CMS Launches ACCESS Model: The Tools Directory Opportunity for Digital Health Vendors
The Centers for Medicare & Medicaid Services (“CMS”) recently launched one of the most ambitious value-based payment demonstrations in a decade. Under the “ACCESS Model” – the “Advancing Chronic Care with Effective, Scalable Solutions Model,” CMS will test a national 10-year Medicare payment model that promotes outcomes-based reimbursement rather than traditional fee-for-service billing. Alongside the ACCESS Model, CMS will create the ACCESS Tools Directory (the “Directory”), a first-of-its-kind resource where digital health vendors (“Vendors”) can list technology that facilitates model participation. The Directory will help organizations that participate in the ACCESS Model (each an ACCESS Model Organization or “AMO”) identify technologies and that may support model participation and compliance.
For Vendors of remote monitoring technologies, wearables, software platforms, clinical decision support tools, interoperability solutions, lifestyle apps, and identity verification systems, the Directory creates a new entry point for digital health into the Medicare ecosystem. It also signals a clear shift: technology that enables measurable health improvement is no longer optional; it is now essential.
To be considered for the ACCESS Model’s first performance period beginning July 1, 2026, applications must be submitted by April 1, 2026. Applications received after this date will be considered for a January 1, 2027 start. Below, we break down what the ACCESS Model means for health tech vendors and how your digital health company can prepare for listing in the Directory.
Overview of the ACCESS Model: A Shift to Outcomes, Not Activities
The ACCESS Model aims to address a longstanding gap in traditional Medicare, where payment is based on individually billable services, such as through time-based or activity-based payment codes. That approach has never fully captured the value of technology-enabled care. The ACCESS Model changes this dynamic by tying Medicare reimbursement to Outcome-Aligned Payments (“OAPs”) across four major chronic condition tracks:
Early Cardio-Kidney-Metabolic (eCKM): Hypertension, Dyslipidemia, Obesity/Pre-diabetes.
Cardio-Kidney-Metabolic (CKM): Diabetes, CKD, Heart Disease.
Musculoskeletal (MSK): Chronic pain (lasting >3 months).
Behavioral Health (BH): Depression and anxiety
What Technologies does the ACCESS Model Encourage?
The ACCESS Model encourages AMOs to deliver integrated, technology-enabled care to improve outcomes, including through the use of:
Remote or asynchronous clinical support
Lifestyle and behavioral coaching
CMS API integration support
App-based interventions
Connected device monitoring
Data-driven care coordination
FDA-authorized or FDA-enforcement-discretion devices
Secure information exchange with primary care providers
Ongoing reporting to CMS through standardized APIs
For AMOs to succeed, they need tools that help patients achieve and maintain clinical outcomes. That’s where the Directory comes in.
What is the ACCESS Tools Directory?
The Directory is an upcoming, CMS-hosted listing of optional technologies that may support ACCESS Model compliance and success. It is not a certification program or endorsement mechanism. Instead, it serves as a practical discovery hub for AMOs looking to build their tech stack. The Directory will sit directly in the workflow of every AMO, including virtual care organizations, chronic disease management companies, digital MSK providers, virtual behavioral health practices, and integrated clinical networks.
Digital health vendors can voluntarily submit listings for:
Remote patient monitoring devices
Connected clinical tools (e.g., blood pressure cuffs, glucometers, wearables)
HIPAA-compliant software platforms
Interoperability and health data exchange solutions
FDA-authorized or FDA-enforcement-discretion technologies
Behavioral health apps using validated PROMs
Identity verification and onboarding tools
Documentation and care coordination platforms
Tools that support outcome tracking for blood pressure, HbA1c, lipids, weight, pain, depression, and anxiety
Each Vendor must self-certify that their tool complies with all applicable requirements, including HIPAA, state licensure laws, and FDA regulations where applicable. CMS will review listings for completeness and relevance but will not independently verify clinical performance.
The ACCESS Opportunity for Digital Health Companies
Competitive advantages for Vendors listed in the Directory include:
Visibility at the moment of vendor selection by each AMO and first-mover status. AMOs will need to integrate digital tools that drive outcomes. The Directory puts a Vendor’s product in their workflow when it matters most: during vendor evaluation and care model design.
Alignment with the future of outcome-based care and OAPs. The ACCESS Model is a 10-year model, with new cohorts entering annually through 2033. Getting listed early allows your company to establish trust and build relationships over time.
Clear demonstration of compliance readiness. Self-certification of HIPAA compliance and FDA status sets your organization apart. Many AMOs, especially newer entrants to Medicare, will seek tech partners who are legally sound and implementation-ready.
Ability to offer compliant promotional credits or discounts to AMOs. CMS will allow vendors to include optional promotional offers (e.g., discounts, service credits) in their listings, provided they comply with federal and state beneficiary inducement laws. That opens the door to compelling, compliant go-to-market strategies.
How Health Tech Vendors Can Prepare Now
Map your product to ACCESS Model outcome requirements and OAPs. Review the four initial clinical tracks and determine where your solution can help improve Blood pressure, Lipids, Hemoglobin A1c, Weight, Pain and function, Mood and anxiety symptoms, or CKD metrics (eGFR, UACR).
Review FDA status and applicable regulatory pathways. CMS expects participating organizations to use tools that are legally marketed for their intended use
Confirm HIPAA-covered entity or business associate status and strengthen interoperability capabilities. AMOs must share updates with referring clinicians, connect to Health Information Exchanges (HIEs), and report data to CMS through APIs
Prepare a value proposition tied to measurable outcomes. This requires clearly defining the key performance indicators (KPIs) that will demonstrate the financial or operational impact of your solution.
Build a compliance-forward marketing narrative. Ensure all claims are supported by verifiable data and regulatory guidelines to establish immediate trust and mitigate risk.
How Nixon Law Group Can Help
If your digital health company is evaluating whether to participate in the ACCESS Tools Directory or wants guidance on building a compliant ACCESS Model strategy, Nixon Law Group is ready to help by assessing alignment with the ACCESS Model track requirements, preparing compliant self-certifications, evaluating FDA compliance status, updating HIPAA documentation, designing safe promotional offers, and building ACCESS Model-ready contracting strategies.
The ACCESS Model will shape how Medicare pays for technology-enabled chronic care for the next decade. Vendors who prepare early will be best positioned to support AMOs and expand their role in the Medicare ecosystem. Contact us to learn more.