CMS ACCESS Updates.

ACCESS is a 10-year CMS Innovation Center model in Original Medicare that starts July 5, 2026 and is designed to expand access to technology-supported chronic care by replacing activity-based payment with recurring outcome-aligned payments. CMS targets four track areas: early cardio-kidney-metabolic risk, cardio-kidney-metabolic disease, chronic musculoskeletal pain, and behavioral health conditions. ^[1],[4]

This sits at the intersection of priorities CMS is actively signaling: chronic disease prevention, home-based data collection, behavior support, and better coordination between digital care organizations and traditional clinicians. ^[1],[4]

Under ACCESS, CMS pays participating organizations predictable recurring amounts tied to whether patients achieve measurable outcomes such as blood pressure improvement or symptom improvement on validated scales. Organizations must be Medicare Part B–enrolled, designate a physician clinical director, and report through standards-based APIs.^[1]

The model also formally supports coordination with PCPs and referring clinicians, who can bill a separate co-management payment of about $30 per service for documented review and care-coordination actions. ^[1]

ACCESS explicitly says participants may integrate beneficiary-owned items on a voluntary bring-your-own-device basis, including wearable devices such as fitness trackers and smartwatches. Participants cannot require patients to buy a clinical item out of pocket as a condition of participation. ^[1]

A BYOD wearable layer can widen engagement and lower CAC, but the product still needs a device-agnostic workflow. Wearable data should be treated as an enhancement layer, not the only route to service delivery. ^[1]

Continuity's "save locally, private by design, local model" architecture fits the policy mood, but ACCESS participation still requires the organization to be a HIPAA-covered entity and to maintain administrative, technical, and physical safeguards for PHI.^[1]

Local storage and on-device inference are differentiated features, but a compliant cloud or exchange layer is still needed for consented, minimum-necessary sharing with clinicians and CMS-facing reporting.^[1]

The safest regulatory posture is to describe the AI as a coaching, summarization, and motivational support engine that helps users understand patterns and prepare for episodic clinician interactions. CMS and FDA both distinguish wellness functions from tools intended for diagnosis or treatment. ^[1],[3]

Language matters. "Here are 3 possible behavior adjustments to discuss with your clinician" is materially safer than "you likely have atrial fibrillation." ^[1],[3]

FDA's TEMPO pilot, launched in connection with ACCESS, lets certain digital health device manufacturers participate while collecting real-world evidence under a risk-based enforcement approach. ^[1],[3],[5]

That creates two paths. Path one: stay in general wellness, care navigation, and coaching support. Path two: pursue disease-specific therapeutic claims with FDA strategy planned early and a possible future TEMPO-aligned route. ^[1],[3]

CMS's 2026 physician fee schedule final rule added flexibility for remote monitoring with new codes for 2–15 days of device data collection and a 10-minute treatment-management option rather than forcing every case into a 20-minute threshold.^[2],[6],[7]

CMS also expanded payment policies for Digital Mental Health Treatment to include ADHD-related devices. Behavioral health is promising, but reimbursement usually favors regulated, treatment-oriented tools over broad wellness positioning. ^[8],[9],[10]

The best wedge is a two-layer model: consumer engagement plus provider-connected chronic care operations. Start with a membership app that gives users a private health cockpit, but architect it so the same system can later support clinicians, care updates, risk stratification, and ACCESS-compatible workflows.^[1]

As a venture thesis, the first wedge would be hypertension + sleep + stress + weight behavior change for adults 50+. A second expansion could be depression and anxiety support, including journaling, symptom tracking, nudges, and visit preparation, without treatment claims unless the regulatory path is clear. ^[1],[8]