Rock Weekly: A New Federal Effort to Expand Digital Health Access: The “ACCESS” Model

Maverick Health Policy is a consulting firm located in the Washington, D.C. area that specializes in digital health and payment policy. Maverick tracks and analyzes the activity inside the beltway and industry activity beyond the beltway on topics like health data exchange, price transparency, telehealth, artificial intelligence, and value-based care. In collaboration with Rock Health, Maverick is identifying the federal health policy activity that is most relevant to readers of the Rock Weekly.

The following is what you need to know about the latest effort by the federal government to create public policies that will drive the greater use of digital health tools.

Medicare’s new payment experiment signals a major shift in how the nation’s largest payer, and eventually private insurers, will reimburse clinicians for healthcare services. The Trump Administration is determined to give patients modern tools that help them manage their conditions at home and avoid unnecessary institutional care. This model is the first concrete step in that direction.

The other important thing about this new Medicare payment model is that it is designed to last for 10 years. Normally, experiments with new payment models are much shorter in duration. But the ACCESS model is 10 years long because it is an attempt to fundamentally shift Medicare payments from fee-for-service to paying for outcomes, and it also testing whether tech tools can improve health and lower costs – which will require new data collection and analysis. Improving chronic conditions like diabetes and heart disease takes time, and providers will need time to invest in technology, create new workflows, and adjust over time to determine if this is a model worth scaling over the longer-term.

Participating providers that use technology to help patients manage their chronic diseases will receive recurring “Outcome-Aligned Payments” (OAPs) based on whether their patients show measurable improvements in health. The model includes four clinical tracks: (1) early cardio-kidney-metabolic, (2) cardio-kidney-metabolic, (3) musculoskeletal, and (4) behavioral health, each with its own specific measures and outcome targets. Organizations may participate in more than one track but must manage all qualifying conditions within any track they select.

Providers who are enrolled in Medicare Part B (hospitals, primary care practices, multispecialty groups, home- and community-based providers, etc.). Durable medical equipment suppliers, prosthetics and orthotics providers, and laboratory suppliers are not eligible.

Primary care physicians play an important role in the model because they will likely be the principal way patients are referred to ACCESS participants. Primary care physicians and referring providers can bill for an ACCESS co-management payment for documented review of patient updates ($30 per review) from associated ACCESS participants. It is not clear, yet, if the co-management payment is enough to encourage primary care participation.

The Access Model is intentionally designed to operate alongside, not in place of, the Medicare Shared Savings Program — Medicare’s primary vehicle for value-based care and Accountable Care Organizations (ACOs).

Patients who are enrolled in Traditional Medicare (not Medicare Advantage) may sign up directly with participating ACCESS organizations or enroll after a referral from their primary care practitioner (PCP) or another clinician. When the program gets underway, patients can go to the CMS public directory of ACCESS participants to find out who they are.

In its FAQs about the ACCESS model, CMS stated that states may allow Medicaid managed care plans to voluntarily implement ACCESS-like approaches through the In Lieu of Services and Settings (ILOS) authority. States have flexibility to determine whether and how an ACCESS-like model qualifies as an ILOS and how it is reflected in managed care contracts.

CMS is launching an ACCESS Tools Directory that will be part of the ACCESS application and participant portal. The directory will help providers identify optional software and hardware tools that may support model participation and compliance, such as data exchange and interoperability solutions, identity verification systems, optional connected clinical devices like blood pressure cuffs, and tools that support HIPAA compliance.

Vendor participation in the directory would be voluntary and non-endorsing. Vendors would submit their own listings and self-certify that their products meet all applicable federal and state requirements, including applicable FDA requirements (or are otherwise subject to FDA enforcement discretion).

CMMI and the FDA are working together on this new model. The FDA is creating its own program called the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices pilot, to increase the availability of solutions to use for the ACCESS Model.

The voluntary pilot will waive certain regulatory requirements for approximately 40 (~10 per ACCESS clinical track) digital health device manufactures participating in the ACCESS Model. The goal is to increase the number of solutions available to participating patients and providers. Companies selected for the TEMPO pilot will be able to collect real-world evidence to support future device authorization.

CMS has not yet released the request for applications for potential participants, but applications to participate in the model will open January 12, 2026, and close April 1, 2026. Providers may begin preparing right away by vetting technology partnerships and developing technology-support access.

The FDA will begin accepting statements of interest for participation in TEMPO beginning January 2, 2026, and will issue follow-up requests for information around March 2, 2026.

This is the CMS website about the ACCESS model:

https://www.cms.gov/priorities/innovation/innovation-models/access

If you’re a provider interested in working with the ACCESS model, an interest form is available and you will be notified when applications open.

If you’re a digital health device manufacturer, the FDA will seek statements of interest for the TEMPO pilot in January 2026.