The longest ACCESS article you’ll ever find: CMS builds a chronic care market where half your money lives in escrow and clinical outcomes to determine whether you ever see it
Table of Contents
- What ACCESS Actually Is and Why CMS Built It This Way
- The Four Clinical Tracks and Why Bundling Kills Point Solutions
- Payment Mechanics: OAPs, Withholding, and Two Independent Ways to Lose Revenue
- The Substitute Spend Trap: CMS Pricing Your Ability to Stay Primary
- Measurement as Infrastructure: Device Provenance, PROMs, and FHIR Plumbing
- Care Coordination Requirements That Actually Have Teeth
- Eligibility, Enrollment, and the Evaluation Randomization Problem
- The FDA TEMPO Pilot and What It Means for Device Regulation
- ACO Benchmark Treatment and Cross-Payer Alignment Mechanics
- The ACCESS Tools Directory and What It Signals About CMS Strategy
- What Has to Be True Operationally for Anyone to Make Money
- Underwriting Framework for Investors
- Twenty Company Examples: Who Fits, Who Gets Wrecked, and Why
- What to Watch Before Rate Cards Drop in 2026
Abstract
The Centers for Medicare and Medicaid Services Innovation Center released the Request for Applications for the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model on January 12, 2026. This is a ten-year nationwide voluntary model running July 1, 2026 through June 30, 2036, with rolling applications through early 2033 and quarterly cohort starts beginning January 1, 2027. The first cohort launches July 1, 2026 for applications received by March 20, 2026.
ACCESS introduces Outcome-Aligned Payments for technology-enabled chronic disease management across four initial clinical tracks: early Cardio-Kidney-Metabolic syndrome (eCKM), Cardio-Kidney-Metabolic syndrome (CKM), Musculoskeletal pain (MSK), and Behavioral Health (BH). The payment structure is fixed per beneficiary per track for twelve-month care periods, but only up to fifty percent of the annual payment is distributed during the care period via quarterly installments. The remaining fifty percent is withheld and reconciled after the care period ends based on performance against two adjustment mechanisms.
The Clinical Outcome Adjustment compares each participant’s Outcome Attainment Rate (the percentage of completed care periods where all required outcome measure targets were met) against an Outcome Attainment Threshold set at fifty percent in year one. The Substitute Spend Adjustment compares the Substitute Spend Rate (the percentage of aligned beneficiaries who did not receive defined substitute services from other Medicare providers for the same condition) against a Substitute Spend Threshold set at ninety percent in year one. CMS applies only the larger of the two adjustments in each semi-annual reconciliation period, with the Clinical Outcome Adjustment capped at fifty percent payment reduction and the Substitute Spend Adjustment capped at twenty-five percent reduction.
Participation requires Medicare Part B enrollment at the organizational TIN level as provider or supplier excluding DMEPOS and laboratory suppliers, designation of a Medicare-enrolled physician as Clinical Director (the FAQ clarifies this role, differing slightly from the Medical Director terminology in the RFA), individual Medicare enrollment of all clinicians furnishing or supervising care with reassigned billing rights, standardized electronic care coordination with primary care and referring clinicians, FHIR-based clinical and patient-reported outcome data submission, compliance with health information technology requirements including HIE connectivity within twelve months, and compliance with applicable FDA requirements or FDA enforcement discretion. An FFS exclusion prevents participants and affiliated entities from billing Medicare fee-for-service for aligned beneficiaries during active care periods.
CMS clarifies via FAQ that for 2026 and 2027, ACCESS Outcome-Aligned Payments will have no impact on ACO benchmark and performance year calculations for the Medicare Shared Savings Program and ACO REACH, with ACCESS expenditures to be included beginning in 2028. This creates a two-year window where ACOs can leverage ACCESS participants without benchmark impact.
CMS will launch an ACCESS Tools Directory within the application and participant portal to help organizations identify optional software and hardware tools supporting model participation including data exchange and interoperability solutions, identity verification systems, optional connected clinical devices like blood pressure cuffs, and tools supporting HIPAA compliance. Vendors may include promotional offers for ACCESS participants subject to all applicable federal and state laws.
FDA introduces the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot specifically for ACCESS, allowing manufacturers of certain digital health devices to request FDA enforcement discretion for devices used in ACCESS that would generally require FDA premarket authorization but have not yet obtained such authorization. Under TEMPO, manufacturers can offer devices to ACCESS participants for intended uses expected to be covered by ACCESS while collecting real-world performance data under FDA oversight. TEMPO participation is optional and requires enhanced beneficiary consent informing them the device is participating in an FDA pilot and certain data will be shared with FDA.
For investors, ACCESS creates a fundamentally different underwriting problem than typical digital health models. The fifty percent withholding creates working capital intensity that scales with patient volume. The outcome-based payment adjustments introduce revenue uncertainty tied directly to clinical performance across the patient panel. The measurement provenance requirements for blood pressure (validated upper arm cuffs with timestamped, source-verifiable transmission, manual entry prohibited) and other biomarkers eliminate self-reported data. The substitute spend controls penalize participants when beneficiaries receive duplicate services elsewhere, making leakage management a core operational competency. The FDA compliance requirements add regulatory complexity for device-dependent business models, though TEMPO provides a path for devices not yet cleared. The combination rewards well-capitalized organizations with proven clinical outcomes, mature measurement operations, FDA compliance infrastructure, and care coordination capabilities, while punishing undercapitalized or operationally immature entrants regardless of product quality or commercial traction.
What ACCESS Actually Is and Why CMS Built It This Way
ACCESS is not another value-based care arrangement where Medicare splits theoretical savings with provider groups. It is not an extension of fee-for-service with digital add-ons like the remote patient monitoring codes that created a cottage industry of device distribution companies with questionable clinical impact. ACCESS is CMS attempting to buy finished clinical results for specific chronic conditions using fixed prospective payments that are only fully earned if predefined outcome thresholds are met and duplicate spending is minimized.
The CMS FAQ frames this explicitly: “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.” This is CMS acknowledging that activity-based payment does not align with how technology-enabled care actually works and creates administrative burden that undermines efficiency.
The design reflects four explicit policy intentions visible throughout the RFA and FAQ. First, CMS wants to remove activity-based billing as the primary economic driver for technology-enabled chronic care because fee-for-service incentivizes volume over outcomes and creates administrative burden. Second, CMS wants to avoid the cost explosion risk of broadly available RPM codes where the business model became collecting device readings without demonstrated clinical impact. Third, CMS wants to create an outcome-comparable market across vendors by standardizing measure definitions, reporting mechanisms, and public transparency of risk-adjusted performance. The FAQ emphasizes that “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.” Fourth, CMS wants Medicare to become a viable payer channel for digital chronic care without ceding price control or enabling cherry-picking.
Every structural choice follows from these goals. The fixed payment per beneficiary per track eliminates billing complexity and volume incentives. The outcome thresholds and public reporting create quality-based competition. The substitute spend controls prevent participants from capturing payments while beneficiaries receive parallel care elsewhere. The measurement provenance requirements and FHIR submission standards ensure outcome data is auditable and comparable. The ten-year duration and rolling cohort design signal this is intended as permanent infrastructure, not a temporary demonstration.
The RFA explicitly states that technology-enabled care organizations deeply integrate technology into delivery to provide continuous high-value care for chronic disease prevention and management, noting that most currently serve commercially insured populations where more flexible payment arrangements make participation feasible. CMS is acknowledging that Medicare patients have limited access to these models because existing payment structures do not support them, and ACCESS is designed to fix that market failure by creating a payment pathway aligned with how technology-enabled care actually works.
The implied economic theory is that technology reduces marginal cost of continuous care delivery, making outcome-based payment models more viable than they would be for traditional brick-and-mortar provider organizations. AI-assisted documentation, remote monitoring, asynchronous engagement, and automated patient support can deliver sustained clinical management at scale with lower variable costs than visit-based care. If that theory holds, the fixed OAP should cover costs and generate margin for effective participants. If it does not hold, participants will discover that technology-enabled care still requires expensive human clinical labor and the unit economics fail under the payment rates CMS eventually sets.
The Four Clinical Tracks and Why Bundling Kills Point Solutions
