For medical device companies seeking commercial success in the United States, understanding the regulatory and reimbursement environments is crucial. The first important step is to secure premarket authorization for a new medical device from the Food and Drug Administration (FDA), but successful market adoption often relies on whether an appropriate coverage pathway and payment system under the Centers for Medicare & Medicaid Services (CMS) are available for the new device. A new and unprecedented collaboration between the FDA and CMS offers a promising pathway and payment system for manufacturers of digital health devices interested in exploring new and innovative solutions for patient care.
On December 5, 2025, the FDA and CMS announced a coordinated effort to accelerate the adoption of technology-enabled chronic care. This collaboration brings together two major initiatives, the FDA’s Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot and CMS’s Advancing Chronic Care with Effective, Scalable Solutions Model (ACCESS).
Under TEMPO, the FDA may exercise enforcement discretion for key regulatory requirements (e.g., premarket authorization investigational device exemption, informed consent, and institutional review boards rules) when manufacturers offer digital health technologies to or by ACCESS participants to improve patient outcomes in care expected to be covered by ACCESS.
Highlights of TEMPO and ACCESS include:
- TEMPO provides enforcement discretion to selected digital health device manufacturers to deploy devices in real-world settings before they have FDA authorization, which may generate data for use in future FDA regulatory submissions.
- ACCESS is a 10-year, outcome-based payment system for certain categories of devices related to chronic disease care.
- Together, TEMPO and ACCESS are intended to provide regulatory flexibility and value-based payment, with the goal of accelerating adoption of and evidence generation for digital health medical devices.
- Important limitation: Devices offered under TEMPO may not be marketed for the same intended use outside of ACCESS while relying on TEMPO enforcement discretion.
Overview of ACCESS
ACCESS is a 10-year national payment model under the Center for Medicare and Medicaid Innovation scheduled to begin on July 5, 2026 and run through June 30, 2036. ACCESS introduces outcome-aligned payments (OAPs) that are intended to provide predictable, recurring payments to participating organizations for managing patients with qualifying chronic conditions.
Unlike traditional Medicare fee-for-service reimbursement, which is tied to discrete services or devices, CMS intends to link OAPs to the achievement of certain measurable health outcomes, such as improvement or control of blood pressure for hypertension. Participating organizations (Medicare Part B–enrolled organizational entities identified by a single tax identification number) will be given flexibility to use technology, clinical tools, and care models best suited to each patient. To reduce financial barriers to accessing technology-enabled care, ACCESS participants can choose to waive patient cost-sharing for OAPs under the safe harbor at 42 C.F.R. § 1001.952(ii)(2).
Under ACCESS, participants will receive 50% of their total annual OAP during the care period, paid in quarterly installments. The remaining 50% will be reconciled and adjusted based on clinical outcomes across the full patient population (the clinical outcome adjustment) and the ACCESS participant’s ability to limit or eliminate the delivery of “substitute” services (the substitute spend adjustment). ACCESS participants also must comply with applicable federal and state requirements (including HIPAA and FDA requirements, or enforcement discretion where applicable) and designate a physician clinical director responsible for clinical and compliance oversight.
Initial Four Clinical Tracks under ACCESS
ACCESS will initially focus on four clinical tracks targeting common chronic conditions. ACCESS participants will have to provide care for all qualifying conditions that a beneficiary has within the selected clinical track.
- Early Cardio-Kidney-Metabolic (eCKM). Hypertension (high blood pressure), dyslipidemia (abnormal or elevated lipids, including cholesterol), obesity or overweight with marker of central obesity, and prediabetes
- Cardio-Kidney-Metabolic (CKM). Diabetes, chronic kidney disease, or atherosclerotic cardiovascular disease
- Musculoskeletal (MSK). Chronic musculoskeletal pain
- Behavioral Health (BH). Depression or anxiety
CMS indicated that additional tracks and conditions may be considered in the future.
ACCESS is currently accepting applications for the first cohort deadline of April 1, 2026. The first cohort will begin participation on July 5, 2026. Applications will be accepted on a rolling basis through April 1, 2033 for cohorts beginning on January 1, 2027, and quarterly thereafter through July 1, 2033.
TEMPO and Enforcement Discretion
Digital health technologies that meet the definition of a medical device under Federal Food, Drug, and Cosmetic Act (FDCA) Section 201(h) generally require FDA marketing authorization, such as 510(k) clearance or premarket approval, or have an investigational device exemption (IDE). Under TEMPO, the FDA intends to exercise enforcement discretion for selected digital health medical devices that fall into the four clinical tracks and will not enforce premarket authorization requirements or IDE requirements when those devices are offered to or by the ACCESS participants to improve patient outcomes in care expected to be covered by ACCESS. This may apply, for instance, when the digital health device manufacturer participates directly in ACCESS or when the manufacturer supplies the device to other organizations that are participating in ACCESS.
The FDA may also, as appropriate, exercise enforcement discretion for certain requirements under 21 C.F.R. Parts 50 and 56 (informed consent and institutional review boards) for participating manufacturers and will work with participants to determine when discretion is appropriate.
Although the FDA may exercise enforcement discretion during the pilot, the agency expects manufacturers to ultimately seek appropriate marketing authorization (e.g., 510(k) or other applicable authorization pathway) using data collected during pilot participation, and the FDA intends to discuss proposed timelines for submissions with participants.
Real-World Data Generation and Future Marketing Applications
A key benefit of TEMPO is the ability to generate real-world data (RWD) on device performance and patient outcomes during real-world clinical use under ACCESS. These data serve multiple purposes. RWD collected through TEMPO can help inform or augment the FDA’s understanding of the benefit-risk profile of devices at various points in their life cycle. Manufacturers will then be able to use the data to support future FDA marketing submissions, though additional data may still be required.
Importantly, the FDA notes that participation in TEMPO does not guarantee eventual FDA clearance or approval. Rather, it provides an opportunity for early engagement with the FDA, iterative feedback through mechanisms such as focused “sprint” discussions on a specific topic within a set period that is shorter than a regular pre-submission timeline, and facilitates the collection of RWD without seeking premarket authorization or IDE approval.
TEMPO Eligibility and Scope
Digital health devices must meet four criteria to be eligible for TEMPO:
- Meet the definition of a device under Section 201(h) of the FDCA.
- Be used in conjunction with clinician-supervised outpatient treatment to patients with conditions in one of the four ACCESS clinical use areas.
- Not present potential for serious risk to patient health, safety, or welfare.
- Be used to improve patient outcomes consistent with ACCESS.
If a manufacturer wishes to offer its device for the same intended use outside ACCESS, it falls outside TEMPO and the device must be authorized by the FDA for that intended use. In other words, the enforcement discretion provided under TEMPO applies only when the device is offered to or by ACCESS participants for the specific intended use within ACCESS; marketing the device for the same intended use outside ACCESS would require FDA authorization.
Basic TEMPO Submission Information
The FDA began to accept statements of interest for TEMPO on January 2, 2026. Statements of interest should identify the manufacturer and device, include a proposed indications-for-use statement, and request that the FDA exercise enforcement discretion. Statements should be titled “Statement of Interest for Participation in the TEMPO Pilot” and be submitted by email to FDA-TEMPOPilot@fda.hhs.gov. The statement should:
- Identify the manufacturer and the manufacturer’s device, including any current authorizations or prior FDA interactions (e.g., relevant submission numbers) related to the device.
- Include a proposed indications-for-use statement identifying the intended use to improve patient outcomes in a clinical use area consistent with participation in ACCESS.
- Include a request for FDA enforcement discretion for certain legal requirements.
Following submission of a statement of interest, the FDA expects to invite a subset of manufacturers to provide additional information; requests may vary based on the specific device.
As part of its selection process, the FDA has indicated that it intends to evaluate whether the digital heath device would present the potential for serious risk to the health, safety, or welfare of patients. The FDA has also indicated that it will select digital health products in the four clinical tracks that meet the definition of a device under FDCA Section 201(h).
The FDA has not specified a deadline for submitting statements of interest but encourages manufacturers to submit before March 2, 2026 because it expects to begin sending follow-up requests to certain potential pilot participants around that date. Upon receipt of a statement of interest, the FDA may request additional information to help inform its selection process, such as:
- A device description, including proposed indications for use and claims describing the intended use to improve patient outcomes within ACCESS.
- Data demonstrating the device’s safety, functionality, and a reasonable expectation of patient benefit (such as published and unpublished studies).
- Information about the manufacturer’s quality management system.
- A risk mitigation and RWD collection plan.
- Proposed performance goals and a statistical analysis plan for patient outcomes.
- A proposed timeline for data collection and submission of a premarket notification (510(k)) or other marketing submission, as applicable.
- An interim reporting plan, including frequency, to report adverse events, new risks, and progress toward milestones.
The FDA expects to select up to about 10 manufacturers based in the United States in each of the four clinical use areas identified for TEMPO. It is not explicitly stated whether follow-up requests will be sent to a broad group of applicants or only to a limited number, nor is it clear whether the FDA will continue accepting statements of interest after it begins sending follow-up requests.
Why Apply?
If your company is developing digital health solutions for chronic disease management, TEMPO and ACCESS together offer an attractive opportunity for exploring new use cases for those digital health solutions in a real-world setting. By participating, manufacturers can accelerate real-world evaluation of their technologies, engage directly with the FDA and CMS, and generate the clinical evidence needed for both regulatory and reimbursement success. Manufacturers can also take advantage of this unprecedented coordination between two key agencies to streamline the FDA premarket authorization process and obtain payment and coverage guidance directly from CMS.
However, the FDA and CMS have released only limited information about this collaboration. CMS has announced that it intends to release ACCESS OAP payment rates and related parameters before the first application deadline of April 1, 2026, while the FDA has only stated that it will follow up with manufacturers that submit statements of interest to request additional information to help the FDA make a decision on participation.
Our dedicated FDA and CMS teams have extensive experience guiding digital health companies through both regulatory and reimbursement pathways. We can help you craft a compelling TEMPO application and navigate the complexities of ACCESS, ensuring your innovation is well-positioned for success.
More information about the specifics of requesting participation in TEMPO or ACCESS can be found in the FDA’s Federal Register notice announcing the TEMPO pilot program, the FDA’s FAQs for TEMPO, and the ACCESS request for applications and application portal.
If you have any questions, or would like additional information, please contact one of the attorneys on our FDA: Drug & Device team.
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