Payment-Model Participation Opportunity — Not a Grant
The Centers for Medicare & Medicaid Services Innovation Center (CMMI) is accepting organizations into the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model. ACCESS is a voluntary Original Medicare payment model designed to expand technology-supported care for chronic conditions. It is not a grant program; participating organizations receive recurring Outcome-Aligned Payments tied to management and health outcomes under model rules.
Why ACCESS Matters
ACCESS is built around technology-supported chronic care and can include virtual care, asynchronous care, diagnostic testing and imaging, care coordination, medication management, behavioral and lifestyle interventions, and FDA-authorized devices or software. CMS identifies tracks covering early cardiovascular-kidney-metabolic conditions, cardiovascular-kidney-metabolic conditions, musculoskeletal chronic pain, and behavioral health conditions including depression and anxiety.
Who Can Participate
CMS states that participants must be Medicare Part B-enrolled organizations under an eligible provider or supplier type, excluding DMEPOS suppliers and laboratory suppliers, and must designate a Medicare-enrolled physician Medical Director. Participants must also comply with applicable state licensure, Medicare program-integrity requirements, HIPAA, FDA requirements, and model-specific technical and operational standards. Medicare enrollment is required for participation, although CMS has stated it is not necessarily required at the time of application. The current Request for Applications controls all eligibility details.
Where N9+ Fits
N9+ Fit Score: 94/100. ACCESS expressly supports technology-enabled care, remote and virtual care workflows, diagnostic testing, connected-device use, and chronic-condition management. That creates a strong potential role for N9+ remote physical examination, vitals and clinical-data capture, and connected examination workflows when deployed within an eligible participant’s compliant care model. N9+ should be positioned as a clinical technology capability supporting the participant’s care model, not as a substitute for Medicare enrollment or other participant qualifications.
Direct Dr. Miltie Status
Conditional — not yet advanced as a direct participant. Direct participation by Dr. Miltie, LLC would require independent confirmation that all CMS participant requirements are legitimately satisfied, including the required Medicare Part B organizational enrollment and physician Medical Director structure. Until those requirements are confirmed, the stronger near-term path is to pursue eligible provider organizations as ACCESS participants or partners and position N9+ where it legitimately supports the funded care-delivery model.
Application Status
CMS accepts ACCESS applications on a rolling basis through April 1, 2033. Under the current Request for Applications, applications received after the initial April 1, 2026 deadline and before October 1, 2026 are considered for participation beginning January 1, 2027. The RFA does not assign a clock time or time zone to the October 1, 2026 milestone. Subsequent cohorts begin quarterly through July 1, 2033, and CMS states that cohort-specific deadlines will be announced on the ACCESS website and listserv. Applicants should use the current ACCESS RFA and Participant Portal as the controlling application sources.
September 2026 Co-Management Payment Update
CMS published updated ACCESS Co-Management Payment billing guidance on September 10, 2026. Eligible Medicare Part B practitioners may bill $30 for qualifying ACCESS-related co-management using HCPCS G0676 for the early cardiovascular-kidney-metabolic and cardiovascular-kidney-metabolic tracks, G0677 for the musculoskeletal track, and G0678 for the behavioral health track. Modifier AC adds $10 to the first applicable code per billing provider, beneficiary, and ACCESS track for initial onboarding support, including beneficiary enrollment and device, application, and data-sharing setup. CMS states these payments may be billed up to three times in a 12-month period per beneficiary per ACCESS track.
CMS also states that Federally Qualified Health Centers, Rural Health Clinics, and pharmacies with specialty code A5 become eligible for the Co-Management Payment beginning October 1, 2026. This creates a more concrete implementation pathway for qualified ACCESS partners using connected clinical technology, including the Nonagon N9+ device and platform where clinically appropriate. These billing codes do not constitute payment for N9+ itself and do not establish device-specific Medicare coverage or direct ACCESS eligibility for Dr. Miltie.
September 15, 2026 ACCESS Expansion
Current ACCESS Participants
CMS now lists more than 160 participating health care organizations in ACCESS and provides a public participant directory by organization and clinical track. CMS states that most listed organizations had not previously served Medicare beneficiaries and are bringing additional technology-supported care options into Original Medicare. Beneficiaries and referring clinicians can use the CMS participant directory and Medicare.gov/ACCESS to identify participating organizations by condition and location. This participant list may change as CMS updates participation status.
Official CMS ACCESS Model Participants
CMS expanded ACCESS with new tracks beginning April 1, 2027 for heart failure, chronic obstructive pulmonary disease (COPD), substance use disorder, and tobacco cessation, and added a follow-on period for chronic musculoskeletal pain. CMS states that current ACCESS participants and applicants do not need to reapply to participate in the new tracks. The expansion materially broadens the model’s relevance to home-based chronic care, remote monitoring, connected devices, virtual care, symptom management, and coordinated clinical services.
For technology partners, the expansion strengthens potential use cases involving remote physiologic and physical examination workflows, especially for heart failure and COPD, but ACCESS remains an outcome-aligned care payment model rather than device-specific Medicare coverage. Any Nonagon N9+ device and platform role must be clinically appropriate and implemented through an eligible ACCESS participant under CMS, FDA, licensure, privacy, and model requirements.
September 16, 2026 ACCESS Tools Directory Update
CMS now states that it will launch an ACCESS Tools Directory within the ACCESS application and participant portal. The optional directory is intended to help ACCESS organizations identify software and hardware that may support model participation and compliance, including data exchange and interoperability solutions, identity verification systems, connected clinical devices such as blood pressure cuffs, and tools supporting HIPAA compliance.
CMS says vendor participation will be voluntary and non-endorsing. Vendors will submit their own listings and self-certify that their products meet applicable federal and state requirements, including applicable FDA requirements or that the product is otherwise subject to FDA enforcement discretion. CMS will conduct a basic review for completeness and relevance but will not independently verify, approve, or endorse listed products. Vendors may also include optional promotional offers, subject to applicable federal and state law.
CMS has not yet made the directory application form available. Vendors interested in notice when the form becomes available can use the ACCESS Interest Form. A prospective technology vendor should confirm its authority to represent the product and its ability to make the required regulatory self-certifications before submitting a listing. See the official CMS ACCESS Technical FAQs.
FDA TEMPO Direct-Vendor Path
The FDA’s Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot is directly connected to the CMS Innovation Center ACCESS Model and remains open for manufacturer statements of interest. TEMPO is not a grant or CMS procurement. It allows eligible U.S.-based manufacturers of certain finished digital health devices to request FDA enforcement discretion for specified requirements when the device is offered to or by ACCESS participants for an intended use to improve patient outcomes in an eligible ACCESS clinical use area.
FDA currently expects to select up to about ten manufacturers in each eligible clinical use area and states that there is no specified deadline for statements of interest. Eligible devices must meet FDA’s published manufacturer, device, risk, intended-use, and ACCESS clinical-use-area requirements; devices without a functioning prototype are not eligible. Statements of interest are submitted directly to FDA at FDA-TEMPOPilot@fda.hhs.gov with the title Statement of Interest for Participation in the TEMPO Pilot and must identify the manufacturer and device, relevant FDA authorizations or interactions, the proposed indication and ACCESS-aligned intended use, and the requested enforcement discretion. See the official FDA TEMPO pilot page.
Direct-vendor gate: A Dr. Miltie or N9+ TEMPO submission is not cleared. FDA’s official 510(k) record identifies N9+ as K223785 with Nonagon Ltd. in Caesarea, Israel as the applicant. Accordingly, any TEMPO path must first establish that the submitting manufacturer independently satisfies FDA’s current U.S.-based manufacturer requirements and has authority for the device. Before any statement of interest, Atlas must independently verify the submitting legal manufacturer, U.S. Federal Tax ID, FDA-registered U.S. facility and applicable quality-system records, exact device identity and FDA status, functioning/finished-device status, proposed indication, eligible ACCESS clinical-use-area fit, patient-risk profile, real-world-data plan, and the submitter’s authority to make the regulatory representations. No manufacturer or regulatory fact should be inferred.
Atlas Analysis
Atlas Opportunity Score: 96/100. ACCESS is a high-priority national CMMI opportunity because it is currently accepting applications, explicitly supports technology-enabled chronic care, and aligns closely with remote examination, diagnostics, virtual care, and connected-device workflows. The opportunity is strongest for Medicare-enrolled provider organizations that can satisfy the model’s clinical, operational, enrollment, and compliance requirements.
Official source: CMS Innovation Center — ACCESS Model.