CMS’s New ACCESS Model - An Open Door For Healthcare Technology

The ACCESS Model, announced December 1, 2025, is a pilot payment model from the CMS Innovation Center (CMMI) that will test outcome‑aligned payments (“OAPs”) as a method of incentivizing providers treating Original Medicare beneficiaries to adopt technology that improves care. The ACCESS Model is the clearest signal yet that CMS is finally ready to pay for outcomes instead of volume and recognizes the important role that healthcare technology can play in improving outcomes and access to care. This is the opportunity that healthcare visionaries have been waiting for.

How ACCESS Improves Access to Healthcare Technology

The ACCESS Model embraces healthcare technology and innovative care models in several important ways:

Acknowledging that traditional fee-for-service payment models are outdated and miss the mark on how modern patients expect to access care.

• Embracing OAPs rather than typical fee-for-service and volume-based payments to incentivize providers to adopt digital health tools like health apps, wearable devices, and remote monitoring tools.
• Introducing the ACCESS Tools Directory (“Tools Directory”) to help organizations identify software and hardware tools available in the marketplace and allowing the companies behind those tools to identify themselves.‍
• Establishing a public directory of ACCESS Model participants (separate from the Tools Directory) to enable seamless care coordination and patient referrals and paying referring providers a “Co-Management” fee.
• Eliminating cost-sharing requirements for both OAPs and Co-Management fees.
• Hosting a “standards-based” API for easy reporting.

The Basics

Here’s the quick-and-dirty on how it will work:

• ACCESS is a 10-year voluntary model that startsJuly 1, 2026, with initial applications due April 1, 2026. The application is not yet available, but companies interested in participating can complete the ACCESS Model Interest Form to be notified when applications become available. CMS also plans to publish an “Implementation Guide” to give interested participants a more detailed pathway to success.
• Program goals include improving patient access to tech-enabled care options to manage chronic conditions, expand providers’ ability to offer and embrace innovative, digital health tools and care models, and promote transparency
• It involves four separate clinical tracks spanning conditions that impact two-thirds of Medicare beneficiaries: (1) Early cardio-kidney-metabolic (eCKM) conditions; (2) cardio-kidney-metabolic (CKM) conditions; (3)Musculoskeletal (MSK) conditions; and (4) Behavioral Health (BH) conditions.Participants can participate in multiple tracks.
• OAPs will be structured as recurring payments linked to three defined clinical targets: (1) Achievement of condition-specific, guideline-informed outcome measures (specific measures listed here under “Prospective Participant FAQs”); (2) A minimum performance threshold (percentage of enrolled patients who meet the defined outcome) that increases annually; and (3) regular reporting of required baseline and follow-up measures
• The Co-Management fee for providers who refer patients to ACCESSParticipants for co-management of their patients will be approximately $30 per beneficiary with an additional $10 bonus for referring providers who help patients with onboarding and set-up. Fees will be capped at $100 per beneficiary annually.
• Medicare Advantage and state Medicaid plans are authorized to adopt and implement ACCESS-like payment models without obtaining a waiver or risking their MLR
• Compliance is key: participants and the tools they use are expected to comply with applicable state and federal laws, rules, and regulations, including HIPAA, AKS, and Stark Law and their state equivalents.
• CMS will publicly report aggregated, risk‑adjusted outcomes to drive transparency, market competition, and informed patient/referrer choices.

Why It Matters — The Problem ACCESS Aims to Fix

Under traditional “fee‑for‑service” Medicare, many technology‑supported chronic‑care services are hard (or impossible) to bill: payment opportunities are limited for providers implementing remote monitoring, coaching, continuous care, data integration, and digital-first care models. This leaves many patients without access to modern, tech‑enabled care options and slows provider adoption.

Where Healthcare Technology Comes In

Healthcare organizations interested in participating in the ACCESS Model must first enroll in Medicare Part B. This means that most healthcare technology companies won’t be eligible for direct participation or receipt of OAPs.

However, the Tools Directory will give participants a direct line to a broad array of technology, allowing digital health companies to market themselves as essential to participants’ success.And there are plenty of ways for those tools to deliver on their promise:

• Remote monitoring tools can support data collection, data analysis, andoutcomes tracking related to the model’s defined outcomes measures
• FHIR and HL7 APIs can support seamless information sharing between referring providers and ACCESS participants, enabling providers’ co-management efforts
• Risk-stratification and analysis tools can help providers allocate resources to patients effectively and efficiently to keep them on track to achieving required outcomes measures
• Patient-education tools can support patient onboarding and keep patients informed and engaged, further enabling co-management

An unprecedented agency partnership: FDA TEMPO

Just three days after CMMI announced the ACCESS Model, CMMI and FDA’s Digital Health Center of Excellence jointly introduced the Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot (TEMPO). TEMPO is a parallel program to the ACCESS Model intended to further enable safe access to the digital health tools ACCESS participants adopt. Here’s what the initial announcement indicates:

• PMA waivers will be available to TEMPO participants. For accepted manufacturers (including SaMD manufacturers), FDA may temporarily agree to exercise enforcement discretion for tools that would otherwise require pre-market authorization.‍
• Real-world data will be the price of admission. Participants must generate and share outcomes data with FDA while involved in ACCESS and ultimately use it to pursue full authorization where required.‍
• Limited early slots and narrow clinical focus: FDA expects to pick ~10 manufacturers in each of the four clinical ACCESS tracks. ‍
• Applications are expected to open in 2026. FDA will begin accepting statements of interest in 2026, the process and timing for which will be announced via the federal register.

Is there a catch?

While the ACCESS Model is an exciting new way for patients and providers to access healthcare technology, there are a few limiting factors digital health companies should be aware of.

Differentiation and direct sales outreach will still help you win.

While details are minimal to date, the Tools Directory is intended to be a list of optional technologies that may be used to support ACCESS Model participants and eligible beneficiaries.This will no doubt be a great way for digital health companies to get in front of their target customers. Plus, CMS will not independently review or vet applicants who wish to be listed, which likely means it will be fairly simple to join.

However, we expect this will also result in a high volume of listings, likely out of the gate. While we hope the directory will include helpful filtering functions to allow providers to easily find the tools that are most relevant to them, companies submitting listings should also be prepared to augment that effort with strategic differentiation and direct outreach to stand out among the crowd.

Compliance remains crucial.

As noted above, model participants and the tools they adopt will still be subject to the complex web of healthcare laws and regulations they know and love (or is the “love” part just us?). This means that cost-sharing waivers, pricing structure, privacy and security practices, referral relationships, and billing practices will still have to comply with the rules that govern them.

And while companies listed in the Tools Directory will be permitted to offer discounts and other promotional items, the Anti-kickback Statute and state equivalents will still govern how those promotions are structured and delivered. And CMS will require companies listed to self-certify compliance, meaning CMS may have a direct interest in their compliance with state laws and regulations that they otherwise may not have.

Your success (or failure) will be on display.

With risk‑adjusted outcomes reporting, providers and the tools they use 1will be on public display. While this is great for accountability and transparency, it may also come with reputational risk in the event that participants do not meet minimum performance thresholds. Digital health companies supporting ACCESS Model participants should prepare to independently monitor success and adjust in real-time where necessary.

Financial opportunities remain unclear.

OAPs, Co-Management fees, and cost-sharing waivers have the potential to improve incentive alignment among patients, participating providers, and healthcare technology companies. But CMS has yet to provide detailed information about the amount of additional payments participants should expect to receive, Co-Management fees are capped at $100 per beneficiary per year, and cost-sharing waivers simply mean providers agree to accept lower payment for their services. Interested parties should run careful analyses and comparisons to make informed decisions about pricing and implementation.

What healthcare visionaries can do today to prepare for the July 2026ACCESS Model start date

There are several takeaways for health tech and digital health companies:

• Start early: Monitor CMS announcements and get ready for the application process. CMS says the “Request for Applications” will be released soon, and organizations wishing to join must apply by April 1, 2026, for a July 2026 start(or can apply later for a January 2027 start). Submit your ACCESS Model Interest Form and check out a recent blog series from Elevare Law Co-founder Rebecca Gwilt for tips on selling into healthcare to start planning now.‍
• Design for outcomes: Build your plan (i.e., workflows, sales pitches, budget) around measurable, clinically meaningful outcomes based on the specific metrics CMS has already identified (listed here under “Prospective Participant FAQs”). Leverage the data you already have to demonstrate how your technology can drive the relevant outcomes.‍
• Plan for compliance from day one: Ensure you are compliant with applicable federal and state privacy and security, licensing, medical device (e.g., FDA) laws, rules, and regulations. Design your success plan with compliance as a foundational pillar and consider leveraging a Value-based Safe Harbor to ensure your sales pitch and pricing model are permissible.‍
• Prepare for what’s next: Remember that the ACCESS Model is a 10-year program. If the currentlyselected conditions do not fit your model or technology, don’t ignore the ACCESSModel. CMS has said it will look to expand the eligible conditions, providers, andpatients as stakeholders demonstrate how technology-enabled care improvesoutcomes in other areas.

As always, we’re watching updates closely and will keep you informed. Subscribe for updates.