CMS is now paying for results. Not services. Not visits. Results — specifically, measurable improvements in blood pressure, glucose control, musculoskeletal pain, and depression scores. The program is called ACCESS (Advancing Chronic Care with Effective, Scalable Solutions), and the first application window closes April 1, 2026.
If your health system isn’t filed by then, you’re waiting until January 2027.
The ACCESS model, announced by CMS in late 2025, is the first payment program explicitly structured around technology-enabled chronic disease management — and it runs in direct coordination with the FDA’s TEMPO Pilot, which grants enforcement discretion to AI-enabled devices that haven’t yet received premarket authorization. Together, these two programs create something that hasn’t existed before in U.S. healthcare: a federally structured pathway to deploy AI tools, generate real-world evidence, and get paid based on patient outcomes — simultaneously.
That’s not a future possibility. It’s operational July 5, 2026.
Clinical Context
CMS built ACCESS around a specific problem: two-thirds of Medicare beneficiaries have at least one of four chronic conditions — hypertension, type 2 diabetes, chronic musculoskeletal pain, or depression — and existing fee-for-service reimbursement gives health systems no financial incentive to use technology to manage those conditions better.
The model fixes that by replacing volume-based payment with outcome-aligned payments (OAPs): recurring payments tied to whether patients achieve measurable health outcomes. For hypertension, that means controlled blood pressure. For diabetes, it means HbA1c targets. The program runs 10 years — July 2026 through June 2036 — and CMS will accept applications on a rolling basis through 2033.
The structural shift that matters most: CMS is waiving patient cost-shares for services delivered under ACCESS. That single change removes one of the most persistent barriers to remote monitoring and digital health adoption. Remote patient monitoring programs have historically struggled with Medicare patient uptake because beneficiaries still face co-pays. Under ACCESS, those co-pays disappear for enrolled patients.
The TEMPO Pilot runs alongside ACCESS as the FDA’s mechanism for getting AI-enabled devices into patients’ hands before full premarket authorization. FDA will select up to 10 U.S. manufacturers per disease area. Selected manufacturers operate under enforcement discretion, collecting real-world data that feeds directly into their eventual FDA marketing submissions. Statements of interest opened January 2, 2026. FDA began sending follow-up requests to selected candidates around March 2, 2026.
Two federal agencies. One coordinated strategy. This is not a pilot in the typical CMS sense — it’s a 10-year program with a defined reimbursement structure and a regulatory clearance runway built in.
Four Findings That Change the Math
The disease targets are the four most pharmacy-intensive chronic conditions in Medicare. Hypertension, diabetes, musculoskeletal pain, and depression are also the conditions most actively managed through medication therapy management (MTM), remote patient monitoring (RPM), and adherence programs. The question isn’t whether pharmacy expertise is relevant to ACCESS — it’s whether health systems are structuring their applications to include it.
CMS waives patient cost-shares for ACCESS-enrolled services. Patient cost-sharing was the most commonly cited barrier to RPM non-enrollment in Medicare populations. Under ACCESS, participating organizations can offer technology-supported services with no out-of-pocket cost to the patient. For any health system running a chronic disease management program, this changes the enrollment math immediately.
FDA’s TEMPO Pilot creates a pre-authorization deployment window for AI-enabled devices. TEMPO is not a regulatory free pass. Manufacturers must obtain enhanced patient consent, disclose the device’s pilot status, and share real-world data with FDA. The trade-off: market access before premarket authorization, in exchange for generating the evidence that supports the eventual marketing submission. FDA is selecting up to 10 manufacturers per disease area — that ceiling is by design.
Physician referral incentives up to $100 per patient per year are built into the model. Participating organizations can pay referring physicians up to $100/patient/year for co-managing ACCESS-enrolled patients. This closes the referral loop that typically breaks telehealth and digital health programs. If your system runs a pharmacy-led chronic disease management program, this is the financial structure that makes physician buy-in achievable.
Operational Impact: Three Decision Points
Eligibility check. To participate, organizations must be enrolled in Medicare Part B and designate a clinical director responsible for care quality and compliance. DME suppliers and clinical laboratories are excluded. If your organization bills under Part B and manages chronic disease patients, you likely meet the threshold — but the clinical director requirement means someone has to own the program operationally, not just administratively.
Workflow architecture. ACCESS pays based on outcomes, which means your data capture infrastructure has to be strong enough to document that a patient’s blood pressure is controlled, their HbA1c has improved, or their pain scores have declined. This is not achievable with a standard EHR workflow. You need either an integrated RPM platform, a structured MTM documentation system, or both. Organizations entering ACCESS without this infrastructure will generate the effort without the payment.
Application timing. Applications for the July 5, 2026 performance period start must be received by April 1, 2026. Organizations that miss April 1 can still apply, but the next performance period start date is January 1, 2027 — a six-month delay and six months of potential outcome-aligned payments left on the table. The TEMPO Pilot operates on a separate track: FDA’s follow-up requests went out around March 2, 2026. New entrants in this cycle are largely closed out.
TheraIntel Perspective: Why Pharmacy Is Missing from Most ACCESS Applications
ACCESS is being discussed primarily in digital health and health tech circles. Most pharmacy directors and clinical pharmacy leaders haven’t heard of it. That’s the gap.
The four chronic conditions at the center of ACCESS are conditions where clinical pharmacists deliver measurable, documented value. Pharmacist-managed diabetes programs have demonstrated HbA1c reductions of 1.0–2.4%. Hypertension management by pharmacists in collaborative practice agreements consistently outperforms standard care by 10–15 mmHg systolic reduction in controlled trials. These aren’t soft outcomes. They’re exactly the outcome metrics CMS is paying for.
The problem is structural. Health systems applying for ACCESS are building their clinical programs around physician- or NP-led models, because that’s the default organizational design. Pharmacy is an afterthought — or not in the room at all. The result is that ACCESS programs will be built without the highest-leverage clinical resource for chronic disease management that most health systems already employ.
If you run telepharmacy operations, you need to be on the phone with your CMO this week — not next quarter — asking where pharmacy fits in your system’s ACCESS application. If your system is building an ACCESS program without clinical pharmacy embedded in the workflow, you’re leaving both outcomes and revenue behind.
Executive Takeaway: Three Actions Now
File or escalate your ACCESS application immediately. April 1 is the deadline for the July 2026 performance period. If your organization hasn’t started, contact CMS Innovation Center today. Missing this window means January 2027 at the earliest — six months of outcome-aligned payments forfeited.
Audit your outcome documentation infrastructure. ACCESS pays for results, not activity. Pull your current chronic disease patient data and assess whether your existing RPM, MTM, or care management platforms can generate the outcome documentation CMS requires. If the answer is no, that’s a workflow gap to close before enrollment begins.
Put clinical pharmacy in the ACCESS room. The four target conditions are the four conditions where pharmacist-managed care generates the strongest outcome data. If your health system’s ACCESS planning team doesn’t include clinical pharmacy leadership, fix that this week. The program rewards outcome performance — and pharmacists are your highest-leverage clinical asset for delivering it.
“Every pharmacy AI platform targeting diabetes or hypertension management just got a reimbursement pathway. The question is whether your organization is structured to use it.”