4 minute read | December.12.2025
Last week, CMS and the FDA announced coordinated efforts to widen access to technology-enabled care for Medicare beneficiaries with certain chronic conditions.
CMS unveiled the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model. The ACCESS Model is a 10-year test of an outcomes-based payment approach that aims to expand access to technology-supported care for Medicare beneficiaries with chronic conditions.
In announcing the ACCESS Model, CMS stated that digital technologies are changing how care is delivered and helping people manage chronic conditions with continuous support beyond the doctor’s office. Examples include telehealth software, wearable devices and coaching apps that support lifestyle changes. CMS also identified a challenge: Medicare beneficiaries have limited access to technology-supported care. Medicare fee-for-service, according to CMS, lacks a payment option that adequately supports novel technology-enabled care.
To complement the ACCESS Model, the FDA is launching the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot. The pilot is designed to align with rapid digital health development and to expand patient access to innovative technologies.
The TEMPO pilot focuses on the same chronic conditions as CMS’s ACCESS Model. While the FDA generally expects manufacturers to obtain authorization for devices intended to improve patient outcomes, the TEMPO pilot will allow manufacturers to request enforcement discretion when the device is offered to ACCESS Model participants for use in providing care under the model.
CMS expects ACCESS Model participants to offer integrated, technology-supported care. Such care may include:
The model emphasizes patient outcomes rather than specific services, giving organizations flexibility to design their care approach.
ACCESS participants will track condition-specific measures and outcomes. CMS will make “outcome-aligned payments” based on the overall share of patients that meet outcome targets.
Primary care physicians and other clinicians can refer their patients to ACCESS participants and receive regular patient progress updates. These referring providers may bill for co-management services, for reviewing and coordinating care with the ACCESS participant.
ACCESS participants must be enrolled in Medicare Part B as providers or suppliers, excluding DMEPOS suppliers and laboratories. The organization must appoint a clinical director responsible for clinical oversight and compliance, and the offering must otherwise comply with applicable federal and state laws. In particular, ACCESS participants must ensure the medical devices used in the model are in compliance with FDA requirements, except to the extent the device is subject to FDA enforcement discretion.
The ACCESS Model will focus on four tracks:
To encourage beneficiary engagement, CMS intends to offer safe harbor protection for ACCESS organizations that do not want to impose patient cost-sharing requirements.
There is no patient cost-sharing when the referring providers bill for a co-management fee. The goal is to support strong collaboration between traditional providers and technology-enabled care teams.
Applications are due April 1, 2026. CMS will release more information in advance, including a request for applications and an implementation guide. Organizations can complete the ACCESS Model Interest Form to receive notice when the application is available.
For more information, see ACCESS Model overview and ACESS Technical Frequently Asked Questions.
The TEMPO pilot will allow manufacturers that want to offer their devices for use within the ACCESS Model — where the intended use would generally require FDA premarket authorization, but the device does not yet have that authorization — to request that the FDA exercise enforcement discretion.
Under this pilot, the FDA would not enforce certain requirements — such as premarket authorization — when offered to ACCESS participants for use in providing care under the model. The devices used would generate real-world data that may support future FDA marketing submissions, and the pilot will facilitate use of devices in a controlled context while such real-world data is collected.
FDA plans to select about 10 manufacturers in each of the four chronic condition “tracks” of ACCESS Model.
Yes. If an ACCESS participant uses a device in the TEMPO pilot, they must get beneficiary consent, including informing them that the device is part of an FDA pilot and certain data will be shared with FDA.
FDA will collect statements of interest for participation starting in January 2026.
For more information, see the FDA press announcement, FDA Digital Health Center of Excellence, and ACESS Technical Frequently Asked Questions.
If you have any questions, please contact Amy Joseph, Georgia Ravitz, Jeremy Sherer, Thora Johnson or another Orrick team member.