Since the publication of this Alert, CMS has officially released the Request for Applications (RFA), which provides clarifications and significantly more detail on eligibility criteria, application timelines, requirements for each ACCESS Participant’s Medical Director, eligibility for inclusion in the Tools Directory, and the model’s financial structure. Interested organizations should carefully review the RFA for specific requirements that were not available at the time this Alert was published and may contact Wilson Sonsini’s Digital Health practice with any questions.

Executive Summary

1. CMS’s new ACCESS Model for innovative technology-supported care establishes a voluntary, outcome-aligned payment program designed to enable technology-supported management of Medicare beneficiaries’ chronic conditions.
2. Only Medicare Part-B enrolled providers and suppliers who support one of four clinical tracks are eligible to serve as ACCESS Participants and receive outcome-aligned payment tied to patient results in addition to co-management service and set-up fees.
3. ACCESS also includes an ACCESS Tools Directory, which allows for digital health companies to voluntarily list and market their software, hardware, or clinical-support tools to patients and ACCESS Participants who wish to enhance their service offerings. Vendors listed in the Directory are not compensated by CMS unless they enroll in Medicare and become an ACCESS Participant.
4. Digital health tools that have not been authorized by the U.S. Food and Drug Administration (FDA) for the intended use under the ACCESS Model may request to participate in the FDA’s TEMPO pilot, under which the FDA will exercise enforcement discretion and not enforce certain requirements during participation in the pilot program.
5. Digital health companies that wish to participate should work proactively to either i) enroll as a Medicare Part B provider or supplier either directly or through an affiliated clinical entity, such as a friendly Professional Corporation (PC); or ii) partner with an enrolled Medicare Part B provider or supplier to supply tools or services that support delivery of tech-enabled chronic condition management.
6. Providers and suppliers participating in the ACCESS model will be subject to HIPAA and may need to consider compliance and data use and exchange implications.

Overview

The Centers for Medicare & Medicaid Services (CMS) has announced that the Center for Medicare and Medicaid Innovation is testing an outcome-aligned payment model known as the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model.

The ACCESS Model will test an outcome-aligned payment approach to expand access to technology-supported care that helps beneficiaries improve their health and prevent or manage chronic disease. This 10-year voluntary model, beginning July 1, 2026, is limited to four clinical tracks and targets conditions including hypertension, diabetes, chronic musculoskeletal pain, and depression.

To be considered for the ACCESS Model’s first performance period beginning July 1, 2026, applications must be submitted by April 1, 2026. Applications received after this date will be considered for a January 1, 2027, start.

Unlike most other CMS care management models, beneficiaries may enroll in this model directly or be referred by a provider. ACCESS offers Medicare Part B-enrolled provider or supplier participants outcome-aligned payments (OAPs) for managing a patient’s qualifying condition, with payment tied to achieving measurable health outcomes.

The ACCESS Model creates a significant opportunity for digital health companies, including those leveraging artificial intelligence (AI), to serve more Medicare beneficiaries. Under the ACCESS Model, digital health companies that wish to participate can:

1. enroll as a Medicare Part B provider or supplier directly or through an affiliated clinical entity, such as a friendly PC;
2. establish a partnership with an enrolled Medicare Part B provider or supplier to supply tools or services that support delivery of tech-enabled chronic condition management; or
3. be listed in the ACCESS Tools Directory.

While speaking at a telehealth conference in Washington, D.C., last week, CMS Administrator Dr. Mehmet Oz highlighted the ACCESS Model as an example of CMS’s efforts to create innovative payment mechanisms that incentivize providers and developers to empower patients with health information and tools. Administrator Oz suggested that CMS was working on guidance to further clarify how the ACCESS Model would function and would also be announcing additional pilot programs soon.

In tandem, the FDA announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a voluntary program that allows manufacturers of certain non-FDA-authorized digital health devices to pilot their use in ACCESS.

If you’d like to learn more about the Management Services Organization—Professional Corporation (MSO-PC) model, see The Corporate Practice of Medicine: Essential Guidance for Digital Health Companies and Investors.

Who Can Participate?

     1. Providers/Suppliers

Medicare Provider Eligibility

ACCESS participants must be Medicare Part B-enrolled providers or suppliers (Participants) (excluding durable medical equipment, prosthetics, orthotics, and supplies and laboratory suppliers) and designate a Medicare-enrolled clinical director to oversee clinical care quality and compliance. Additional details on requirements related to the clinical director will be included in CMS’s Request for Applications, which has not yet been released. CMS acknowledges the lengthy lead time for Medicare enrollment and encourages those interested in participating in ACCESS to begin the Medicare enrollment process if they aren’t already enrolled “as early as possible.” Digital health companies that are not Medicare-enrolled may still be listed in the ACCESS Tools Directory, but the Directory listing does not make the company an ACCESS Participant and does not confer eligibility for payment. Digital health companies that wish to participate directly and receive CMS payments may be able to enroll as a supplier or could potentially do so by creating or partnering with a Medicare-enrolled clinical entity, such as through an MSO-PC structure.

HIPAA Covered Entities

Participants must be covered entities as defined by HIPAA and must comply with applicable federal requirements for protecting beneficiaries’ protected health information. HIPAA covered entities are healthcare providers that transmit health information electronically for certain transactions (e.g., claims, eligibility), health plans, and healthcare clearinghouses. While it is possible that a small healthcare provider practice or a supplier that does not submit electronic claims is not a HIPAA covered entity, it is unlikely in the case of Medicare Part B-enrolled providers and suppliers that meet all of the requirements of the ACCESS Model. Digital health companies that are considering becoming Participants, may need to assess the impact of becoming subject to HIPAA.

Other Requirements

ACCESS Participants must meet certain required measures using standards-based Application Program Interfaces (APIs) that CMS will host. Participants must also integrate with a Health Information Exchange (HIE) or similar trusted network to allow referring clinicians to securely access updates. Finally, Participants must comply with all state licensure requirements, maintain a taxpayer identification number, and meet all FDA requirements (or otherwise be subject to FDA enforcement discretion).

     2. Technology: ACCESS Tools Directory

CMS will also launch an ACCESS tools directory (Tools Directory) which will help Participants identify optional software and hardware tools that may support model participation and compliance, such as data exchange and interoperability solutions, optional connected clinical devices like blood pressure cuffs, and tools that support HIPAA compliance. Participation in the directory will be voluntary but serves as an opportunity for ACCESS Tools Directory vendors (Vendors) to connect with Participants who may be in need of their technologies to support their patients and enrollment in ACCESS. Vendors will submit their own listings and self-certify that their products meet all applicable federal and state requirements, including applicable FDA requirements (or are otherwise subject to FDA enforcement discretion, see discussion on the TEMPO pilot below). CMS will conduct a basic review for completeness and relevance but will not independently verify, approve, or endorse any listed products. CMS acknowledges that Vendors listed in the directory may also choose to include optional promotional offers, such as product discounts or service credits for Participants but any such discounts must comply with all state and federal inducement laws. As of the date of this Alert, there is no indication that CMS intends to reimburse or otherwise compensate Vendors listed in the Tools Directory, nor that Vendors will be required to pay a fee to be included. Rather, any contractual relationship will likely exist directly between the Participant and the Vendor.

To the extent a digital health company wants to increase its opportunities in the ACCESS Model, Vendors may consider implementing an MSO-PC structure, as outlined in our Guide, and enroll the PC as a Medicare Part B provider to become a direct ACCESS Participant, eligible for separate payment, rather than only operating only as a Vendor to existing Participants. The PC will also need to be able to report outcomes using CMS standards-based APIs and integrate with an HIE.

     3. Medicare Beneficiaries

ACCESS is open to Medicare beneficiaries who have qualifying chronic conditions included in one of the model’s four clinical tracks:

• 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

Beneficiaries can either enroll directly with a participating Participant or be referred by their provider and can sign up in multiple different tracks from the same or different Participants.

Payments/Cost-Sharing

1.       Outcome-Aligned Payments

ACCESS provides Participants with recurring OAPs 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. The model will pay for results, not for a specific set of services, and enables technology-supported digital healthcare that improves patients’ health. As of the date of this Alert, the amount to be paid has not yet been released.

2.       Access Model Co-Management Payments

In addition, to encourage ongoing care coordination and engagement, clinicians or primary care providers who help co-manage ACCESS beneficiaries with a Participant may bill a new ACCESS Model co-management service. The service will reimburse approximately $30 per use (subject to geographic and standard Medicare adjustments) and requires the clinician to review the ACCESS Care Update and document an assessment and any coordination action in the EHR. Clinicians who help a beneficiary with onboarding or initial setup may bill the code with a CMS-specified modifier once per beneficiary to receive an additional payment of approximately $10. Overall, this payment is limited to once every four months per beneficiary per track, totaling up to roughly $100 per year.

3.       Waiving of Cost-Sharing

CMS explicitly permits Participants to waive cost-sharing for patients. Specifically, Participants can rely on the patient incentive safe harbor (42 C.F.R. § 1001.952(ii)(2)), which allows Participants to offer certain items or services (such as waiving copays and deductibles) without violating the federal Anti-Kickback Statute (AKS). AKS is a federal law that prohibits offering, paying, soliciting, or receiving anything of value to induce or reward referrals for items or services reimbursable by federal healthcare programs. Under this safe harbor, Participants may choose to waive beneficiary cost-sharing for OAPs as a way to encourage beneficiary engagement and reduce financial barriers to enrollment. If a Participant selects this approach, the waiver must be applied uniformly to all beneficiaries.

Alternatively, Participants may choose to collect the standard Medicare cost-sharing amounts from beneficiaries. If a Participant takes this approach, CMS requires a clear, upfront disclosure of the expected out-of-pocket cost before the beneficiary enrolls. Further, there are no cost-sharing requirements for any provider that coordinates or assists beneficiaries with enrolling in ACCESS. CMS maintains that removing a co-pay requirement for these services will support stronger collaboration between technology-enabled care teams and traditional providers.

4.       Fraud and Abuse

Because ACCESS allows Participants to waive beneficiary cost-sharing, the model creates heightened compliance risks, particularly around marketing and beneficiary inducement. Participants and Vendors must ensure their outreach complies with Medicare marketing rules (e.g., avoiding misleading statements and high-pressure tactics), and any Vendor that lists a discount or promotion on the ACCESS Tools Directory must ensure that such offers comply with federal beneficiary-inducement laws.

Participants that elect not to waive beneficiary cost-sharing must also ensure full compliance with Medicare transparency obligations and applicable surprise and balance-billing requirements. This includes clearly disclosing expected out-of-pocket costs prior to enrollment, adhering to federal protections for Medicare beneficiaries, and avoiding billing practices that could be construed as coercive. These transparency requirements operate alongside the model’s fraud-and-abuse safeguards: because waiving cost-sharing can raise AKS concerns outside of the model’s safe harbor, Participants must follow CMS’s requirements precisely and apply any waivers uniformly.

Careful adherence to Medicare marketing rules, the AKS safe harbor conditions, transparency and disclosure obligations, and federal beneficiary-protection laws will be essential as organizations leverage the ACCESS model.

Impact on Medicare Advantage

CMS noted that 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. Outcome-based payments for patient care would generally be considered medical expenses in the Medical Loss Ratio numerator when the benefits and payment arrangements satisfy regulatory requirements to qualify as incurred claims or quality improvement activities and are not otherwise excluded.

FDA TEMPO Pilot Expands Access to Technologies Connected to the ACCESS Model

In connection with the ACCESS model, the FDA announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot. TEMPO is a voluntary pilot intended to allow manufacturers to pilot the use of certain non-FDA-authorized digital health devices under the ACCESS Model, providing a new risk-based enforcement approach that supports access to certain digital health devices intended to improve patient outcomes in cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions while collecting, monitoring and reporting real-world performance data. Specifically, participating manufacturers may request that the FDA exercise enforcement discretion for certain requirements, such as premarket authorization and investigational device requirements, while they collect and share real-world performance data. The FDA will work with participants to identify the circumstances when enforcement discretion may be appropriate and expects the data collected during the TEMPO pilot will be used to seek the appropriate FDA marketing authorization. Participants will have an opportunity to engage in sprint discussions with the FDA to facilitate their planned marketing submission. The FDA notes that participation in the TEMPO pilot is not an indication of whether the FDA will issue a positive decision for any future marketing submission.

The FDA is seeking statements of interest for participation in the TEMPO pilot beginning January 2, 2026, and expects to send follow-up requests around March 2, 2026. The FDA plans to select up to 10 U.S.-based manufacturers of digital health products that meet the definition of a device under the Federal Food, Drug, and Cosmetic Act, including AI-enabled devices, and are intended to be used in conjunction with clinician-supervised outpatient treatment to patients with conditions in each of the four clinical use areas (described above and below). In selecting the participants, the FDA will also consider whether the digital health device would not present a potential for serious risk to health, safety, or welfare of patients. Such devices may rely on off-the-shelf platforms or wearable products that may or may not be regulated by the FDA.

Manufacturers interested in participating are encouraged to submit the following information to the FDA: 1) a device description with the proposed indications for use and proposed claims; 2) data to demonstrate the device is adequately safe, can function as designed, and supports a reasonable expectation of providing a benefit to patients; 3) information regarding the manufacturer’s quality management system; 4) a risk mitigation plan and plan for collecting, monitoring, analysis, and reporting of real-world performance data; 5) proposed performance goals and a statistical analysis plan for patient outcomes; 6) a proposed timeline for data collection and submission of an application to seek marketing authorization for the device; and 7) a proposed interim reporting plan to report adverse events, new risks, and progress. Additional details on the TEMPO pilot can be found here.

Conclusion

The ACCESS Model provides payment to support technology-enabled monitoring, collaboration and chronic care improvements for CKM, MSK, and BH. This payment presents opportunities for healthcare providers, digital health companies, payers, device manufacturers, and vendors that support Participants in managing toward care outcomes. The TEMPO pilot provides a new risk-based enforcement approach that supports access to certain digital health devices intended to improve patient outcomes. Implications related to regulatory compliance and data access and use will need to be considered by Participants and digital health companies that partner with Participants.

Wilson Sonsini’s Digital Health practice advises companies on the regulatory and structural considerations implicated by CMS’s ACCESS Model and FDA’s TEMPO pilot, as well as interoperability, health data exchange, and data use issues that will be necessary for implementation. For more information, please contact Jodi Daniel, Andrea Linna, Eva Yin, Lidia Niecko-Najjum, Nawa Lodin, or Seamus Taylor.