You Better Move Fast: ACESS to TEMPO

On December 5, FDA’s Digital Health Center of Excellence announced the “Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot,” in conjunction with the Center for Medicare and Medicaid Innovation (CMMI) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model. FDA’s press release states that TEMPO is a “voluntary pilot designed to promote access to certain digital health devices while safeguarding patient safety.”

TEMPO will use a “risk-based enforcement approach that supports digital health devices intended for use to improve patient outcomes in cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions.” The devices in the TEMPO pilot must be for uses “covered by the CMMI ACCESS model while collecting, monitoring, and reporting real-world performance data.” The ACCESS model intends to address a current challenge faced by developers of many digital health products, namely, that these products have not historically been covered by CMS, minimizing, if not entirely precluding, their uptake. ACCESS will allow CMS to offer coverage based on “outcomes over activities, enabling clinicians to offer innovative technology-supported care that improves patients’ health and complements traditional care.”

There are a few points of particular interest in this announcement. First, FDA states:

Under this approach, participating manufacturers may request that the FDA exercise enforcement discretion for certain requirements, such as premarket authorization and investigational device requirements, while manufacturers collect and share real-world data demonstrating the device’s performance. The FDA will work with participants in the TEMPO pilot to identify the circumstances when enforcement discretion may be appropriate for that manufacturer’s device.

It is not clear how a manufacturer would go about requesting enforcement discretion, the circumstances in which FDA would find it appropriate to exercise such discretion, or what happens after the manufacturer is done collecting and sharing “real-world data demonstrating the device’s performance.” Would the manufacturer, at that point, have to go back and obtain a premarket authorization? This would be an extraordinarily odd outcome, if the device is already being reimbursed by CMS, utilized for clinical decision-making, and essentially used commercially as if it were already authorized. This also does not address whether FDA would exercise enforcement discretion for other related requirements, for example, registration and listing and quality system requirements. It also is worth pointing out that it is not clear whether FDA has the statutory authority to permit differential treatment of certain devices, allowing some on the market without premarket authorization while requiring similar devices that are not part of the program to obtain premarket authorization before commercialization.

Relatedly, while not necessarily clear on FDA’s website, CMS’s website more explicitly calls out the types of conditions that devices in the pilot should be intended to treat, namely:

• Early cardio-kidney-metabolic conditions (eCKM): hypertension (high blood pressure), dyslipidemia (high or abnormal lipids, including cholesterol), obesity or overweight with marker of central obesity, and prediabetes
• Cardio-kidney-metabolic conditions (CKM): diabetes, chronic kidney disease (3a or 3b), and atherosclerotic cardiovascular disease, including heart disease
• Musculoskeletal conditions (MSK): chronic musculoskeletal pain
• Behavioral health conditions (BH): depression and anxiety

The first category above is particularly interesting, given FDA’s recent pushback on any blood pressure product that has not been cleared by FDA, stating that without such clearance there is no assurance of safety and effectiveness. See our posts on the WHOOP Warning Letter and FDA’s recent safety alerts regarding risks associated with use of unregulated blood pressure monitors. FDA now seems to be saying that products of this type may not need premarket authorization, at least not if they are part of this pilot program, which seems to call into question FDA’s prior statements about the necessity of such oversight to assure safety and effectiveness.

Given the historical challenges associated with coverage of digital health products, the TEMPO pilot is an overdue initiative and one with the potential to help provide access to critical digital health products for the Medicare population. In order to allow interested parties to proceed appropriately, however, additional clarification is needed. For example, it is not clear whether a party needs to submit both a “statement of interest” to the FDA, as indicated in the announcement, as well as an “ACCESS Model Interest Form” to CMS, or whether submission of one is adequate. It is also not clear whether CMS would need to first determine that the device is eligible for coverage under the ACCESS Model prior to the device being considered for the TEMPO pilot, or whether such a determination will be made collaboratively between CMS and FDA. Furthermore, it may be helpful for FDA to update its page to more specifically identify the conditions to be treated by a device in the pilot and mirror what is on CMS’s website, indicated above.

CMS’s website also states that the ACCESS Model Interest Forms must be submitted before April 1, 2026, and the program is intended to begin in July 2026. While FDA’s announcement indicates that interested parties can submit “statements of interest” beginning in January 2026, it does not include the April 1 deadline, nor does it indicate an intent to begin the program in July. Given that ACCESS and TEMPO are intertwined, it is reasonable to assume that these dates apply for both parties.

We are happy to help you keep up your “tempo” to be able to “access” both initiatives in a timely manner.