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December 11, 2025 – “Harnessing new digital technologies to treat chronic conditions and improve health outcomes.” If you think this sounds like a goal that directly aligns with one of the administration’s top priorities, making America healthy again, you would be correct. However, achieving this goal does not come without questions, such as, how do you pay for these technologies, and how can new technologies be approved quickly enough for use before newer, more innovative technologies take their place? Last week, the Centers for Medicare & Medicaid Services (CMS) Innovation Center and the US Food and Drug Administration (FDA) attempted to answer these questions by introducing a pair of models (i.e., tests):
Taken together, these models are intended to reduce administrative and regulatory barriers and introduce payment incentives that will enable millions of Medicare beneficiaries to access digital health devices. To help me lay out what we know (and don’t know) about how the models will work together to achieve their intended goal, I’m bringing in my colleague Simeon Niles.
For more on ACCESS and TEMPO, listen to our Health Policy Breakroom podcast.
We do not know all the details of the CMS Innovation Center’s new model yet, as we are still waiting for CMS to release the request for applications for potential participants (which usually includes a lot of information about the model). However, here’s what we do know: the model is voluntary, meaning that it does not require any entity or provider to participate, and it is set to last 10 years (July 1, 2026, to July 1, 2036). The length of the model is noteworthy, since the CMS Innovation Center has recently prioritized shorter models.
ACCESS is aimed at modernizing traditional Medicare (i.e., not Medicare Advantage) by leveraging enhanced digital health technologies to improve access, care delivery, and patient support. The model will focus on four clinical areas or tracks:
Digital health technologies sit at the core of ACCESS, both in terms of how providers currently support patients and in how CMS expects the model to evolve over time. Participating organizations must be enrolled in Medicare Part B as a provider or supplier to comply with licensure standards. While any Medicare Part B provider or supplier (excluding durable medical equipment, prosthetics, orthotics, and supplies and laboratory suppliers) can participate, it may be more likely that digital device companies will apply (if they are not yet enrolled in Part B, they would have to do so in order to be participate)—but once the request for applications is released we will get an even better understanding of what types of providers want to apply.
Participating organizations are expected to offer integrated, tech-enabled care that runs the gamut from lifestyle and behavioral support (e.g., nutrition, exercise, smoking cessation) to ordering and interpreting diagnostic tests/imaging, to use of FDA-authorized devices, such as software as a medical device. Participants must also designate a physician clinical director who will be responsible for clinical oversight and compliance. These organizations will receive outcome-aligned payments (OAPs), recurring payments for managing qualifying conditions, with full payment tied to achieving measurable health outcomes. Each track will include a set of condition-specific measures and outcomes targets. Most tracks will include an initial year of care followed by an optional continuation period at a reduced payment rate. To promote access in underserved areas, CMS will apply a fixed adjustment to rural patients in qualifying tracks.
Although primary care providers (PCPs) are not the direct targets of ACCESS, they will remain critical to the model’s success. PCPs will be able to refer patients to model participants and may also bill a new co-management payment ($30 per service, billed at most quarterly) for review of patient updates and associated coordination activities. An interesting twist is that CMS will allow Medicare beneficiaries to sign up directly with participants. To help Medicare beneficiaries and PCPs choose the most appropriate participant for their conditions, CMS will maintain a directory of all participants, including the conditions they treat and their risk-adjusted outcomes.
CMS wants to move quickly on the ACCESS model. The request for applications is expected to be released later this month, with the application portal opening in January 2026. The first application deadline is in April 2026, and participants are expected to be announced on a rolling basis.
The ACCESS model’s emphasis on tech-enabled care is also reflected in CMS’s collaboration with the FDA on TEMPO. TEMPO, which FDA Chief of Staff Jim Traficant described as a “regulatory sandbox,” is a key component of the FDA’s Home as a Health Care Hub initiative. TEMPO will allow manufacturers of certain non-FDA-authorized digital health devices to pilot the use of those devices in ACCESS. Under the pilot, the FDA may exercise enforcement discretion and choose not to enforce certain requirements related to the device’s use within ACCESS during the pilot period, such as premarket authorization or investigational device exemption requirements. The FDA expects pilot participants to collect and share real-world data with the FDA regarding the device’s use in improving patient outcomes. The FDA also expects that this data will be used to seek appropriate marketing authorization eventually.
TEMPO is open to US-based manufacturers of digital health products that meet the definition of a device under the Federal Food, Drug, and Cosmetic Act (including artificial-intelligence-enabled devices). The FDA plans to limit participation to approximately 10 devices in each of ACCESS’s four clinical use areas. Selection will include an evaluation of whether the device presents a potential for serious risk to patient health or safety.
The FDA will begin accepting statements of interest for participation in TEMPO beginning January 2, 2026, and will issue follow-up requests for information around March 2, 2026. The FDA indicated that the following information would be helpful in conjunction with statements of interest:
Although CMS and the FDA have outlined the broad contours of ACCESS and TEMPO, there are still many unanswered questions that may affect how organizations prepare and position themselves for the models. A few topics we’ll be eagerly awaiting more information on include:
Another key area of interest is how CMS intends to treat OAPs when Medicare beneficiaries are already attributed to existing value-based care models. CMS has only indicated that ACO models will receive a two-year reprieve; beginning in 2028, OAPs will be included in ACO benchmark and performance year calculations. This raises important questions about how ACCESS could interact with total-cost-of-care or episode-based models, particularly because patients will be able to self-refer. That dynamic creates the potential for direct-to-consumer marketing, which introduces risks related to fragmented care and misaligned incentives.
While ACCESS is limited to traditional Medicare, CMS issued detailed FAQs that signal a broader vision for multi-payer alignment. The agency clarified that OAPs made under arrangements such as ACCESS may count toward the Medicare Advantage medical loss ratio when they meet regulatory requirements for incurred claims or quality improvement activities and are not otherwise excluded. CMS went even further by addressing whether states may permit Medicaid managed care plans to adopt ACCESS-like approaches under the “in lieu of services and settings” authority. It will be important to watch which plans and states move to operationalize this flexibility. While we don’t yet know the size of the OAPs, simply being accepted into the model and appearing on a CMS-approved participant list could carry strategic value in commercial markets, even if the model’s payments are modest.
Both ACCESS and TEMPO emphasize patient protection, including cybersecurity, privacy, and clear communication with patients. The CMS Innovation Center has made it clear that it expects the model to grow – either by expanding the number of participating organizations or the number of conditions or clinical tracks – as long as the digital health ecosystem continues to expand. At a kick-off event for the models on December 4, 2025, CMS and FDA stated that they have already received a lot of interest in the models. We will see in relatively short order how that initial interest will translate into actual participation.
Until next week, this is Jeffrey (and Simeon) saying, enjoy reading regs with your eggs.
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