US pilot links premarket digital devices to Medicare payments

The US Food and Drug Administration (FDA) announced its first TEMPO participant on July 22, 2026 and now lists Cadence Solutions and Dexcom in the pilot. Selected digital health devices can enter Medicare-supported chronic care before the agency grants marketing authorization for the uses under review. The FDA says the devices' effectiveness for those intended uses has not yet been evaluated by the agency, and each manufacturer must collect, monitor and report real-world data.

The Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot is paired with the US Centers for Medicare & Medicaid Services' Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model. TEMPO does not confer clearance or approval. It lets the FDA decide not to enforce specified requirements in defined circumstances while ACCESS supplies a payment route for the care in which a selected device is used.

Two agencies control different parts of the route

ACCESS began on July 5, 2026 as a 10-year voluntary model in Original Medicare, the US public insurance program in which the government pays participating providers directly. CMS says participating care organizations receive recurring payments for managing qualifying chronic conditions, with full payment tied to measurable patient outcomes rather than a list of individual services.

TEMPO addresses the regulatory side. A manufacturer may ask the FDA to exercise enforcement discretion when its device is offered to or by an ACCESS participant for an intended use connected to covered care. The FDA then determines which requirements it will not enforce and under what conditions for that device.

Enforcement discretion is not authorization

The distinction changes what the public can infer about a participating device. Marketing authorization follows an FDA review under an applicable pathway, such as a 510(k) premarket notification or premarket approval. Enforcement discretion is an agency decision about whether to enforce particular legal requirements in a specified setting; it is not an affirmative determination that a device is safe and effective for the use being evaluated.

The FDA says a TEMPO request may cover premarket authorization, investigational device exemption requirements and the informed-consent and institutional-review-board rules in Parts 50 and 56 of Title 21 of the US Code of Federal Regulations. The exact scope is participant-specific. The agency may also set conditions involving labeling, records, risk controls and reporting.

The boundary around the pilot is narrow. A manufacturer cannot use TEMPO to market the same unapproved intended use outside ACCESS. The FDA also expects participants eventually to seek the appropriate marketing authorization, using pilot data and any additional evidence needed for a formal submission.

Eligibility limits the size and scope of the test

The FDA plans to select up to about 10 US-based manufacturers in each of four ACCESS clinical areas. Those areas cover early cardio-kidney-metabolic conditions; diabetes, chronic kidney disease and atherosclerotic cardiovascular disease; chronic musculoskeletal pain; and depression or anxiety. Devices must be finished products intended for clinician-supervised outpatient care and must not present the potential for serious risk to patient health, safety or welfare.

Selection is not based on a brief product description alone. The FDA says it may examine evidence that a device can function as designed, the manufacturer's quality system, plans to mitigate risk, proposed outcome measures and a statistical plan. It may also seek a schedule for real-world data collection, interim reports and a later marketing submission.

The two listed participants illustrate the range. Cadence Solutions' HypertensionOS is under evaluation for a clinician-supervised role in starting and adjusting antihypertensive medication under predefined rules. Dexcom's Glucose Health Program is under evaluation for metabolic monitoring, tailored guidance, AI-supported insights and screening assistance related to prediabetes and type 2 diabetes.

Payment and oversight remain conditional

ACCESS pays for a package of technology-supported care, not simply for possession of a device. Participating organizations must enroll in Medicare Part B, comply with applicable US federal and state rules, and appoint a physician clinical director to oversee quality and compliance. CMS says it will monitor clinical outcomes, claims and program-integrity data and may remove organizations that fail quality, safety or compliance standards.

The model is limited to Original Medicare. Medicare Advantage plans, which deliver Medicare benefits through private insurers under contracts with the US government, may establish similar arrangements independently, but they are not participating in the ACCESS test itself. Patients enroll voluntarily and retain their existing Medicare rights and access to other Medicare providers.

This structure connects evidence collection, regulatory oversight and reimbursement more directly than a conventional sequence in which coverage is considered only after authorization. It also moves some evidence generation into routine care. The trade-off is that patients and clinicians may encounter a device before the FDA has evaluated its effectiveness for that use, making the pilot's reporting, supervision and exit controls central to its credibility.

Frequently asked questions

Are TEMPO devices FDA-approved?
No. The FDA may decline to enforce specified premarket and investigational requirements for a selected device in defined ACCESS use. The agency explicitly says it has not yet evaluated the listed devices' effectiveness for the intended uses under review.

Can a manufacturer sell the same use outside ACCESS?
Not under TEMPO. The FDA says offering the device for that intended use outside the ACCESS context falls beyond the pilot and generally requires the appropriate US marketing authorization.

Does ACCESS cover every person enrolled in Medicare?
No. ACCESS is being tested in Original Medicare. Medicare Advantage organizations may choose to build similar payment arrangements with their contracted providers, but those arrangements are separate from the federal model test.