yet released the specific payment amount, though based on comparable care coordination codes this could range from $20-40 per service. This is CMS’s attempt to keep primary care engaged rather than just handing patients off to a digital health vendor and never hearing from them again.

Care delivery can happen any way that works which is the whole point. In-person, virtual, asynchronous, through FDA-authorized devices or software, whatever gets results. CMS is explicitly not mandating care delivery models which is smart because the whole value prop of digital health is flexibility and innovation in how you engage patients. The requirements are around outcomes and safety not process.

Organizations have to enroll in Medicare Part B as providers or suppliers which is a big deal for tech companies that haven’t traditionally operated in the healthcare provider space. You can’t just be a software vendor or device manufacturer participating indirectly. You need to be a Medicare-enrolled provider accepting assignment which means you can’t balance bill patients and you’re subject to all the compliance obligations that come with provider enrollment. This is going to be a barrier for some companies but CMS seems to think it’s necessary to maintain quality oversight and beneficiary protections.

Every participant needs to designate a physician Clinical Director responsible for clinical oversight and compliance. This can’t just be a medical director role where some doc reviews stuff once a quarter. The Clinical Director has real accountability for care quality and safety and CMS can come after them if things go sideways. For tech companies this means either hiring a physician into a senior operational role or partnering with physician groups who can provide that oversight.

The compliance requirements are actually pretty reasonable given how much flexibility CMS is offering on care delivery. You need to meet state licensure requirements for wherever you’re providing care, maintain HIPAA compliance as a covered entity, comply with applicable FDA requirements or be subject to enforcement discretion through TEMPO, exchange data bidirectionally with referring clinicians and integrate with a health information exchange, and report outcomes data to CMS on their timeline. The data exchange piece is probably the heaviest lift for companies that don’t already have robust interop infrastructure.

CMS is going to maintain a public directory of all ACCESS participants showing which tracks they operate in, what tools they use, and their risk-adjusted clinical outcomes. This is transparency on steroids compared to most Medicare programs and means your performance data is going to be out there for competitors and potential partners to see. It also means patients and referring providers can comparison shop which should drive quality competition but also creates reputation risk if your outcomes suck.

The directory is paired with an ACCESS Tools Directory where technology vendors can list their solutions even if they’re not direct participants. So if you make blood pressure cuffs or glucose monitors or digital therapeutic apps or interoperability platforms, you can get listed in the directory as a resource for ACCESS organizations. This is basically CMS creating a marketplace and it’s going to become a key discovery channel for tech vendors trying to reach the organizations that are participating.

Applications open January 12, 2026 with a first deadline of April 1, 2026 for the initial cohort launching July 1, 2026. Then rolling applications through 2033 which gives multiple entry points. The model runs ten years through June 30, 2036 and if it shows it can improve quality without increasing costs or reduce costs without harming quality, the HHS Secretary can make it permanent or expand it through rulemaking. So this could become the standard way Medicare pays for chronic care long-term.

The Payment Mechanics We Know and the Huge Questions That Remain