On December 1, 2025, the Centers for Medicare & Medicaid Services (CMS) Innovation Center announced its latest model—ACCESS (Advancing Chronic Care with Effective, Scalable Solutions). A national, voluntary 10-year model designed to test outcomes-focused payment for technology-enabled care used in managing chronic conditions common among Original Medicare (fee-for-service) beneficiaries, ACCESS addresses the long-standing gap between Medicare’s payment system and technology’s capacity to improve healthcare delivery.
The digital health technology and provider communities have expressed considerable interest in ACCESS. The US Department of Health and Human Services (HHS) and CMS highlighted the model at the December 4, 2025, Modernizing America’s Care for the Better event (recording here), noting over 250 organizations have already expressed interest in the model. Nonetheless, many details need clarification before the program launches.
Health Management Associates (HMA) has reviewed the ACCESS model and is engaging with those agencies and organizations working on design and implementation. In this article, we share early insights and considerations for Medicare organizations and technology manufacturers interested in participating, as well as potential implications for the broader market.
Model Overview
ACCESS aligns with the administration’s strategic priorities for the Innovation Center, including:
- Incentivize greater use of technology in chronic disease prevention and management
- Increase access to tech-enabled care by overcoming payment barriers, while ensuring care is clinician-guided, coordinated, and accountable
- Expand clinicians’ ability to offer innovative care through a straightforward payment pathway
- Promote competition by publishing risk-adjusted performance results
- Reduce overall Medicare costs
Core Requirements for ACCESS Participants
Participants in the model (ACCESS care organizations) must be Medicare Part B participating providers or suppliers, exclusive of durable medical equipment, prosthetics, orthotics, and laboratory suppliers. Notably, these organizations must designate a Medicare-enrolled medical director to oversee care quality and compliance. These organizations will collaborate with primary care providers and other referring clinicians to offer tech-enabled services that complement traditional care, including:
- Telehealth software
- Wearable devices for continuous monitoring (e.g., sleep, heart rate, movement, glucose, etc.)
- Apps to track and coach lifestyle changes
Care may be delivered in person, virtually, asynchronously, or through other clinically appropriate tech-enabled methods.
While CMS has yet to release full details on covered digital health solutions, ACCESS care organizations are expected to offer integrated, technology-supported care, which may include:
- Clinician consultations
- Lifestyle and behavioral support (e.g., nutrition, exercise, smoking cessation)
- Therapy and counseling
- Patient education
- Care coordination
- Medication management
- Ordering and interpreting diagnostic tests and imaging
- Use or monitoring of Food and Drug Administration (FDA)-authorized devices
ACCESS is intended to be a supplemental approach to traditional care. Primary care physicians and specialists will be able to refer patients to ACCESS organizations and will receive regular electronic updates on patient progress.
New Options for Beneficiaries
Unlike most other Innovation Center models, beneficiaries will be able to voluntarily sign up directly with an ACCESS organization or receive a referral from a physician. CMS will maintain a public directory of ACCESS participants, including the conditions they treat and their risk-adjusted outcomes, to help providers and beneficiaries make informed choices based on their needs.
Chronic Condition Focused Clinical Tracks
ACCESS will launch with four clinical tracks, grouping related conditions with similar care approaches. Although CMS may add additional tracks and conditions in the future, the first four tracks address common chronic conditions among Medicare beneficiaries (affecting over two-thirds of Medicare beneficiaries).
- Early Cardio-Kidney-Metabolic (eCKM): Hypertension, dyslipidemia, obesity, prediabetes
Outcome measures: Control of or improvement in blood pressure (BP), lipids, weight, HbA1c - Cardio-Kidney-Metabolic (CKM): Diabetes, chronic kidney disease (CKD), atherosclerotic cardiovascular disease (ASCVD)
- Outcome measures: Control or improvement in BP, lipids, weight, HbA1c; CKD/diabetes require eGFR (estimated glomerular filtration rate) and UACR (urine albumin-to-creatinine ratio) data submission
- Musculoskeletal (MSK): Chronic pain
Outcome measures: Improvement in pain intensity, interference, function (via validated patient-reported outcome measures [PROMs]) - Behavioral Health: Depression and/or anxiety
Outcome measures: Improvement in symptoms (Patient Health Questionnaire-9 [PHQ-9], Generalized Anxiety Disorder-7 [GAD-7]); submission of World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) for overall function
Participant organizations must manage all qualifying conditions within their chosen track.
Payments
CMS will release more details in the forthcoming request for applications (RFA). The model will use two payment approaches:
- Outcomes-Aligned Payments (OAPs): Paid to ACCESS organizations that achieve desired clinical outcomes, support technology-enabled interventions, and net savings for Medicare. OAPs are expected to be recurring (likely monthly) payments
- Co-management Payments: Referring clinicians will receive approximately $30 per service, plus a one-time $10 bonus, for onboarding beneficiaries
To promote access in underserved areas, CMS will apply a fixed adjustment to OAPs for rural patients in qualifying tracks.
FDA’s Complementary TEMPO Pilot
The FDA’s Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot will work collaboratively with the ACCESS model. Manufacturers of digital health devices that have yet to receive FDA authorization can apply to TEMPO for enforcement discretion, allowing their devices to be used by ACCESS participants for covered care. The FDA is seeking statements of interest for participation in the TEMPO pilot beginning in January 2026. The agency plans to select up to 10 manufacturers in each of four specific clinical use areas to participate in the pilot.
Next Steps
Interested applicants should begin exploring participation as a Medicare Part B-enrolled provider if they have yet to enroll. Other key considerations for Medicare organizations include:
- Submit a nonbinding letter of interest to the Innovation Center
- Evaluate readiness to deliver technology-enabled, outcomes-focused care
- Assess capacity to manage qualifying conditions across clinical tracks
- Plan for data collection, reporting, and performance measurement
- Consider partnerships with technology vendors and referring clinicians
- Monitor regulatory developments and payment methodology updates
How HMA Can Help
HMA can help organizations navigate the application process, develop implementation strategies, and position your organization for success in the evolving Medicare landscape. If your organization is considering participation in ACCESS or wants to understand how this model could affect your market, contact our experts below.
