ACCESS

Medicare’s payment architecture has not changed structurally for digital health since the program was created in 1965. Fee-for-service reimburses defined activities: a visit, a procedure, a device implanted, a test ordered. It does not reimburse outcomes. It does not reimburse continuous monitoring between visits. It does not reimburse the software that aggregates wearable data into a clinical dashboard, or the asynchronous care management workflow that a digital therapeutics company runs to keep a hypertensive patient on medication. These are exactly the things that health technology companies have spent fifteen years proving can improve chronic disease outcomes at scale — and they sit entirely outside the reimbursement boundary that Medicare draws.

For the digital health sector, the federal reimbursement gap has been the central strategic problem since the first wave of venture capital arrived in consumer health technology. Companies that could demonstrate outcomes in commercial insurance populations or employer self-funded markets could not replicate those results in Medicare because Medicare would not pay for the care model, only for the component activities it chose to recognize. The result was a bifurcated market: digital health products that worked in commercial and were unavailable or unaffordable in Medicare, serving the population with the highest chronic disease burden and the greatest need for the kind of continuous, remote, technology-enabled management these tools provide.

The ACCESS model, announced December 4, 2025, and taking first participants in a July 2026 launch cohort, represents the first systematic attempt by CMS to address that gap at scale.

What ACCESS Tests

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ACCESS, Advancing Chronic Care with Effective, Scalable Solutions, is a 10-year voluntary CMMI model that introduces a new payment mechanism for technology-enabled chronic disease management in Original Medicare. It runs from July 5, 2026, through June 30, 2036. Applications are accepted on a rolling basis through April 1, 2033, creating a model that can absorb new participants over a seven-year window rather than requiring a single application cohort at launch.

The model’s core innovation is the Outcome-Aligned Payment, or OAP: a fixed, recurring annual payment per beneficiary that replaces activity-based billing for the conditions and time periods covered by the model. The OAP is not paid for doing things. It is paid for achieving things — measurable, pre-specified clinical improvements in the condition the participating organization has contracted to manage. Full payment is contingent on demonstrated outcomes. Partial payment is available for organizations that achieve outcomes for a significant share of their patient population but fall below full attainment thresholds.

CMS makes monthly advance payments equal to one-twelfth of the annual OAP amount for a given beneficiary and track, but caps cumulative monthly disbursements at 50 percent of the annual total. The remaining 50 percent is withheld and reconciled at the end of the 12-month care period based on two adjustments: a Clinical Outcome Adjustment that evaluates what share of aligned beneficiaries met their outcome targets, and a Substitute Spend Adjustment that evaluates whether beneficiaries received the same services covered by the ACCESS track from outside providers, which would indicate fragmented care rather than integrated management. Organizations that achieve outcomes for at least 50 percent of their aligned beneficiaries — the Outcome Attainment Threshold set for the first model year — receive full payment. Those below that threshold receive a proportional reduction.

The payment mechanism is designed to create viable economics for care models that are structurally incompatible with activity-based billing: continuous remote monitoring, asynchronous care management, algorithm-driven patient engagement, behavioral nudging, app-based chronic disease coaching. These interventions are less supply-constrained than in-person clinical services, can operate at scale across large patient populations, and generate clinically meaningful improvements in outcomes data — but they cannot be decomposed into billable CPT codes without distorting the care model or generating compliance risk under existing fraud and abuse frameworks.

The Four Clinical Tracks

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ACCESS organizes its payment structure around four clinical tracks, each targeting a cluster of related chronic conditions that affect more than two-thirds of Medicare beneficiaries and carry outsized shares of Medicare spending.

The Early Cardio-Kidney-Metabolic track, designated eCKM, covers hypertension, dyslipidemia, obesity or overweight with central adiposity marker, and prediabetes. These are the earlier-stage cardiometabolic conditions where prevention and lifestyle modification have the strongest evidence base for delaying or averting progression to more expensive, more debilitating disease states. The qualifying condition for eCKM track enrollment is hypertension alone, or any two of the remaining conditions together; not all four must be present. Outcome targets include blood pressure reduction, lipid improvement, weight loss in overweight beneficiaries, and HbA1c improvement in prediabetes cases. The payment model is longitudinal: if a beneficiary achieves guideline-directed control by the end of an initial 12-month period, the follow-on period targets a maintenance or continued improvement standard rather than resetting to baseline. The model accounts for the fact that managing someone who has already achieved control is a different care challenge than managing someone who has not.

The Cardio-Kidney-Metabolic track, designated CKM, covers the more advanced presentations: diabetes mellitus, chronic kidney disease at stages 3a or 3b, and atherosclerotic cardiovascular disease. These are the conditions that consume the largest share of Medicare chronic disease spending and that have the strongest evidence base for technology-enabled management interventions: continuous glucose monitoring and remote titration in diabetes, eGFR and urine albumin-to-creatinine ratio monitoring in CKD, and cardiac rehabilitation support and medication adherence monitoring in ASCVD. Outcome targets in CKM include HbA1c, eGFR trajectory, urine albumin-creatinine ratios, blood pressure, and lipids.

The Musculoskeletal track covers chronic musculoskeletal pain broadly, without specifying an anatomical site, reflecting CMS’s intent to encompass the range of digital physical therapy, remote therapeutic monitoring, and pain management tools that have emerged in the digital health market. The MSK track is structured differently from the metabolic tracks in one significant respect: it does not include an optional follow-on period. The model treats MSK chronic pain as a condition with a defined active management phase, after which the participant’s engagement concludes. The clinical logic is that effective MSK digital intervention resolves or substantially reduces pain during the active period rather than requiring indefinite maintenance management.

The Behavioral Health track covers depression and anxiety. This track’s inclusion is clinically and structurally significant. Medicare has historically been the most underserved major payer for behavioral health technology, in part because FFS billing for behavioral health services requires provider-type credentials that many digital mental health platforms either do not hold or hold inconsistently across states. By creating an OAP track for behavioral health outcomes, ACCESS opens a direct path for digital mental health platforms, telepsychiatry organizations, and integrated behavioral health programs to participate in Medicare reimbursement without decomposing their care models into individual billable service codes. The outcome target for BH is patient-reported symptom improvement on validated depression and anxiety scales.

Who Can Participate and What That Means

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The participation criteria for ACCESS are structured to maximize eligibility for technology-enabled organizations while establishing minimum accountability requirements.

Eligible participants must be enrolled in Medicare Part B as providers or suppliers. This category is broad: it includes physician practices, group practices, hospital outpatient departments, federally qualified health centers, rural health clinics, and, critically, digital health companies and digital therapeutics organizations that have obtained the relevant Medicare billing credentials. CMS explicitly signals in the REQUEST for Applications that digital health and digital therapeutics companies meeting Part B enrollment criteria are eligible. This is not an incidental provision — it reflects a deliberate policy decision to treat digital health organizations as first-class participants in the model rather than as subcontractors or vendors to traditional providers.

The exclusions are precise and consequential. Durable medical equipment, prosthetics, orthotics, and supplies suppliers are excluded. Laboratory suppliers are excluded. These exclusions reflect CMS’s intent to fund the care management and outcomes-improvement layer rather than the commoditized inputs — devices and tests — that will continue to be billed under standard Medicare Part B payment rules. A CGM manufacturer cannot be an ACCESS participant for the diabetes patient whose glucose readings the device generates. The primary care organization or digital diabetes management company that acts on those readings, adjusts medications, coaches behavior, and achieves glycemic control can be.

Each ACCESS participant must designate a Medical Director who is a Medicare-enrolled physician, an MD or DO, responsible for clinical oversight and compliance with the model’s care quality standards. This requirement ensures that technology-led organizations without traditional physician leadership structures have a designated accountability mechanism at the clinical level. Digital health companies that have operated outside of physician-led governance frameworks will need to either develop that internal capacity or establish affiliated physician relationships that can serve the Medical Director function.

The FFS exclusivity requirement deserves specific attention because it is the provision most likely to shape participant selection and partnership structure. ACCESS participants cannot bill Medicare FFS for services provided to their aligned beneficiaries in the tracks where those beneficiaries are enrolled. The exclusion applies to the participant organization and its affiliates, defined by co-ownership, control, or reassignment relationships. The practical effect is that an organization that becomes an ACCESS participant for its attributed beneficiaries’ cardiometabolic conditions cannot continue to bill standard chronic care management CPT codes, remote patient monitoring codes, or other activity-based codes for those same conditions in those same beneficiaries. The OAP replaces, rather than supplements, activity-based reimbursement for the covered conditions and the covered beneficiaries during the model period.

This is both ACCESS’s most important structural feature and its most significant operational constraint. Organizations that have built revenue models on remote patient monitoring billing or chronic care management coding will need to model whether the ACCESS OAP for their tracked conditions generates comparable or superior economics. For organizations that have been unable to access those codes at all — digital health companies without the billing infrastructure for RPM or CCM — the OAP pathway is additive rather than substitutive, and the economics are straightforwardly favorable if outcomes can be achieved.

The Randomized Control Design

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ACCESS incorporates a beneficiary-level randomized controlled trial design, with a 90:10 intervention-to-control ratio in the initial model years. A small share of beneficiaries who attempt to enroll in a specific ACCESS track will be randomly assigned to a control group for that track and will not receive ACCESS-model care, instead remaining in standard FFS Medicare.

This design choice is notable and, for CMMI, uncommon. Most CMMI models use comparison group methodologies that match participants against similar non-participants in the same geographic area or specialty, rather than randomizing within the participant’s own patient population. The 90:10 ratio limits the number of beneficiaries excluded from the intervention while providing statistical power sufficient to establish a genuine causal effect on outcomes and costs.

The RCT design reflects the certification imperative discussed in MCR-01.02: the Actuary’s certification of savings requires evidence that can withstand methodological scrutiny. A well-powered randomized trial produces the kind of evidence that CBO and the Actuary can score with confidence. If ACCESS’s first evaluation period generates statistically significant reductions in total cost of care for the treated population relative to the control group, the path to expansion or permanence is substantially cleaner than if the evidence rests on observational methods with selection bias concerns. The 10-year model duration and rolling application structure are also consistent with this design: a long horizon and large eventual participant pool provide the statistical power needed for subgroup analyses by condition, technology type, and population characteristic.

The PCP Co-Management Payment and ACO Interaction

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ACCESS is explicitly designed to complement rather than replace existing primary care relationships, ACO arrangements, and other Medicare care coordination infrastructure. Two provisions operationalize this design intent.

The co-management payment allows primary care physicians and referring clinicians to receive a payment of approximately $30 per service for documented review of patient progress updates from ACCESS participants and documented care coordination actions taken in response to those updates, such as medication adjustments, problem list changes, or specialist referrals. The payment is limited to once every four months per beneficiary per clinical track, generating a maximum of approximately $100 per beneficiary per track per year. It does not require beneficiary cost-sharing. The effect is to align the referring PCP’s financial interest with the ACCESS participant’s care management effort: PCPs who actively engage with ACCESS-generated clinical updates and act on them receive a payment stream that reflects the coordination value they add.

The ACO interaction has been handled in a phased manner. For 2026 and 2027, ACCESS OAP expenditures will not affect ACO benchmark or performance year calculations in MSSP or ACO REACH. This protection prevents participating ACOs from being penalized during the model’s initial period for the additional Medicare expenditures that ACCESS payments generate before outcome data is available to show whether those payments reduce other utilization. Beginning in 2028, ACCESS OAPs will be incorporated into ACO benchmarks on the standard schedule, reflecting CMS’s expectation that by that point the model will have demonstrated enough operational and clinical history to be treated as part of the attributed population’s cost profile.

CMS explicitly does not expect ACCESS to qualify as an Advanced Alternative Payment Model under MACRA’s Quality Payment Program framework. This means ACCESS participants will not automatically receive the 5 percent APM bonus available to qualifying APM participants or count their ACCESS participation toward the threshold required for that bonus. The exclusion matters for the hybrid organizations — tech-enabled primary care groups, digital health companies with clinical affiliates — that have been building their strategy around QPP positioning. ACCESS is not a QPP vehicle; it is a direct Medicare payment arrangement for outcomes-measured chronic care.

The FDA TEMPO Pilot: Regulatory Coordination at the Federal Level

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On December 5, 2025, the day after ACCESS was announced, the FDA’s Center for Devices and Radiological Health announced the Technology-Enabled Meaningful Patient Outcomes pilot, or TEMPO, in explicit connection with ACCESS.

TEMPO is a formal FDA pilot program under which manufacturers of certain digital health devices may request that the FDA exercise enforcement discretion with respect to applicable requirements — including, in some cases, premarket authorization requirements — when those devices are offered to or used by ACCESS participants for an intended use that improves patient outcomes consistent with the ACCESS model’s framework. Manufacturers must be U.S.-based, must submit a statement of interest to participate, and must comply with ongoing FDA oversight requirements including access to records and inspections.

The clinical significance of TEMPO is that it removes the single most significant regulatory barrier to digital health device deployment in a Medicare payment context: the requirement for FDA premarket clearance or approval before a device can be used in a Medicare-reimbursed care model. For software-as-a-medical-device products and connected monitoring tools that may have commercial evidence but not yet completed the FDA’s formal authorization process, TEMPO creates a structured pathway to participate in ACCESS without waiting for the full regulatory review cycle to complete.

The coordination of CMS and FDA action on the same policy objective — removing barriers to technology-enabled care in Medicare — on consecutive days in December 2025 is not coincidental. It reflects deliberate interagency coordination under the MAHA policy framework and signals an intention to create the full regulatory stack for digital health Medicare participation: CMS payment via ACCESS OAPs and FDA regulatory facilitation via TEMPO. The two pilots together constitute the most significant federal policy opening for digital health in the Medicare FFS market since the program’s creation.

What ACCESS Does Not Do

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The scope limitations of ACCESS are as analytically important as its coverage, and they are the source of the most significant frustration in the digital health sector’s early response to the model.

ACCESS is FFS Medicare only. Medicare Advantage enrollees, representing more than 54 percent of Medicare beneficiaries, are entirely excluded from ACCESS participation. An organization that builds an ACCESS care model for FFS beneficiaries is serving a minority of the Medicare market — and the minority that, on average, is older, sicker, lower-income, and more likely to be dual eligible. CMS notes that MA organizations may independently adopt similar outcome-aligned payment arrangements with their contracted providers, and the ACCESS model’s design is explicitly intended to inform that possibility. But there is no mandate, no regulatory vehicle, and no timeline for MA plan adoption of ACCESS-comparable structures.

The DMEPOS and laboratory exclusions, discussed above, mean that device manufacturers, diagnostic companies, and equipment suppliers whose products are central to digital health chronic disease management cannot be ACCESS participants. They can be infrastructure providers to ACCESS participants, but they cannot receive OAP payments directly. For CGM manufacturers, remote monitoring hardware companies, and diagnostic device makers whose business model depends on fee-for-service reimbursement for their equipment, ACCESS changes the institutional buyer in the care model rather than creating a new reimbursement stream for the device itself.

The FFS exclusivity requirement means that organizations entering ACCESS must make a commitment to the model’s outcomes-based economics and cannot hedge by maintaining parallel activity-based revenue for the same patient population in the same conditions. This is a deliberate design choice to prevent the payment optimization behavior that has undermined other CMMI models — enrolling the patients most likely to achieve outcomes while maintaining FFS billing for those most likely to need the higher-reimbursement services the FFS codes cover. But it is also an organizational commitment that smaller digital health companies or primary care practices with limited capital reserves may find difficult to make without more certainty about OAP payment levels and outcomes achievement rates.

The payment rates released February 13, 2026, generated a more tempered response from the digital health industry than the model’s announcement had produced. Industry observers noted that the OAP amounts appear calibrated to the resource economics of software and mobile application-based care models rather than hardware-intensive remote monitoring deployments. For companies that have built their clinical protocols around connected medical devices, continuous physiologic monitoring, or high-touch care management staffing, the OAP levels may not cover operating costs at the beneficiary volumes achievable in a model year. The economics favor lean, scalable technology platforms with low marginal costs per beneficiary over capital-intensive monitoring infrastructure.

The ACCESS-to-MAHA ELEVATE Pipeline

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ACCESS and MAHA ELEVATE, announced one week apart in December 2025, are designed as sequential rather than parallel instruments within the same policy framework. ACCESS handles the documented chronic conditions — the hypertensive patient, the diabetic patient, the patient with stage 3 CKD — where Medicare spending is occurring and where technology-enabled management has measurable cost and quality impact. MAHA ELEVATE handles the upstream population: the pre-symptomatic, the high-risk, the individuals whose lifestyle patterns are generating the chronic disease pipeline that ACCESS then manages.

The ACCESS tracks include prediabetes and obesity among qualifying eCKM conditions, which means the model’s early cardiometabolic track is explicitly designed to address the precursor population before it develops into the CKM-track conditions that carry the highest per-beneficiary costs. Organizations that build technology platforms for the eCKM population are directly addressing the prevention-to-management pipeline that both models are trying to redirect.

MAHA ELEVATE, discussed in MCR-01.06, operates as a cooperative agreement grant program rather than a direct payment model. It funds up to 30 organizations over three-year agreements to develop, test, and document lifestyle and functional medicine interventions for FFS Medicare beneficiaries, with the explicit design intent of generating evidence that can support expanded Medicare coverage or payment in the future. The pathway from MAHA ELEVATE to mainstream Medicare payment traces the same route that the Medicare Diabetes Prevention Program followed: HCIA demonstration grant, external evaluation, coverage expansion through rulemaking. ACCESS exists at the downstream end of that pipeline — the point where an intervention has established enough evidence for outcomes-based payment — while MAHA ELEVATE is generating the pipeline’s upstream inputs.

For digital health companies evaluating their positioning relative to both models, the strategic question is where in the chronic disease timeline their technology operates and what Medicare beneficiary population is eligible to receive it. Companies with interventions targeted at prevention and lifestyle modification in pre-symptomatic populations are MAHA ELEVATE candidates. Companies with interventions targeted at controlling established chronic conditions in enrolled Medicare beneficiaries with documented diagnoses are ACCESS candidates. Companies with platform capabilities across the continuum can potentially participate in both.

The Structural Precedent

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The ten-year duration of ACCESS and its rolling application structure signal that CMS intends this to be a permanent feature of the Medicare payment landscape if the evaluation supports expansion, not a time-limited pilot that retires regardless of results. The explicit language in the RFA and the CMS FAQ — that successful certification of quality improvement without cost increase or cost reduction without quality harm will trigger consideration of permanence through rulemaking — follows the same expansion pathway established for the Home Health Value-Based Purchasing model, the only CMMI model certified for expansion in the Obama and first Trump administration periods.

The precedent being set matters beyond ACCESS itself. For twenty-five years of digital health investment and development, the central limiting belief has been that Medicare would not pay for outcomes-based technology care until the technology had been validated through traditional clinical trial and FDA regulatory processes that the existing FFS payment system was designed to recognize. ACCESS is a direct challenge to that belief: it creates a payment mechanism that reimburses outcomes before the underlying technologies have been individually evaluated and coded under the physician fee schedule.

If ACCESS demonstrates that a payment structure designed for technology-enabled care generates better outcomes at comparable or lower cost to the CBO-scorable baseline, the downstream policy implication is that the physician fee schedule’s CPT-code architecture is not the only viable payment infrastructure for Medicare. That implication, if it survives a rigorous 10-year evaluation, restructures the reimbursement conversation for digital health in every federal health program. ACCESS is not just a Medicare payment model. It is a test of whether outcome-aligned payment can become the structural basis for how Medicare pays for care that does not look like a doctor’s office visit.

Related Reading

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MCR-06_01 The HealthTech Policy Opening: ACCESS, WISeR, and the Digital Medicare Moment MCR-12_04 The HealthTech Company Ecosystem: What Medicare Policy Actually Allows vs. What Companies Claim MCR-08_03 Mental Health, Depression, and Medicare: How ACCESS, MAHA ELEVATE, and Star Ratings Are Reshaping the Policy Landscape