Earlier this month, CMS launched the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model, prompting renewed discussion across the digital-native health, AI-forward coaching, and accountable care sectors. ACCESS is part of a broader industry shift toward value-based, technology-enabled chronic care management. The model is distinctive in that it supports services like AI-enabled chat and coaching deployed at scale, which will be subject to the same regulatory scrutiny applied to any other covered clinical service. This combination of features merits sustained attention from technology-enabled healthcare solutions operating in adjacent markets.
Applications built on AI-enabled tools have developed rapidly in consumer and enterprise contexts and have rarely been subject to the full scope of federal healthcare regulation, Medicare provider obligations, and civil rights laws. ACCESS represents one of the first efforts to determine whether AI-enabled solutions can meet these requirements simultaneously at scale and under a variety of conditions. Credible participation requires carefully balancing regulatory and commercial readiness. ATI has identified several features of the ACCESS rollout that are likely to shape which participants succeed.
The regulatory requirements are more substantial than they may initially appear
ACCESS requires organizations using AI-enabled chat and coaching functionality to layer it on top of existing HIPAA Privacy and Security requirements, nondiscrimination and accessibility laws such as the ADA and Section 1557, and Medicare Part B documentation and audit standards. Organizations with prior experience building compliant virtual care products are finding these frameworks meaningfully expand the risk surface when applied to an AI-enabled chat and coaching solution.
To ensure compliance while minimizing disruption, participants might consider:
- Establishing a complete set of requirements across legal, product, and engineering functions prior to development. A build-first approach, in which compliance review follows product development, may introduce delay and rework.
- Understanding the full scope of compliance and implications for their business model. The scope of the compliance obligation is broad and entails becoming a direct HIPAA–covered entity and a fully assigned Medicare Part B provider, a different organizational posture than most digital health and coaching companies have held historically.
- Finalizing compliance requirements early. Given the rolling go-live dates of August 1 and October 1, organizations that prioritize early compliance are better positioned to meet timelines without a late-stage scramble.
ACO partnership can strengthen ACCESS participation
ACCESS can function as a wraparound service for primary care providers (PCPs) participating in accountable care organizations (ACOs). ATI is monitoring for potential integration into LEAD’s Tech Enablement program, Geo AHEAD, and TEAM. While ACOs are beginning to recognize the relevance of ACCESS to their operations, broader market awareness has not yet matured.
Federal agency coordination signals a longer runway for the model
The FDA has begun aligning its own regulatory tools with ACCESS. This month, the agency began a pilot of Technology-Enabled Meaningful Patient Outcomes (TEMPO), a program that allows device manufacturers to request FDA enforcement discretion for certain requirements when a device is offered to or by ACCESS participants for uses tied to the model. TEMPO establishes a pathway toward marketing authorization but does not supplant that process. Organizations with device or diagnostic components to their offering may find that this pathway gives them enhanced regulatory support.
Organizational profile determines the strategic entry point
Organizations that already partner with ACOs may have an easier path to expanding into ACCESS-related use cases, but that relationship alone does not constitute a compliant, use case-specific product. Some organizations with existing clinical management models are developing a technology-enabled “sub-clinical” product for ACCESS, rather than a staff-intensive approach, and wrapping that service around traditional care delivery for more acute clinical needs. Those most likely to succeed recognize the wraparound service as an entry point rather than an end goal.
The magnitude of the opportunity remains uncertain
ACCESS may represent the first phase of a substantially larger shift in chronic care delivery. Organizations can approach the model with a realistic understanding of its current scope and limitations. While early movers gain valuable experience testing a new market, the opportunity for participants is still maturing and the durability of early gains will be clearer as the model continues. ACCESS is already a novel data sharing and revenue generation pathway that has pushed the boundaries of the healthcare system. For organizations with the resources and capabilities to participate, as well as a commitment to growing AI-based interventions for older adults, ACCESS is a promising platform for pressure-testing solutions in a federally regulated environment, with potential to help establish credibility and infrastructure.
Commercial strategy is as consequential as regulatory readiness
Beyond regulatory compliance, several questions will help potential ACCESS participants build a case for commercial viability, including:
- How to build or adapt a solution that meets ACCESS requirements at the lowest sustainable cost, and whether there is a credible return-on-investment case for the clinical and business model adjustments it requires.
- Whether to pursue ACO partnership, and if so, which ACOs have the patient volume and care priorities to make the relationship mutually beneficial.
- How to collaborate with PCPs in ACOs to act on care updates for chronic pain, weight management, or mild anxiety, which providers may not have known patients were receiving.
- Which channel mix and messaging will be used to reach beneficiaries, including owned and partner platforms and CMS itself.
ATI is working with organizations to answer these questions early so that ACCESS participation enhances their broader ACO and value-based care strategy.