On December 8, 2025, FDA announced a pilot for certain digital health devices in connection with the Center for Medicare and Medical Innovation’s (CMMI’s) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) payment model.
CMMI’s ACCESS model is designed for exploration of outcome-aligned payments (OAPs) to expand digital health technology access to help Medicare individuals improve their health and manage chronic disease.
FDA has released scant details about its Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot, but has indicated that manufacturers who participate can request that FDA exercise enforcement discretion to not enforce applicable requirements, such as premarket authorization requirements, investigational device exemption (IDE) requirements, and requirements in 21 CFR Parts 50 and 56 related to informed consent and investigational review boards.
While it is encouraging to see the agencies working together to help solve the access gap for digital health technologies, the TEMPO pilot is unlikely to significantly impact the FDA side of the equation.
A Tale of Two Pilots
Historically, Medicare has lacked a payment option to support novel technology–supported care. The CMMI’s ACCESS model tests an OAP approach in Medicare, paying participating Medicare-enrolled organizations on a recurring basis for managing patients with qualifying conditions with full payment tied to measurable outcomes, such as objective criteria for clinical improvement or control of a condition. Qualifying conditions include blood pressure, diabetes, chronic musculoskeletal pain, and depression.
CMMI’s announcement references the transformative possibilities of digital health technologies for chronic conditions, such as telehealth software; wearable devices that monitor sleep, heart rate, movement, blood sugar, and other functions; and apps that coach individuals on lifestyle changes that can benefit both their behavioral and physical health. The listed technology types have often struggled with reimbursement, even after obtaining FDA authorization, and CMMI’s model could provide a solution or at least allow for such digital health technologies to gather evidence needed to support reimbursement in the future.
Conversely, FDA’s TEMPO pilot lacks concrete detail about the benefits of participating in the pilot. The pilot is limited to up to 10 participants (a similar number to the PreCert pilot years ago). The TEMPO pilot is designed for participants in CMMI’s ACCESS model who do not have FDA authorization and allows these companies to request that FDA exercise enforcement discretion.
FDA indicates that it will work with the pilot participants to identify the “circumstances when enforcement discretion may be appropriate for the device” such as “when the labeling includes appropriate cautions and FDA requests that certain records be maintained.” FDA further expresses that the broader purpose is for devices used as part of the ACCESS model to share data with FDA. The real-world data collected may be used to generate real-world evidence to help inform or augment FDA’s understanding of the benefit-risk profile of a participating device and could be used to support FDA premarket authorization.
Implications for Industry
- While speeding innovation and access to digital technologies is a laudable goal, FDA authorization has not been the primary barrier to access. Many digital health technologies are not regulated by FDA, and others fall within existing enforcement discretion policies such as the policy for devices intended to maintain or encourage a general state of health or healthy activity, or to help sustain a healthy lifestyle with help to reduce the risk or impact of certain chronic disease or conditions (commonly referred to as general wellness products).
- Not all clinical studies involving digital health technology will require FDA review: only clinical investigations of significant risk devices require FDA approval of an IDE application. Many digital health technologies may have minimal or no IDE requirements when they are studied clinically. Should a clinical study involving digital health technology be subject to the IDE requirements, one of the more significant benefits of enforcement discretion under the TEMPO pilot would be that the company could commercialize and charge for use of an investigational device.
- Companies should keep in mind that the enforcement discretion under the TEMPO pilot may be temporary. FDA’s announcement mentions enforcement discretion under the pilot as allowing the company to gather real-world evidence that could support a premarket submission. FDA will likely want participating devices to eventually obtain premarket authorization and come into compliance with all applicable FDA requirements.
- Companies that have already obtained FDA authorization for their digital health technology would likely see little benefit from participating in the TEMPO pilot even if they choose to participate in the CMMI ACCESS model.
- Participating in pilots can be resource-intensive. Companies should carefully weigh whether participation is desirable, taking into considerations the specifics of the company, the device, and the device’s stage of development.
Conclusion
The CMMI ACCESS model is an important step toward solving the digital health access gap. While FDA’s TEMPO pilot may not benefit most device companies, the partnership between FDA and CMS is of note and shows ongoing awareness at the federal level of the need to ease barriers to access to help patients improve or control their chronic conditions. We are closely watching the outcomes of these programs as they may have broader implications for the future of the digital health industry.