ACCESS Technical Frequently Asked Questions

• Model Overview FAQ
• Prospective Participant FAQs
• Other Provider FAQs
• Payer FAQs

Model Overview FAQs

What is the ACCESS Model?

The ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model is a 10-year national test of a new payment approach designed to expand access to technology-supported care for people with chronic conditions. ACCESS will evaluate whether a new, outcome-aligned payment method can improve health outcomes, enhance patient choice, and reduce overall Medicare costs.

How does the model work?

ACCESS provides participating organizations with predictable, recurring payments for helping patients manage qualifying chronic conditions. Full payment depends on achieving measurable health outcomes, such as improvement or control of blood pressure for hypertension. Rather than paying for a specific set of services, the model rewards results — giving care teams flexibility to use technology, clinical tools, and care approaches that best support each patient’s needs.

To participate, organizations must be enrolled in Medicare Part B as providers or suppliers and designate a physician Clinical Director responsible for care quality and compliance. Participants must also meet all applicable federal and state requirements, including licensure and compliance with HIPAA requirements for covered entities and applicable FDA requirements (or otherwise be subject to FDA enforcement discretion).

Patients with Original Medicare may sign up directly with participating ACCESS organizations or enroll after a referral from their primary care practitioner (PCP) or another clinician. To promote transparency, CMS will maintain a public directory of ACCESS participants, including the conditions they treat and their risk-adjusted clinical outcomes, so patients and referring providers can make informed choices.

After confirming eligibility, ACCESS participants collect baseline measures for each patient—such as blood pressure for hypertension or a validated patient-reported outcome measure for depression—which serve as benchmarks for tracking improvement or control. Participants are responsible for helping patients achieve their targets, such as lowering blood pressure by 10 mmHg or reaching a guideline-informed goal. By linking payment to outcomes rather than individual activities, ACCESS enables care teams to deliver modern, technology-supported, patient-centered care that drives better results.

ACCESS also supports strong care coordination with primary care and referring clinicians. Participants must electronically share care plans and updates at key moments, including treatment initiation, completion, and defined clinical milestones, and integrate with a Health Information Exchange (HIE) or similar trusted network to allow referring clinicians to securely access updates. To further support collaboration, PCPs and referring clinicians may bill a co-management payment (without beneficiary cost-sharing) for reviewing updates and documenting related care-coordination actions, such as medication adjustments or problem-list updates.

To facilitate continued clinical support, most tracks include an optional continuation period, with CMS paying a reduced payment rate to the organization that reflects lower resource needs once care is established. The MSK track is focused on resolving chronic pain during the initial care period and does not include an optional follow-on period.

When does the ACCESS Model begin, and how long will it run?

ACCESS will begin on July 5, 2026, and operate for 10 years, through June 30, 2036. CMS will accept applications on a rolling basis beginning January 2026 through 2033 to allow multiple entry points for organizations. Consistent with CMS Innovation Center authority under Section 1115A of the Social Security Act, the ACCESS Model will be evaluated for its impact on quality of care and Medicare spending. If the model is found to improve quality without increasing costs — or to reduce costs without harming quality — and the CMS Office of the Actuary certifies those findings, the Secretary of Health and Human Services may consider expanding or making the model permanent through rulemaking.

What conditions does ACCESS focus on?

ACCESS will initially include four clinical tracks focused on common chronic conditions:

• 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 may consider additional tracks and conditions in the future.

Who can use ACCESS services?

ACCESS is open to people with Original Medicare who have qualifying chronic conditions included in one of the model’s clinical tracks. Patients can enroll directly with a participating ACCESS organization or be referred by their health care provider. People can sign up in multiple different tracks from the same or different organizations.

Because the model’s new payment approach is being tested, a small share of people who try to enroll in a specific ACCESS track may be randomly assigned to a control group for that track. This process helps CMS evaluate the model’s impact, consistent with the Innovation Center’s authority. Individuals in a control group continue to have full access to all regular Medicare services and can work with their usual health care providers.

Medicare Advantage enrollees are not included in ACCESS, though plans may choose to offer similar programs.

How does the ACCESS payment approach differ from Original Medicare fee-for-service?

Original Medicare fee-for-service payments are tied to specific activities or devices. ACCESS introduces Outcome-Aligned Payments (OAPs), a recurring payment for managing a patient’s qualifying condition, with payment tied to achieving measurable health outcomes. This approach rewards results, not activities, and enables flexible, technology-supported care that improves patients’ health.

How does ACCESS support clinical quality and patient safety?

ACCESS embeds strong safeguards to support clinical quality and accountability. Organizations must enroll in Medicare as providers or suppliers and designate a physician Clinical Director to oversee clinical quality and compliance. All participating organizations must comply with all applicable federal and state regulations — including licensure requirements, HIPAA regulations for covered entities to safeguard protected health information, and FDA requirements (or otherwise be subject to FDA enforcement discretion). CMS will monitor performance and may disenroll participants who fail to meet quality, safety, or outcome standards. To promote transparency, CMS will publish risk-adjusted outcomes in a public directory.

Is there cost-sharing for patients in the ACCESS Model?

CMS intends to offer the CMS-sponsored model patient incentive safe harbor (42 CFR § 1001.952(ii)(2)) to ACCESS participants who wish to forego collection of beneficiary cost-sharing for OAPs as a beneficiary engagement incentive. ACCESS Participants may indicate in the model application whether they will collect or forego collection of OAP cost-sharing. Participants must apply this policy uniformly to all beneficiaries, consistent with the requirements to be set forth in the applicable governing documentation and all applicable laws and regulation. If an ACCESS Participant elects to collect OAP beneficiary cost-sharing, they must clearly disclose the expected beneficiary payment amount before beneficiary enrollment.

There is no cost-sharing for the separate co-management payment billed by primary care or referring clinicians when they review and coordinate care with ACCESS participants. This supports stronger collaboration between technology-enabled care teams and traditional providers.

Prospective Participant FAQs

Who is eligible to participate in ACCESS?

Organizations that are Medicare Part B–enrolled providers or suppliers (excluding durable medical equipment and laboratory suppliers) are eligible to participate. Each organization must have an active Taxpayer Identification Number (TIN), comply with applicable state licensure, HIPAA, and FDA requirements (or otherwise be subject to FDA enforcement discretion), and designate a physician Clinical Director responsible for clinical and compliance oversight. For more information about participant requirements and responsibilities, please see the Request for Applications.

How can organizations apply?

CMS will accept applications through an online portal beginning in 2026, with rolling admissions through early 2033. Each cohort will begin on a set start date, with the first cohort launching July 5, 2026 for applications received by March 20, 2026. CMS will post application materials, deadlines, and updates on the ACCESS Model webpage.

How is performance measured and how are payments determined?

Each clinical track includes a set of guideline-informed, condition-specific measures and outcome targets. CMS determines payment based on the overall share of patients who meet their defined outcomes, compared to a minimum threshold that increases with each participation year. This balances accountability with accessibility and rewards strong overall performance.

¹ Outcome measures and targets are guideline-based and defined in consultation with experts. Control refers to meeting guideline-directed targets.

² Obesity defined as Body Mass Index (BMI) greater than or equal to 30. Overweight defined as BMI 25 – 29.99 along with marker of central obesity, specifically waist circumference greater than 40 inches (102 cm) for men or 35 inches (88cm) for women.

³ Stage 3a and 3b only.

⁴ Chronic is defined as pain lasting more than three months. Musculoskeletal disorders are defined broadly to include conditions affecting bones, joints, muscles, and connective tissues.

What are the reporting and compliance requirements?

Participants must report required measures to CMS using standards-based Application Programming Interfaces (APIs) which CMS will host. Organizations must maintain compliance with applicable state licensure, HIPAA, and FDA requirements (or otherwise be subject to FDA enforcement discretion), and cooperate with CMS program integrity and evaluation activities. CMS will release an implementation guide in the coming months with additional details.

Can organizations participate in more than one clinical track?

Yes. Organizations may participate in multiple tracks. Participating organizations are responsible for managing all qualifying conditions in a track, supporting integrated, patient-centered care. When a beneficiary is enrolled in multiple tracks with the same participant, CMS will apply a discount to the total payment amount to reflect administrative and operational efficiencies associated with delivering integrated care.

What does FDA compliance mean for ACCESS participants?

Some digital tools and connected devices used in ACCESS — such as mobile applications, wearables, or remote monitoring equipment — may meet the definition of a device under the Federal Food, Drug, and Cosmetic Act (FD&C Act) if they are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or any function of the body. These devices are generally subject to FDA oversight to provide a reasonable assurance of safety and effectiveness.

Software functions focused only on general wellness, data storage, or administrative support are typically not regulated as medical devices. For products that are regulated, FDA may require premarket authorization (e.g., clearance of a premarket notification (510(k)), or approval of a premarket approval application (PMA)), depending on the device’s classification and risk.

ACCESS participants are responsible for ensuring that medical devices used in the model are legally marketed with an intended use for which the device is used in the model (for example, appropriately cleared, approved, 510(k)-exempt, or otherwise in compliance with applicable FDA requirements), except to the extent the device is subject to FDA enforcement discretion.

ACCESS does not change existing FDA policies regarding the practice of medicine, including a clinician’s ability to exercise professional judgment in using legally marketed devices for patients.

For more information on how FDA regulates digital health technologies — including software as a medical device (SaMD), for example, mobile medical applications, and connected hardware — please visit the FDA Digital Health Center of Excellence and Regulatory Accelerator, a new initiative featuring specific FDA resources that have been curated and presented to meet the information needs of digital health innovators.

What is the FDA TEMPO pilot and how does it relate to ACCESS? 

The Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot (the TEMPO pilot) is an FDA initiative for manufacturers of certain digital health devices that wish to offer their devices in connection with the ACCESS model for an intended use that would generally require FDA premarket authorization, but have not yet obtained such authorization. 

Under the TEMPO pilot, manufacturers may request that FDA exercise enforcement discretion and not enforce certain applicable requirements, such as FDA premarket authorization requirements, when their device is offered to or by ACCESS participants for an intended use to improve patient outcomes, to be used in providing care expected to be covered by the ACCESS model. Under the ACCESS model, ACCESS participants may use a device consistent with any plan for mitigating risks to patients and collecting, monitoring, analyzing, and reporting real-world performance data that the manufacturer has discussed with FDA in connection with FDA’s determination that it is appropriate to exercise enforcement discretion for the device under the TEMPO pilot. During ACCESS participation, use of devices under the TEMPO pilot will generate real-world data that may support assessment of safety, performance, and potential future FDA marketing submissions, and additional data collection beyond what is ordinarily reported in the ACCESS may be provided to FDA as agreed upon with FDA.

TEMPO pilot participation is optional. It may be particularly valuable for organizations developing certain digital health devices that would generally require FDA premarket authorization, by facilitating the use of those devices in a controlled context while real-world data are collected under FDA oversight.  

ACCESS participants that choose to use a device in the TEMPO pilot must obtain enhanced consent from enrolled beneficiaries, informing them that the device is participating in an FDA pilot and that certain data will be shared with FDA, consistent with all applicable federal privacy and security requirements. 

Manufacturers interested in TEMPO should apply directly to FDA once the application process opens. For more information on TEMPO, please visit https://www.fda.gov/medical-devices/digital-health-center-excellence.

What privacy and security requirements are in place for ACCESS participants?

To participate in the ACCESS Model, organizations must be covered entities as defined by HIPAA and must comply with applicable federal requirements for protecting beneficiaries’ protected health information (PHI). This generally includes, among other requirements, maintaining administrative, technical, and physical safeguards to protect patient data; limiting uses and disclosures to the minimum necessary; obtaining patient authorization for any use or disclosure of PHI that is not related to the patient’s treatment, payment, or health care operations, and not conditioning care or participation on the patient providing such authorization; and having written agreements in place with any business associates that handle PHI on their behalf. For more information on HIPAA requirements and resources for covered entities, visit the HHS Office for Civil Rights HIPAA for Professionals page.

How do organizations enroll in Medicare to participate in ACCESS?

To participate in the ACCESS Model, organizations must be enrolled in Medicare Part B as a provider or supplier under the Medicare fee-for-service program. Enrollment can be completed online through the Provider Enrollment, Chain, and Ownership System (PECOS).

Organizations that are not already enrolled should first obtain a National Provider Identifier (NPI) through the National Plan and Provider Enumeration System (NPPES) before submitting their Medicare enrollment application. Once the application is submitted, the organization’s Medicare Administrative Contractor (MAC) will review the materials, request any additional information if needed, and notify the applicant once enrollment is approved.

ACCESS participants must also meet all standard Medicare participation requirements, meaning they agree to accept Medicare assignment and the Medicare-allowed amount as payment in full for covered services. All physicians and non-physician practitioners furnishing or supervising care must be individually Medicare-enrolled and have reassigned their billing rights to the ACCESS participant organization.

After enrollment, participants must keep their information current in PECOS. Providers and suppliers are required to report changes in ownership or adverse legal actions within 30 days, and all other changes within 90 days.

Because ACCESS applications cannot be approved until Medicare enrollment is complete, organizations that are not yet enrolled are encouraged to begin the Medicare enrollment process as early as possible to avoid delays in model participation.

For more information or to begin the enrollment process, visit Become a Medicare Provider or Supplier on CMS.gov.

What is the ACCESS Tools Directory?

To further support participation, CMS will launch an ACCESS Tools Directory — a CMS-hosted informational resource within the ACCESS application and participant portal. The directory will help organizations identify optional software and hardware tools that may support model participation and compliance, such as data exchange and interoperability solutions, identity verification systems, optional connected clinical devices like blood pressure cuffs, and tools that support HIPAA compliance.

Other Provider FAQs

What role do primary care and referring providers play in the ACCESS Model?

Primary care and referring clinicians are central partners in the ACCESS Model. The model gives them new ways to support patients with chronic conditions while remaining actively involved in their ongoing management. PCPs and referring clinicians can refer patients to ACCESS participants, which they can identify via a CMS directory of participating organizations, conditions they treat, and their risk-adjusted outcomes. 

Several mechanisms ensure that primary care providers and other clinicians can seamlessly integrate care from ACCESS organizations into their patient care plans, for example:

• To support care coordination, ACCESS participants will be required to send electronic updates via health information exchanges or CMS Aligned Networks to patients’ referring or primary care providers at initiation, completion, and clinical milestones.

• Primary care physicians and referring providers can bill for an ACCESS co-management payment for documented review of patient updates from associated ACCESS participants.

How does the ACCESS Co-Management Payment work?

To support ongoing care coordination and encourage continued engagement between referring health care providers and ACCESS participants, clinicians who co-manage ACCESS beneficiaries with an ACCESS participant may bill a new ACCESS Model Co-Management service for documented review of ACCESS updates and care coordination activities.

The service will be paid at approximately $30 per service, subject to the geographic adjustment and standard Medicare payment adjustments. To bill the Co-Management code, the consulting clinician must review the ACCESS Care Update and place a brief written note in the EHR documenting the assessment and any care-coordination action, such as a medication change or reconciliation, updated problem list, monitoring instruction, or referral. Clinicians who assist a beneficiary with onboarding and initial setup activities may also bill the Co-Management code with a CMS-specified modifier the first time they bill for that beneficiary to receive an additional payment of approximately $10, subject to the adjustments described above. The payment will be limited to once every four months per beneficiary per track, up to approximately $100 per year.

There will not be Part B beneficiary cost-sharing for this service and advance consent from beneficiaries would not be required.

The ACCESS Co-Management Payment G-code, modifier, and additional billing guidance will be shared in 2026.

How does ACCESS interact with Accountable Care Organizations (ACOs) and other shared savings models?

ACCESS is designed to complement existing ACO and risk-bearing arrangements by incentivizing ACOs to leverage technology-enabled care to meet quality and savings goals. For 2026 and 2027, CMS will be making system changes to support model operations and CMS anticipates that there will be no impact from ACCESS Outcome-Aligned Payments (OAPs) on ACO benchmark and performance year calculations for the Medicare Shared Savings Program and ACO REACH. Beginning in 2028, expenditures associated with ACCESS OAPs will be included in ACO benchmark and performance year calculations.

Does ACCESS qualify as an Advanced or MIPS Alternative Payment Model (APM)?

CMS does not expect ACCESS to qualify as an Advanced Alternative Payment Model (A-APM). CMS anticipates that ACCESS services would not contribute to MIPS reporting obligations.

Payer FAQs

How does ACCESS support cross-payer alignment?

ACCESS is designed to promote consistent, outcome-based payment structures across payers. CMS will make available payer implementation resources, including reference provider agreements, source code, and technical documentation, to help payers optionally align their contracting and performance models with ACCESS.

Can Medicare Advantage (MA) plans participate in ACCESS?

ACCESS is being tested in Original Medicare, but Medicare Advantage (MA) organizations may independently adopt similar outcome-aligned payment arrangements with their contracted providers. MA plans do not need a waiver to implement such arrangements and have flexibility to structure payments under existing program requirements.

Would payments made under arrangements like ACCESS count toward the MA Medical Loss Ratio (MLR)?

Outcome-based payments for patient care would generally be considered medical expenses in the MLR numerator when the benefits and payment arrangements satisfy the requirements under 42 CFR § 422.2420(b)(2) and § 422.2430(a), to qualify as incurred claims or quality improvement activities and are not claims or activities that are otherwise excluded under regulations. Therefore, no MLR policy changes are needed to support these types of payments.

Can Medicaid plans implement ACCESS-like models?

States may allow Medicaid managed care plans to voluntarily implement ACCESS-like approaches through the In Lieu of Services and Settings (ILOS) authority under 42 CFR § 438.3(e)(2)and 438.16. Under this authority, plans have the option to provide services or settings that are medically appropriate and cost-effective substitutes for services or settings covered under the state plan to willing beneficiaries if authorized by the state.

States have flexibility to determine whether and how an ACCESS-like model qualifies as an ILOS and how it is reflected in managed care contracts, as long as the state complies with all of the requirements in 42 CFR part 438. Because the ILOS authority is part of existing managed care regulations, states typically do not need a separate CMS waiver to implement such a model. However, states must meet all applicable documentation, monitoring, and reporting requirements outlined in CMS’s managed care regulations and related guidance under 42 CFR part 438.

Plans also always retain the ability to cover services that are in addition to those covered under the Medicaid state plan in accordance with 42 CFR § 438.3(e)(1), although the cost of such services cannot be included when determining the payment rates under 42 CFR § 438.3(c).