Eligibility Requirements
Before applying to the ACCESS Model, your organization must meet specific eligibility criteria. This page outlines who can participate, what requirements must be met, and how to prepare your organization.
Key Requirement
ACCESS participants must be Medicare Part B–enrolled organizations and designate a Medicare-enrolled physician Medical Director to oversee care quality and compliance.
Organization Eligibility
Who Can Participate
The ACCESS Model is open to organizations that meet the following criteria:
Medicare Part B Enrollment
Your organization must be enrolled in Medicare Part B as a provider or supplier. Organizations not currently enrolled must complete the enrollment process before participating.
Eligible Organization Types
Most Medicare Part B enrolled organizations are eligible, excluding:
- Durable Medical Equipment (DME) suppliers
- Prosthetics, Orthotics, and Supplies (POS) suppliers
- Laboratory suppliers
Clinical Leadership
Organizations must designate a Medicare-enrolled physician Clinical Director responsible for:
- Clinical oversight of all ACCESS services
- Quality assurance and compliance
- Coordination with patients' other providers
Eligible Organization Examples
Organizations that may be well-suited for ACCESS include:
- Digital health companies with technology-supported care platforms
- Physician practices expanding into technology-enabled care
- Health systems launching digital chronic care programs
- Specialty clinics focusing on chronic condition management
- Telehealth providers with clinical care capabilities
- Integrated care organizations with chronic disease expertise
Not Currently Enrolled?
If your organization is not currently enrolled in Medicare Part B, you should begin the enrollment process immediately. Enrollment can take several months to complete. See our guide on becoming a Medicare provider.
Clinical Capabilities
Technology-Supported Care
ACCESS organizations are expected to offer integrated, technology-supported care. Your organization should have capabilities to deliver:
- Remote patient monitoring — Using FDA-authorized devices and wearables
- Virtual consultations — Telehealth and video visits with clinicians
- Digital coaching — App-based lifestyle and behavioral support
- Asynchronous care — Messaging, education, and check-ins
- Care coordination — Integration with patients' existing providers
Track-Specific Requirements
Each clinical track has specific clinical capabilities requirements:
| Track | Required Clinical Expertise |
|---|---|
| eCKM | Hypertension management, metabolic health, lifestyle intervention |
| CKM | Diabetes care, nephrology, cardiology, medication management |
| MSK | Pain management, physical therapy, behavioral approaches |
| BH | Behavioral health, therapy/counseling, depression/anxiety treatment |
Can we participate in multiple tracks?▼
Yes, organizations can apply to participate in one or more clinical tracks, provided they demonstrate the required clinical expertise and infrastructure for each track. You don't need to participate in all tracks.
Regulatory Compliance
FDA Requirements
Organizations must comply with all applicable FDA requirements for any devices or software used in care delivery. This includes:
- FDA-authorized devices — Medical devices must have appropriate FDA clearance or approval
- FDA enforcement discretion — Some digital health tools may operate under FDA enforcement discretion policies
- Clinical decision support — Software providing clinical recommendations must meet applicable requirements
FDA TEMPO Pilot
The FDA TEMPO (Total Evaluation and Monitoring Process for Software as a Medical Device) pilot is available for organizations seeking streamlined review of AI/ML-based Software as a Medical Device (SaMD). This may be relevant for ACCESS participants using advanced digital health tools.
HIPAA Compliance
All ACCESS participants must:
- Be HIPAA-covered entities or business associates
- Implement required privacy and security safeguards
- Maintain secure systems for patient data
- Follow HIPAA requirements for data sharing with referring providers
State Licensure
Organizations must comply with applicable state licensure requirements for:
- Healthcare providers delivering care
- Telehealth services (including interstate practice)
- Professional licensing for clinicians
Infrastructure Requirements
Technology Systems
ACCESS participants need technology infrastructure to support:
| Capability | Purpose |
|---|---|
| CMS API Integration | Eligibility verification, enrollment, reporting |
| Electronic Health Records | Clinical documentation and care coordination |
| Patient Portal/App | Patient engagement and communication |
| Data Analytics | Outcome tracking and performance monitoring |
| Secure Messaging | Provider-to-provider and provider-to-patient communication |
Reporting Capabilities
Organizations must be able to:
- Submit required data to CMS through designated systems
- Track and report clinical outcomes by patient and track
- Provide electronic updates to patients' primary care providers
- Support CMS monitoring and evaluation activities
Application Requirements
Required Documentation
When applying, organizations must provide:
- Organization information — Legal name, NPI, Medicare enrollment status
- Clinical track selection — Which tracks you're applying for
- Clinical Director designation — Named physician with Medicare enrollment
- Capability attestations — Confirmation of required capabilities
- Compliance documentation — Evidence of regulatory compliance
Attestations
Organizations must attest to:
- Current Medicare Part B enrollment (or in-process enrollment)
- Commitment to comply with all ACCESS Model requirements
- Capability to deliver technology-supported care
- Compliance with FDA, HIPAA, and state requirements
- Designation of qualified Clinical Director
Preparing Your Organization
Pre-Application Checklist
Verify Medicare Enrollment
Confirm your organization's Medicare Part B enrollment status. If not enrolled, begin the process immediately.
Identify Clinical Director
Designate a Medicare-enrolled physician to serve as Clinical Director with appropriate clinical oversight experience.
Assess Clinical Capabilities
Evaluate your organization's ability to deliver technology-supported care in your target clinical tracks.
Review Regulatory Compliance
Ensure compliance with FDA, HIPAA, and state licensure requirements for your intended services.
Prepare Technology Infrastructure
Assess and prepare systems for CMS integration, reporting, and care coordination.
Express Interest
Submit the ACCESS Model Interest Form to receive updates and application information.
Frequently Asked Questions
Can a new company without Medicare enrollment participate?▼
Organizations not currently enrolled in Medicare Part B must complete enrollment before participating in ACCESS. Given that enrollment can take several months, new organizations should begin this process immediately if they want to participate in early cohorts.
What if we only have expertise in one clinical track?▼
That's perfectly fine. Organizations can participate in one or more tracks based on their capabilities. You should apply only for tracks where you can demonstrate appropriate clinical expertise.
Are there geographic restrictions?▼
ACCESS is available nationwide. Organizations can serve patients across states, subject to applicable telehealth and licensure requirements. Rural patients receive a payment adjustment in qualifying tracks.
Can we partner with other organizations to meet requirements?▼
Organizations may work with partners, but the applying organization must meet all eligibility requirements and take responsibility for care delivery and outcomes. Partnership arrangements should be described in the application.
What if our FDA authorization is pending?▼
If you're using devices or software requiring FDA authorization, that authorization should be in place before delivering care to ACCESS patients. You may apply while authorization is pending, but must have clearance before treating patients.
Contact & Resources
For questions about eligibility, contact the ACCESS Model team:
Email: ACCESSModelTeam@cms.hhs.gov
Next Steps
Application Process
Step-by-step guide to applying for the ACCESS Model
Medicare Enrollment Guide
How to enroll in Medicare Part B if not already enrolled
Submit Interest Form
Express your interest and receive application updates