FDA Picks Dexcom as First Participant in Its TEMPO Digital Health Devices Pilot

Federal regulators took another step this week toward reimbursing chronic care that runs through devices and data instead of office visits. On July 22, 2026, the FDA announced that Dexcom is the first company selected for a new pilot meant to test how digital health devices perform in the real world and to line them up with a Medicare payment model that pays for outcomes rather than individual services.

The move matters to telehealth and remote care because it signals how the FDA and the Centers for Medicare and Medicaid Services (CMS) plan to evaluate, and eventually pay for, connected devices that monitor patients between visits. Below is what the TEMPO pilot is, how it connects to the CMS ACCESS Model, and the parts that are not yet settled.

What the FDA announced

On July 22, 2026, the FDA said Dexcom is the first manufacturer selected for its Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot. According to the agency's announcement, the pilot is a partnership between the FDA and the CMS Innovation Center designed to modernize how digital health technologies reach patients while generating real-world evidence and safeguarding patient safety. Michelle Tarver, director of the FDA's Center for Devices and Radiological Health, said in the announcement that access to the right technology at the right time can be life-changing for people managing chronic conditions.

What the TEMPO pilot is

TEMPO stands for Technology-Enabled Meaningful Patient Outcomes. The FDA describes it as a voluntary pilot in which participating manufacturers collect, monitor, and report real-world data (RWD) relating to the intended uses of their devices in order to improve patient outcomes. The agency says it plans to select up to about 10 pilot participants in each of four clinical use areas that mirror the CMS ACCESS Model's tracks.

• Focus: real-world performance of digital health devices used to manage chronic conditions, not a replacement for existing device review pathways.
• Scale: the FDA says it intends to select up to roughly 10 participants in each of four clinical use areas.
• Data duty: participants collect, monitor, and report real-world data tied to their devices' intended uses.
• Partners: the FDA runs the pilot with the CMS Innovation Center, linking device evidence to a Medicare payment model.

How TEMPO connects to the CMS ACCESS Model

TEMPO is aligned with the CMS ACCESS Model, short for Advancing Chronic Care with Effective, Scalable Solutions. According to CMS, ACCESS tests a new payment approach in Original Medicare (traditional fee-for-service, not Medicare Advantage) and will run for 10 years beginning July 5, 2026, with additional rolling start dates. CMS says the model is voluntary and targets chronic conditions that affect more than two-thirds of people with Medicare.

Rather than paying separately for each service, ACCESS uses what CMS calls Outcome-Aligned Payments: recurring payments for managing a patient's qualifying condition, with full payment tied to achieving measurable health outcomes. The model's initial clinical tracks are early cardio-kidney-metabolic conditions, cardio-kidney-metabolic conditions, musculoskeletal conditions, and behavioral health conditions. Abe Sutton, a CMS deputy administrator, said the model rewards measurable improvements in patient health rather than individual services.

What Dexcom will do in the pilot

Dexcom's entry is the Dexcom Glucose Health Program, an AI-powered program that integrates data from the company's G7 and Stelo glucose monitoring systems with contextual information such as nutrition, physical activity, sleep, and stress. Dexcom says the program is meant to support screening for prediabetes and type 2 diabetes and to help improve glycemic control, and to give patients and clinicians more personalized insights. Jake Leach, Dexcom's president and chief executive, said being the first company selected for the pilot marks another first for the company and underscores its focus on innovation.

What this means for telehealth and remote care

For virtual and remote care, TEMPO is a signal about direction rather than a finished rule. It pairs an FDA evidence pilot with a CMS payment model that is explicitly built around technology-supported, continuous chronic care in traditional Medicare. If the approach holds, device makers and the telehealth platforms that deploy their tools would have a clearer route to demonstrate real-world value and to be reimbursed for managing conditions over time instead of billing visit by visit. That aligns with a broader 2026 policy shift in Washington toward tying remote monitoring payment to genuine clinical outcomes and relationships.

Limits and what is not settled

Several things remain open. TEMPO is described as a pilot to generate real-world data and support access under the ACCESS Model, and the FDA has said it plans to add more participants over time, so the roster and rules will keep developing. CMS is accepting ACCESS applications on a rolling basis for later performance periods, which means participation and covered services can change. Nothing in the announcement should be read as a guarantee of coverage for any specific patient or product, and long-term outcomes from the pilot are not yet known. This article is general information for a telehealth audience, not medical or legal advice. Patients and clinicians should rely on their own licensed professionals and the primary FDA and CMS documents for decisions about care or program participation.