CMS ACCESS Model: Transforming Digital Health Reimbursement Through Outcome-Aligned Payments

The ACCESS Model: A Paradigm Shift in Medicare Reimbursement

Model Fundamentals

The ACCESS Model represents CMS's most ambitious attempt to align Medicare payments with patient outcomes rather than service volume. Launching July 1, 2026, and operating through June 30, 2036, the voluntary program addresses chronic conditions affecting approximately two-thirds of Medicare beneficiaries.¹ Unlike traditional fee-for-service (FFS) reimbursement tied to specific activities or devices, ACCESS introduces Outcome-Aligned Payments (OAPs)—recurring payments for managing qualifying conditions, with full reimbursement contingent on achieving measurable clinical improvements.²

Four Clinical Tracks

The model launches with four carefully selected chronic disease categories, each representing significant Medicare expenditure and amenable to technology-enabled intervention:

Early Cardio-Kidney-Metabolic (eCKM) Conditions: This preventive track targets hypertension, dyslipidemia, obesity, and prediabetes—conditions where early intervention can prevent progression to more severe disease states requiring costly treatments.³

Cardio-Kidney-Metabolic (CKM) Conditions: Focusing on established disease, this track addresses diabetes, chronic kidney disease, and atherosclerotic cardiovascular disease, conditions that collectively drive substantial Medicare spending and benefit from continuous monitoring and management.³

Musculoskeletal Conditions: Chronic musculoskeletal pain represents both a quality-of-life issue and a driver of opioid use, making it a strategic target for non-pharmacological, technology-enabled interventions.³

Behavioral Health Conditions: Depression and anxiety affect health outcomes across all chronic conditions, yet traditional Medicare has struggled to adequately reimburse integrated behavioral health support, particularly through digital modalities.³

Eligible Participants and Enrollment

Organizations must be Medicare Part B–enrolled entities (excluding DME, prosthetics, orthotics, supplies, and laboratory suppliers) and designate a Medicare-enrolled Medical Director to oversee care quality and compliance.² Organizations not currently enrolled in Medicare Part B must enroll to participate. CMS accepts applications on a rolling basis from January 2026 through January 2033, with applications due by March 20, 2026, for the first performance period beginning July 1, 2026.⁴

Notably, Medicare beneficiaries retain all rights, coverage, and benefits, including freedom to see any Medicare healthcare provider. Patients may enroll directly with participating ACCESS organizations or upon provider referral, creating a patient-centric model that emphasizes choice and transparency.²

The Value-Based Care Mechanism: How Outcome-Aligned Payments Work

From Volume to Value: The Payment Structure

Traditional Medicare FFS payment operates on a transactional model: specific services generate specific payments regardless of whether the patient's health improves. This creates perverse incentives that reward higher service volume over better outcomes. ACCESS fundamentally restructures this relationship by introducing Outcome-Aligned Payments that reward results rather than activities.⁵

Under ACCESS, participating organizations receive recurring payments for managing patients' qualifying conditions. However, full payment is conditional: organizations must achieve measurable health outcomes based on each patient's starting point. For example, helping a hypertensive patient lower blood pressure by 10 mmHg or assisting a diabetic patient in reducing HbA1c by 1%.²

Performance-Based Payment Calculation

The payment mechanism balances accountability with accessibility. Rather than requiring every patient to meet their individual target—an unrealistic standard given patient heterogeneity and social determinants of health—CMS bases payment on the overall share of an organization's patients who meet their outcome targets.² This allows organizations to earn full payment through strong overall performance even if some individual patients don't reach their goals.

Critically, payment thresholds increase with each participation year, creating continuous pressure for improvement and preventing organizations from settling into comfortable but suboptimal performance levels.⁶ CMS will publish risk-adjusted outcomes, enabling transparent performance comparisons and empowering patients to choose high-performing organizations.²

Condition-Specific Measures and Targets

Each clinical track includes guideline-informed, condition-specific measures and outcome targets. These may include biomarkers such as blood pressure, hemoglobin A1c, lipid levels, or weight, as well as validated Patient Reported Outcome Measures (PROMs) assessing pain, mood, and function.⁷ Most tracks include an initial year of intensive care followed by an optional continuation period at a reduced rate, facilitating ongoing patient support after initial control is achieved.⁷

To promote access in underserved areas, CMS applies a fixed adjustment for rural patients in qualifying tracks, recognizing the additional challenges of delivering technology-enabled care in areas with limited broadband access or digital literacy.⁷

Downstream Cost Impact Measurement

Beyond measuring improvement in condition-specific biomarkers, CMS evaluates whether these clinical improvements translate into lower total cost of care. This includes tracking hospitalizations, emergency department visits, and overall Medicare spending for patients enrolled with ACCESS participants.⁸ Organizations that achieve both clinical improvement and cost reduction demonstrate the core value proposition of truly effective chronic disease management.

How ACCESS Achieves Value-Based Care Transformation

Shifting Incentives from Volume to Value

The fundamental innovation of ACCESS lies in its payment structure. Fixed, outcome-aligned payments reward cost-effective health improvement and channel innovation toward value rather than volume.⁹ By making payment contingent on results, ACCESS aligns organizational financial incentives with patient health outcomes—the Holy Grail of value-based care that previous models have struggled to achieve.

Unlike earlier outcome-based payment attempts that focused on highly technical procedure bundles or the total cost of care through Accountable Care Organizations, ACCESS defines very specific clinical outcomes and allows organizations to use whatever approaches and technologies they need to achieve those outcomes without assuming global risk for the patient's entire care.¹⁰ This targeted approach makes value-based care participation more accessible to specialized organizations while maintaining rigorous accountability for defined conditions.

Emphasizing Prevention Over Reaction

Prevention sits at the heart of the ACCESS model. Payments are tied to control or improvement of leading health indicators—blood pressure, weight, HbA1c, cholesterol—meaning organizations succeed financially by keeping people healthy rather than treating complications.⁹ This represents a profound shift from the reactive, episodic care model that dominates current practice.

The inclusion of the early CKM track specifically targets conditions at the pre-disease stage, creating financial incentives for preventing diabetes, cardiovascular disease, and chronic kidney disease before they develop. This preventive focus has the potential to reduce Medicare's long-term expenditures substantially while improving population health—the core promise of value-based care.³

Fostering Care Coordination and Integration

ACCESS recognizes that effective chronic disease management requires coordination across the care team. The model includes a novel co-management payment mechanism: primary care providers and referring clinicians can receive up to $100 per year per beneficiary for reviewing patient updates and coordinating care with ACCESS participants.¹¹ This payment stream creates financial incentives for PCPs to actively engage with technology-enabled care providers rather than viewing them as competitors.

Furthermore, ACCESS participants must share patient information including care plans and outcomes data electronically through Health Information Exchanges or similar means with primary care providers and referring clinicians.¹¹ This mandatory interoperability requirement addresses one of the persistent barriers to integrated care: the fragmentation of health information across disconnected systems.

Strategic Advantages for Digital Health Solutions

Removing Structural Reimbursement Barriers

Digital health technologies have long faced a fundamental mismatch with traditional Medicare payment structures. Software-based interventions, continuous remote monitoring, asynchronous patient engagement, and AI-driven clinical decision support don't fit neatly into FFS billing codes designed for in-person encounters and discrete procedures. Many innovative digital health solutions have struggled to achieve sustainable reimbursement despite demonstrating clinical value.¹²

ACCESS addresses this barrier directly. Rather than paying for specific services or requiring developers to navigate complex coding and coverage determinations, the model rewards outcomes. If a digital therapeutic helps patients lower their blood pressure or manage their diabetes more effectively, the organization using that tool receives payment based on those results. The specific modality—whether in-person visits, telehealth consultations, mobile app engagement, or wearable device monitoring—becomes irrelevant as long as outcomes are achieved.²

Creating Direct Payment Pathways

For digital health companies, ACCESS creates a direct route to Medicare reimbursement that previously didn't exist. Rather than convincing CMS to create new billing codes for specific technologies, companies can demonstrate clinical value through the ACCESS framework. Organizations that successfully integrate effective digital health tools and achieve superior outcomes will earn higher payments, creating market-driven demand for proven technologies.¹³

Significantly, CMS waives patient co-payments for ACCESS services, removing a potential barrier to adoption and making technology-enabled care more accessible to Medicare beneficiaries.¹³ This contrasts with traditional Medicare where 20% co-insurance can represent a significant out-of-pocket cost, particularly for lower-income seniors.

Nurturing a Technology-Enabled Care Ecosystem

The model is explicitly designed to foster a robust ecosystem of technology-enabled care organizations and supporting tools. This includes AI diagnostics that identify patients who might benefit from ACCESS services, devices that monitor biomarkers continuously, wearables that track physical activity and vital signs, and software that streamlines clinical workflows and patient engagement.⁹

Because ACCESS uses standard Medicare billing infrastructure rather than requiring specialized payment processing, the model can potentially scale to other payers, including Medicare Advantage, Medicaid, and commercial insurance plans.⁹ This scalability creates a pathway for successful ACCESS interventions to achieve broader market adoption beyond Original Medicare's fee-for-service population.

The FDA TEMPO Pilot: Accelerating Innovation

A critical companion initiative enhances ACCESS's potential to drive digital health innovation. The FDA's Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot allows manufacturers of certain digital health devices that haven't yet received FDA authorization to participate in ACCESS under enforcement discretion.¹⁴

Under TEMPO, manufacturers of approximately 40 selected devices can offer their products for intended uses that would typically require FDA premarket authorization while collecting real-world performance data. This creates a structured pathway for emerging technologies to demonstrate clinical value in actual practice settings while simultaneously generating evidence for eventual FDA authorization.^14,15

The TEMPO pilot addresses a persistent challenge in digital health: the difficulty of obtaining FDA authorization without substantial real-world evidence, coupled with the challenge of generating that evidence without market access. By allowing controlled deployment through ACCESS while collecting rigorous performance data, TEMPO creates a practical pathway for promising technologies to prove their value and achieve both clinical adoption and regulatory clearance.¹⁵

Strategic Implications for Pharmaceutical Digital Health Portfolios

Alignment with CVRM Therapeutic Focus

For pharmaceutical companies with cardiovascular, renal, and metabolic disease portfolios, ACCESS presents exceptional strategic alignment. The eCKM and CKM tracks directly address the disease areas where many pharmaceutical companies have deep therapeutic expertise and extensive commercial presence. Digital health solutions that complement pharmaceutical interventions—medication adherence tools, remote monitoring systems, lifestyle modification programs—can now access sustainable Medicare reimbursement through the ACCESS framework.³

Consider the example of a company with strong diabetes franchises. An integrated digital diabetes management platform that combines continuous glucose monitoring, insulin titration support, medication adherence tracking, and lifestyle coaching could participate in ACCESS's CKM track. If the platform successfully helps patients achieve HbA1c targets, it receives recurring payments independent of specific pharmaceutical sales. This creates a complementary revenue stream while potentially improving pharmaceutical adherence and effectiveness.

Real-World Evidence Generation Infrastructure

The combination of ACCESS outcome measurement requirements and the TEMPO pilot creates an unprecedented infrastructure for generating real-world evidence. Every ACCESS participant must track standardized, guideline-informed outcome measures and report performance data to CMS.⁷ TEMPO devices must collect, monitor, and report real-world performance data as a condition of enforcement discretion.¹⁵

For pharmaceutical companies developing digital health solutions, this creates opportunities to generate robust RWE in actual clinical practice settings with Medicare populations—exactly the type of evidence that regulators and payers increasingly demand. The standardized outcome measures and data reporting requirements ensure comparability across organizations and interventions, facilitating evidence synthesis and comparative effectiveness research.

Competitive Differentiation Through Value Demonstration

ACCESS fundamentally changes the competitive landscape for chronic disease management. The model creates standardized, apples-to-apples comparisons of outcomes and cost savings in chronic disease management.⁸ CMS's publication of risk-adjusted outcomes enables transparent performance comparison, empowering patients and referring providers to identify high-performing organizations.²

This transparency creates both opportunity and risk. Organizations that consistently achieve superior outcomes will gain competitive advantage through demonstrated value, while underperforming organizations face market pressure and potential disenrollment by CMS for failing to meet quality, safety, or outcome standards.¹⁶ For digital health solution providers, this means that proven effectiveness translates directly into market success—a stark departure from healthcare markets where marketing often matters more than evidence.

Scalability Beyond Medicare Fee-for-Service

While ACCESS initially operates in Original Medicare, its architecture supports broader adoption. Medicare Advantage organizations don't need waivers to implement similar outcome-aligned payment arrangements with their contracted providers and have flexibility to structure payments under existing program requirements.¹¹ All outcome-aligned payments for patient care are considered medical expenses for purposes of calculating medical loss ratios, meaning they don't count as administrative expenses—an important consideration for MA plan financial management.¹¹

Commercial payers and Medicaid programs can also adopt ACCESS-like models, creating potential for digital health solutions that succeed in ACCESS to achieve multi-payer coverage. The use of standard billing infrastructure rather than specialized payment processing facilitates this scalability.⁹

Strategic Positioning Considerations

Organizations positioned to succeed in ACCESS share several characteristics. They demonstrate financial discipline to invest prepaid outcome-aligned revenue in program improvement rather than short-term profit maximization. They possess clinical expertise in care management for the targeted chronic conditions. They maintain robust data and analytics capabilities for performance tracking, risk adjustment, and continuous improvement. Most importantly, they understand that effective chronic disease management requires consistent, systematic, technology-enabled engagement that compounds over time rather than episodic interventions.⁶

For pharmaceutical companies considering ACCESS participation or partnerships with ACCESS organizations, these success factors should inform due diligence. The model rewards organizations that view technology as an enabler of continuous patient engagement and clinical excellence, not simply as a cost reduction tool or marketing differentiator.

Implementation Challenges and Critical Success Factors

Data Integration and Interoperability

The most frequently cited challenge for ACCESS adoption is data integration. Effective participation requires seamless information flow between ACCESS organizations, primary care providers, referring clinicians, and CMS. Organizations must establish connections with Health Information Exchanges, integrate data from multiple clinical devices and software platforms, reconcile patient identities across systems, and ensure compliance with HIPAA and other privacy regulations.¹⁷

This technical infrastructure is substantial and represents a barrier to entry for organizations without existing digital health capabilities. However, it also creates opportunities for platform providers and integration specialists who can offer turnkey solutions for ACCESS participants.

Risk Selection and Performance Measurement

While CMS uses risk adjustment to account for baseline patient characteristics, concerns remain about potential gaming through favorable patient selection. Organizations might preferentially enroll patients most likely to achieve outcome targets while avoiding more challenging cases. CMS's minimum performance thresholds that increase annually create countervailing pressure, but this tension between performance accountability and equitable access will require ongoing monitoring.⁶

The publication of risk-adjusted outcomes should help identify organizations that achieve excellent results with complex patient populations, but the adequacy of risk adjustment methodologies will be critical. Pharmaceutical companies participating in or partnering with ACCESS organizations should monitor risk adjustment approaches and advocate for methodologies that appropriately account for disease severity, social determinants of health, and other factors beyond organizational control.

Organizational Culture and Change Management

Perhaps the most fundamental challenge is organizational culture. ACCESS requires a fundamentally different operating model than traditional fee-for-service practice. Success demands continuous patient engagement, proactive outreach, population health management, and systematic process improvement—capabilities more common in value-based care organizations than traditional medical practices.⁶

For established healthcare organizations considering ACCESS participation, this may require significant cultural transformation. Leadership must articulate a clear vision for value-based care, invest in workforce training and development, redesign clinical workflows around population health outcomes, and accept that some traditional revenue streams may decline as care becomes more efficient.

Future Directions and Model Evolution

Potential Expansion to Additional Conditions

While ACCESS launches with four clinical tracks, the model's architecture supports expansion to additional chronic conditions. Potential candidates include asthma and chronic obstructive pulmonary disease, heart failure, cancer survivorship care, and neurological conditions like Parkinson's disease or multiple sclerosis. Each of these conditions affects substantial Medicare populations, generates significant costs, and could benefit from technology-enabled continuous management.

The initial four tracks were likely selected for their combination of prevalence, amenability to technology-enabled intervention, and availability of validated outcome measures. As the model matures and demonstrates success, expect CMS to expand to additional disease categories, creating growing opportunities for specialized digital health solutions.

Integration with Other CMS Innovation Models

ACCESS exists within a broader portfolio of CMS Innovation Center initiatives. Potential synergies exist with Primary Care First models, which emphasize comprehensive primary care with outcome-based payments; Accountable Care Organizations, which could contract with ACCESS participants to manage specific conditions; and the Kidney Care Choices model, which focuses on kidney disease progression and dialysis prevention. Strategic thinkers should consider how ACCESS participation could complement engagement with these other models.

Commercial and Medicaid Adoption

If ACCESS demonstrates that outcome-aligned payments for technology-enabled chronic care improve health outcomes while reducing total costs, expect rapid adoption by commercial payers and Medicaid programs. Commercial insurers face many of the same challenges as Medicare in reimbursing digital health innovations and would benefit from a proven payment framework. Medicaid programs, which serve populations with high chronic disease burden and substantial social barriers to care, could particularly benefit from technology-enabled continuous management models.

Conclusion

The CMS ACCESS Model represents the most significant shift in Medicare chronic disease payment policy in decades. By introducing outcome-aligned payments that reward measurable health improvements rather than service volume, ACCESS removes longstanding barriers to digital health adoption while creating direct pathways to sustainable reimbursement. The model's emphasis on prevention, care coordination, transparent performance measurement, and technology-enabled continuous engagement aligns with the fundamental principles of value-based care that have long been discussed but rarely fully implemented.

For pharmaceutical companies with digital health portfolios focused on cardiovascular, renal, metabolic, musculoskeletal, or behavioral health conditions, ACCESS creates unprecedented opportunities. The model provides a framework for demonstrating value through real-world outcomes, generating evidence in actual clinical practice, achieving sustainable reimbursement independent of pharmaceutical sales, and scaling successful interventions across multiple payer types.

Success in this new landscape will require more than innovative technology. Organizations must build robust data integration capabilities, develop expertise in population health management, cultivate cultures focused on continuous improvement, and demonstrate sustained commitment to outcome accountability. The winners in the ACCESS era will be those who view technology not as a product to sell but as an enabler of fundamentally better chronic disease care.

As CMS begins accepting applications in January 2026, the time for strategic planning is now. Organizations should evaluate their capabilities, identify partnership opportunities, begin building necessary infrastructure, and position themselves to participate in what may become the dominant model for chronic disease management in Medicare and beyond. The transformation of healthcare payment toward value-based care has been promised for decades—ACCESS may finally make it real.