CMS and FDA provide a new Medicare pathway for tech-enabled chronic care

The Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) have begun a pair of programs that could increase the availability and affordability of digital health devices as treatment for chronic disease for Medicare patients.

The Advancing Chronic Care with Effective Scalable Solutions (ACCESS) payment model is a voluntary program from CMS that will provide payment under Medicare Part B for integrated tech-supported care that focuses on providing recurring payments to participating providers and suppliers who can show improvement in patients’ chronic conditions. Additionally, the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices pilot program from the FDA’s Center for Devices and Radiological Health (CDRH) provides a pathway for digital health device companies who wish to participate in the ACCESS model to request enforcement discretion from FDA for certain requirements like pre-market authorization and investigational device requirements.

There are still some details to flesh out with both programs and there will be further communications from the federal government in the new year. However, FDA will begin to collect statements of interest for participation in the TEMPO program starting on January 2, 2026. Also, the first performance period for the ACCESS model will begin on July 1, 2026 and applications for that period will be due by April 1, 2026.

In this post, we will detail what we know about both programs and what they could mean for health care providers and suppliers and digital health device companies.

ACCESS at a glance: What is it and who qualifies

ACCESS is a voluntary Section 1115A payment model that the CMS Innovation Center is exploring and  will run from July 1, 2026 through June 30, 2035. The model is based on recurring outcome-aligned payments to participating providers and suppliers for managing patients with qualifying conditions. Full payment depends on achieving measurable health outcomes from each patient’s baseline.

Participating organizations must be enrolled in Medicare Part B, designate a Medicare-enrolled Medical Director and complete the Model Interest Form prior to applying for status as a ACCESS participating organization. We await an official notice from CMS as to when the applications will be available. But, for now, filling out the Interest Form above is the best way to get further information.

What care does ACCESS cover?

Participants must offer integrated, tech-supported care, in person or virtually (including asynchronously). Covered care activities include:

• Clinician consultations

• Lifestyle and behavioral support (nutrition, exercise, smoking cessation)

• Therapy and counseling

• Patient education and care coordination

• Medication management

• Ordering and interpreting diagnostic tests and imaging

• Use or monitoring of Food and Drug Administration (FDA)-authorized devices, including devices or software, or devices that are subject to FDA enforcement discretion

ACCESS will launch with four clinical tracks (with the possibility of more later):

• Early cardio-kidney-metabolic conditions: 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: diabetes, chronic kidney disease (3a or 3b), and atherosclerotic cardiovascular disease, including heart disease

• Musculoskeletal conditions: chronic musculoskeletal pain

• Behavioral health conditions: depression and anxiety

There will be a fixed adjustment applied to rural patients to promote access in underserved areas.

TEMPO: Faster FDA pathway for home-based digital health devices

TEMPO is an FDA pilot program that offers digital health device companies an opportunity to request enforcement discretion from FDA while their device is either in the process of approval or not yet approved to be made available for use in the ACCESS program. Through TEMPO, participating manufacturers will collect and share real-world, real-time data about the device’s effectiveness and performance and be afforded time-limited FDA enforcement for certain requirements (for example, pre-market authorization and investigational device standards) 

To qualify, a device’s intended use must be to improve patient outcomes in one of the clinical tracks required for ACCESS program participation. The program is also part of the FDA’s Home as a Health Care Hub Initiative, encouraging digital health device companies to consider how people will use their medical devices in the home and how they can improve that experience.

How can device makers participate in TEMPO?

Manufacturers may submit statements of interest beginning January 2, 2026. FDA will begin decisions and follow‑ups around March 2, 2026, in anticipation of ACCESS applications due April 1, 2026. 

Statements of interest should identify the manufacturer and device (including any authorizations or prior FDA interactions), propose an indications‑for‑use that aligns with ACCESS, and request FDA’s statement of enforcement discretion for the specified device. Statements should be emailed to FDA in an email titled “Statement of Interest for Participation in TEMPO Pilot”.

Why this matters 

For health care providers and suppliers

ACCESS creates a Medicare payment pathway for tech‑enabled chronic disease prevention and management with recurring, risk‑aware, outcome‑tied payments and:

• Strong incentives to deliver measurable population‑level outcome improvement rather individual patient goal accomplishment.

• Flexibility to use in‑person, virtual, and asynchronous care—plus remote monitoring and home‑based devices.

• Risk‑adjusted outcome publishing to recognize excellent clinical performance, and a rural adjustment to support access.

For digital health device companies

ACCESS + TEMPO offers a route to Medicare reimbursement and accelerated market entry under FDA oversight. The dual programs will open up the traditional Medicare marketplace to many devices that are covered by private insurance but have not yet achieved Medicare coverage.

What’s next

For health care providers and suppliers, the near‑term priority is operational readiness: governance, care pathways and remote workflows, device data integration, patient onboarding, and partner selection anchored to measurable outcomes. For digital health device companies, the priority is a submission‑ready TEMPO package, evidence generation plans aligned to ACCESS outcomes, and provider partnerships that can demonstrate impact in real‑world use.

Reed Smith will continue to follow developments in the regulation of digital health technology and the availability of new Medicare payment models. If you have any questions about these programs please reach out to the authors or your health care lawyers at Reed Smith.