红领巾瓜报

On December 1, 2025, the Centers for Medicare & Medicaid听Services听(CMS)听Innovation Center announced its latest model鈥�听(Advancing Chronic Care with Effective, Scalable Solutions).听A听national, voluntary 10-year model听designed to听test outcomes-focused payment for听technology-enabled care听used听in managing chronic conditions common among Original Medicare (fee-for-service) beneficiaries, ACCESS addresses the long-standing gap between Medicare鈥檚 payment system and technology鈥檚 capacity to improve healthcare delivery.听

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听December听4, 2025,听Modernizing America鈥檚 Care for the Better听event听(recording听here), noting over 250 organizations have already expressed interest in the model.听Nonetheless,听many details听need听clarification before听the听program launches.听听

红领巾瓜报 (红领巾瓜报)听has reviewed the ACCESS model and听is engaging with听those听agencies听and organizations听working on听design and implementation.听In this article, we听share听early insights and considerations for Medicare organizations听and technology manufacturers听interested in听participating, as well as potential implications for the broader market.听

Model Overview听

ACCESS听aligns with the administration鈥檚 strategic priorities for听the Innovation Center,听including:听

• Incentivize greater use of听technology听in听chronic听disease prevention and management听
• Increase access to听tech-enabled care听by overcoming听payment听barriers, while ensuring care is clinician-guided, coordinated, and accountable听
• Expand听clinicians鈥櫶齛bility to offer innovative care through听a听straightforward payment pathway听
• Promote competition by publishing risk-adjusted performance results听
• Reduce overall Medicare costs听

Core Requirements for ACCESS Participants听

Participants in the model听(ACCESS care organizations)听must be Medicare Part听B听participating听providers or suppliers,听exclusive of听durable medical听equipment, prosthetics, orthotics, and laboratory suppliers. Notably, these organizations must听designate听a Medicare-enrolled听medical听director听to oversee care quality and compliance. These organizations听will听collaborate with primary care providers听and other referring clinicians to offer tech-enabled services听that听complement traditional care, including:听

• Telehealth software听
• Wearable devices for continuous monitoring (e.g., sleep, heart rate, movement, glucose, etc.)听
• Apps听to听track and coach lifestyle changes听

Care may be听delivered听in person, virtually, asynchronously, or through other听clinically听appropriate听tech-enabled听methods.听

While CMS has yet听to听release full details on covered digital health solutions, ACCESS care organizations听are听expected to offer integrated, technology-supported care,听which may include:听

• Clinician consultations听
• Lifestyle and behavioral support (e.g., nutrition, exercise, smoking cessation)听
• Therapy and counseling听
• Patient education听
• Care coordination听
• Medication management听
• Ordering and interpreting diagnostic tests and imaging听
• Use or听monitoring听of Food and Drug Administration听(FDA)-authorized devices听

ACCESS is听intended听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.听

New听Options for听Beneficiaries听

Unlike most other听Innovation Center听models, beneficiaries will be able to voluntarily sign up directly听with an听ACCESS organization听or听receive a听referral from听a听physician. CMS will听maintain听a public directory of ACCESS participants,听including the conditions they treat and their risk-adjusted outcomes, to help听providers and beneficiaries听make informed choices based on their needs.听

听Chronic Condition Focused听Clinical Tracks听

ACCESS will听launch with听four clinical tracks, grouping听related conditions听with听similar听care approaches.听Although听CMS may add听additional听tracks and conditions in the future, the first four tracks address common chronic conditions among Medicare beneficiaries (affecting听over听two-thirds of Medicare听beneficiaries).听

1. Early Cardio-Kidney-Metabolic (eCKM):听Hypertension, dyslipidemia, obesity, prediabetes
   Outcome measures:听Control听of听or improvement in听blood pressure听(BP), lipids, weight, HbA1c听
2. Cardio-Kidney-Metabolic (CKM):听Diabetes,听chronic kidney disease听(CKD),听atherosclerotic听cardiovascular听disease听(ASCVD)听
3. Outcome measures:听Control or improvement in BP, lipids, weight, HbA1c; CKD/diabetes require eGFR听(estimated听glomerular听filtration听rate)听and UACR听(urine听albumin-to-creatinine听ratio)听data submission听
4. Musculoskeletal (MSK):听Chronic pain
   Outcome measures:听Improvement in pain intensity, interference, function (via validated听patient-reported听outcome听measures听[PROMs])听
5. Behavioral Health:听Depression and/or anxiety
   Outcome measures:听Improvement in symptoms (Patient Health Questionnaire-9听[PHQ-9],听Generalized听Anxiety听Disorder-7听[GAD-7]);听submission of听World Health Organization Disability Assessment Schedule 2.0听(WHODAS 2.0)听for overall function听

Participant organizations must manage all qualifying conditions within their chosen track.听

Payments听

CMS听will release more details in the forthcoming听request for听applications (RFA).听The model will use two payment approaches:听

• Outcomes-Aligned Payments (OAPs): Paid to ACCESS organizations听that听achieve听desired clinical outcomes, support technology-enabled interventions,听and net savings for Medicare. OAPs are expected to be听recurring听(likely听monthly) payments
• Co-management听Payments:听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.听

FDA鈥檚 Complementary听TEMPO Pilot听

The听FDA鈥檚听听(TEMPO)听pilot听will work collaboratively with the ACCESS model.听Manufacturers听of digital health devices听that have听yet听to receive听FDA听authorization听can apply to TEMPO for enforcement discretion, allowing their devices to be used听by听ACCESS participants for covered care.听The FDA is seeking statements of interest for participation in the TEMPO pilot beginning in January 2026.听The agency听plans to select up to听10听manufacturers in each of four specific clinical use areas to听participate听in the pilot.听

Next Steps听

Interested applicants听should begin exploring听participation听as a Medicare Part B-enrolled听provider听if听they听have yet to enroll.听Other key considerations for Medicare organizations听include:听

• 听a nonbinding letter of interest to听the Innovation Center听
• Evaluate readiness to deliver technology-enabled, outcomes-focused care听
• Assess capacity to manage qualifying conditions across clinical tracks听
• Plan for data collection, reporting, and performance measurement听
• Consider partnerships with technology vendors and referring clinicians听
• Monitor regulatory developments and payment听methodology听updates听

How 红领巾瓜报 Can Help听

红领巾瓜报听can help organizations听navigate the application process, develop implementation strategies, and position your organization for success in the evolving Medicare landscape.听If your organization is considering听participation in ACCESS or wants to understand how this model could听affect听your market,听contact听our experts,听Amy Bassano听and听.听

On听December听8, 2025, the Centers for Medicare & Medicaid Services (CMS) issued听anticipated听听on Medicaid community engagement requirements, as听established听in听the 2025 budget reconciliation听legislation (P.L. 119-21,听referred to as OBBBA).听This guidance arrives at a pivotal moment, as states begin budget planning and legislative sessions.听

红领巾瓜报 (红领巾瓜报) reviewed the guidance in the context of other policy and financing shifts that are affecting the Medicaid program. This article highlights key takeaways, addresses considerations for implementation, and issues for policymakers and healthcare organizations to track.听

Brief Background听

Generally听speaking,听Section听71119听of听OBBBA听requires states to implement community engagement requirements as a condition of Medicaid eligibility for individuals in the expansion population听ages听19鈭�64 who are听neither听pregnant听nor听enrolled in Medicare or any other mandatory Medicaid group.听The guidance explains听the statutory requirements related to听how听states verify community engagement, notify applicants and beneficiaries, ensure compliance with federal standards as the January 2027 deadline approaches, and other core components of the policy.听

Starting January 1, 2027, states must require certain Medicaid expansion applicants to demonstrate community engagement for at least one month and may require up to three consecutive months immediately prior to the month of application.听If compliance or exemption status听is听unverifiable听at the time of application, states must provide notice and an opportunity to respond. These听enrollees听will听maintain听coverage during the response period. States are also expected to听establish听clear documentation standards and proactive communication processes for applicants and enrollees.听

Three Key Takeaways听from the Initial Guidance听

1. Organizations must understand the key dates leading up to January 1, 2027

Limited听new听funding听and听tight timelines make听January 1,听2027,听a critical deadline听for听implementation.听Medicaid organizations need to听consider, however,听the听full听sequence of events leading听up听to that date,听including听providing required advance notification to individuals about听the听changes听and their eligibility status.听Documentation and progress tracking are essential, both for compliance and to听demonstrate听that听CMS听deadlines are being met.听

Although听the guidance outlines notice and response requirements, it leaves open critical questions about how states will prevent procedural disenrollments, manage increased appeals volume, and mitigate due process legal risk if eligibility and verification systems fail at scale.听

2. Medicaid managed care organizations (MCOs) have a limited role in decision-making but are key to engagement

Medicaid听managed care听organizations听are prohibited from making听the听determination that an individual听has听met听the community engagement requirement; however,听they听have听an听opportunity to听support individuals in a range of ways.听Recent changes under听OBBBA听give听plans clearer authority to conduct proactive outreach on eligibility and renewal requirements, which strengthens their ability to help members navigate deadlines, reporting expectations, and documentation needs.听This听capacity听will be important because a lack of predictability in enrollment and churn can meaningfully听affect听the risk profile of plans and, as a result,听increase volatility in provider negotiations.听

Plans, providers, community organizations, and听state听and local听agencies听can collaborate to听develop effective听engagement strategies, aligned听messaging, and听ongoing touch points.听Helping members understand what is听required鈥攁nd when鈥攁nd connecting them with resources to听take action听will be听essential for successful implementation.听

3. States and partner organizations need a global view of IT changes and functionality

CMS emphasizes that the听eligibility determinations for the听community engagement听requirements should function seamlessly with new and existing system functionality.听Meeting this expectation requires states to have听a听deep听understanding of听whether and how policies can be operationalized in their systems without adding听administrative听burden for individuals and听others that engage with the systems.听

Meeting听federal expectations听may be听particularly challenging听for听states听with听county-based Medicaid systems, as implementing听these requirements听across听multiple听jurisdictions听may听necessitate听a longer transition period.听The听OBBBA听includes听$200 million in total听grant funding for听implementation activities in听2026, and听states can apply for听enhanced federal听IT听funding听at the 90/10听or 75/25听rates听for certain costs and activities.听Federal resources are听otherwise听limited,听so听it is听critical that states and partner organizations听establish听a听well-defined strategy to maximize available funding听to听support the听system听changes听required听to implement听OBBBA听eligibility requirements.听

What to Watch听

The guidance arrives as many governors begin releasing their budget proposals and听planning for听upcoming legislative sessions. Although the guidance provides clear information on the overarching parameters and a preliminary听road听map, certain critical details are forthcoming.听State budgets听should reflect the requirements听and听anticipate听the need for rapid system and process development.听

CMS will听issue an interim final rule by June 1, 2026,听and states must implement the听community engagement听requirement听no later than听January 1, 2027.听States must听comply with听these requirements听and听act quickly to develop, pay for, and implement new systems, policies, and processes鈥攊deally听before听the latter half of听2026.听

CMS听is developing听additional听guidance in several areas, including:听

• Use of reliable data sources听and听how to听satisfy听the definition of engagement听
• Implementation of the requirement to conduct renewals every six months for certain individuals听
• Specific documentation requirements for community engagement听
• Potential role that managed care plans can play听unrelated to听determining听beneficiary compliance听

States and Medicaid organizations should closely听monitor听these developments and be prepared to adjust their strategies as听new information听becomes available.听

Connect with Us听

红领巾瓜报鈥檚 experts are trusted problem听solvers, partnering with states to navigate the complexities of community engagement planning,听even as requirements and details continue to evolve. Drawing on deep state and federal experience, as well as lessons learned from听previous听large-scale eligibility reforms, our team helps听Medicaid-focused organizations听quickly design听and implement practical, context-specific strategies that align with OBBBA requirements. Whether听it鈥檚听strategy development, system design, or crafting effective听messages, 红领巾瓜报 brings a flexible, solutions-oriented approach to maximize continuity of coverage and meet each client鈥檚 unique needs.听

Contact听our featured experts,听Loren Anthes,听Andrea Maresca,听Juan Montanez,听and听Tonya Moore听to discuss how we can support your team in navigating these changes and building effective engagement strategies.听